NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Old Version 1

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version Current

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Replaced contents with Include Page macro pointing to versioned include page with same contents.

...

width40%
Panel
titleTopic Links

Table of Contents
maxLevel4
minLevel2

...

Column

This section introduces you to NCI Clinical Trials Reporting Program (CTRP) Registration, and provides instructions for registering for an account.

About Registration

Registration provides cancer clinical trial access to researchers who have CTRP accounts. It enables these users to register, amend, and update trials one at a time, and to view details of existing trials submitted by members of the cancer research community. You can register Complete and Abbreviated interventional and non-interventional trials.

About Clinical Trial Details

Registration captures clinical trial details, a sanctioned set of key data elements. This set of recorded data enables the research community to share and analyze standardized clinical trial details.

Tip

The glossary on the CTRP web site at http://www.cancer.gov/aboutnci/organization/ccct/ctrp/glossary provides definitions, attributes, and examples of metadata associated with trials. You can access other CTRP resources from the same page.

As a CTRP account holder, you can search for and review a subset of registered data that has been submitted to CTRP and validated by the Clinical Trials Reporting Office (CTRO).

What's New in this Release of Registration

This version of the CTRP Trial Registration application has the following new features and improvements:

...

MultiExcerptNamewhatsnew

...

sortColumn2
columnTypesS,I,I,S,S,S

...

The new section for this feature is Managing Targeted Accrual.

...

To view the revised notes, search for "when you close a trial" in each of the following pages:

...

Return to top of page

 

Typical Life Cycle of a Trial

This section describes, in words and visually, the typical life cycle of a trial:

...

  1. If the trial is not complete, the specialist sends a request to the submitter for information. The trial has a processing status of On Hold. When the CTRO receives the requested information, a Document Specialist takes the trial off hold. The trial's  processing status returns to the previous status, which in this case would be Submitted.
  2. If the trial is not valid, the specialist rejects the submission. The trial has a processing status of Rejected.
  3. If the trial is complete and valid, the specialist accepts the submission. The trial has a processing status of Accepted.

...

The following diagram illustrates the typical life cycle of a trial and the relationship between actions and processing statuses:

Diagram of a typical life cycle of a trial, as described in the textImage Removed

For more information, refer to Trial Processing Statuses and Amendment Process Life Cycle.

Return to top of page

Role-Based Tasks in Registration

Multiexcerpt

Each person who registers for a CTRP account is associated with a role. One registered user from an organization can request an Administrator role from the CTRO. That Administrator can grant administrative privileges to other users in the Administrator's organization.

CTRP account holders can perform only those tasks that are associated with their assigned roles.

The following table is a matrix of roles and tasks. A Yes or No in each table cell indicates whether someone with a given role can perform the task.

TasksUserSite Administrator
Manage Accrual AccessNoYes
  • A registered user logged in as the Lead Organization's Site Administrator for any trial other than DCP or CTEP trials    
  • Super Abstractor for DCP and CTEP trials
View Accrual Assignment HistoryNo

Yes

For Administrator's organization's or family member organization's trials.

Display Trial OwnershipNo

Yes

For any trial owned by the Administrator's site for which the organization is the lead organization. 

Manage Trial OwnershipNoYes
Manage Participating Site Record OwnershipNo

Yes

For registered users who are affiliated with the Administrator's organization. 

Grant Administrative AuthorityNo

Yes

For registered users who are affiliated with the Administrator's organization. 

Manage Program CodesNo

Yes

For details, refer to Managing Program Codes.

Request Administrative AuthorityYesYes
Manage System-Generated Emails

Yes

Globally, for user's own account
(receive all messages or none)

Yes

The system sends emails (including TSRs) to Site Administrators automatically only if the site Administrator's affiliated organization is the trial's lead organization, or if the Site Administrator is the trial submitter and/or trial owner.
Site Administrators can manage their own email notification globally, and other users' notifications on a trial-by-trial basis.

Register TrialsYesYes
Update/Amend TrialsYesYes
Add/Update Participating Site InformationYesYes

Return to top of page

Trial Categories (Study Sources)

...

MultiExcerptNametrialcategories

...

Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category. Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 for further information.

...

Return to top of page

Creating CTRP Accounts

...

MultiExcerptNamecreateaccount

...

Info

New users must have access to a valid email address to create an account.

Return to top of page

Creating New CTRP Accounts via Email

...

MultiExcerptNamecreateaccountemail

...

If you are new to Registration and you do not have an NCI account, request a CTRP account via the Registration account creation feature.

...

Return to top of page

Creating New CTRP Accounts Using NIH or NCI Credentials

...

MultiExcerptNamecreateaccountcredentials

...

Return to top of page

Requesting Organization Admin Rights

...

MultiExcerptNamerequestrights

...

  • Site administration - Accept or reject requests for Admin rights from other users within your organization
  • Trial ownership management - Assign and unassign ownership of your organization's trials to other registered users within your organization
  • Accrual access - Assign and unassign access to Accrual to registered users within your organization
  • Program code management - Manage the set of program codes and program code assignments for your organization family. For details, refer to Managing Program Codes.
Info
titleCondition for Admin Requests

The Request for Admin Access check-box on the My Account page is displayed only if no one else in your organization is an administrator.

How to Request Admin Rights

  1. On the top right corner of any page, click Your Username > My Account.
    The My Account page displays all of your Registration account information.
  2. Select the Request for Admin Access check box.

Return to top of page

Managing Registration Email Notifications

...

MultiExcerptNamemanageemail

The CTRP system can automatically send you an email message whenever some aspect of a trial you have submitted or own has changed. For example, the system would notify you when the CTRO has accepted a trial that you submitted. It would send another message when the Trial Summary Report (TSR) is available for review. You can choose to receive all messages or none of them.

...

How to Manage Registration Email Messages

  1. On the top right corner of any page, click Your Username > My Account. The My Account page displays all of your Registration account information.
  2. You have the following choices:
    • To receive all system messages, set Receive Email Notifications to Yes.
    • To opt out, set Receive Email Notifications to No.
  3. Click Save.

Return to top of page

 

Include Page
Getting Started with Registration v4.4
Getting Started with Registration v4.4