CTRP Accrual Users Guide

Attachment 7 - CTRP_Accrual_User_Guide.pdf

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

CTRP Accrual Users Guide

OMB: 0925-0600

Document [pdf]

Download: pdf | pdf

1. NCI CTRP Accrual User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 CTRP Accrual Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 Accrual Data Elements for Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1 Accrual Data Elements with CTRP-Accepted Values for Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2 Accrual Data Elements for Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1 Accrual Data Elements with CTRP-Accepted Values for Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3 PATIENT_RACES TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4 PATIENTS TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5 COLLECTIONS TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Getting Started with Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1 About Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2 Accrual Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2.1 Requesting Permission to Submit Accrual Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2.2 Preparing a Trial Record to Receive Accrual Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.3 Using the Toolbar in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.4 Getting Help in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.5 Changing the Color Scheme in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Searching for and Selecting Your Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.1 Searching for Trials in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.2 Viewing Trial Details in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 Working with Complete Trial Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.1 Adding Study Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2 Searching for Diseases and Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2.1 Searching for Diseases from the Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2.2 Selecting Diseases for Study Subject Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2.3 Selecting Sites for Study Subject Records Using ICD-O-3 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.3 Searching for Study Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.4 Reviewing Study Subject Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Working with Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.1 About Participating Site Accrual Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.2 Deleting Participating Site Accrual Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.3 Recording and Updating Participating Site Accrual Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 Working with Non-Interventional Trial Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6.1 Submitting Accruals at the Subject Level for Non-Interventional Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6.2 Submitting Accruals at the Summary Level for Non-Interventional Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Working with Prior Accrual Submission Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.1 About Accessing Trials with Prior Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.2 Reviewing and Updating Prior Accrual Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.3 Downloading Accrual Batch Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8 Submitting Accrual Data Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.1 Preparing CTRP Accrual Batch Files Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.2 Key Facts about CTRP Accrual Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.2.1 An Introduction to Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.2.2 File Naming Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3 Accrual Batch File Data for Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3.1 Complete Trial Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3.2 Complete Trial Data Elements and Field Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3.3 Complete Trial Data Record Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3.4 Complete Trial Record Data Field Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.3.5 Complete Trial Record Data Field Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.4 Accrual Batch File Data for Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.4.1 Abbreviated Trial Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.4.2 Abbreviated Trial Data Record Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.4.3 Abbreviated Trial Record Data Field Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.4.4 Abbreviated Trial Data Field Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.5 Uploading Accrual Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.6 Resolving Accrual Batch File Upload Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.9 Downloading Accrual Count Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.10 Managing Your CTRP Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11 Working with Accrual Tables and Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11.1 Filtering Accrual Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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NCI CTRP Accrual User Guide
Contents of this Page

About this Guide
Audience

Accrual Links

NCI CTRP Accrual
Accrual Batch File Tool (Excel)

CTRP Resources

CTRP Website
ClinicalTrials.gov (http://clinicaltrials.
gov)
PRS and U.S. Public Law 110-85 (htt
p://prsinfo.clinicaltrials.gov/fdaaa.
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 Application Support.

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.
In the following panel, you can search within or browse the page tree for this guide:

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

CTRP Accrual Reference
The following pages provide tables and other references relevant to CTRP Accrual:

Accrual Data Elements for Complete Trials
This section contains detailed information on each of the data elements included in the Batch Upload 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.

For instructions, refer to the following pages:

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

Mandatory=M;
Optional=O
Conditional =
C

Definition

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 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

Patient /
postalAddress

Mandatory if patient’s Country of
Residence is U.S.

Country of
Residence

For non-U.S. residents only. This should be used when patient participation 2-letter ISO
from foreign countries is involved. For patients from outside the U.S., enter
Country
the foreign country code. Leave blank if the patient is a U.S. resident.
Codes
CTRP is using the International Standards Organization country codes. Note
: Either Zip code (if U.S resident) or country code (if not U.S resident) is
mandatory.

Patient /
postalAddress

Mandatory if not U.S.

Patient’s
Date of Birth

The month and year on which the person was born

Patient /
birthDate

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

Ethnicity

YYYYMM

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

Patient /
Male
sexCode
Female
Unspeci
fied
Unknown

Identification of gender is based upon
self-report and may come from a form,
questionnaire, interview, etc.
Genders in batch files do not have to
correspond to the gender indicated as a
trial eligibility criterion.

Patient /
-Hispani ethnicGroupCode
c or
Latino
Not
Hispani
c or
Latino
Not
Reported
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

StudySubject /
Private
paymentMethod
Insuran Code
ce
Medicare
Medicar
e and
Private
Insuran
ce
Medicaid
Medicai
d and
Medicare
Military
or
Veteran
s
Sponsor
ed,
NOS
Military
Sponsor
ed
(Includi
ng
CHAMP
US &
TRICAR
E)
Veteran
s
Sponsor
ed
SelfPay
(No
Insuran
ce)
No
Means
of
Paymen
t (No
Insuran
ce)
Manage
d Care
State
Supple
mental
Health
Insuran
ce
Other
Unknown

Subject
Registration
Date

Date the subject was registered to the study

YYYYMMDD

PerformedSubje
ctMilestone /
registrationDate

Registering
Group Code

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

StudySubject /
registrationGrou
pId

For trials with Group participation,
provide CTEP Group Code, if available

Study Site
Identifier

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

CTRP Person
/Organization
ID (PO ID)

Study Site /
identifier

Subject
Disease
Code

Code that identifies a disease

For SDC
Disease Code:
StudySubject /
diease_identifier

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

CTEP
Simplifi
ed
Disease
Code
(SDC)
terms
ICD-9CM
codes
ICD-O3 codes
ICD-10

For ICD-9
Disease Code:
StudySubject /
icd9diease_iden
tifier

Payment Method Codes in batch files
are not case-sensitive.

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

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 ( ; ). Site codes are
available at http://training.seer.cancer.
gov/head-neck/abstract-code-stage
/codes.html.
Use Histology codes when C codes are
not available (for example, for Multiple
Myeloma, NHL, Leukemia).
For Disease Codes for disease not
specified, healthy volunteers and donors
see Disease Codes for Disease not
Specified, Healthy Volunteers and
Donors - Include v4.4

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

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

1
2
NULL

AccrualCollectio
ns /
changeCode

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

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

Accrual Data Elements for Abbreviated Trials
This section contains detailed information on each of the data elements included in the Batch Upload 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.

For instructions, refer to the following pages:

Accrual Data Elements 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

Cut-Off Date

The date from which the cumulative accrual count was
calculated.

YYYYMMDD

(TBD)

PATIENT_RACES TABLE
CDUS Fields

Fields Used by CTRP?

Protocol_ID

Yes

Patient_ID

Yes

Race_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

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

Getting Started with Accrual
This page tree introduces you to NCI Clinical Trials Reporting Program (CTRP) Accrual:
For browser information, refer to Browser Support.

About Accrual
Accrual is the total number of patients either currently enrolled or anticipated to be enrolled on the clinical trial. Enrolled means a participant’s, or their
legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants
who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise
specified by the protocol. For more information, refer to https://prsinfo.clinicaltrials.gov/definitions.html#IntEnrollment.
The CTRP Accrual web application 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 accrual based on the trial category: Complete (National,
Externally Peer-Reviewed, or Institutional trials), or Abbreviated (Industrial or Other trials). For information on these types, refer to CTRP Trial Categories,
Study Sources or https://cancercenters.cancer.gov/GrantsFunding/eData#dt4.
The CTRP Accrual web application allows users to enter the following types of accrual data:
Patient level: Study subject demographic data for Externally Peer-Reviewed and Institutional trials. (Accruals for National trials are reported
internally at NCI.)
Summary level: Patient accrual counts for Abbreviated trials that have been abstracted (that is, trials that have been fully abstracted) as well as
those that have been approved or withdrawn.

Accrual Prerequisites
Before you can submit accrual data to a given trial in CTRP, the system requires the following:
You must have a CTRP user account with authorization to submit accrual to your trials.
The trial (Externally Peer-Reviewed, Institutional, or Industrial) must be registered in CTRP and fully abstracted. If a trial has been rejected or
terminated in CTRP, you will not be able to submit accrual on the trial record. Rejected and submission terminated trials will not display for your
center in CTRP Accrual.
For instructions on each of these, refer to the following pages:

Requesting Permission to Submit Accrual Data
To view and submit accrual data for your trials:
1. Create a CTRP account. For instructions, refer to Creating a CTRP Account.
2. Request permission to submit accrual data for your trials. 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
Accrual Access in the NCI CTRP Registration User's Guide.
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.
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 the lead organization on the trial to submit accrual.

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 the lead
organization on the trial to submit accrual.

Preparing a Trial Record to Receive Accrual Data
To prepare a trial record:
1. Register the trial in CTRP. For information and instructions, refer to Getting Started with Registrationin the NCI CTRP Registration User's Guide.
2. The trial must be fully abstracted and that abstraction verified before accrual can be submitted to CTRP. If the CTRO requests more information
about the trial once the trial is registered, respond in a timely manner to facilitate the abstraction process.
3. Participating sites must be in an open/recruiting trial status before initial accrual can be loaded. Open statuses include the following:
Active
Available
Enrolling by Invitation
Temporarily Closed to Accrual
Temporarily Closed to Accrual and Intervention
Temporarily Not Available

Using the Toolbar in Accrual
1. Visit the CTRP Accrual home page at https://trials.nci.nih.gov/accrual.
2. Log in.
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 in Accrual
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
1. Visit the CTRP Accrual home page at https://trials.nci.nih.gov/accrual.
2. Log in.
3. 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
1. Visit the CTRP Accrual home page at https://trials.nci.nih.gov/accrual.
2. Log in.
3. On the right side of the toolbar, click Help.

How to Return to this User's Guide
1. Visit the CTRP Accrual home page at https://trials.nci.nih.gov/accrual.
2. Log in.
3. On the toolbar, click Quick Links > Accrual User's Guide.

Changing the Color Scheme in Accrual
You can choose a site-wide color scheme to suit your preferences.
How to Change the Color Scheme
1. Visit the CTRP Accrual home page at https://trials.nci.nih.gov/accrual.
2. Log in.
3. On the top right corner of any page, click (User Name) > My Account.

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

Searching for and Selecting Your Trials
This page tree 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, refer to Working with Accrual Tables and Search Results.

Accessing your trials
If you do not see any studies listed when you log in, consider the following points:
Your CTRP user account must have authorization to submit accrual data to your trials.
Trials appear in the list after they have been registered and fully abstracted in CTRP. The Participating Site (PS) on the trial record
must be in one of the recruiting statuses before accrual can be loaded/submitted.
For instructions on each of these, refer to Accrual Prerequisites.
How to Search For Trials
1. On the toolbar, click Trial Search.
The Trial Search page appears.

2. Enter the NCI Trial Identifier, ClinicalTrials.gov Identifier, for 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.

Each trial is listed by NCI Trial Identifier, Official Title, Current Trial Status, Trial Type, and Accrual Disease Terminology. For information on trial
statuses, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.

Viewing Trial Details 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.

Working with Complete Trial Accruals
This page tree describes how to search for, add, update, and delete study subjects associated with Complete clinical trials.
For information about Abbreviated trials, refer to Working with Abbreviated Trials.
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 If

necessary, refer to 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 Searching for and Selecting Your Trials, 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, refer to 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.

Select one or more values for race.
Study
Subject 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*

For non-U.S. residents only. This should be used when patient participation from foreign countries is involved. For patients
from outside the U.S., enter the foreign country code. Leave blank if the patient is a U.S. resident. CTRP is using the
International Standards Organization country codes. Note: Either Zip code (if U.S resident) or country code (if not U.S
resident) is mandatory.

Study
Subject Zip
Code

Enter the study subject’s zip code. This field is mandatory if the Study Subject Country is the U.S.

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.
For Complete trials, lead organizations report all subjects accrued for the trial (both in the lead organization and in all participating sites). For Abb
reviated trials, each participating site reports the number of its own accruals (accrual count) only.
---

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
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, refer to 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)

Healthy volunteer

7002

(NA)

Disease not specified

7001

(NA)

Donors

(NA)

3. From the Disease Code System drop-down list, select one of the following:
ICD-9 (International Classification of Diseases, 9th Revision)
ICD-10 (International Classification of Diseases, 10th Revision)
ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition)
SDC (CTEP'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.

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 Searching for and Selecting Your Trials, 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)

Healthy volunteer

7002

(NA)

Disease not specified

7001

(NA)

Donors

(NA)

5. From the Disease Code System drop-down list, select one of the following:
ICD-9 (International Classification of Diseases, 9th Revision)
ICD-10 (International Classification of Diseases, 10th Revision)
ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition)
SDC (CTEP'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. Refer to Working with Accrual Tables and Search Results. The system
populates the Disease field for you.

Selecting Sites for Study Subject Records Using ICD-O-3
Codes
For trials that use ICD-O-3 disease coding, select a site to associate with a study subject.
How to Search for Sites
1. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials, 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. Refer to Working with Accrual Tables and Search Results. The system populates the Site
field for you.

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, refer to 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 Searching for and Selecting Your Trials, 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.

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 nonindustrial trial registered with the CTRP.
How to Review Study Subject Records
1. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials, 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.

Working with Abbreviated Trials
This section describes how to record, update, and delete the total number of accruals (accrual count) associated with Abbreviated and Other clinical trials,
via the web application. For instructions for submitting accrual data for Complete trials, refer to Working with Complete Trial Accruals. For instructions on
submitting accrual data via batch upload, refer to Submitting Accrual Data Batch Files.
Pharmaceutical companies are not users of CTRP, therefore each participating site on an Abbreviatedtrial must enter its own accrual count into CTRP. For
Abbreviatedtrials, the lead organization is usually a pharmaceutical company or non-NCI Designated Cancer Center.
.
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.
For instructions, refer to the following pages:

About 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.

Deleting Participating Site Accrual Counts
How to Delete Site Subject Accrual Counts
1. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial
Identifier link. The Participating Site Subject Accrual Count page appears.
2. In the Actions column of the record you want to delete, click Delete (the trash can icon). A message appears, prompting you to confirm deletion
of the accrual count(s).
3. Click OK. The system deletes all of the accrual counts for the site(s) you selected.

Recording and Updating Participating Site Accrual Counts
How to Record and Update Site Subject Accrual Counts
1. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial
Identifier link. The Participating Site Subject Accrual Count page appears.
2. To record the accrual information for the first time, in the Actions column, click on the Plus “+” icon.
3. In the # of Subjects Enrolled field, enter the number of subjects currently enrolled in studies at your site.
4. (Optional) In the Cut-Off Date field, specify the date from which the cumulative accrual count was calculated. If you do not specify a cut-off date,
the system considers the accrual submission date to be the cut-off date.
5. In the Actions column of the record you want to update, click Save (the floppy disk icon). A message at the top of the table indicates that the
record has been updated successfully.
6. Designated Cancer Center users may view, add, edit or delete an entry. Clicking on an arrow will allow the user to expand the most recent
summary record and view the history of updates made to the accrual count/cutoff history records.

Guidelines/Notes on accrual records:
The accrual should be cumulative and increasing in sequence (e.g., avoiding a scenario of 1, 3, 2).
Do not enter more than one accrual submission value on the same date (e.g., only one value on one day).
If you update accrual data in CTRP Accrual, it will not show up on your CTRP DT4 report until the next day.
This capability applies to Abbreviated trials, for additional information refer to Working with Abbreviated and Other Trial Accruals.

Working with Non-Interventional Trial Accruals
This section describes how to submit and update accruals for non-interventional trials. Summary/cumulative level accrual is reported for each participating
site by the Lead Organization. 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.

For instructions, refer to the following pages:

Submitting Accruals at the Subject Level for NonInterventional 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 Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial
Identifier link. 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 Submitting
Accruals at the Summary Level for Non-Interventional Trials. 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, refer to Accrual Data Elements for Complete Trials.

Descriptions and instructions for study subject demographic data fields
Study Subject
Information
Study Subject ID*

Instruction/Description

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. This field is mandatory if the country of origin is other than the United States.

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 ICD-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 ICD-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.
5. Click Save. The study subject record appears in the List of Study Subjects.

Submitting Accruals at the Summary Level for NonInterventional 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. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial
Identifier link. 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.
2. (Optional) 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.
3. In the # of Subjects Enrolled field(s), enter the number of subjects currently enrolled in this study at your site.
4. (Optional) In the Cut-Off Date field, specify the date from which the cumulative accrual count was calculated. If you do not specify a cut-off date,
the system considers the accrual submission date to be the cut-off date.
5. In the Actions column of the record you want to update, click Save (the floppy disk icon). 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.

Working with Prior Accrual Submission Records
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.

This page tree describes how to perform these tasks:

About Accessing Trials with Prior Accruals
The system displays accrual records according to your organization affiliation within CTRP and whether your organization is the Lead Organization or a
Participating Site on any given trial.

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 accruals for your site or any organization affiliation member sites
within CTRP

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

Abbreviated Trials Category:
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 accruals for your site or any organization affiliation member sites
within CTRP

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

Reviewing and Updating Prior Accrual Submissions
Guidelines/Notes on accrual records:
The accrual should be cumulative and increasing in sequence (e.g., avoiding a scenario of 1, 3, 2).
Do not enter more than one accrual submission value on the same date (e.g., only one value on one day).
If you update accrual data in CTRP Accrual, it will not show up on your CTRP DT4 report until the next day.
This capability applies to Abbreviated trials, for additional information refer to Working with Abbreviated and Other Trial Accruals.

Downloading Accrual Batch Data Files
Only the ZIP file submitter 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 feature. For
information about this feature, refer to Submitting Accrual Data Batch Files.
All trials to which you have been granted access, per the rules described in About Accessing Trials with Prior Accruals, are listed automatically when you
open the Prior Submissions page. 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. 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.

2. 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.
3. In the File/Subject column for the non-industrial trial of interest, click the link to the file.
Follow your browser/operating system instructions to view or save the document.

Submitting Accrual Data Batch Files
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. For instructions, refer to Requesting Permission to Submit Accrual Data and Preparing Accrual Batch
Files.
For instructions, refer to the following pages:

Preparing CTRP Accrual Batch Files Introduction
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
/protocolDevelopment/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. Comparison
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 (Externally Peer Reviewed, and
Institutional) than for Abbreviated Trials (Industrial). Instructions are provided below for preparing batch files for both Complete 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 Compl
ete and Abbreviated Trials.
Accruals for National trials are submitted directly to CTRP from CTEP and/or DCP.
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.

Initial Accrual Batch File Submission:
The initial accrual batch file submitted to CTRP will add accrual records for either Summary Level Accrual or Subject Level Accrual
based on the selection.

Subsequent Accrual Batch File Submissions:
For Summary Level Accrual (typically provided for Abbreviated/Imported - e.g., Industrial trials), subsequent accrual batch file uploads
will replace previously submitted/uploaded accrual data. Batch uploads will not append data; cumulative accrual data must be
uploaded with each accrual file submitted to CTRP.
Please ensure that your CTRP accrual batch file contains all cumulative accrual data for each participating site to
date before uploading to CTRP. Failure to include cumulative accrual data will result in erasing your accrual history.
For Subject Level Accrual (typically provided for Complete trials), subsequent accrual batch file uploads will append data.
If there are duplicate records (all fields are the same) within the batch file being submitted, the file will not be loaded and a
notification will be sent to the user asking for the duplicate record(s) to be removed and the file resubmitted.
If an element is changed, for example Gender, then the record is considered an update not a duplicate.

COLLECTIONS,,,,,,,,,,
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site

1","2","20170630"
1","2","20170731"
1","4","20170831"
1","5","20170930"
1","6","20171031"
1","10","20171130"
1","12","20171231"
1","15","20180131"
1","15","20180228"
1","18","20180331"
1","18","20180430"
1","18","20180531"
1","21","20180630"
1","21","20180731"
1","25","20180831"

"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site
"ACCRUAL_COUNT","NCI-2017-00225","Site

2","1","20170630"
2","1","20170731"
2","5","20170831"
2","5","20170930"
2","8","20171031"
2","9","20171130"
2","13","20171231"
2","13","20180131"
2","14","20180228"
2","18","20180331"
2","22","20180430"
2","30","20180531"
2","31","20180630"
2","32","20180731"
2","33","20180831"

Abbreviated/Imported (e.g., Industrial Trials) Example Batch File - Accrual Changes
COLLECTIONS,,,,,,,,,,
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site

1","1","20170215"
1","2","20170820"
1","4","20180331"
1","6","20180910"
1","10","20181202"

"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site
"ACCRUAL_COUNT","NCI-2016-00225","Site

2","2","20170128"
2","4","20170710"
2","5","20170825"
2","7","20171031"
2","9","20171122"
2","12","20180107"

For additional information, refer to the following pages:

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
AUTOMOBILE

VIN
ABC-123456

Make
Ford

Model
Mustang

Color
Black

Year
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 (for a
single file) or .zip for compressed .txt files.

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 Recordin
g Participating Site Subject Accrual Counts.
For instructions, refer to the following pages:

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

(Excluding the Table Name)

Purpose

COLLECTIONS

Identifies the study for this data file

PATIENTS

Subject-specific accrual data

PATIENT_RACES

Subject's Race

For a list of all the CDUS fields for these tables, refer to Comparison of CTRP and CDUS Accrual Data Elements.

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

Special Characters
If you include any of the following characters in a value, enclose the field with double quotes:
! " # $ % & ' ( ) * +

, -

. / : ; < > = ? @ [] \^ _{} | ~

If you enclose a field with double quotes (as in "NCI-2012-00225"), CTRP interprets the string inside the quote exactly as presented. If the field
does not contain any special characters, the quote marks are optional.

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.
For field requirements, refer to the following pages:

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.
___

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 Rec
ording Participating Site Subject Accrual Counts.
For instructions, refer to the following pages:

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

Number of CDUS Fields

Number of Fields Used by CTRP

(Excluding the Table Name)

Purpose

COLLECTIONS

Identifies the study for this data file

ACCRUAL_COUNT

(TBD: 0 or 1)

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.

To download a copy of the of the CTRP Accrual Batch File Tool (includes instructions), go to:
CTRP Accrual Batch File Tool
For Summary Level Accrual (typically provided for Abbreviated/Imported - e.g., Industrial trials), the following is an example batch file for one trial with two
participating sites supporting monthly accrual updates. Site 1 and 2 in the below example map to "PO ID" (unique to each Participating Site).
Note: Submit one trial per batch load. You can also include individual batch load files in one zip.
Example Batch File
COLLECTIONS,,,,,,,,,,
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","2","20170630"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","2","20170731"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","4","20170831"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","5","20170930"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","6","20171031"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","10","20171130"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","12","20171231"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","15","20180131"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","15","20180228"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","18","20180331"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","18","20180430"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","18","20180531"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","21","20180630"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","21","20180731"
"ACCRUAL_COUNT","NCI-2017-00225","Site 1","25","20180831"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","1","20170630"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","1","20170731"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","5","20170831"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","5","20170930"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","8","20171031"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","9","20171130"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","13","20171231"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","13","20180131"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","14","20180228"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","18","20180331"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","22","20180430"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","30","20180531"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","31","20180630"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","32","20180731"
"ACCRUAL_COUNT","NCI-2017-00225","Site 2","33","20180831"

Special Characters
If you include any of the following characters in a value, enclose the field with double quotes:
! " # $ % & ' ( ) * +

, -

. / : ; < > = ? @ [] \^ _{} | ~

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.
For field requirements, refer to the following pages:

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.

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 locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your
account, contact us at ctrp_support@nih.gov. If you have forgotten your password, or if you want to reset it for any reason, refer to Resetting
Your Password.
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 backgroundWhen 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.
A subject is duplicate if
1. There is already an accrual with same subject id on the same PS for a trial.
2. If following attributes (subject id, dob, gender, ethnicity) match for a subject on any other PS on the trial(not including the PS accrual is
added to).
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.

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.

Downloading Accrual Count Reports
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
The following pages (in the NCI CTRP Registration User Guide) provide instructions for modifying your CTRP account.

Working with Accrual Tables and Search Results
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.

For additional instructions, refer to Filtering Accrual Search Results.

Filtering Accrual 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.

File Type	application/pdf
File Modified	2019-05-02
File Created	2019-05-02