ClinicalTrials.gov

Public registration of clinical trial information is required:

When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (42 CFR Part 11).  This includes:

• Controlled clinical trials of FDA-regulated drugs or biologics (Phases II – IV); and
• Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies).

See the ClinicalTrials.gov “Applicable Clinical Trial (ACT)” checklist to determine if registration of a study is required per federal regulations. 

When conducting a clinical trial funded by the National Institutes of Health (NIH) per NIH policy. If the answer is “yes” to all four of the following questions, then the research study would be considered a clinical trial according to the NIH definition:

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect being evaluated a health-related biomedical or behavioral outcome?

See NIH Definition of Clinical Trial Case Studies for additional guidance in determining if a research study is an NIH defined clinical trial.

For publication in a journal that follows the International Committee of Medical Journal Editors’ (ICMJE) policy, which requires registration of clinical trials in a public trials registry as a condition of consideration for publication.  

When to Register

Per federal regulations and NIH policy, new qualifying trials/studies must register no later than 21 days after the first participant is consented.  ICMJE recommends registration before beginning participant enrollment.

Who Should Register

The individual responsible for registering a clinical trial/study is considered the “Responsible Party.”  At Texas A&M, for investigator-initiated research, the Principal Investigator (PI) is expected to take on the role of the Responsible Party, with two exceptions:

• If there is an IND or IDE held by someone other than the PI, the IND or IDE holder is the Responsible Party

Multi-site studies should designate one PI and one institution as the Responsible Party.  Typically, the Texas A&M PI is the Responsible Party if Texas A&M is the lead performance site.

How To Register a Clinical Trial

Step 1: Request an individual account to ClinicalTrials.gov

Request an individual account to the ClinicalTrials.gov Protocol Registration and Results Submission System (PRS).  A principal investigator (PI), as well as any administrator who will assist him/her, should each obtain an individual account.

Step 2: Register the Clinical Trial

• Log into the PRS system and select “New Record” from the Quick Links menu.
• The “Record Owner” of the registration record is the individual who begins the record.  At Texas A&M, the Responsible Party should also be the Record Owner.  Once the Responsible Party has created the new record, they can give access to the record to any administrators who will help with registration.
• Enter the required data elements.  Use the protocol, informed consent document(s), and the IRB application to complete the registration form. 
• Ensure the IRB number is listed as the “Unique Protocol ID”.
• Preview, inspect, and submit the registration record. 
• Verify in PRS that the Record Status is “Released.”  ClinicalTrials.gov will not process the record unless it is released.  

For additional guidance, review ClinicalTrials.gov’s Protocol Registration Data Element Definitions.  

Step 3: Address PRS Review Comments

Anytime the Responsible Party releases a record, PRS staff will review it for any apparent errors, deficiencies, and/or inconsistencies based on the PRS Review Criteria.  If PRS Staff identify potential issues with your record, they will add comments to your record.  Major comments must be corrected or addressed.  Comments identified as Advisory, should be addressed to improve clarity of the record. 

Once a record is released, the Responsible Party should:

• Monitor the record for any PRS review comments.
• Respond, in a timely fashion, to any communications from Texas A&M oversight units regarding PRS review comments related to your study record.  
• Make corrections in response to PRS review comments within 15 days.
• Release the record for PRS review, once all corrections have been made.

Once the record is accepted by ClinicalTrials.gov staff for publication, the record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.

Required Updates to an Active ClinicalTrial.gov Record

In general, the Responsible Party must review and update, as necessary, an active study record at least annually.  Failure to do so will result in the record being identified as having a problem that needs to be addressed.

Some updates must be made more frequently than annually.  Specifically, the Responsible Party must update the registration record in ClinicalTrials.gov within 30 days of a change to the following:

• Overall Recruitment Status (for the entire study across all sites).
  • Note, if at least one facility in a multi-site clinical study has an Individual Site Status of “Recruiting,” then the Overall Recruitment Status for the study must be “Recruiting.”
• Individual Site Status (i.e., the recruitment status of each participating facility in a multi-site clinical study).
• Primary Completion Date
  • The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.

As a best practice, anytime you review or make a change to the record, update the record verification date to the current month and year before releasing it for review.

How to Report Clinical Trial Results

Federal regulations and NIH policy require the Responsible Party to report results information for the clinical trial no later than one (1) year after the Primary Completion Date indicated in the registration record.

The Primary Completion Date is the “date that the last subject was examined or received an intervention to collect final data for the primary outcome measure” of the study.

Results will be required if your study is registered as an Applicable Clinical Trial (ACT), Probable Applicable Clinical Trial (pACT), and/or is an NIH funded clinical trial.

Step 1: Review the Requirements for Reporting Results

• Review the Results Data Elements Definitions to understand what information is required.
• Review the guidance for each of the four required results modules, which are tabular summaries of:
  • Participant Flow-the progress of participants through each stage of a study.
  • Baseline Characteristics-the data collected at the beginning of the study for all participants.
  • Outcome Measures and Statistical Analyses-the pre-specified primary and secondary outcome measure values 
  • Adverse Events-all anticipated and unanticipated serious adverse events and unanticipated other adverse events exceeding a frequency threshold of five percent (5%) within any arm of the clinical trial.

Step 2: Complete the Results Modules

• Login to the ClinicalTrials.gov PRS, open the applicable record, and click “Enter Results”.
• Complete the required and optional data elements.  See ClinicalTrials.gov Results Review Criteria for guidance. 

Step 3: Upload Supplemental Documentation

As part of the results reporting, the following documentation must be uploaded to the study’s registration record in PDF format:

• Full study protocol
• Statistical analysis plan-if separate from the protocol.

Each document must be the most recent version reviewed by the IRB and include a cover page with the Official Title of the study, the NCT number (if available), and the date of the document.

The Responsible party may redact the following from the protocol prior to results submission:

• Trade secret and/or confidential commercial information 
• Names, addresses, and other personally identifiable information, and/or

Step 4: Release the Record

• Preview, inspect, and submit the registration record. 
• Verify in PRS that the Record Status is “Released.”  ClinicalTrials.gov will not process the record unless it is released.

Step 5: Address PRS Review Comments

Anytime the Responsible Party releases a record, PRS staff will review it for any apparent errors, deficiencies, and/or inconsistencies based on the PRS Review Criteria.  If PRS Staff identify potential issues with your record, they will add comments to your record.  Major comments must be corrected or addressed.  Comments identified as Advisory, should be addressed to improve clarity of the record. 

Once a record is released, the Responsible Party should:

• Monitor the record for any PRS review comments.
• Respond, in a timely fashion, to any communications from Texas A&M oversight units regarding PRS review comments related to your study record.  
• Make corrections in response to PRS review comments within 25 days.
• Release the record for PRS review, once all corrections have been made.