Registration - FAQs
Registration, Amendments/Updates - FAQs
- Are usernames and passwords required to register trials to CTRP?
- Is batch registration available?
- Will NCI work with us and/or our vendor to develop a link to CTRP?
- How do I know that my trials have been registered successfully?
- When can I view a trial?
- How do I modify trials or handle errors?
- How do I know if a trial has been previously submitted to NCI?
- How do I remove or delete study subject records, and what are the circumstances under which a study subject record should be deleted?
- How do I add my center as a participant site to an industrial trial not currently registered in CTRP?
- Can I register an Industrial trial without an NCT number?
- What formats are acceptable to upload supporting trial documents?
- What is the NCI Division/Program Code?
- What should be in the NCI Grant Information section?
Are usernames and passwords required to register trials to CTRP?The NCI CTRP Registration Site requires a username and password. It is a self-registering process and the user sets up his or her own account and password.
Is batch registration available?Yes. The Excel specification for batch registration is available.
Will NCI work with us and/or our vendor to develop a link to CTRP?Yes, NCI is willing to work with sites on their registration process. No "link" is required. System developers and vendors can configure their applications to use NCI Enterprise Services. CTRP is working with various vendors and institutions to facilitate registration via Clinical Data Management Systems (CDMS). If you have questions or comments regarding this approach, please contact us at NCICTRO@mail.nih.gov.
How do I know that my trials have been registered successfully?
Once you have submitted your trial for registration, you will receive an automated email acknowledgment from the NCI Clinical Trials Reporting Office (CTRO) confirming the submission. The CTRO will review your registration, abstract additional data elements from the protocol, and create a Trial Summary Report (TSR). You will receive an email notice from CTRP along with the TSR as an attachment in a Word format that you can edit. You will be asked to verify the accuracy of the abstracted information within the TSR and respond to the CTRO with your corrections or acceptance. If you do not respond, after 5 business days NCI will assume you have accepted your TSR.
You will receive an email message from the CTRO if your registration cannot be accepted, along with the reason(s) for its rejection (e.g., missing information, missing attached documents, etc.).
When can I view a trial?Once a trial has been reviewed and successfully registered in CTRP, a limited set of registration data elements can be viewed by all CTRP users with valid accounts.
How do I modify trials or handle errors?Modifications to data entered (but not yet submitted) may be made by trial submitters at any time during an online session prior to clicking on the "Submit to NCI" button in the NCI CTRP Registration Site. Once a trial has been submitted to NCI, direct access to the data elements for editing is not available. Submitted trial modifications may be done through direct communication with the CTRO via email at NCICTRO@mail.nih.gov.
How do I know if a trial has been previously submitted to NCI?Before submitting a trial, it is recommended that you search previously submitted trials to avoid duplication. The following steps outline how to search submitted trials:
- Go to https://trials.nci.nih.gov/registration
- Login using your registration account. If you do not have a registration account; click "New Account/Reset Password" and follow the online instructions.
- Once you have successfully logged in, the Search Trials page will appear.
- Click "Search Trials" in the left menu sidebar
- Click "Search My Trials" for all trials you have submitted. Click "Search All Trials" to view all trials you have submitted, as well as those trials that have been successfully registered in CTRP (registration data elements only).
- Provide one or more search criteria for the trial you want to retrieve.
- The search results page will appear with a list of trials that meet your criteria.
Note: Only submitters will be able to view their submitted trials prior to their validation by the CTRO. Once the trials have been validated by the CTRO and registered in CTRP, a limited set of registration data elements will be able to be viewed by all CTRP users with valid accounts.
How do I remove or delete study subject records, and what are the circumstances under which a study subject record should be deleted?
The only reasons a study subject should be deleted are:
1. If a subject has been enrolled to an incorrect study, or
2. If a subject is added due to an administrative error.
To delete a study subject record:
- Navigate to the trial you want to work on by following the instructions in "Selecting Listed Trials" or "Searching for Trials", and then click the corresponding "NCI Trial Identifier" link.
- If the "Search Study Subject/List of Study Subjects" page is not already displayed on the main menu, click "Study Subject Search"/List of Study Subjects page.
- In the list of study subjects, click the "Delete" icon. Be sure to select the "Delete" icon for the proper record. Once you have deleted a study subject record, there is no way to retrieve it. However, you can add it back to the trial later.
- Select the reason for deleting this subject-either "Enrolled in Incorrect Study" or "Other Administrative Error"-and then click "OK".
How do I add my center as a participating site to an industrial trial not currently registered in CTRP?
After requesting import/registration of an Industrial/Other trial, use the "Add My Site" feature on the CTRP Registry Site to add your site as a participant. This feature will be available no later than 5 days after registration. Note that you cannot add your site until the trial has progressed to Accepted. Also note that the registration of your trial in CTRP will not be complete until you return to CTRP and add your site as a participant.
Can I register an Industrial trial without an NCT number?
Yes, but we encourage you to provide: 1) the NCT number or 2) the protocol document, so that CTRO staff can abstract the necessary information for CTRP trial registration. In the rare event that you cannot provide either the NCT number or the protocol document, contact the CTRO at email@example.com. They will work with you to gather the necessary data elements for registering the trial in CTRP.
What formats are acceptable to upload supporting trial documents?
CTRP accepts Microsoft Word, Adobe PDF and WordPerfect formats.
What is the NCI Division/Program Code?
NCI Division/Program Code refers to acronyms and corresponding names for organizational units within the NCI's Divisions, Programs, and Offices that provide funding. NCI organizational units that provide funding include the following:
- CCR: Center for Cancer Research
- CDP: Cancer Diagnosis Program
- CIP: Cancer Imaging Program
- CTEP: Cancer Therapy Evaluation Program
- DCB: Division of Cancer Biology
- DCCPS: Division of Cancer Control and Population Sciences
- DCEG: Division of Cancer Epidemiology and Genetics
- DCP: Division of Cancer Prevention
- DEA: Division of Extramural Activities
- DTP: Developmental Therapeutics Program
- OD: Office of the Director
- RRP: Radiation Research Program
- SPOREs: Specialized Programs of Research Excellence
- TRP: Translational Research Program
What should be in the NCI Grant Information section?
The information requested in the grant section consists of several elements that identify the funding mechanism. Additional information on grants can be found by accessing the website: http://deainfo.nci.nih.gov/
A breakdown of a complete sample grant number is provided below; however, you only need to enter the Funding Mechanism, Institute Code, and Serial Number into the NCI CTRP Registration site:
Grant number example: 1Y01CM009999-01A1S2
|Type||Funding Mechanism||Institute Code||Serial Number||Year||Suffix|
Type: A single-digit code that appears at position 1 of the example. It identifies the type of application received and processed. Note: this is not required for CTRP.
Funding Mechanism: A three-character code, located at positions 2-4. It is used to identify areas of extramural research activity applied to funding mechanisms.
Institute Code: A two-character code (positions 5-6) which identifies the NIH Institute that directly funded the award. It identifies the first major-level subdivision and the organization that supports a grant, contract, or inter-agency agreement. The support may be financial or administrative.
Serial Number: A 6 digit number (positions 7-12) that is assigned sequentially to a series within an Institute, Center, or Division. Used as an identifier for the grant.
Year: A two-digit number (positions 13-14) that specifies the current year within an award. The number listed indicates the actual segment or budget period of a project. Note: this is not required for CTRP.
Suffix: A numeric or alphanumeric string, beginning in position 15. It is the code that identifies grant supplement, amendment or a fellowship's institutional allowance. Suffix designation follows the grant year. Note: this is not required for CTRP.