ClinicalTrials.gov Registration and Reporting

Complete the ClinicalTrials.gov Registration Form on REDCap.

NEW - Office Hours

ORS to offer office hours for your ClinicalTrials.gov needs.

Starting Jan 16, 2024, every Tuesday from 2pm-3pm

For zoom link, please request through the Research 411 Portal.

Useful Information

New short webinar series on YouTube from the FDA.

Useful Information

* ISMMS ClinicalTrials.gov Policy recently updated – see under Resources

+ See Appendix A for some guidance on determining whether study is required to be registered on ClinicalTrials.gov.

* See below for Tips and Other Important Information

And always, check with your sponsor for their requirements.

COVID-19 CT.gov Guidance

ClinicalTrials.gov requests results to be posted for COVID-19 related studies as soon as possible.

If your study has been put on hold due to COVID-19 or is now enrolling after being on pause please contact the ORS via our ticket system.

What

ClinicalTrials.gov is a registry of federally and privately funded clinical trials conducted in the United States and around the world. Managed by the National Library of Medicine (NLM) at the National Institute of Health (NIH), ClinicalTrials.gov aims to increase transparency and improve public awareness of research. It is a public information resource intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers. In 2005 the International Committee of Medical Journal Editors (ICMJE) began requiring trial registration as a condition of publication.

• Civil monetary penalties
• Withholding of remaining or future grant funds from HHS agencies and offices, and
• Rejection of manuscripts for publications in journals

As per the ISMMS ClinicalTrials.gov Registration and Reporting Policy, the Department will be responsible for financial penalties incurred by a Principal Investigator (PI) who is not compliant.

Refer to the information on this page for step-by-step guidance on ClinicalTrials.gov requirements and responsibilities.

Who

MSHS Principal Investigators (PIs) are responsible for:

1. Determining if their study is required to be registered
2. Registering, updating and reporting of results on ClinicalTrials.gov
3. Providing updates, dates, and documents in a timely manner

Which Studies

To determine whether study registration is required:

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

When

FDAAA and NIH Policy: The Responsible Party (that is, the sponsor or designated PI) must register the trial no later than 21 days after enrollment of the first subject.

ICJME Compliance: The ICJME requires registration before the first subject is enrolled.

ClinicalTrials.gov QA reviews all registrations prior to making the study record publicly available and issuing an NCT registration number. It is highly recommended that study teams allow a lead time of 14 business days to complete the registration process.

How

The Office of Research Services (ORS) facilitates ClinicalTrials.gov registration and reporting for MSHS researchers. See detailed instructions below.

While ORS facilitates ClinicalTrials.gov registration, maintenance and reporting, ORS is not the “Responsible Party” as per the FDAAA definition. The MSHS Principal Investigator is the “Responsible Party” and is responsible for study registration, registration updates, reporting results and ensuring accuracy of records. For more information, refer to the ISMMS ClinicalTrials.gov Registration and Reporting Policy.

Registration of Studies

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

1. 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.
2. 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.
3. 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.

Updates of Studies

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.

How

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

Reporting Results

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.
  1. 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.
    1. PI will be given a draft to review and correct before results are released on ClinicalTrials.gov.
    2. 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

      Principal Investigator Leaving Institution

      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

      Submit a Research 411 ticket and provide the information for:

      1. Study continuing at ISMSS

      1. Change responsible party to new PI
      2. IND holder transferred to new PI, if applicable
      3. Provide names and contact information for PI and CRC, if different
      4. Review record for accuracy

      2. Study continuing at PI’s new institution

      1. Provide ORS Team with new institution’s ClinicalTrials.gov organization name and user name account. User account can be PI’s account at new institution or the PRS Manager account at new institution

      3. Study closing

      1. Provide correct status of study – Completion versus Termination
      2. Provide Primary Completion date – Last date of the last study visit or data collected for the Primary Outcome measure.
      3. Provide Completion date – Last date of the last study visit or the last date that data was collected for the study.
      4. Provide the number of participants enrolled into the study.
      5. Ensure record information is accurate.
      6. Provide required results for the study.
      7. Or provide contact information for the PI and anyone involved with data analysis to ensure data is enter within 365 days of the Primary Completion date.

      When

      This process can take as long as 2-3 months. Please notify the Office of Research Services by submitting a ORS Research 411 ticket as soon as possible.

      Transferring ClinicalTrial.gov Records to ISMMS

      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

      Submit a Research 411 ticket and provide the information for:
      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.

      Penalties

      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
      Institutional Policy

      As per the ISMMS ClinicalTrials.gov Policy, the Department will be responsible for financial penalties incurred by a Principal Investigator (PI) who is not compliant.

      Tips and Other Important Information

      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
            1. phone number is required – please do not use your personal mobile number.

            Results

            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.