NCI_CTRP_Attachment 3A_CTRP_quick_start_guide

CTRP Quick Start Guide
Step 1
Decide whether your organization's
interventional trials need to be reported
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Has the trial already been reported to NCI
through its Cancer Therapy Evaluation
Program (CTEP) or the Division of Cancer
Prevention (DCP)?

Create An Account. Enter an email account
and create a password. You will receive a
confirmation email.

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If yes, you do not have to register the trial with
CTRP. NCI will transfer data for this trial to
CTRP.

Account Profile. Click on the link listed in your
confirmation email to activate your account and
to enter your Account Profile information.

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Is your organization an NCI-Designated
Cancer Center that is not a CTRP original
site?

Log In. After entering the Account Profile info
you will be asked to log in again. If you forgot
your password, then reset it.

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Search Screen. You will be routed to a Search
Screen after log-in.

You are scheduled to begin registering new
interventional trials beginning July 1, 2009
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Step 3
Create User Account

Are you a grantee who is not at an NCIDesignated Cancer Center?
You are scheduled to begin registering new
interventional trials on October 1, 2009

Step 4
Search Trials
You may want to check if you or someone at your
organization has already submitted the trial(s) that you
are registering. Also, for multi-center trials you can check
if other centers have already registered the trial.

Step 2
Gather Required Information

Search My Trials. Use this feature to find trials that
have been submitted through your account.

Before you begin to register your trials with CTRP, it will
be helpful to gather the following information for each
trial:

Search All Trials. Use this feature to view select data
on all registered trials within CTRP from all submitting
organizations.

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Lead Organization Trial Identifier
Trial Title, Type, Phase, Purpose (prevention,
treatment, diagnostic)
Lead Organization and Principal Investigator
Sponsor / Responsible Party
Summary 4 Information (Funding Category and
Funding Sponsor)
Status and Status Date (Study Start and
Completion Date)
NIH Grant Information (Funding Mechanism,
Institute Code, Serial Number, NCI Division or
Program Code)
IND/IDE Information (Number, Grantor, Holder
Type)

You will also need to upload the following trial-related
documents in support of each trial's registration:
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Protocol Document
Informed Consent (if not embedded within the
protocol document)
IRB Approval
List of participating Sites for Multi-Center
Studies (if not already described within the
protocol document)

Step 5
Submit Trials
Enter Trial Information. Complete the data fields for
each trial. “Drop down” menus can help you make a
selection. Fields marked with an asterisk are required.
You will not be able to register the trial without
completing these fields.
Upload Trial Documents. The following trial-related
documents are required as part of your trial's registration
to CTRP:
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Protocol document
Informed consent (if not embedded within the
protocol document)
IRB approval
List of participating sites for multi-center studies
(if not already described within the protocol
document)

You can attach these files just like you attach a file to an
email. You can "browse" the files on your computer and
select a file.

Submit. Review the trial information that you have
entered and click “Submit.”
If you need to make any changes after you have
submitted the trial, please contact the CTRP staff by
email.

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If you have questions or comments regarding this
document, or other CTRP topics, please contact
NCICB Applications Support at:
Email:

ncicb@pop.nci.nih.gov

Web site:

http://ncicb.nci.nih.gov/NCICB/support

Review. You will receive an email within 48
hours letting you know whether the trial has
been accepted or rejected to CTRP.

Toll-free:

888-478-4423

Phone

301-451-4384

CTRP will include reason(s) if the trial is rejected
rejection in the email (e.g., a duplicate
submission, missing documents). The email will
also provide you with a unique identifier
assigned by NCI for your trial.

Live telephone support is available Monday to Friday, 8
a.m. to 8 p.m. Eastern Time, excluding federal
holidays.

Step 6
Verify Trials Data
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For Assistance

Abstraction. CTRP will abstract information
from the protocol and the other supporting
documents. CTRP will contact you via email if
there are any questions or need for clarification.
Confirmation. CTRP will send you an email
with a Trial Summary Report for your review.
You can email us with corrections or questions
about the Trial Summary Report.
Verify that the trial has been abstracted correctly
and respond within 5 business days to let CTRP
know if the abstraction is correct.
If we have not heard from you within 5 business
days, CTRP will assume the Trial Summary
Report is acceptable.
You will also receive a file that includes the
abstracted data elements in a format that may
be used to submit the trial to the National Library
of Medicine's ClinicalTrials.gov database.

CTRP:

http://www.cancer.gov/ncictrp