CTRP Accrual Users Guide

Attach_7_CTRP-Accrual-UsersGuide.pdf

The Clinical Trials Reporting Program (CTRP) Database (NCI)

CTRP Accrual Users Guide

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1. NCI CTRP Accrual User's Guide v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 Contents - NCI CTRP Accrual User's Guide v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 Getting Started with Accrual v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2 Searching for and Selecting Your Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3 Working with Complete Trial Accruals v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4 Working with Abbreviated and Other Trial Accruals v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5 Working with Non-Interventional Trial Accruals v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.6 Working with Prior Accrual Submission Records v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7 Submitting Accrual Data Batch Files v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.8 Downloading Accrual Count Reports v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.9 Managing Your CTRP Account v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.10 Working with Accrual Tables and Search Results v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.11 Accrual Data Elements for Complete Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.12 Accrual Data Elements for Abbreviated Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.13 Comparison of CTRP and CDUS Accrual Data Elements v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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NCI CTRP Accrual User's Guide v4.3
NCI CTRP Accrual User's Guide v4.3
Contents of this Page
About this Guide
Audience
Navigating Accrual
Application Support

Accural Links
NCI CTRP Accrual
Overview of NCI CTRP
Applications
Accrual Batch File Tool
(Excel)

CTRP Resources
CTRP Issue Tracker
(JIRA) (Login required)
CTRP Website
ClinicalTrials.gov (http://
clinicaltrials.gov)
PRS and U.S. Public
Law 110-85 (http://prsin
fo.clinicaltrials.gov/fdaa
a.html)
Dictionary of cancer
terms
Terminology resources
You can print and export wiki pages
You can send this page to a printer or convert it to a PDF, HTML, or Word document. See Printing and Exporting Wiki Pages.

Application Support
If you have problems with the program or have suggestions for any of the CTRP User's Guides, contact the NCI Clinical Trials
Reporting Office using the information and guidelines provided in the Application Support section below.

About this Guide
This guide provides instructions for using NCI Clinical Trials Reporting Program (CTRP) Accrual to report accrual data for clinical studies
registered with the CTRP.

Audience
This guide is designed for authorized users who want to view or submit accrual data for specific trials and sites.

Navigating Accrual
Using the Toolbar
The toolbar runs across the top of each page and remains in place even if you scroll down the page. Menus on the toolbar provide access to
sub-menus whenever an arrow appears next to a menu name. Otherwise, clicking a menu item launches another web page.

Your name appears on the upper right corner of the page and the associated arrow provides access to the My Account page.
You can also sign out of the application from this sub-menu.

Getting Help
Help is available on both a field and page level. More comprehensive information is available in this User's Guide.
A Help icon

is available beside most fields in which you enter trial data.

How to Display Instructions/Information for a Field
Hover your cursor over the Help icon

next to it.

Online Help provides instruction/information for the topic you are working on.
How to Launch Online Help
On the right side of the toolbar, click Help.

How to access the User's Guide

On the toolbar, click Quick Links > Accrual User's Guide.

Changing the Color Scheme
You can choose a site-wide color scheme to suit your preferences.
How to Change the Color Scheme
1. On the top right corner of any page, click (User Name) > My Account.

2. Scroll to the bottom of the My Account window and select one of the five color schemes.

Application Support
Email: ncicbiit@mail.nih.gov
Call: 240-276-5541

When submitting support requests, please include:
Your contact information, including your telephone number
The name of the application/tool you are using
The URL if it is a Web-based application
A description of the problem and steps to recreate it
The text of any error messages you have received

Contacting the Clinical Trials Reporting Office
If you have questions or comments regarding this document, or other CTRP topics, contact the Clinical Trials Reporting Office (CTRO) at ncictro
@mail.nih.gov.

Contents - NCI CTRP Accrual User's Guide v4.3

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Getting Started with Accrual v4.3
Getting Started with Accrual v4.3

Topic Links
About Accrual
What's New in this Release of
Accrual
Prerequisites
Requesting Permission to Submit
Accrual Data
How to Request Access to
Your Studies

Tested Browsers
This version of the Registration and
Accrual applications have been tested
on Internet Explorer v10.
This version of the Protocol Abstraction
application and the Person and
Organization Curation application have
been tested on Internet Explorer v10
and the latest version of Firefox.
CTRP should work with all recent browsers.
However, please note that it has been tested
only on the browsers listed. If you discover a
browser related issue in a non-tested browser,
please submit it to Application Support at ncicbii
t@mail.nih.gov. Please include your browser
version, OS version, and, when possible, a
screen shot illustrating the difficulty.
This section introduces you to NCI Clinical Trials Reporting Program (CTRP) Accrual, and provides instructions for creating an account and
logging in to the system.

About Accrual
Accrual provides authorized members of the cancer research community with access to cancer clinical trials registered with the CTRP for the
purpose of reporting accrual data for clinical studies. It enables users to enter patient (study subject) demographic data for Complete trials and
patient accrual counts for Abbreviated trials that have been abstracted (i.e., have reached the Abstracted status) as well as those that have been
approved or withdrawn. These trials are categorized as follows:
Complete Trials:
National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism
supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems.
Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing
scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center
investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting
results.
It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial
should clearly be the intellectual product of the center investigator.
This category may also include:
Institutional studies authored and implemented by investigators at another Center in which your Center is
participating.
Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and
externally peer-reviewed studies should be listed with those categories, not as Institutional studies.)
Abbreviated Trials:
Industrial/Other: A pharmaceutical company controls the design and implementation of these clinical research studies.

What's New in this Release of Accrual
This version of the CTRP Accrual application has the following new features and improvements:
Issue Type

Development
#

Documentation
#

Description

Link to
Content in
this User
Guide

Comments

Task

PO-9352

Add information to Accrual User Guide to cover ICD10
codes for Disease not specified and Healthy Volunteer

Searching for
Diseases and
Sites

Bug

PO-9213

Issues with RESTful fine-grained accrual service not
applying rule that lets SuAbstractors submit accruals for
CTEP and DCP trials

Improvement PO-9114

PO-9131

Accrual REST Service needs to support CDUS batch file
submission for asynchronous processing.

Task

Run script to remove accruals for specified OHSU Knight
Cancer Center trials

Improvement PO-9095

PO-9131

Allow use of DCP ID with REST Accrual service

Task

PO-9010

Create a report showing subject records submitted by
users with incorrect accrual submission privileges

Bug

PO-9002

Major: CTRO #41179: Accrual Issue - NCI-2011-03659

Task

PO-8989

Add a checklist in Accrual Users Guide showing
preconditions for submitting accruals to trials

Prerequisites

Bug

PO-8980

Accrual: If Disease code is not Valid for a given Disease
code System it shall give a proper message

New Feature

PO-8951

CTRP 4.3 Documentation

(Refer to other
links in this
column.)

Bug

PO-8939

Accrual REST Service is producing a confusing error
message when study subject's disease coding system
does not match that of trial

Bug

PO-7153

Accruals - check the COUNTRY table for country instead
of regulatory authority for UI and Batch

PO-9097

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Prerequisites
Before you can submit accrual data to a given trial in CTRP, the system requires the following:
The trial must be registered in CTRP. For information and instructions, refer to Getting Started with Registration v4.3 in the NCI CTRP
Registration User's Guide.
Once the trial has been registered, it must be fully abstracted. This work is done by the CTRO. Trial owners can help by responding to
their requests for information in a timely manner.
You must have a CTRP user account. There are two ways to register for a CTRP account, as follows:
Via your email address. If you are a new user and you do not have an NCI account, you can request one via your email
address using the CTRP account creation feature. For instructions, refer to Creating New CTRP Accounts via Email in the NCI
CTRP Registration User's Guide.
Via your NCI credentials. If you are a new user and you have an NCI account, create a CTRP account via your NCI credentials
using the CTRP account feature. For instructions, refer to Creating New CTRP Accounts Using NIH or NCI Credentials in the
NCI CTRP Registration User's Guide.
Once you have obtained a CTRP User Account, request authorization to access your trials. For instructions, refer to Requesting
Permission to Submit Accrual Data, below.
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Requesting Permission to Submit Accrual Data
In order to view and submit accrual data for your trials, you must be a registered CTRP user. Additionally, you must request permission to submit
accrual data for your trials.
If you do not have a CTRP account, register for one via the CTRP account feature. For instructions, see Creating NCI CTRP User
Accounts.
Your administrator can grant you permission to submit accrual data by assigning you one of the following roles:
Trial submitter. Submits accrual data on a trial-by-trial basis. (Only Super Abstractors can submit accrual data for CTEP and DCP trials.)

Site Accrual submitter. Submits accrual data for all eligible trials (institutional and externally peer-reviewed) in the submitter's
organization that are currently registered in the CTRP, and for trials that will be registered in the CTRP in the future.
The Site Accrual Submitter's affiliated organization must be a lead or participating site.
Organization Family Accrual Submitter. Submits accrual data for all eligible trials that are currently registered in the CTRP, and for
trials that will be registered in the CTRP in the future.
The Organization Family Accrual Submitter's affiliated organization or any of the organization's family members must be a lead
or participating site.

How to Request Access to Your Studies
Contact your organization's site administrator to request accrual access for your studies. Site Administrators manage Accrual access via the
Registration application. Instructions for Site Administrators are in Assigning and Unassigning Access to Accrual in the NCI CTRP Registration
User's Guide.
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Searching for and Selecting Your Trials v4.3
Searching for and Selecting Your Trials v4.3
Topic Links
Searching for Trials in Accrual
Viewing Trial Details in Accrual
Selecting Listed Trials in Accrual
This section describes how to use Accrual to search for and select the trials for which you want to provide new or updated accrual data.

Searching for Trials in Accrual
The list of trials to which you have been granted access is displayed automatically when you log in to Accrual. For information on navigating and
working with lists of trials, see Working with Accrual Tables and Search Results .

Accessing your trials
If you do not see any studies listed when you log in, you may not have been granted access to submit accrual data for any trials yet. Be
sure to request access from your organization's administrator as explained in Requesting Permission to Submit Accrual Data .
How to Search For Trials
1.

1. On the toolbar, click Trial Search.
The Trial Search page appears.

2. Enter the NCI Trial Number, ClinicalTrials.gov Identifier, or Official Title in the fields provided.
3. Press ENTER or click Search Trials.
You can search for a trial by one or more criteria, or you can list all trials to which you have been granted access by leaving all
of the search criteria fields blank. If you search by the Official Title, use keywords and wildcards rather than phrases or the
entire title. Doing so minimizes the potential for excluding any titles with misspellings or slightly different phrasing from the
search results. For example, a Phase II trial may have been recorded as a Phase 2 trial.
The Search Trials page refreshes and displays the trial(s) you searched for.
DCP and CTEP Trials are restricted
DCP and CTEP trials are listed among the results for users affiliated with the trial's lead organization and Super Abstractors
only. However, only Super Abstractors can edit the accrual records.

Each trial is listed by NCI trial identifier, official title, current trial status, trial type, and Accrual disease terminology. Trial statuses are
defined in the table below.
In Review - Trial is currently under IRB review.
Withdrawn - Trial has been withdrawn from development and review prior to enrollment of the first participant.
Approved - Trial has been approved, but is not yet recruiting or enrolling participants.
Active - Trial is open for accrual and enrollment.
Enrolling by Invitation - Participants are being (or will be) selected from a predetermined population.
Temporarily Closed to Accrual - Participant recruitment or enrollment has been halted prematurely but may resume.
Participants already on trial continue to receive intervention.

Temporarily Closed to Accrual and Intervention - Participant recruitment or enrollment has been halted prematurely but may
resume. Participants already on trial do not receive intervention.
Closed to Accrual - Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive
treatment and/or examination).
Closed to Accrual and Intervention - Trial has been closed to participant accrual. Participants already on trial do not receive
treatment, but continue to be monitored for endpoints such as long-term survival.
Administratively Complete - Participant recruitment or enrollment has been halted prematurely (for example, due to poor
accrual, insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the trial do not receive further
treatment or examination.
Complete - Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and
participants are no longer monitored for trial endpoints (i.e., last patient's visit has occurred). The trial has met its objectives.
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Viewing Trial Details in Accrual
To view details for a given clinical trial record, click its associated NCI Trial Identifier link. See Selecting Listed Trials in Accrual .
Return to top of page

Selecting Listed Trials in Accrual
How to Select Trials on the List of Trials Page
1. Navigate to the trial you want to work with by following the instructions in Working with Accrual Tables and Search Results .
2. To view a given trial, click its corresponding NCI Trial Identifier link.

Accrual displays the Trial Search (top) and the List of Trials (bottom) sections on the first page automatically after you have logged in. The List of
Trials contains the trials to which you have been granted access.
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Working with Complete Trial Accruals v4.3
Working with Complete Trial Accruals v4.3

Topic Links
Adding Study Subjects
Searching for Diseases and Sites
Searching for Diseases
from the Toolbar
Selecting Diseases for
Study Subject Records
Selecting Sites for Study
Subject Records Using
ICD-O-3 Codes
Searching for Study Subjects
Reviewing Study Subject Records

This section describes how to search for, add, update, and delete study subjects associated with Complete clinical trials. For information about Ab
breviated trials, see Working With Abbreviated Trial Accruals .
When working with study subject records, use either ICD-9, ICD-O-3, ICD-10, or SDC code terminology, regardless of your submission
method (via the web application or batch upload); do not use different codes for the same record.

Adding Study Subjects
You can add one or more study subject accrual records for any trial to which you have been granted access.
1

See Requesting Permission to Submit Accrual Data .
Study subject records include demographic data as well as the disease name.
How to Add Study Subject Records
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
The Search Study Subject page appears.

2. Click Add New Study Subject.
The Add Study Subject page appears.

3. Enter the appropriate demographic information in the text fields and drop-down lists. The following table describes the fields. An asterisk
(*) indicates a required field. For a list of valid values and formats for each field, see Accrual Data Elements for Complete Trials .
Descriptions and instructions for study subject demographic data fields
Study Subject Information

Instruction/Description

Study Subject ID*

Enter the unique Patient ID as per the lead organization or the study site where the subject is
registered.

Study Subject Birth Date*

Enter the subject's month and year of birth in the format MM/YYYY .

Study Subject Gender*

Select the subject’s gender. If gender information is not available, select Unknown.

Study Subject Race*

Select one or more values for race.
To select multiple races, select one race, and then press and hold the CTRL/CMD key as
you select the other(s).

Study Subject Ethnicity*

Select a value for ethnicity.

Study Subject Country*

Select the subject’s country of origin.

Study Subject Zip Code

Enter the subject’s Zip Code if known. This field is mandatory if the country of origin is United States.

Registration Date*

Enter the date that the subject was registered for the trial.

Study Subject Method of
Payment

For United States study subjects only, select the appropriate payment method.

Site*

Click Look Up, and follow the instructions in Selecting Sites for Study Subject Records Using ICD-O-3
Codes.
Mandatory for ICD-O-3 trials unless you record a CD-O-3 Disease Code. Optionally, record both Site
and Disease codes.
Site codes are available at http://training.seer.cancer.gov/head-neck/abstract-code-stage/codes.html.

Disease*

Click Look Up, and follow the instructions in Selecting Diseases for Study Subject Records.
Mandatory for ICD-9 and SDC trials; and for ICD-O-3 trials unless you record a CD-O-3 Site Code.
Use Histology codes when C codes are not available (for example, for Multiple Myeloma, NHL,
Leukemia).

Participating Site*

Select the appropriate site from the drop-down list.

4. Click Save.
The study subject record appears in the List of Study Subjects.
You can submit accrual data to the NCI CTEP's Clinical Data Update System (CDUS) on a quarterly basis (i.e., December 31, March
31, June 30) up to 30 days following the end of the quarter.
For Complete trials, lead organizations report all subjects accrued for the trial (both in the lead organization and in all participating
sites). For Abbreviated trials, each participating site reports the number of its own accruals (accrual count) only.
--1 If your organization currently submits subject accrual information for studies to CTEP or DCP via the CDUS system, continue to report subject

accrual information via CDUS. The NCI will manage the transfer of subject accrual data for CDUS trials internally. Otherwise, submit your
organization's subject accrual data to CTRP.
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Searching for Diseases and Sites
You can search for diseases directly from the toolbar or while adding or entering study subject records. Refer to the instructions below.
Searching for Diseases from the Toolbar
Selecting Diseases for Study Subject Records
Selecting Sites for Study Subject Records Using ICD-O-3 Codes
Return to top of page

Searching for Diseases from the Toolbar
You can search for diseases by name or code directly from the toolbar. For instructions for selecting diseases, for example, when you add or edit
a study subject record, see Selecting Diseases for Study Subject Records.
How to Search for Diseases from the Toolbar
1. On the toolbar, click Disease Search.
The Search Diseases window appears.

2. In the Disease Name field, type part or all of the disease/condition or site being studied, or, in the Disease Code field, enter part or all of
the disease or site code.
Search tips
Enter as many letters of the disease/condition name as possible to reduce the number of search results. The system adds
wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (%)
between characters of the string as necessary.

The following table lists codes for disease not specified, healthy volunteer, and donors:
Category

ICD-10

SDC

ICD9

Disease not specified

Z1000

80000001

V100

Healthy volunteer

Z76.3

80000000

V99

Donors

Z52.9

(NA)

3. From the Disease Code System drop-down list, select either ICD-9 (International Classification of Diseases, 9th Revision), ICD-10 (Inter
national Classification of Diseases, 10th Revision) ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition) or SDC (C
TEP's Simplified Disease Classification).
4. Press Enter, or click Search.
The system searches for the disease/condition or site in the database, and returns a list of results.

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Selecting Diseases for Study Subject Records
The procedure for searching for diseases while adding or entering study subject records is the same as that for searching for them using the
Disease Search menu. The difference is that in addition to searching for diseases, you can select them for association with the study subject
record.
How to Search for and Select Diseases
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
2. At the bottom of the Search Study Subject section, click Add New Study Subject.
The Add Study Subject page appears.

3. To assign a disease to the study subject, next to the Disease field, click Look Up.
The Search Diseases window appears.

4. In the Disease Name field, type part or all of the disease/condition or site being studied, or, in the Disease Code field, enter part or all of
the disease or site code.
Search tips
Type as many letters of the disease/condition or site name as possible to reduce the number of search results. The system
adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard
symbols (%) between characters of the string as necessary.

The following table lists codes for disease not specified, healthy volunteer, and donors:
Category

ICD-10

SDC

ICD9

Disease not specified

Z1000

80000001

V100

Healthy volunteer

Z76.3

80000000

V99

Donors

Z52.9

(NA)

5. From the Disease Code System drop-down list, select either ICD-9 (International Classification of Diseases, 9th Revision), ICD-10 (Inter
national Classification of Diseases, 10th Revision) ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition) or SDC (C
TEP's Simplified Disease Classification).
If the trial has at least one existing study subject record, the Disease Code System displays only the code system associated
with the existing record(s). This ensures that all subjects in the study share the same terminology.
6. Press Enter, or click Search.
The system searches for the disease/condition in the database, and returns a list of results.

7. Navigate to the disease/condition being studied, and click Select. See Working With Accrual Tables and Search Results .
The system populates the Disease field for you.
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Selecting Sites for Study Subject Records Using ICD-O-3 Codes
For trials that use ICD-O-3 trials, select a site to associate with a study subject. The site code is optional if you associate(ed) a disease code with
the subject.
How to Search for Sites
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
2. At the bottom of the Search Study Subject section, click Add New Study Subject.
The Add Study Subject page appears.
3. To assign a site to the study subject, next to the Site field, click Look Up.
The Search Sites window appears.

4. In the Site Name field, type part or all of the site being studied. The Site Code System, ICD-O-3 (International Classification of Diseases
for Oncology, 3rd Edition) is preselected for you.
Search tips
Type as many letters of the site name as possible to reduce the number of search results. The system adds wildcards on both
sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (%) between
characters of the string as necessary.
5. Press Enter, or click Search.
The system searches for the site in the database and returns a list of results.

6. Navigate to the site being studied, and click Select. See Working with Accrual Tables and Search Results .
The system populates the Site field for you.
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Searching for Study Subjects
You can search for a particular study subject record using any combination of the following three criteria:

Study Subject ID
Participating Site
Birth Date
You must select a trial before you can search for study subjects. For instructions, see Searching for and Selecting Your Trials .
How to Search for Study Subjects
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
The Search Study Subject page appears.

2. Type or select your search criteria from one or more of the fields provided.
You can list all study subjects
You can search for a trial by one or more criteria, or you can list all subjects associated with trials to which you have been
granted access by leaving all of the search criteria fields blank.
3. Click Search.
Your search results are displayed in the List of Study Subjects section of the page. The list is sorted by Study Subject ID and includes the
following information:
Study Subject ID
Date on which the subject was registered at a given participating site
The Participating Site where this subject is registered
Date/Time when this record was updated in CTRP

4. To delete a study subject record, click the Delete icon (trash can).
5. To edit a study subject record, click the Edit icon (pencil), and follow the instructions in Adding Study Subjects .
Return to top of page

Reviewing Study Subject Records
CTRP Accrual site enables you to review the collection of non PII (Personally Identifiable Information) study subject data associated with a
particular non-industrial trial registered with the CTRP.
How to Review Study Subject Records
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
The Accrual Submissions page displays any accrual records that may have been submitted previously.

2. Click the Study Subject ID of interest.
The Study Subject page displays the study subject's demographic details recorded to date as well as information about the record itself.

3. To return to the accrual record, click Back.
4. To change the study subject record, click Edit, and follow the instructions in Adding Study Subjects .
Return to top of page

Working with Abbreviated and Other Trial Accruals v4.3
Working with Abbreviated and Other Trial Accruals v4.3
This section describes how to record, update, and delete the total number of accruals (accrual count) associated with Abbreviated and Other clinic
al trials. For instructions for submitting accrual data for Complete trials, see Working with Complete Trial Accruals .
Because pharmaceutical companies do not enter their data into CTRP, each participating site on an Abbreviated trial must enter its own accrual
count into CTRP. For Abbreviated trials, the lead organization is the pharmaceutical company running the trial.
Study subject demographic data
Abbreviated and Other study records include the total number (count) of study subjects accrued per site on a given trial; full patient
demographic data is not recorded.

When working with study subject records, use either ICD-9, ICD-10, ICD-O-3, or SDC code terminology, regardless of your submission
method (via the web application or batch upload); do not use different codes for the same record.

Recording Participating Site Accrual Counts
You can record, update, or delete the number of patients that your site accrued to date per Abbreviated or Other trial.
You can record/update/delete accrual counts only if you are a registered member of one or more of the Participating Sites or you are
affiliated with the site for a given trial.

The CTRP system records each COUNT you submit as the total (cumulative) number of subjects accrued to date, no matter how frequently you
submit them. That is, the system does not add the count you enter here (or by the batch submission process) to previously-recorded counts.
For example, if you submit an initial 10 subjects in December, the CTRP system records the counts you submit the following March per the table
below.

If the Number of
Subjects You
Submit in
December is
This...

...and the Number of
Subjects You Submit
the following March
is This...

...Then the
number of
Subjects CTRP
Records is
This:

Explanation

CTRP records the most recent total COUNT.

CTRP records the most recent total COUNT. It does not add your latest
submission to your previous count. If you had intended to record a count
of 25 (10 + 15), you would have had to submit a count of 25 in March.

CTRP records the most recent total COUNT. It does not add/subtract
your latest submission from your previous count. If you had intended to
record a count of 10 (10 + 0), you would have had to submit a count of 10
in March.

This holds true whether you submit your counts by day, quarter, or year. The count includes the numbers of subjects you submit by the batch file
process.
For example,
If You
Submit
Your
Count on
This
Date...

And the
Number of
Subjects
You Submit
is This...

...Then the
number of
Subjects
CTRP
Records is
This:

Explanation

March 30

CTRP records the most recent total COUNT.

March 31

CTRP records the most recent total COUNT. It does not add your latest submission to your
previous count. If you had intended to record a count of 25 (10 + 15), you would have had to
submit a count of 25.

CTRP records the most recent total COUNT. It does not add the number of subjects you
submit in the user interface to the number you submit via the batch process. If you had
intended to record a count of 30 (15 + 15), you would have had to submit a count of 30 either
in the batch file or the user interface.

March 31

15 via the
user
interface
15 via the
batch file
process

Do not submit a count that is less than the previously submitted count unless the previous submission was an error
If you submit a new count that is less than the CTRP system previously recorded, the CTRP system considers your previous
submission an error. Do not submit a lesser value unless you are intentionally correcting/deleting accruals. For example, if the CTRP
system previously recorded 100 subjects, and you submit 85, the CTRP system records 85.
How to Record and Update Site Subject Accrual Counts

1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and
clicking the corresponding NCI Trial Identifier link.
The Participating Site Subject Accrual Count page appears.

2. In the Number (#) of Subjects Enrolled field, enter the number of subjects currently enrolled in studies at your site.
3. In the Actions column of the record you want to update, click the Save icon.
A message at the top of the table indicates that the record has been updated successfully.
How to Delete Site Subject Accrual Counts
1. In the Actions column of the record you want to delete, click the Delete icon (trash can).
2. Click OK on the pop-up message to confirm that you want to delete the accrual count(s).
All the accrual counts for the site(s) you selected are deleted.

Working with Non-Interventional Trial Accruals v4.3
Working with Non-Interventional Trial Accruals v4.3
Topic Links
Submitting Accruals at the Subject
Level for Non-Interventional Trials
Submitting Accruals at the
Summary Level for
Non-Interventional Trials
This section describes how to submit and update accruals for non-interventional trials. Participating sites enter accrual data at the summary level
by default. The summary level consists of the accrual count per site only. However, if there are no accrual records for your trial in CTRP currently,
you can enter demographic accrual information at the study subject, or patient level. Once a participating site has recorded accruals, you can no
longer choose which level to use; you must enter subsequent accrual data at the same level.

Submitting Accruals at the Subject Level for Non-Interventional Trials
How to Submit Accruals at the Subject Level for Non-Interventional Trials
1. Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual .
The Search Study Subject/List of Study Subjects page appears. If no accrual counts have been recorded for this trial previously, you can
elect to submit your accrual data at the summary level instead of the subject level.

2. Optionally, to record accrual counts at the summary level, click Switch to Summary Level Accrual, and follow the instructions in Submit
ting Accruals at the Summary Level . Otherwise, continue with the next steps.
3. Click Add New Study Subject.
The Add Study Subject page appears.

4. Enter the appropriate demographic information in the text fields and select items from drop-down lists. The following table describes the
fields. An asterisk (*) indicates a required field. For a list of valid values and formats for each field, see Accrual Data Elements for
Complete Trials .
Descriptions and instructions for study subject demographic data fields
Study Subject Information

Instruction/Description

Study Subject ID*

Enter the unique Patient ID as per the lead organization or the study site where the subject is
registered.

Study Subject Birth Date*

Enter the subject's month and year of birth in the format MM/YYYY .

Study Subject Gender*

Select the subject’s gender. If gender information is not available, select Unknown.

Study Subject Race*

Select one or more values for race.
To select multiple races, select one race, and then press and hold the CTRL/CMD key as
you select the other(s).

Study Subject Ethnicity*

Select a value for ethnicity.

Study Subject Country*

Select the subject’s country of origin.

Study Subject Zip Code

Enter the subject’s Zip Code if known. This field is mandatory if the country of origin is United States.

Registration Date*

Enter the date that the subject was registered for the trial.

Study Subject Method of
Payment

For United States study subjects only, select the appropriate payment method.

Site*

Disease*

Participating Site*

Select the appropriate site from the drop-down list.

5. Click Save.
The study subject record appears in the List of Study Subjects.
You can submit accrual data to the NCI CTEP's Clinical Data Update System (CDUS) on a quarterly basis (i.e., December 31, March
31, June 30) up to 30 days following the end of the quarter.
For Complete trials, lead organizations report all subjects accrued for the trial (both in the lead organization and in all participating
sites). For Abbreviated trials, each participating site reports the number of its own accruals (accrual count) only.
Return to top of page

Submitting Accruals at the Summary Level for Non-Interventional Trials
Each participating site can submit/update the number of patients accrued to date per trial.
How to Submit Accruals at the Summary Level for Non-Interventional Trials
1. Locate the trial of interest by following the instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual .
2. Click the trial's NCI Trial Identifier.
The Participating Site Subject Accrual Count page appears. If no accrual counts have been recorded for this trial previously, you can
elect to submit your accrual data at the subject level instead of the summary level.

3. Optionally, to record accrual counts at the subject level, click Switch to Subject Level Accrual, and follow the instructions in Submitting
Accruals at the Subject Level for Non-Interventional Trials . Otherwise, continue with the next steps.
4. In the Number of Subjects Enrolled field(s), enter the number of subjects currently enrolled in this study at your site.
5. To clear all the entries, click Reset. Otherwise, be sure to c lick the Save icon for each site.
A message at the top of the table indicates that the record has been updated successfully. Because you submitted accrual counts at the
summary level, you must continue to record accruals at this level in the future.

Return to top of page

Working with Prior Accrual Submission Records v4.3
Working with Prior Accrual Submission Records v4.3
Topic Links
Accessing Trials with Prior Accruals
Records
Reviewing and Updating Prior
Accrual Submissions
Downloading Accrual Batch Data
Files
The CTRP system maintains records of all prior accrual submissions on a trial-by-trial basis. Additionally, the system records the method that was
used to submit the information to the CTRP. Those methods include the Accrual user interface (UI), single submissions and batch uploads, and
the Accrual service.
The Accruals Historical Submissions Page allows you to do the following:
List all of your organization's previous accrual submissions
Limit the list of trials displayed to a particular submission date or a range of dates
Access the accrual records (trial counts and subject details) for a given trial, allowing you to modify existing data and add new accrual
records
Download accrual batch upload TXT files previously submitted
Download accrual batch upload Zip files
Only the user who submitted the batch file can download the Zip files.

Accessing Trials with Prior Accruals Records
The system displays accrual records according to your affiliation with organizations and the role organizations play in any given trial. The following
tables show the relationships between you, your affiliated organization, and the records available to you.

Complete Trials Category:
User Access to Accruals by Trial

Affiliated
Organization
Role

Submissions View

Access to trial for own site

Participating Site

Submissions for own site only

Access to trial for own site and other sites that are members of the
organization family of user's affiliated organization

Participating Site

Site submissions and accruals submitted by
organization family member sites

Access to trial for own site and other sites that are not members of the
organization family of user's affiliated organization

Participating Site

Submissions for own site only

Access to a given trial

Lead
Organization

All accrual submissions for the trial by any and
all participating sites

User Access to Accruals by Trial

Affiliated
Organization
Role

Submissions View

Access to trial for own site

Participating Site

Submissions for that trial only

Access to trial for own site and other sites that are members of the
organization family of user's affiliated organization

Participating Site

Site submissions and accruals submitted by
organization family member sites

Access to trial for own site and other sites that are not members of the
organization family of user's affiliated organization

Participating Site

Submissions for that trial only

Abbreviated Trials Category:

All trials to which you have been granted access, per the rules described in the tables above, are listed automatically when you open the Prior
Submissions page . Optionally, you can limit the list of prior submissions that are displayed to a given date or range of dates.
The system displays the following information for each trial:
Trial ID. Trial identification given to the trial when it was registered with the CTRP
Files/Subject. Links to the following accrual details:
Batch file (when applicable)
Trial subjects
Trial counts
Submission Method. Mechanism used to submit accrual data, i.e., via Accrual (web application), batch uploads, or the Accrual service
Submission Date/Time. Date the accrual record was either added or modified in CTRP
Submitted by. Name of the registered CTRP user who submitted the accrual information
Submission Accepted?. Indicates whether or not the submission was processed successfully (Yes), or there were errors in the
submission (No). Immediately after submitting new or updated accrual data, the system sends you an email message that indicates
whether the submission passed or failed. If the processing failed, the email message explains the nature of the errors.
Export Options
You can export historical accrual submission records as listed to Excel spreadsheets and/or CSV (comma-separated values) files.
Return to top of page

Reviewing and Updating Prior Accrual Submissions
For Complete trials, the system displays all subject records that have been previously submitted, whether a subject record was added, modified,
or deleted. Each study subject is listed with its associated trial record individually.
How to Review and Modify Prior Complete Trial Accrual Submissions
1. On the toolbar, click Prior Submissions.
All of your organization's prior accrual submission records to which you have been granted Accrual access are listed automatically.

2. Optionally, to limit the list of submissions to a date, or range of dates, in the From field, select or enter the first date of the range or the
exact date of the submission you are searching for. In the To field, enter the last date of the range. Then click Search.
You can sort and filter Submission Records
To filter and sort the list of prior submissions, see Working with Accrual Tables and Search Results.
3. Optionally, to export the historical accrual submission records, scroll to the bottom of the list of records, click CSV to download the
records as a comma-separated-value text file, or Excel to download the records as an Excel spreadsheet. Follow your browser/operating
system instructions to view or save the document.
4. To view a subject's demographic and submission data, in the File/Subject column, select the Study Subject ID link.
The View Study Subject page displays all the data recorded to date.

5. To update a subject's demographic data, click the Edit icon (pencil).
Return to top of page

Downloading Accrual Batch Data Files
Only the ZIP file submitter and Super Abstractors can download ZIP files from the Prior Submissions page.
From the Prior Submissions page, you can download previously submitted accrual files (.txt or .zip) that were uploaded via the Batch Upload featu
re.
All trials to which you have been granted access, per the rules described in Accessing Trials with Prior Accruals Records , are listed automatically
when you open the Prior Submissions page . Optionally, you can limit the list of prior submissions that are displayed to a given date or range of
dates.
How to Download Submitted Subject Accrual Files
1.

1. On the toolbar, click Prior Submissions.
All trials to which you have been granted Accrual access that have existing subject accrual records are listed automatically.

Submitting Accrual Data Batch Files v4.3
Submitting Accrual Data Batch Files v4.3

Topic Links
Preparing CTRP Accrual Batch
Files
Key Facts about CTRP Accrual
Batch Files
An Introduction to Batch
Files
File Naming Conventions
Accrual Batch File Data for
Complete Trials
Complete Trial Tables
Complete Trial Data
Elements and Field
Formats
Complete Trial Data
Record Formats
Complete Trial Record
Data Field Requirements
Accrual Data
Elements Table
with
CTRP-Accepted
Values
Accrual Data
Elements Table
with
CDUS-Accepted
Values
Complete Trial Record
Data Field Formats
Accrual Batch File Data for
Abbreviated Trials
Abbreviated Trial Tables
Abbreviated Trial Data
Record Formats
Abbreviated Trial Record
Data Field Requirements
Accrual Data
Elements with
CTRP-Accepted
Values
Accrual Data
Elements with
CDUS-Accepted
Values
Abbreviated Trial Data
Field Requirements
Uploading Accrual Batch Files
Resolving Accrual Batch File
Upload Errors

This section provides instructions for uploading batch files via the Accrual user interface. It also provides instructions for resolving any errors that
may have occurred during the import process.
The batch upload feature enables you to submit accrual data for multiple subjects and one or more trials at a time rather than having to enter data
for each subject/study individually.
Once you have been granted permission to submit accrual data, you can upload accrual data files singly as plain text files or in multiple
text files that have been compressed into a Zip file. See Preparing Accrual Batch Files for detailed instructions.
Only Super Abstractors can upload accrual data batch files for CTEP and DCP trials. For these trials, the system assigns default patient disease
codes if the disease code was not included in the batch file. The following table maps disease code systems to their default codes.
Disease Code System

Default Code Assigned

ICD-O-3

C998 (site code)
7001 (histology code)

ICD-9

V100

ICD-10

Z1000

SDC

8000001

If a trial currently has no existing study subjects, and if all study subjects are missing the disease code in the CDUS file being submitted, the
system assigns the CTEP SDC "disease not specified code, i.e., " 80000001, by default. The system cannot process files in which invalid study
subject disease codes are provided.

Preparing CTRP Accrual Batch Files
When a trial has accrued many subjects, rather than entering the data subject-by-subject via the user interface (UI), you can upload all study
subject data into CTRP using a batch file upload. The information that follows provides all the details you need to create an Accruals batch file.
Use the Batch File Utility as a guide
If you are new to the batch file creation process, you can use the CTRP Accrual Batch File Tool to get you started. With it you can
produce properly-formatted batch files that you can upload in the Accrual application

When you create a batch file, ensure that each data element conforms to the requirements:
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
After you have prepared a batch file, you can upload it to CTRP. For instructions on submitting batch files, see Uploading Accrual Batch Data
Files .

Key Facts about CTRP Accrual Batch Files
The Accrual batch file format is based on the CTEP Clinical Data Update System (CDUS) file format. You can obtain a copy of the CDUS
Instructions and Guidelines, which explains the CDUS file format in great detail, at the CTEP web site at http://ctep.cancer.gov/protocolD
evelopment/electronic_applications/cdus.htm.
Although the CTRP accrual batch file format is CDUS-compatible, CTRP captures a subset of all the CDUS required data elements. Co
mparison of CTRP and CDUS Accrual Data Elements provides a list of all the CDUS fields with a note next to each field indicating
whether CTRP captures it.
Different data elements are required and expected when submitting accrual data to CTRP for Complete trials (National, Externally Peer
Reviewed, and Institutional) than for Abbreviated Trials (Industrial). Instructions are provided below for preparing batch files for both Com
plete and Abbreviated Trials.
A CTRP accrual batch file is a TXT (.txt) file with fields delimited (separated) by commas. The text file can be UTF-8 or ANSI-encoded.
Each CTRP batch text file contains accrual data for a single trial. You can compress one or more CTRP accrual batch text files into a
single Zip file and then upload this Zip file into CTRP. CTRP will unzip the file and process each TXT file. Your Zip file can include batch
files for both Complete and Abbreviated Trials.
Only Super Abstractors can upload accruals for CTEP and DCP trials in the CTRP.
Do not include the following items in Zip files that you intend to upload:
Folders or other Zip files
Path names. Some ZIP/compression tools provide an option to include the entire file path name when compressing a file. Path
names describe the location of the file.
Each batch submission uploaded into CTRP is treated as an update to existing records or as an addition of new ones.
Upload accruals for CTEP and DCP trials via CTEP CDUS batch accrual files only.
If you upload data to a trial that already has accrual data, the batch file is considered an update. The system compares your new data
to existing data using identifiers. When the identifiers match, existing data in CTRP is updated. When there are no matching identifiers,
data is added to the existing trial. For Abbreviated trials, the system updates the accrual counts.

An Introduction to Batch Files
This section provides general background information about batch file structure. Subsequent sections provide specific details about the
Accrual batch file structure.

Each line of text in a batch file corresponds to one record that consists of various required or optional data elements. Each data element is
separated by a comma.
Traditional Table Structure
Column 1

Column 2

Column 3

Column 4

Row 1-Field 1

Row 1-Field 2

Row 1-Field 3

Row 1-Field 4

Row 2-Field 1

Row 2-Field 2

Row 2-Field 3

Row 2-Field 4

Corresponding Comma-Delimited Structure

Comma-Delimited Structure
Field 1,Field 2,Field 3,Field 4
Field 1,Field 2,Field 3,Field 4

The number of fields in a row is dictated by the number of fields required in a CTRP or CDUS record. The Complete Trial Table and Abbreviated
Trial Table indicate how many fields are required in each CDUS record, and how many are required in a CTRP record. The batch file must contain
values or place holders (commas) equal to the number of required fields corresponding to the CDUS format. Leave fields that are not required by
CTRP blank, but keep the commas to indicate the "missing" field values.
For example, if a CDUS record requires six fields, as shown below, and the CTRP record requires only three, use commas to indicate the
"missing" values.

Fields Required for CDUS Records
CDUS Field 1,CDUS Field 2,CDUS Field 3,CDUS Field 4,CDUS Field 5,CDUS Field 6

Fields Required for CTRP Batch File
CTRP Field 1,CTRP Field 2,,,,CTRP Field 6

In a traditional table grid structure, the column headings indicate the order in which the field values occur. In CTRP batch files, the column
heading is implicit, and the field order is sequential from left to right, beginning at Field 1.
Traditional Table Structure
Column 1

Column 2

Column 3

Column 4

Row 1-Field 1

Row 1-Field 2

Row 1-Field 3

Row 1-Field 4

Comma-Delimited Structure
Field #1,Field #2,Field #3,Field #4

The first field in each record is reserved for the table name, which is always in CAPITAL letters. The exact field number for each data element is
provided in the Complete Trial Record Data Field Requirements and Abbreviated Trial Record Data Field Requirements tables.
Example - Using Automobiles Instead of Patients
Suppose CDUS stores information about cars (rather than accrued patients) in its database in a table called AUTOMOBILES.
In this example, CDUS records each of the following six data elements:
Table Name
VIN (Vehicle Identification Number)

Make
Model
Color
Year
These data elements are arranged in the following sequence:
Table Name

VIN

Make

Model

Color

Year

The corresponding comma-delimited sequence is as follows:

Comma-Delimited Data Elements
,,,,,

A traditional table structure for these CDUS data elements and their values are shown below.
Table Name

VIN

Make

Model

Color

Year

AUTOMOBILE

ABC-123456

Ford

Mustang

Black

1965

The corresponding comma-delimited structure is as follows:

Comma-Delimited Data Values
AUTOMOBILE,ABC-123456,Ford,Mustang,Black,1965

And, to extend this example, suppose that CTRP does not capture the Model nor Color of the car. In this case, the final record in the CTRP batch
file would be as follows:

Comma-Delimited CTRP Data Values
AUTOMOBILE,ABC-123456,Ford,,,1965

File Naming Conventions
The CTRP Accrual Batch File is a TEXT file with fields delimited (separated) by commas. The file can have any name. However, we recommend
using the following file naming conventions:
NCI Protocol Number_date.txt (with the date format: YYYYMMDD)

Example File Name
NCI-2012-00XXX_20090430.txt

The total number of characters in the file name including the file path must be less than or equal to 260. Use the file extensions .txt (f
or a single file) or .zip for compressed .txt files.
Return to top of page

Accrual Batch File Data for Complete Trials
The CTRP Accrual Batch File conforms to the CDUS file specification, but it only uses a limited number of fields from that file. Data in the rest of
the fields are ignored, but the place holders (commas) must still be present in the data file, whether empty or filled.
Before you begin

CTRP considers each accrual submitted as the total (cumulative) count to date. Be sure to read the information about accrual counts in
Recording Participating Site Subject Accrual Counts.

Complete Trial Tables
Tables identify the record type for each record. The CTRP uses the following tables for complete trials.
Table Name

Number of CDUS Fields

Number of Fields Used by CTRP

Purpose

(Excluding the Table Name)

COLLECTIONS

Identifies the study for this data file

PATIENTS

Subject-specific accrual data

PATIENT_RACES

Subject's Race

See Comparison of CTRP and CDUS Accrual Data Elements for a list of all the CDUS fields for these tables.

Complete Trial Data Elements and Field Formats
Each row in a batch file is associated with a single record in the database. The first field in each line identifies the name of the table that a record
belongs to. Subsequent fields contain different data element values for the same table. The number of fields required in each record, and the
values they must contain, are provided in the Complete Trial Record Data Field Requirements table. Because many more elements are required
in CDUS records than in CTRP records, many fields in your batch file will be null (contain no field values at all). In these cases, use a comma to
indicate a field for which there is no datum.
If a comma is part of the value, enclose the fields in double quotes. Otherwise the use of double quotes is optional.

Complete Trial Data Record Formats
Each line of the data file contains one record, is prefixed by the table name, and is comma delimited.
Important!
Use blank fields for those fields that are included in the CDUS standard but not used by the CTRP.

Valid Record Formats and Field Sequence
COLLECTIONS,,,,,,,,,,
PATIENTS,,,,,,,,,,,,,,,,,,,,,,,
PATIENT_RACES,,,

The following is an example batch file for a study that has three study subjects, and one race per subject using CTRP accepted valid values. In
the example below "Male", for example, is used instead of a CDUS accepted numeric value of "1".

Example Batch File
COLLECTIONS,NCI-2011-03861,,,,,,,,,1
PATIENTS,NCI-2011-03861,873222899999999,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,,
PATIENTS,NCI-2011-03861,8732228,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,,
PATIENTS,NCI-2011-03861,1,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,185.0,,
PATIENT_RACES,NCI-2011-03861,8732228,White
PATIENT_RACES, NCI-2011-03861,873222899999999,Asian
PATIENT_RACES,NCI-2011-03861,1,White

The following is another example batch file, accepted by CTRP, for the same study but using CDUS accepted numeric codes instead of the text
values used in the example above .

Example Batch File
COLLECTIONS,NCI-2011-03861,,,,,,,,,1
PATIENTS,NCI-2011-03861,873222899999999,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,
,,,,,238.7,,
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,238
.7,,
PATIENTS,NCI-2011-03861,1,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,185.0,,
PATIENT_RACES,NCI-2011-03861,8732228,01
PATIENT_RACES, NCI-2011-03861,873222899999999,05
PATIENT_RACES,NCI-2011-03861,1,01

ICD-O-3 Trial Format for Disease and Site Codes
For trials using ICD-O-3 codes, use the Subject Disease Code position for ICD-O-3 Site and/or Histology codes. If you use both Site and
Histology codes, separate them by a semi-colon as per the example below.
Format: site code; histology code
Code: C64.9;8000
Examples:
SDC Disease Code:
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,238.7,,
ICD-O-3 Site and Histology Codes:
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,C64.9;8000,,
ICD-O-3 Site Code only:
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,C64.9;,,
ICD-O-3 Histology Code only:
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,, ;8000,,

Complete Trial Record Data Field Requirements
The tables in this section contain detailed information about each of the data elements included in the Batch Upload file. The CDUS Accepted
Values are provided to show differences in case your system is already producing the CDUS file. In most cases, both CTRP and CDUS values
are accepted.

Accrual Data Elements Table with CTRP-Accepted Values
Accrual Data Elements table with CTRP-Accepted values for Complete trials
Accrual
Data
Element
Name

Mandatory=M; Definition
Optional=O
Conditional =
C

CTRP Accepted
Values

Information Model Class /
Diagram Mapping

Comments/Conditions

Study
Identifier

Unique
identifier
assigned to
the study

NCI, CTEP, or DCP
Identifier

Study Protocol /
assignedIdentfier

Study
Subject
Identifier

Unique
identifier
(numeric or
alphanumeric)
assigned to
subjects in a
study

Any numeric or
alphanumeric value
assigned to a study
subject

Study Subject / identifier

ZIP Code

String of
5 digit numeric ZIP
characters
code
used to
identify the
five-digit Zone
Improvement
Plan (ZIP)
code that
represents
the
geographic
segment that
is a subunit of
the ZIP code,
assigned by
the U.S.
Postal
Service to a
geographic
location to
facilitate mail
delivery.

Patient / postalAddress

Mandatory if U.S.

Country of
Residence

Name of a
country from
which a
person or
their
biological
family had
previous
residence or
past
ancestors.

2-letter ISO Country
Codes

Patient / postalAddress

Mandatory if not U.S.

Patient’s
Date of
Birth

The month
and year on
which the
person was
born

YYYYMM

Patient / birthDate

Year and Month are mandatory.

Patient / sexCode

Identification of gender is based upon self-report and may c
form, questionnaire, interview, etc.

Gender of a M
Person

Text
designations
that identify
gender.
Gender is
described as
the
assemblage
of properties
that
distinguish
people on the
basis of their
societal roles

Male
Female
Unspecified
Unknown

Genders in batch files do not have to correspond to the gen
as a trial eligibility criterion.

Ethnicity

Text for
reporting
information
about
ethnicity
based on the
Office of
Management
and Budget
(OMB)
categories

Hispanic or
Latino
Not Hispanic or
Latino
Not Reported
Unknown

Patient / ethnicGroupCode

Payment
Method

Term for an
entity,
organization,
government,
corporation,
health plan
sponsor, or
any other
financial
agent who
pays a
healthcare
provider for
the
healthcare
service
rendered to a
person or
reimburses
the cost of the
healthcare
service

Private
Insurance
Medicare
Medicare and
Private
Insurance
Medicaid
Medicaid and
Medicare
Military or
Veterans
Sponsored,
NOS
Military
Sponsored
(Including
CHAMPUS &
TRICARE)
Veterans
Sponsored
Self-Pay (No
Insurance)
No Means of
Payment (No
Insurance)
Managed Care
State
Supplemental
Health
Insurance
Other
Unknown

StudySubject /
paymentMethodCode

Payment Method Codes in batch files are not case-sensitive

Subject
M
Registration
Date

Date the
subject was
registered to
the study

YYYYMMDD

PerformedSubjectMilestone -/ registrationDate

Registering
Group
Code

Unique CTEP
Group code
assigned to
the group that
originally
registered the
patient for the
study

StudySubject /
registrationGroupId

Study Site
Identifier

Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study

CTRP
Study Site / identifier
Person/Organization
ID (PO ID)

For trials with Group participation, provide CTEP Group Cod
available

Subject
Disease
Code

Code that
identifies a
disease

CTEP
Simplified
Disease Code
(SDC) terms
ICD-9-CM
codes
ICD-O-3 codes
ICD-10

For SDC Disease Code:
StudySubject /
diease_identifier
For ICD-9 Disease Code:
StudySubject /
icd9diease_identifier

Disease code is mandatory for all trials except those manag
PIO.

Cancer specific ICD-9-CM disease codes in the range 140 t
Information about these disease codes is available at http://
a.com

For trials using ICD-O-3 terminology, use this position for Si
Histology Codes. When using both Site and Histology codes
them by a semicolon ( ; ). Site codes are available at http://t
cancer.gov/head-neck/abstract-code-stage/codes.html.

Use Histology codes when C codes are not available (for ex
Multiple Myeloma, NHL, Leukemia).

For uploading CDUS batch files, see the note below this tab
Race

Text for
reporting
information
about race
based on the
Office of
Management
and Budget
(OMB)
categories

American
Patient / raceCode
Indian or
Alaska Native
Asian
Black or African
American
Native
Hawaiian or
Other Pacific
Islander
Not Reported
Unknown
White

Multiple races in batch files are permissible even if "Not Rep
"Unknown" is indicated.

Change
Code

Additions or
changes
since the last
report

1
2
NULL

1 or NULL = changes in the file; the CTRP system process
the submission
2 = If the trial's current accrual is 0, the CTRP system proce
as a Code 1 change. If the trial's current accrual is greater t
system saves the file but does not process it.

AccrualCollections /
changeCode

For Super Abstractors uploading CDUS Accrual batch files
Use the following default disease codes when uploading a CDUS accrual batch file:
For patients missing the disease code
ICD-9: V100
SDC: 80000001
ICD-O-3
Site code: C998
Histology code: 7001
ICD-10: Z1000
Use the CTEP SDC "disease not specified code" 80000001 by default if the trial currently has NO existing patients, and all disease
codes in the CDUS file are missing.

Accrual Data Elements Table with CDUS-Accepted Values
Accrual Data Elements table with CDUS-Accepted values for Complete trials
Accrual
Data
Element
Name

Mandatory=M; Definition
Optional=O
Conditional =
C

CDUS
Accepted
Values

Comments/Conditions

Study
Identifier

Unique identifier assigned to the study

CTEP Identifier

Study
Subject
Identifier

Unique identifier (numeric or alphanumeric) assigned to
subjects in a study

Any numeric or
alphanumeric
value assigned
to a study
subject

ZIP Code

String of characters used to identify the five-digit Zone
Improvement Plan (ZIP) code that represents the
geographic segment that is a subunit of the ZIP code,
assigned by the U.S. Postal Service to a geographic
location to facilitate mail delivery.

5 digit numeric
ZIP code

Mandatory if U.S.

Country of
Residence

Name of a country from which a person or their biological
family had previous residence or past ancestors.

2-letter ISO
Country Codes

Mandatory if not U.S.

Patient’s
Date of
Birth

The month and year on which the person was born

YYYYMM

Year and Month are mandatory

Gender of a
Person

Text designations that identify gender. Gender is
described as the assemblage of properties that
distinguish people on the basis of their societal roles

1 = Male
2 = Female
9=
Unknown

Identification of gender is based
upon self-report and may come
from a form, questionnaire,
interview, etc.

Ethnicity

Text for reporting information about ethnicity based on the
Office of Management and Budget (OMB) categories

1=
Hispanic or
Latino
2 = Not
Hispanic or
Latino
8 = Not
Reported
9=
Unknown

Payment
Method

Term for an entity, organization, government, corporation,
health plan sponsor, or any other financial agent who
pays a healthcare provider for the healthcare service
rendered to a person or reimburses the cost of the
healthcare service

1 = Private -Insurance
2=
Medicare
3=
Medicare
and Private
Insurance
4=
Medicaid
5=
Medicaid
and
Medicare
6 = Military
or
Veterans
Sponsored,
Not
Otherwise
Specified
(NOS)
6A =
Military
Sponsored
(including
CHAMPUS
or
TRICARE)
6B =
Veterans
Sponsored
7 = Self
pay (no
insurance)
8 = No
means of
payment
(no
insurance)
98 = Other
99 =
Unknown

Subject
M
Registration
Date

Date the subject was registered to the study

YYYYMMDD

Registering
Group
Code

Unique CTEP Group code assigned to the group that
originally registered the patient for the study

Study Site
Identifier

Unique identifier (PO ID) assigned to the institution
accruing the patient to the study

CTEP Site ID

Subject
Disease
Code

Code that identifies a disease

Race

Text for reporting information about race based on the
Office of Management and Budget (OMB) categories

Change
Code

Additions or changes since the last report

CTEP
Simplified
Disease
Code
(SDC)
terms
ICD-9-CM
codes

Disease code is mandatory for all
trials except those managed by
DCP PIO.

01 = White
03 = Black
or African
American
04 = Native
Hawaiian
or Other
Pacific
Islander
05 = Asian
06 =
American
Indian or
Alaska
Native
98 = Not
Reported
99 =
Unknown

Cancer specific ICD-9-CM
disease codes in the range 140
to 239. Information about these
disease codes is available at http
://www.icd9data.com

Complete Trial Record Data Field Formats
The following table lists the data fields by the table in which they are recorded. It also provides the field number (field position in a row); and the
format and character limits for each field.
Tables

Field (Field Position in a Row)

Format (Maximum Number of Characters)

COLLECTIONS

Study Identifier (2)

Text (35)

COLLECTIONS

Change Code (11)

Number (1)

PATIENTS

Study Identifier (2)

Text (35)

PATIENTS

Study Subject Identifier (3)

Text (20)

PATIENTS

ZIP Code (4)

Text (10)

PATIENTS

Country of Residence (5)

Text (2)

PATIENTS

Patient's Date of Birth (6)

Date (YYYYMM)

PATIENTS

Gender of a Person (7)

Text (10)

PATIENTS

Ethnicity (8)

Text (25)

PATIENTS

Payment Method (9)

Text (50)

PATIENTS

Subject Registration Date (10)

Date (YYYYMMDD)

PATIENTS

Registering Group Identifier (11)

Text (25)

PATIENTS

Study Site Identifier (12)

Text (25)

PATIENTS

Number (10)
Subject Disease Code (22)
1

PATIENT_RACES

Study Identifier (2)

Text (35)

PATIENT_RACES

Study Subject Identifier (3)

Text (20)

PATIENT_RACES

Race (4)

Text (45)

The relation between COLLECTIONS, PATIENTS, and PATIENT_RACES is that COLLECTIONS can have multiple PATIENTS, and
PATIENTS can have multiple PATIENT_RACES. These relations are maintained through the use of consistent Study Identifier and
Study Subject Identifier fields.
Using the format table, you can determine that you must enter the Patient's Date of Birth in the sixth position in a row in the PATIENTS table
as YYYYMM. The following diagram contains a typical line of text from a batch file. Brackets with numbers indicate the field position number.

In the example above, the fifth field position (5) is null (blank) because it (Country of Residence) is a conditionally required field and in
this example is not required.
___
1 For trials using ICD-O-3 terminology, use this position for Site and/or Histology Codes. When using both Site and Histology codes, separate

them by a semicolon ( ; ).
Return to top of page

Accrual Batch File Data for Abbreviated Trials
Abbreviated Studies in CTRP are those with the Data Table 4 trial submission category of Industrial. The CTRP requires users to submit accrual
totals only for these trials. Do not submit subject-specific data. The CTRP Accrual Batch File uses the same file format as CDUS, but the fields
are unique to CTRP.
Before you begin
The CTRP considers each accrual submitted as the total (cumulative) count to date. Be sure to read the information about accrual
counts in Recording Participating Site Subject Accrual Counts.

Abbreviated Trial Tables
Tables identify the record type for each record. CTRP uses the following tables for abbreviated studies.
Table Name

COLLECTIONS

Number of CDUS Fields

Number of Fields Used by CTRP

(Excluding the Table Name)

Purpose

Identifies the study for this data file

ACCRUAL_COUNT

Aggregate accrual data

Abbreviated Trial Data Record Formats
Each line of the data file contains one record, is prefixed by the table name, and is comma delimited.
Use blank fields for those fields that are included in the CDUS standard but not used by the CTRP.

Valid Record Formats and Field Sequence
COLLECTIONS,,,,,,,,,,
ACCRUAL_COUNT,,,< Study_Site_Accrual_Count>

The following is an example batch file for one study and two study sites.

Example Batch File
COLLECTIONS,NCI-2012-00225,,,,,,,,,
"ACCRUAL_COUNT","NCI-2012-00225","Site 1","10"
"ACCRUAL_COUNT","NCI-2012-00225","Site 2","20"

Abbreviated Trial Record Data Field Requirements
The following table contains detailed information about each of the data elements included in the Batch Upload file for Abbreviated Trials. The
CDUS Accepted Values are provided to show differences in case your system is already producing the CDUS file.

Accrual Data Elements with CTRP-Accepted Values
Accrual Data Elements table with CTRP accepted values
Accrual Data
Element Name

Mandatory=M;
Optional=O
Conditional = C

Definition

CTRP Accepted
Values

Information Model Class /
Diagram Mapping

Study Identifier

Unique identifier assigned to the study

NCI, CTEP, or
DCP Identifier

Study Protocol /
assignedIdentfier

Study Site
Identifier

Unique identifier (PO ID) assigned to the institution
accruing the patient to the study

PO ID

Study Site / identifier

Study Site
Accrual Count

Numeric count of subjects accrued at a study site to
date

Numeric

Study Site /
subjectAccrualcount

Accrual Data Elements with CDUS-Accepted Values
Accrual Data Elements table with CDUS-Accepted values
Accrual Data Element
Name

Mandatory=M;
Optional=O
Conditional = C

Definition

CDUS Accepted
Values

Study Identifier

Unique identifier assigned to the study

CTEP Identifier

Study Site Identifier

Unique identifier (PO ID) assigned to the institution accruing the
patient to the study

CTEP Site ID

Study Site Accrual
Count

N/A

Abbreviated Trial Data Field Requirements

Tables

Field (Field Position in a Row)

Format (Maximum Number of Characters)

COLLECTIONS

Study Identifier (2)

Text (35)

ACCRUAL_COUNT

Study Identifier (2)

Text (35)

ACCRUAL_COUNT

Study Site Identifier (3)

Text (25)

ACCRUAL_COUNT

Study Site Accrual Count (4)

Text (10)

The COLLECTIONS and ACCRUAL_COUNT tables are linked by consistent Study Identifier and Study Site Identifier fields. There is no
limit to the number of ACCRUAL_COUNT records.
Return to top of page

Uploading Accrual Batch Files
Be sure to complete your batch file preparation first
Before you begin, gather all the protocol data you need. See Preparing CTRP Accrual Batch Files for instructions.
The system logs you out if it detects that you have not used the application for 90 minutes. The system also logs you out after three
unsuccessful attempts to log in within 24 hours. In the event that you cannot remember your password, contact Application Support at n
cicbiit@mail.nih.gov.
Once you have created your Accrual Batch Upload file, upload it via the CTRP Accrual web interface. Existing accrual data for the study will be
updated and any new data you submit will be added.
The batch upload template currently does NOT provide a way to enter accrual disease code terminology; instead, the default value of
SDC is used.

The batch files you submit do not delete previously accrued patients/patient data. Use the Accrual application user interface to delete
accrued subjects as necessary.
How to Upload Accrual Batch Files
1. On the toolbar, click Batch Upload
The Batch Upload page appears.

2. Click Browse and select the .txt or .zip file that contains your accrual data.
3. Click Submit.
Your file is uploaded to the system and processed in the background
When processing has been completed, the system sends you an email message to inform you of the status of your file(s). It includes the
information listed below. The system will also notify you if it is unable to process your Zip file.
NCI Identifier
Number of subject accruals that the system imported
Details of any errors that may have occurred during the import process

The system checks your submissions to ensure there are no duplicates. The system does not process a study subject record if it
detects that a participating site in the same trial has registered a subject with the same Study Subject ID. The system includes details
about which Study Subject IDs are affected in an error message.

Once you have uploaded your batch file, the CTRP system continues to update the record status both by email and Accrual. To view the
information you uploaded, see Downloading Accrual Batch Data Files and Reviewing and Updating Prior Accrual Submissions .
Return to top of page

Resolving Accrual Batch File Upload Errors
If the email notice you received after uploading a batch file indicated that errors occurred during the the import process, you can use the following
steps to correct them before re-submitting your accruals batch file.
If the batch (.zip) file contains both valid (error-free) and invalid files, the system processes the valid files and notifies you about the files
that it could not process.

If the CTRP system was unable to identify an organization that you submitted in your batch file, it determines if the organization was
nullified and merged with another organization. If so, the system includes the new organization name in the error message.

For Super Abstractors
If a CDUS batch file contains accruals for sites that have not been added yet to the trial in the CTRP, the system processes the valid
sites and then emails you a list of participating sites from your file that are missing in the CTRP. You can correct this type of error by
adding the site(s) to the trial and resubmitting the accrual batch file.
How to Resolve Accrual Batch File Upload Errors
1. Go through the list of errors described in detail in the status email you received for each line in your text file that caused the error.
2. Correct the errors.
3. Save the file and re-submit.
Return to top of page

Downloading Accrual Count Reports v4.3
Downloading Accrual Count Reports v4.3
This section provides instructions for downloading a report that lists site accrual counts. For Complete trials, the report includes accrual counts for
the lead organization. For Abbreviated trials, the report includes accrual counts from participating sites.
The Accrual Count report includes accrual information for your affiliated organization or participating site only. You must have Accrual
access to use this feature.
How to Download Accrual Account Reports
1. On the toolbar, click Accrual Counts.
The Accrual Count page displays trials to which you have access.

2. At the bottom of the list of trials, click CSV to download the report as a comma-separated-value text file, or Excel to download the report
as an Excel spreadsheet.

Managing Your CTRP Account v4.3
Managing Your CTRP Account v4.3
Topic Links
Resetting Your Password
Retrieving Your Username
Managing Your User Account
Profile
This section provides instructions for modifying your CTRP account.

Resetting Your Password
You can reset your NCI password from the NCI Password Station directly, or from the NCI CTRP Registration application.
How to Reset Your NCI Password
Navigate to the NCI Password Station at http://password.nci.nih.gov. Once you have logged in to the NCI Password Station, use the Cha
nge Password feature to create a new password.
- or On the Registration Login page, click Forgot Your Password?.
A pop-up window provides instructions for resetting your password and a link to the NCI Password Station.
Return to top of page

Retrieving Your Username
You can retrieve your username from the CTRP Registration Login page.
How to Retrieve Your Username
1. On the Login Page, click the Forgot Your Username? link.
The Retrieve User Name page is displayed.
2.

2. Enter the email address associated with your account, and click Submit.
The system sends your username to the email address you provided.
Return to top of page

Managing Your User Account Profile
You can update your account information after you have registered for an account and have logged in to Registration.
Changing your Organizational Affiliation results in loss of privileges
If you change your organizational affiliation, the system revokes your existing Site Admin and Accrual Submission privileges.
How to Edit Your Account Information
1. On the top right corner of any page, click Your Username > My Account.
The My Account page appears, populated with the information you previously supplied for your account.
2. In the Your Account Profile section, make any changes as necessary, and then click Save.
Keep your account up to date
The PRS organization name is required for uploading trial records to ClinicalTrials.gov via a system-generated file. The PRS
organization name you include in your profile is included in that file. This precludes having to update the PRS name in the file.
Therefore it is very important for you to update your account whenever there is a change in PRS.
Return to top of page

Working with Accrual Tables and Search Results v4.3
Working with Accrual Tables and Search Results v4.3
The system lists search results in tables. You can navigate through the records in several ways, and choose which columns are of interest to you.
Additionally, you can filter the results by typing a string of characters in a search field.

To do this...

Do this...

Move horizontally across the page

Press the Left arrow (<–) or Right arrow (–>) on your keyboard.

Sort your results by column

Click the Sort icons (up arrow for ascending order; down arrow for descending order).

Move to the first page of results

Click <<.

Move to the previous page of results

Click < or click the preceding page number.

Move to the next page of results

Click > or click the next page number.

Move to the last page of results

Click >>.

Move to a specific page of results

Click a specific page number.

Choose how many rows you want to
display per page

Select the number of rows from the Show selector.

Choose which columns to display

Click Choose columns. A list of available columns appears. Check or clear the boxes to indicate
which columns you want to show or hide.

Search the list of results by keywords

In the Search field, type one or more characters contained in your keyword(s). The results are filtered
as you type subsequent characters.

Export search results to a file

At the bottom of the page, click CSV to export the search results to a comma-separated file or Excel to
export to a file in Microsoft Excel format.

Filtering Search Results
To filter the search results, in the Search field, type one or more characters contained in any of the fields. The list is filtered as you type
subsequent characters.
For example, in the figure below, the results list has been filtered to display only diseases that contain "L9" in the Disease Code.

Adding one more character, "." as shown below, filtered out the remaining diseases because the decimal point (".") was not included in the
Disease Code.

Accrual Data Elements for Complete Trials v4.3

Accrual Data Elements for Complete Trials v4.3
Topic Links
Accrual Data Elements Table with
CTRP Accepted Values
Accrual Data Elements Table with
CDUS Accepted Values
The tables in this section contain detailed information on each of the data elements included in the Batch Upload file. The first table provides
values that are valid for the Batch Upload file. The CDUS Accepted Values in the second table are provided to show differences in values in case
your system is already producing the CDUS file.
Use of CDUS Values
Although you can use CDUS values, they are being phased out in the CTRP. It is best, therefore, to use the CTRP values listed in the
table below.

When you create a batch file, ensure that each data element conforms to the requirements.
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
If a comma is part of the value, enclose the field in double quotes. Otherwise the use of double quotes is optional.

Accrual Data Elements Table with CTRP Accepted Values
Accrual Data Elements table with CTRP-Accepted values for Complete trials
Accrual
Data
Element
Name

Mandatory=M; Definition
Optional=O
Conditional =
C

CTRP Accepted
Values

Information Model Class /
Diagram Mapping

Comments/Conditions

Study
Identifier

Unique
identifier
assigned to
the study

NCI, CTEP, or DCP
Identifier

Study Protocol /
assignedIdentfier

Study
Subject
Identifier

Unique
identifier
(numeric or
alphanumeric)
assigned to
subjects in a
study

Any numeric or
alphanumeric value
assigned to a study
subject

Study Subject / identifier

ZIP Code

Patient / postalAddress

Mandatory if U.S.

Country of
Residence

Name of a
country from
which a
person or
their
biological
family had
previous
residence or
past
ancestors.

2-letter ISO Country
Codes

Patient / postalAddress

Mandatory if not U.S.

Patient’s
Date of
Birth

The month
and year on
which the
person was
born

YYYYMM

Patient / birthDate

Year and Month are mandatory.

Identification of gender is based upon self-report and may c
form, questionnaire, interview, etc.

Gender of a M
Person

Ethnicity

Text
designations
that identify
gender.
Gender is
described as
the
assemblage
of properties
that
distinguish
people on the
basis of their
societal roles

Male
Female
Unspecified
Unknown

Patient / sexCode

Text for
reporting
information
about
ethnicity
based on the
Office of
Management
and Budget
(OMB)
categories

Hispanic or
Latino
Not Hispanic or
Latino
Not Reported
Unknown

Patient / ethnicGroupCode

Genders in batch files do not have to correspond to the gen
as a trial eligibility criterion.

Payment
Method

StudySubject /
paymentMethodCode

Payment Method Codes in batch files are not case-sensitive

Subject
M
Registration
Date

Date the
subject was
registered to
the study

YYYYMMDD

PerformedSubjectMilestone -/ registrationDate

Registering
Group
Code

Unique CTEP
Group code
assigned to
the group that
originally
registered the
patient for the
study

StudySubject /
registrationGroupId

Study Site
Identifier

Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study

CTRP
Study Site / identifier
Person/Organization
ID (PO ID)

Subject
Disease
Code

Code that
identifies a
disease

CTEP
Simplified
Disease Code
(SDC) terms
ICD-9-CM
codes
ICD-O-3 codes
ICD-10

For SDC Disease Code:
StudySubject /
diease_identifier
For ICD-9 Disease Code:
StudySubject /
icd9diease_identifier

For trials with Group participation, provide CTEP Group Cod
available

Disease code is mandatory for all trials except those manag
PIO.

Cancer specific ICD-9-CM disease codes in the range 140 t
Information about these disease codes is available at http://
a.com

Use Histology codes when C codes are not available (for ex
Multiple Myeloma, NHL, Leukemia).

For uploading CDUS batch files, see the note below this tab

Race

Text for
reporting
information
about race
based on the
Office of
Management
and Budget
(OMB)
categories

American
Patient / raceCode
Indian or
Alaska Native
Asian
Black or African
American
Native
Hawaiian or
Other Pacific
Islander
Not Reported
Unknown
White

Multiple races in batch files are permissible even if "Not Rep
"Unknown" is indicated.

Change
Code

Additions or
changes
since the last
report

1
2
NULL

AccrualCollections /
changeCode

Accrual Data Elements Table with CDUS Accepted Values
Accrual Data Elements table with CDUS-Accepted values for Complete trials
Accrual
Data
Element
Name

Mandatory=M; Definition
Optional=O
Conditional =
C

CDUS
Accepted
Values

Comments/Conditions

Study
Identifier

Unique identifier assigned to the study

CTEP Identifier

Study
Subject
Identifier

Unique identifier (numeric or alphanumeric) assigned to
subjects in a study

Any numeric or
alphanumeric
value assigned
to a study
subject

ZIP Code

5 digit numeric
ZIP code

Mandatory if U.S.

Country of
Residence

Name of a country from which a person or their biological
family had previous residence or past ancestors.

2-letter ISO
Country Codes

Mandatory if not U.S.

Patient’s
Date of
Birth

The month and year on which the person was born

YYYYMM

Year and Month are mandatory

Gender of a
Person

Text designations that identify gender. Gender is
described as the assemblage of properties that
distinguish people on the basis of their societal roles

1 = Male
2 = Female
9=
Unknown

Identification of gender is based
upon self-report and may come
from a form, questionnaire,
interview, etc.

Ethnicity

Text for reporting information about ethnicity based on the
Office of Management and Budget (OMB) categories

1=
Hispanic or
Latino
2 = Not
Hispanic or
Latino
8 = Not
Reported
9=
Unknown

Payment
Method

Term for an entity, organization, government, corporation,
health plan sponsor, or any other financial agent who
pays a healthcare provider for the healthcare service
rendered to a person or reimburses the cost of the
healthcare service

Subject
M
Registration
Date

Date the subject was registered to the study

YYYYMMDD

Registering
Group
Code

Unique CTEP Group code assigned to the group that
originally registered the patient for the study

Study Site
Identifier

Unique identifier (PO ID) assigned to the institution
accruing the patient to the study

CTEP Site ID

Subject
Disease
Code

Code that identifies a disease

Race

Text for reporting information about race based on the
Office of Management and Budget (OMB) categories

Change
Code

Additions or changes since the last report

CTEP
Simplified
Disease
Code
(SDC)
terms
ICD-9-CM
codes

Disease code is mandatory for all
trials except those managed by
DCP PIO.

01 = White
03 = Black
or African
American
04 = Native
Hawaiian
or Other
Pacific
Islander
05 = Asian
06 =
American
Indian or
Alaska
Native
98 = Not
Reported
99 =
Unknown

Cancer specific ICD-9-CM
disease codes in the range 140
to 239. Information about these
disease codes is available at http
://www.icd9data.com

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Accrual Data Elements for Abbreviated Trials v4.3
Accrual Data Elements for Abbreviated Trials v4.3
Topic Links
Accrual Data Elements Table with
CTRP Accepted Values for
Abbreviated Trials
Accrual Data Elements Table with
CDUS Accepted Values for
Abbreviated Trials
The tables in this section contain detailed information on each of the data elements included in the Batch Upload file. The first table provides
values that are valid for the Batch Upload file. The CDUS Accepted Values in the second table are provided to show differences in values in case
your system is already producing the CDUS file.
When you create a batch file, ensure that each data element conforms to the requirements.
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
If a comma is part of the value, enclose the field in double quotes. Otherwise the use of double quotes is optional.

Accrual Data Elements Table with CTRP Accepted Values for Abbreviated Trials
Accrual Data Elements table with CTRP accepted values

Accrual Data
Element Name

Mandatory=M;
Optional=O
Conditional = C

Definition

CTRP Accepted
Values

Information Model Class /
Diagram Mapping

Study Identifier

Unique identifier assigned to the study

NCI, CTEP, or
DCP Identifier

Study Protocol /
assignedIdentfier

Study Site
Identifier

Unique identifier (PO ID) assigned to the institution
accruing the patient to the study

PO ID

Study Site / identifier

Study Site
Accrual Count

Numeric count of subjects accrued at a study site to
date

Numeric

Study Site /
subjectAccrualcount

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Accrual Data Elements Table with CDUS Accepted Values for Abbreviated Trials
Accrual Data Elements table with CDUS-Accepted values
Accrual Data Element
Name

Mandatory=M;
Optional=O
Conditional = C

Definition

CDUS Accepted
Values

Study Identifier

Unique identifier assigned to the study

CTEP Identifier

Study Site Identifier

Unique identifier (PO ID) assigned to the institution accruing the
patient to the study

CTEP Site ID

Study Site Accrual
Count

N/A

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Comparison of CTRP and CDUS Accrual Data Elements v4.3
Comparison of CTRP and CDUS Accrual Data Elements v4.3
Topic Links
COLLECTIONS TABLE
PATIENTS TABLE
PATIENT_RACES TABLE
This section provides the full list of CDUS ( Clinical Data Update System ) data elements for Complete trials, and indicates which of the elements
are captured in CTRP. Accrual Data Elements for Complete Trials lists each data element and indicates which are mandatory, conditional, or
optional.

COLLECTIONS TABLE
CDUS Fields

Fields Used by CTRP?

Protocol_ID

Yes

Subm_Date

CutOff_Date

Current_Trial_Status_Code

Current_Trial_Status_Date

Completer_Name

Completer_Phone

Completer_FAX

Completer_Email

Change_Code

Yes

PATIENTS TABLE
CDUS Fields

Fields Used by CTRP?

Protocol_ID

Yes

Patient_ID

Yes

Zip_Code

Yes

Country_Code

Yes

Birth_Date

Yes

Gender_Code

Yes

Ethnicity_Flag

Yes

Method_Of_Payment

Yes

Date_Of_Entry

Yes

Reg_Group_ID

Yes

Reg_Inst_ID

Yes

TX_On_Study

Off_TX_Reason

Last_TX_Date

Off_Study_Reason

Off_Study_Date

Subgroup_Code

Ineligibility_Status

Baseline_PS_Code

Prior_Chemo_Regs

Disease_Code

Yes

Resp_Eval_Status

Baseline_Abnormalities_Flag

PATIENT_RACES TABLE
CDUS Fields

Fields Used by CTRP?

Protocol_ID

Yes

Patient_ID

Yes

Race_Code

Yes

File Type	application/pdf
File Modified	2016-01-21
File Created	2016-01-21