Clinical Trials Registration & Results Reporting
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.
CLINICALTRIALS.GOV TRAINING (CITI)
Want to learn about the basic process for registering and reporting a clinical trial through ClinicalTrials.gov? Take CITI’s Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov course.
U-M offers this course as optional training through the CITI Program. To access U-M’s CITI menu, log in to CITI website, click Courses, then select University of Michigan in the “Show courses for…” drop down field.
HRPP POLICY REFERENCES
HRPP Operations Manual, Part 6, Section II, B.5 & B.6
HRPP Operations Manual, Part 11, Section I, A.2
HRPP Operations Manual
WHERE TO REGISTER
Other public databases exist for registering and reporting clinical trial results. Some may charge investigators a fee for storage and maintenance of results data. There is no charge for listing studies on ClinicalTrials.gov.
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 begining participant enrollment.
WHO SHOULD REGISTER
The individual responsible for registering a clinical trial/study is considered the “Responsible Party.” At the University of Michigan, 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, and
- Within the Oncology CTSU, the University of Michigan Cancer Center may retain Responsible Party status or may designate it to the Principal Investigator.
Multi-site studies should designate one PI and one institution as the Responsible Party. Typically, the U-M PI is the Responsible Party if U-M is the lead performance site.
FAQs
Required Informed Consent Language for Applicable Clinical Trials:
Applicable clinical trials must use the unaltered consent template language provided below in the informed consent document:
- “A description of this clinical trial will be available on the Clinical Trials website, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Required Informed Consent Language for NIH and other Sponsor Requirements for Registration and Reporting
NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017). Use the below language:
- “This trial will be registered and may report results on www.ClinicalTrials.gov, a publicly available registry of clinical trials.”
U-M IRB Informed Consent templates contain the above language. Refer to IRMED Informed Consent Template and IRB HSBS Informed Consent Template
IRB approval is required for the study, but the IRB does not review the registration record in ClinicalTrials.gov. Once registration on ClinicalTrials.gov is complete, add the NCT # to the IRB application.
Failure to register/update a trial/study or providing incomplete, false or misleading registration information may result in:
- Refusal of consideration by ICJME member (or other) journals
- Monetary penalties
- Withholding of federal research funds
- Return of grant funds to the sponsor
References and Resources
ClinicalTrials.gov Support Materials
ClinicalTrials.gov Support Materials The ClinicalTrials.gov site contains all the information you need to register a study, edit a registration record, and report results from policies to specific procedures to data element definitions, templates, and checklists.
Questions?
For questions related to ClinicalTrials.gov, contact:
Campus Units: Office of Research Compliance Review (ORCR) at (734) 764-3628 or orcr-deptemail@umich.edu
Medical School Units: Office of Regulatory Affairs (734) 764-0634