ClinicalTrials.gov Registration and Reporting

What

Determine if study registration is required

• Consult with program sponsor
• Review Appendix A of the ISMMS ClinicalTrials.gov Registration and Reporting Policy
• Contact editor of Journal
• Another resource: Review Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) on ClinicalTrials.gov

Who

Responsible Party (the designated PI)

When

FDAAA and NIH Policy:  must register the trial no later than 21 days after enrollment of the first subject.

ICJME Compliance: must register before the first subject is enrolled.

How

1. Complete the ClinicalTrials.gov Registration Form on REDCap.

Reference guides on completing the registration form:

1. • Protocol Data Element Definitions
   • ClinicalTrials.gov Protocol Registration Quality Control Review Criteria
   • Tips and Other Important Information

2. The ORS Team sends the study team a draft of their new study record in ClinicalTrials.gov to review before continuing to the next step in the registration process.
3. Account information and instructions on releasing the record on the ClinicalTrials.gov website are sent to the Principal Investigator. When all information has been reviewed the PI is responsible for approving and releasing the record on ClinicalTrials.gov.
4. The QA team at ClinicalTrials.gov will review the record and either issue a NCT number or a request for clarifications. The ORS Team will contact the PI and the research team if more information is requested.

What

All records must be reviewed and if applicable, updated every 12 months. In general, clinical trial registration information submitted to ClinicalTrials.gov must be updated not less than once every 12 months. Some data elements may be required to be updated more rapidly, generally 15-30 days.

ClinicalTrial.gov records are required to be updated within 30 days of a change to any of the following:

• Dates: Study Start date, Primary Completion date, Overall Study Completion date (last data collected)
• Recruitment/Enrollment Status – overall, individual sites
• Review Board Status

For more information, refer to ISMMS ClinicalTrials.gov Policy.

Who

Responsible Party (the designated PI)

When

Updates are required within 15 – 30 calendar days of a change. Record Verification Date must be updated not less than once every 12 months.

Refer to the ClinicalTrials.gov Clinical Trial Registration Data Elements for More Frequent Updating Table  for specific information that requires time sensitive updating.

How

Submit a Research 411 ticket for changes within 15 – 30 calendar days.

What

Results are required for any study funded in whole or in by the NIH, whether subject to the final rule or not. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

Results are required for any study that falls under the definition of an Applicable Clinical Trial.

Responsible party (designated PI) must submit results in accordance with the following policies:

FDAAA and NIH Policy: Clinical trial results, including adverse events, must be reported within 12 months after the trial’s Primary completion Date, which is defined as “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 pre-specified protocol or was terminated”. All secondary outcome measure and pre-determined outcome measure results must be reported within 12 months of that outcome. All study results must be entered by the study completion date.  Reporting of Results must occur even when a protocol is terminated earlier than initially planned.

ICJME Compliance: The ICMJE will not consider as prior publication the posting of trial results in any registry that meets the above criteria if results are limited to a brief (500 words) structured abstract or tables (to include trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events).

When

Primary Outcome Measure Results are required to be reported within 12 months of the trial’s Primary Completion Date. All secondary outcome measure and pre-determined outcome measure results must be reported within 12 months of the last date that data was collected, that is, the study completion date reported on ClinicalTrials.gov. Reporting of Results must occur even when a protocol is terminated earlier than initially planned.

How

1. ORS Team will reach out to PI and the research team to initiate the process 2 months prior to the due date. If you do not hear from us, please submit an ORS Research 411 ticket.
2. Prior to 2 months: Ways to initiate the process for entering data results into ClinicalTrials.gov:

• • Responsible Party, PI, or biostatistician enters directly into ClinicalTrials.gov. Send ORS Research 411 ticket request to provide access for biostatistician to enter results if needed.
  • Provide manuscript or published paper, along with the most recent approved protocol, statistical analysis plan, and consent form (informed consent for studies that fall under Common Rule) for ORS Team to make first pass at entering results. Send via ORS Research 411 ticket.
  • Create an ORS Research 411 ticket to request a template of all required fields for reporting results. Provide most recent approved protocol, statistical analysis plan, and consent to be uploaded to ClinicalTrials.gov.

3. If you would like ORS to help with entering results, please submit results to the ORS Team 1-2 months (depending on the difficulty of data and statistics) to allow for adequate time for accurate and correct submission of results.

• • We cannot guarantee results will be ready for release by the required date if we don’t receive all required information within 1-2 months.
  • We can request that the PI will enter results themselves directly into ClinicalTrials.gov if the PI and research team do not respond to the request for results.

4. PI will be given a draft to review and correct before results are released on ClinicalTrials.gov.
5. The protocol, statistical analysis plan, and informed consent (informed consent for studies that fall under Common Rule) will be uploaded to ClinicalTrials.gov and will be accessible to the public. Please provide the date (month, day, year) for each document version provided. The following information may be redacted in the protocol and consent:

• • Names (other than the PI)
  • Addresses
  • Other personally identifying information
  • Trade secrets
  • Confidential commercial information

Reference

• Help: Results Data Entry
• PRS Guided Tutorials for Registering Trials and Posting Results – Training video is on the ClinicalTrials.gov website
• Results Data Element Definitions – descriptions for each field for reporting data for results
• ClinicalTrials.gov Results Quality Control Review Criteria – Introduction and Overview

What

Prior to departure, the Responsible Party for the ClinicalTrials.gov record (the PI) must notify the ORS to transfer or complete the study record. If applicable, a plan for providing results will be required.

How

Principal Transferring Study records from another institution to ISMMS’s account on ClinicalTrials.gov

Requirements – participants to be enrolled at ISMMS, or study visits will be conducted at ISMMS.

How

1. Mount Sinai GCO number
2. Mount Sinai IRB status information
3. PI and CRC contact information
4. NCT number
5. Ensure all info is current and accurate

Note: Records will not be accepted at ISMMS if study visits are completed at PI’s previous institution and study is in data analysis only status.

Failure to comply with Federal, NIH and ICMJE regulations can have serious repercussions for individuals, institutions and research teams including but not limited to:

• Rejection of manuscript submission to journals
• Suspension or termination of grant or contract funding
• Impact future funding decisions
• PI’s name posted on FDAAA, ClinicalTrials.gov and other public lists for noncompliance
• Civil monetary penalties of over 12,000.00 per day, subject to inflation

 Understanding Dates

• Start Date = date of first enrollment
• Primary Completion Date = date of the last date that data was collected for the primary outcome measure
• Study Completion Date = date of the last study visit or the last date that data was collected.

At registration, provide anticipated dates, which are updated as needed, until actual dates are available.

Recruitment and Enrollment concerns as it relates to Completion Dates

**If your study status is actively recruiting, and your last enrollment was 9 months ago, please contact ORS to ensure that your study does not fall into noncompliance due to the dates definition that ClinicalTrials.gov has set.

Completing the Registration Form

1. Please see link at the top of this page.
2. All fields are required. Please provide information for all fields to expedite review process.
3. Do not use first or second person pronouns. Replace “I” and “we” with “the investigator; replace “you” with “participants”.
4. Define all acronyms the first time.
5. If NIH funded, include the NIH Institute or Center as a Collaborator, and provided Grant number in the secondary ID field.
6. Collaborators – do NOT include individuals. This field is for institutions or organizations only, not PIs. If the collaborator is not recognized in ClinicalTrials.gov, you will be asked to verify that the correct name is provided and ClinicalTrials.gov will be asked to recognize that institution or organization.
7. Please delete citations/footnotes from descriptions.
8. Outcome measures
   1. List each measure separately.
   2. List your outcome measure variable, not your aims or objectives.
   3. Surveys and Questionnaires please provide official name of the tool. Scale, please provide the minimum and maximum score on the scale, and what a higher score indicates. If there are subscales, please provide minimum and maximum subscale score and what a higher score indicates.
   4. Timeframes – please be specific (hint: provide a number)
      1. Not acceptable- e.g at discharge
      2. Acceptable – e.g at discharge, average 4 days or at discharge, day 4
9. Central contact and individual site contact information – this information will be on the public site for the layperson interested in participating in your study.
   1. phone number is required – please do not use your personal mobile number.

Results

PRS Guided Tutorials and Training Materials on the ClinicalTrials.gov website’

Good Cause Extension (GCE) Request Information Available

The Final Rule (42 CFR Part 11) Information page has been updated to include the Good Cause Extension Request Process and Criteria document. This document explains the process of submitting a good cause extension (GCE) request, the information to be included in GCE requests, and the criteria NIH uses to evaluate GCE requests. As of February 15, 2023, GCE request submissions will be subject to these criteria.

FAQs Available to Clarify the Good Cause Extension Request Process and Criteria

• How does NIH determine whether to grant or deny a good cause extension request submitted under 42 CFR 11.44(e)?
• What is the process to file an appeal after a good cause extension request for delayed submission of results information has been denied or granted with an earlier deadline than requested?
• Updated related FAQs under the Results Information and Submission Deadlines section linking to Good Cause Extension Request Process and Criteria document.

IF YOU ARE REQUESTING AN EXTENSION, PLEASE NOTE THAT THE PI WILL HAVE TO LOG INTO CLINICALTRIALS.GOV AND GO THROUGH THE PROCESS THEMSELVES. ORS WILL NOT REQUEST ON PI’S BEHALF.