Clinical Trial Registration, Amendments, and Updates
- What trials does NCI expect to be registered in CTRP?
- What data do I need to report and when?
- How do I register trials with CTRP?
- Are usernames and passwords required to register trials to CTRP?
- 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?
- My trial is still in review with the Institutional Review Board (IRB). Can I still submit to CTRP?
- 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?
- How often must trial registration be reviewed for accuracy?
- Who is able to verify trial data?
- What are the requirements to view a TSR file for trial verification?
What trials does NCI expect to be registered in CTRP?
NCI expects CTRP registration for all NCI-supported interventional clinical trials and existing NCI-supported interventional trials that were opened to accrual as of or after January 1, 2009.
"NCI-supported" means "all trials sponsored or otherwise financially supported by NCI." For instance, NCI expects all interventional clinical trials, however sponsored, that are conducted in NCI-designated Cancer Centers to be registered (with the exception below). Thus, trials that NCI-designated Cancer Centers report as interventional trials in the Cancer Center Data Table 4 Report to NCI are expected to be reported through CTRP. Both industry-sponsored and investigator-initiated trials conducted at NCI-designated Cancer Centers should be registered.
NCI also expects awardees outside NCI-designated Cancer Centers to register NCI-supported trials through CTRP, subject to the exception below.
Exception: Trials that are reviewed and monitored by NCI CTEP and DCP PIOs need not be registered through the CTRP website, as this information will be transferred within NCI. This exception applies to all CTEP trials submitted via the Clinical Data Update System (CDUS), including all NCTN trials, and all early phase trials submitted to the Clinical Trials Monitoring Service (CTMS) operated by Theradex.
CTRP supports registration of observational, ancillary and correlative studies, and NCI is reviewing registration requirements.
What data do I need to report and when?
You need to submit all NCI-supported interventional trials that were opened to accrual as of or after January 1, 2009 using the NCI CTRP Registration Site. Registration requires the entry of a limited number of data elements and the required upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites (for multi-site trials).
All study amendments should be reported to CTRP within 20 days of IRB approval and updates should be reported annually.
How do I register trials with CTRP?
Trials may be submitted online via the NCI CTRP Registration Site.
Trials may be registered through the web interface on the NCI CTRP Registration Site. Registration requires entering a limited number of data elements and requires upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites.
Additionally, industrial trials can now be registered in CTRP by specifying the ClinicalTrials.gov identifiers associated with the trials and importing them from ClinicalTrials.gov directly. This avoids the need to manually enter industrial trial information.
Another approach is to register trials utilizing web services. The NCI will work with individual centers to assist them should they wish to adapt their CDMS to use the registration service. If you have questions or comments regarding this approach, please contact us at email@example.com.
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.
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 our 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 firstname.lastname@example.org.
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 is: Accepted, Rejected, or Placed On-Hold with comments for rejection/placed on-hold (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 email@example.com.
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:
- If a subject has been enrolled to an incorrect study, or
- 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 firstname.lastname@example.org. They will work with you to gather the necessary data elements for registering the trial in CTRP.
My trial is still in review with the Institutional Review Board (IRB). Can I still submit to CTRP?
Yes, you can still submit your trial for processing to CTRP. In the absence of the IRB approval form, please attach a Word document that states your trial is still under IRB review and state the name of your IRB. Please be sure to update your record via update in the CTRP Registration Site when your trial has been approved by the IRB.
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.
How often must trial registration be reviewed for accuracy?
Trials must be reviewed for accuracy twice each year. The trial review date is calculated using the last verification date. Automated email reminders will be sent to trial owners, submitters and site administrators 30 days prior and 15 days prior to the trial review due date.
Who is able to verify trial data?
Trial owners and submitters are able to verify trial data.
What are the requirements to view a TSR file for trial verification?
A trial must meet the criteria below in order for you to view the TSR for trial verification and for the “Send TSR/XML” action to appear:
- You are the trial owner
- The trial is a “complete” trial (i.e. not Industrial/Other)
- Process status is one of the following;
- ClinicalTrials.gov “XML Required” field must be marked “YES”*
- Status dates must be valid, e.g., anticipated primary completion date cannot be in the past
If your trial does not meet these criteria, you will be unable to view the TSR file for trial verification. If your trial meets the five criteria above and you are still unable to view the TSR, contact the CTRO at email@example.com.
*Note: If you decide to change the “XML Required” field from “No” to “Yes”, please submit the following data elements to the CTRO:
- Responsible Party
- Trial Oversight Authority Country
- Trial Oversight Authority Organization Name
- FDA Regulated Intervention Indicator
- Section 801 Indicator
- Delayed Posting Indicator
- Data Monitoring Committee Appointed Indicator