COVID-19 CT.gov Guidance

ClinicalTrials.gov has not changed their requirements and if they do, ORS will notify research teams.

If your study has been put on hold due to COVID-19 please contact the ORS via our ticket system and indicated if your study is suspended (study expected to resume in the future) or terminated (study terminated early). If your study is terminated, please also provide the date (month, day, year) of the last study visit or the last date that data was collected, AND the total enrollment number.

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.

Failure to register and report your study in ClinicalTrials.gov can result in, but not limited to:
  • 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

Which Studies

To determine whether study registration is required:

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.

For more information, refer to the ISMMS ClinicalTrials.gov Registration and Reporting Policy.

Tip
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 7-8 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.

Institutional Policy
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

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. Download and complete the ClinicalTrials.gov Registration Form PDF (can also be found at ORS Research 411.)
  2. Create a new ORS Research 411 ticket, and attach the completed PDF form.
  3. 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.
  4. 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
  5. The QA team at ClinicalTrials.gov will review the record within 2-5 business days and either issues a NCT number or a request for clarifications.

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.

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.

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 word) 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 trials Primary Completion Date. All secondary outcome measure and pre-determined outcome measure results must be reported within 12 months for 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.

How

  1. Ways to initiate 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.
    • Provide manuscript or published paper, along with the most recent approved protocol, statistical analysis plan, and consent form 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.
  2. Please submit results to the ORS Team 1-2 months (depending on difficulty of data and statistics) to allow for adequate time for accurate and correct submission of results.
  3. PI will be given draft to review and correct before results are released on ClinicalTrials.gov.
  4. The protocol, statistical analysis plan, and informed consent will be uploaded to ClinicalTrials.gov and will be assessable to the public. Please provide 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

PRS Guided Tutorials: Post Results” Training video is on the ClinicalTrials.gov website

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.

Completing the Registration Form

  1. Please use most recent version found on the ORS ticket request.
  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. 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.
  8. Central contact and individual site contact information – this information will be on the public site for the layperson interested in participating in your study.

Results

PRS Guided Tutorials on the ClinicalTrials.gov website