Frequently Asked Questions - CTD

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Below is a list of Frequently Asked Questions about Clinical Trial Disclosure at the University of Miami. Links to resources and tools have been included within the answers where applicable. Please contact us if you still have unanswered questions. 

  1. My study has not been approved by the IRB. Can I still register it on ClinicalTrials.gov?
  2. Do I need an individual account to register my study?
  3. Are clinical trials using unapproved drugs/biologics/devices required to post results on ClinicalTrials.gov?
  4. What is an applicable clinical trial (ACT) according to the Food and Drug Administration?
  5. Who is responsible for registering protocols and reporting results for applicable clinical trials?
  6. Do I need to register my “Clinical Trial” even if it is not an “Applicable Clinical Trial” under FDAAA?
  7. What are the penalties for failing to register?
  8. My study was terminated, and no patients were enrolled, do I still need to enter results?
  9. My study was terminated; however, data were not collected for all of the outcome measures. Do I still need to enter results?

1. My study has not been approved by the IRB. Can I still register it on ClinicalTrials.gov?

Yes, you can! You do not need to wait for IRB approval to register your study on ClinicalTrials.gov. Once you receive IRB approval, update the Overall Recruitment Status on https://register.clinicaltrials.gov and release for review.

For assistance with completing the section that contains the information for IRB approval, utilize our Oversight Cheat Sheet as a guide.

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2. Do I need an individual account to register my study?
Yes, you will need an individual Protocol Registration and Result Reporting System (PRS) account to register your study. You may obtain your account by using this Link to submit the request form.

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3. Are clinical trials using unapproved drugs/biologics/devices required to post results on ClinicalTrials.gov?
Yes. If you have additional questions or concerns, please complete the form to Request Assistance.

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4. What is an applicable clinical trial (ACT) according to the Food and Drug Administration?
In general, a study is likely subject to the requirements of FDA Amendments Act (FDAAA) Section 801, if 'YES' is answered to all five questions below:
 
  1. Was the study initiated after September 27, 2007 (OR ongoing as of December 26, 2007)?
  2. Is the study ‘interventional’ (i.e., participants are assigned to interventions by protocol)?
  3. Does the study evaluate a ‘drug,’ ‘biological product,’ or ‘medical device’ (whether or not approved for marketing in the United States)?
  4. Is the study not considered a phase I clinical investigation (e.g., a phase 2 study) OR not considered a ‘small feasibility’ device trial (e.g., a pivotal study)?
  5. Does the study have at least one site located in the United States OR is the study conducted under an IND or IDE?
More Details can be found in the Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial document. 

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5. Who is responsible for registering protocols and reporting results for clinical trials?
The University of Miami considers the Principal Investigator (PI) or Sponsor-Investigator (SI) to be responsible (and therefore serve as the Responsible Party) for registering their clinical trial on ClinicalTrials.gov.  The PI/SI may delegate the entry of the information to a team member; however, the Responsible Party is responsible for approving and releasing the record.

If you have additional questions or concerns, please complete the form to Request Assistance.

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6. Do I need to register my “Clinical Trial” even if it is not an “Applicable Clinical Trial” under FDAAA?
Yes, your trial must be registered in ClinicalTrials.gov if it meets the requirements of a University of Miami Applicable Clinical Trial (UMACT), as per policy HSR-P-101.

RCQA has created a Tool to determine whether a study requires registration through a series of questions.

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7. What are the penalties for not registering your study?
For ICMJE: Manuscripts for unregistered trials or late registrations will not be considered for publication in journals that adhere to ICMJE standards.

For FDA: Per FDAAA and 42 CFR § 11, penalties may include civil monetary fees up to $10,000 (increases annually due to inflation) for not complying to submit or for submitting inaccurate information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $10,000 per day until resolved.

For Federally Funded Grants: Penalties may include the withholding or recovery of grant funds.

For CMS: Qualifying services submitted to Medicare without an NCT number may not be reimbursed.

If you have any additional questions or concerns, complete the form to Request Assistance.

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8. My study was terminated and no patients were enrolled, do I still need to enter results?
If participants were never enrolled in the trial, results are not required. Remember to change the Overall Recruitment Status to “Withdrawn.”

For additional assistance on entering your results, please complete the form to Request Assistance.

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9. My study was terminated; however, data were not collected for all of the outcome measures. Do I still need to enter results?
For a trial that was terminated after participants were enrolled, provide all data for Participant Flow, Baseline Characteristics, and Adverse Events. For Outcome Measures, report all available data. If data is not available for any specific outcome, specify zero (“0”) for the "Number of Participants Analyzed" in each Arm/Group, and enter N/A in the data field. In addition, provide an explanation in the "Analysis Population Description" for why zero participants were analyzed; if appropriate, provide information in the "Limitations and Caveats" module.

For additional assistance on entering your results, please complete the form to Request Assistance.

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