ClinicalTrials.gov & CTRP Registration

The Office of Data Quality assists DF/HCC Investigators with National Protocol Registration in the federal database www.ClinicalTrials.gov and the NCI's Clinical Trial Reporting Program (CTRP).

Resources

Related DF/HCC Policies

External Links

NCI Clinical Trials Reporting Program (CTRP) Website Link
ClinicalTrials.gov FDAAA 801 Requirements Link
Committee of Journal Editors (ICMJE) Registration Requirements Link

Logging In

For DFCI, BIDMC or BWH investigators:
1. Go to the ClinicalTrials.gov website: https://register.clinicaltrials.gov/
2. Enter Your Organization as "DFCI".
3. Enter your Username and Password.
4. Click Login button at bottom of page.
For MGH investigators:
1. Go to the ClinicalTrials.gov website: https://register.clinicaltrials.gov/
2. Enter Your Organization as "MassGH".
3. Enter your Username and Password.
4. Click Login button at bottom of page.
The contact will vary based on your home institution. Please see DF/HCC Contacts for ClinicalTrials.gov Accounts and Initial Registration.

Registration

DF/HCC Investigator-sponsored clinical trials that meet the Food and Drug Administration Amendments Act (FDAAA) of 2007 clinical trials registration requirement must be registered and updated on ClinicalTrials.gov. Generally, this includes interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation.

Some types of research are also required to be registered to ClinicalTrials.gov according to the HHS final rule and NIH policy. In addition, most medical journals, including the International Committee of Medical Journal Editors (ICMJE), require ClinicalTrials.gov registration as a condition of consideration for publication.

	FDAAA-801	ICMJE	Department of Health and Human Services-Final Rule	NIH Policy
What information is needed?	Registration and Results Reporting	Registration Only	Registration and Results Reporting	Registration and Results Reporting
What types of research?	Drugs, biological products and devices regulated by the FDA. Not Phase 1.	All phases. All types of interventions.	Drugs, biological products, and devices regardless if approved, licensed or cleared by FDA. Not Phase 1.	All phases. All types of interventions. Trials funded in whole or in part by NIH.
Effective as of	Applicable trials that have reached primary completion date on or after 12/26/2007	N/A	Applicable trials that have a primary completion date on or after 01/18/2017	Applicable trials that have activated for accrual on or after 01/18/2017
What happens if we don't comply?	Fine up to $10,000 per day and/or loss of federal funding	Refusal to Publish	Fine up to $10,000 per day and/or loss of federal funding	Termination of grant funding

The Office of Data Quality (ODQ) will register all interventional, DF/HCC investigator-sponsored clinical trials (regardless of phase) after IRB approval and before activation.

For all other DF/HCC investigator-sponsored clinical trials, you must indicate on the New Project Application that ClinicalTrials.gov registration is needed. You may also contact DFCIODQclinicaltrialsgov@partners.org to request registration.

Once a protocol obtains IRB approval, ODQ will create the initial ClinicalTrials.gov registration and notify the “Responsible Party”, typically the Sponsor-Investigator, that the registration is ready to be Approved and Released.

The Responsible Party must then login to ClinicalTrials.gov, review and update the record, and approve and release.

For more information:
- How/When to Register a Protocol on ClinicalTrials.gov
- DF/HCC Contacts for ClinicalTrials.gov Accounts and Initial Registration
On June 6, 2017, ICMJE announced new requirements for data sharing statements intended to encourage responsible and ethical sharing of data from clinical trials. As part of this effort, trials that begin enrolling participants after January 1, 2019 must include a Data Sharing Statement in the ClinicalTrials.gov registration as a condition for publication.

The ODQ is adding template Data Sharing language to the ClinicalTrials.gov registrations for new trials. However, the investigator acting as the Responsible Party must review for accuracy and make any necessary changes.

For more information, please see: DF/HCC Guidance on Data Sharing Statements for Investigator-Sponsored Research
An NCT number is assigned by ClinicalTrials.gov once a registration is accepted. DF/HCC requires an NCT number prior to activation.

The most common reasons why an NCT number has not yet been assigned include:
- The record has not been “approved” and “released” by the responsible party (typically, the sponsor-investigator).
- The initial ClinicalTrials.gov registration is pending QA review at ClinicalTrials.gov.
- ClinicalTrials.gov QA determined that the registration does not meet ClinicalTrials.gov guidelines and has been reset without an NCT number. Clinicaltrials.gov QA will post “Review Comments” on the fields in the record that need to be addressed.
1. Besides “Next Step” icon, click [ “Entry Complete”].
2. Beside “Next Step”, select “Approve”.
3. Beside “Next Step”, select “Release”.
A Release Confirmation Receipt will appear after the record has been successfully released to Clinicaltrials.gov.
Locate the “Next Step: Address Review Comments” field, found at the top of the Clinicaltrials.gov record.

Then, click on the “Review Comments”, which will bring you to a “read-only” version of the Clinicaltrials.gov record. Scroll through the record, to locate a “Comments” text box with a description of the “issue” found in the record.

To update the record:
1. Select [Edit] field by the protocol section that requires an update.
2. Update the section, per the guidelines specified by the Clinicaltrials.gov QA Comments.
Once the updates have been made Click on “Save” at bottom of page. The Responsible Party then needs to Approve and Release the record to initiate QA review.

Record Updates

At least once every 6 months. However, the Responsible Party, typically the Sponsor-Investigator, must update the record within 30 days of any of the following:
- Locations’ Recruitment Status changes at any participating site (Opened, Suspended, Closed)
- Overall Recruitment Status changes (Opened, Suspended, Closed)
- Primary Completion Date changes
For more information: When/How to Update a ClinicalTrials.gov Record
The Responsible Party must update and verify the ClinicalTrials.gov record every 6 months, even if nothing changes.
- Record Verification Date must be verified (with recorded time stamp) even if there were no other changes made to the record.
- Primary Completion Date (Anticipated) must be reviewed and updated (if needed).
- Study Completion Date (Anticipated) must be reviewed and updated (if needed)
Please notify DFCIODQclinicaltrialsgov@partners.org of any changes made to the Primary or Study Completion Date.

For more information: When/How to Update a ClinicalTrials.gov Record
1. Besides “Next Step” icon, click [ “Entry Complete”].
2. Beside “Next Step”, select “Approve”.
3. Beside “Next Step”, select “Release”.
A Release Confirmation Receipt will appear after the record has been successfully released to Clinicaltrials.gov.
Under the Revised Common Rule (45 CFR Part 46), one consent form version used to enroll participants must be posted on a publicly available Federal website. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Only one version is needed. There is no requirement to post all consent form versions or to update the posted version with any revisions.

DF/HCC sponsor-investigators are expected to comply and post the informed consent document(s) to ClinicalTrials.gov. At this time, ClinicalTrials.gov and Regulations.gov are the only publicly available federal websites that have been confirmed to satisfy the consent form posting requirement.

Generally, studies that were approved by the IRB prior to January 21, 2019 are not subject to the new Common Rule requirements. However, that is not always true. Please use the following links to learn more about the Common Rule revisions and determine if they apply to your research:
- OHRS Information on the new Common Rule
- Training on the new Common Rule

Results Reporting

Results reporting is required for applicable protocols as defined in FDAAA 801. Results reporting may also be required under the HHS final rule and NIH policy. If required, results must be reported within 12 months of either the estimated Primary Outcome Completion Date (as per ClinicalTrials.gov registration) or the actual date of Primary Outcome Completion endpoint.

	FDAAA-801	Department of Health and Human Services-Final Rule	NIH
Applicable Trials	Drugs, biological products and devices regulated by the FDA. Not Phase 1.	Drugs, biological products, and devices regardless if approved, licensed or cleared by FDA. Not Phase 1.	All phases. All types of interventions. Trials funded in whole or in part by NIH.
Effective On:	Applicable trials that have reached primary completion date on or after 12/26/2007	Applicable trials that have a primary completion date on or after 01/18/2017	Applicable trials that have activated for accrual on or after 01/18/2017

The International Committee of Medical Journal Editors (ICMJE) requires registration, but does not require results reporting, as a condition of consideration for publication.

If no participants were ever enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no further results information will need to be submitted.

For a trial that was terminated after participants were enrolled, you must report any available data. If a single or very few subjects were enrolled, and confidentiality is a concern, provide an explanation in all relevant fields for why data isn't being shared.

If no data are available for any of the Outcome Measures, specify zero ("0") for the Number of Participants Analyzed in each Arm/Group, and leave the data fields blank. In this case, provide an explanation in the Analysis Population Description for why zero participants were analyzed and, if appropriate, provide information in the Limitations and Caveats module.

Even if data are not entered for Outcome Measures, submit the available data for the enrolled participants in the Participant Flow, Baseline Characteristics, and Adverse Events modules.

For more information: https://clinicaltrials.gov/ct2/manage-recs/faq#terminated
For detailed instructions, please see When and How to Submit Results to ClinicalTrials.gov.

Results submission needs to involve a person who knows the details of the study design and analysis, such as an investigator or statistician. Results must be submitted within 12 months of the Primary Outcome Completion Date.

Prior to entering results, the ClinicalTrials.gov record must be updated with some required information prior to beginning results reporting.
- Overall Study Status must be consistent with Study Start and Study Completion Dates and cannot have a status of “Recruiting” or “Not Yet Recruiting”.
- Primary Completion Date must be “Actual” and dated in the past
- Enrollment must be “Actual” and will need to be the same as the Number “Started” in Participant Flow.
- Intervention names will need to be consistent with information to be entered in the Results Section.
- Arms/Groups in Protocol Section are consistent with Arms/Groups to be entered in the Results Section.
- Site Recruitment Status for each site in Location Section must be consistent with Overall Study Status
Once updated, the Responsible Party must approve and release. ClinicalTrials.gov QA approval can take 2-5 business days. Results reporting may begin once QA approval is received.

The study results must be summarized in a tabular format, per Arm/Group, in four (4) scientific modules: Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analyses, and Adverse Events. The modules allow for the entry and display of information in a series of data tables with supporting notes but without narrative conclusions about the results. Summary results information may be submitted once data are available for one or more primary outcome measures and for each arm of the study.

External information from ClinicalTrials.gov is available for the following:
- How to Submit Your Results
- Results Data Element Definitions: Details on the results data items (required and optional) that are entered via the PRS
- Results Review Criteria: Describes review criteria for submitted study records.
- Results Modules: Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analyses and Adverse Events
- Example results entries for common study designs (PDF):Parallel; Cross-Over; Factorial; Dose Escalation; Multiple Period
- Results Reporting Online Presentations
1. Besides “Next Step” icon, click [ “Entry Complete”].
2. Beside “Next Step”, select “Approve”.
3. Beside “Next Step”, select “Release”.
A Release Confirmation Receipt will appear after the record has been successfully released to Clinicaltrials.gov.
Locate the “Next Step: Address Review Comments” field, found at the top of the Clinicaltrials.gov record.

Then, click on the “Review Comments”, which will bring you to a “read-only” version of the Clinicaltrials.gov record. Scroll through the record, to locate a “Comments” text box with a description of the “issue” found in the record.

To update the record:
1. Select [Edit] field by the protocol section that requires an update.
2. Update the section, per the guidelines specified by the Clinicaltrials.gov QA Comments.
Once the updates have been made Click on “Save” at bottom of page. The Responsible Party then needs to Approve and Release the record to initiate QA review.

Definitions

The Primary Completion Date is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome whether the clinical trial concluded according to the prespecified protocol or was terminated.

The Primary Completion Date (whether “actual” or “anticipated”) will be used by ClinicalTrials.gov to determine when results must be reported. Therefore, it is very important that this date be reviewed and appropriately updated by the “responsible party.” We recommend review of this date every 6 months (the required record update interval).

This date should remain as “anticipated” until the primary completion has been reached. Then, the responsible party must update the record with the “actual” Primary Completion Date and complete results reporting.

For more information: How to Determine Primary Completion Date
ClinicalTrials.gov defines the Study Completion Date as the date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.
The Record Status is located at the top of record and indicates the current review stage of the ClinicalTrials.gov record. This should not be confused with the Overall Status which is the overall recruitment status of the trial.

The Record Status will be one of the following:
- In Progress: User is creating or modifying the record
- Entry Completed: User has finished updating the record and is ready for review
- Approved: Responsible Party has reviewed record and made necessary changes
- Released: Responsible Party has submitted the record to Clinicaltrials.gov
- PRS Review: The record is currently under review by the Clinicaltrials.gov PRS Team
- Public: The record passed PRS Review and is, or will be, posted (or updated) on the Clinicaltrials.gov website.
The Overall Recruitment Status in ClinicalTrials.gov should reflect the current accrual status of the protocol. The recruitment status must be updated within 30 days of a status change.

One of the following must be selected:
- Not yet recruiting: Participants are not yet being recruited
- Recruiting: Participants are currently being recruited, whether or not any participants have yet been enrolled
- Enrolling by invitation: Participants are being (or will be) selected from a predetermined population
- Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled
- Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred)
- Suspended: Study halted prematurely but potentially will resume
- Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- Withdrawn: Study halted prematurely, prior to enrollment of first participant
For registration fields, please see: Registration-Data Element Definitions

For results reporting, please see: Results-Data Element Definitions

Clinical Trials Reporting Program (CTRP)

As an NCI designated cancer center, all DF/HCC clinical trials are registered with the Clinical Trials Reporting Program (CTRP). Clinical Trial Registration Coordinators within the Office of Data Quality (ODQ) are responsible for centralized registration with CTRP, and updating CTRP with amendments and accrual information.

For more information, please go to the NCI Clinical Trials Reporting Program (CTRP) Website.