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CLINICALTRIALS.GOV requirements for registration and informed consent Developed by: U-MIC University of Michigan IRB Collaborative

Rationale Transparency – public knows how its money is being spent Identify clinical trials for participants Provide a place where researchers can see what is going on elsewhere – even before results exist, to avoid duplication of effort ClinicalTrials.gov

It’s the law since September 2007! Food and Drug Administration Amendment Act (FDAAA) All “Applicable Clinical Trials” must register in ClinicalTrials.gov. “Applicable Clinical Trials” of FDA approved items must register AND report results. Why should I register my study on ClinicalTrials.gov? ClinicalTrials.gov

Required informed consent language “ A description of this clinical trial will be available on as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.” This requirement is a federal regulation, and for that reason, the required language cannot be altered in any way. ClinicalTrials.gov

“Applicable Clinical Trials” If drugs or biologics are involved, controlled clinical investigations subject to FDA regulation except Phase I trials ClinicalTrials.gov

“Applicable Clinical Trials” If a device is involved, prospective studies of health outcomes use an FDA regulated device compare an intervention with the device against a control except feasibility studies ClinicalTrials.gov

Exceptions: expanded access continued access purely retrospective studies purely observational studies some bioequivalence studies more like Phase I than II (most bioequivalence studies are considered applicable clinical trials) ClinicalTrials.gov

“As required by law” Guidance for Sponsors, Investigators, and Institutional Review Boards Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide) Feb If a clinical trial is not subject to the rule, do investigators have to inform trial participants about the availability of clinical trial information on No, if the clinical trial is not subject to the rule (not an applicable clinical trial), then investigators/sponsors do not need to inform participants about the availability of information on the website. The required statement should not be included in informed consent documents or processes for clinical trials that are not applicable clinical trials. However, if investigators/sponsors independently believe that reporting data on may influence subjects’ willingness to participate, nothing in this regulation prevents investigators/sponsors from voluntarily reporting trial data and informing trial participants in an appropriate manner. ClinicalTrials.gov

I want study participants to join my trial! Why else might I want to register my study on ClinicalTrials.gov? I want to publish! ICMJE says, “Register or don’t publish in our journals!” ClinicalTrials.gov

Reasons to Register & Use Informed Consent Language FDAAA Results & AE Reporting ICMJE Registration FDAAA Registration Looking for Participants ClinicalTrials.gov

Additional Resources General ClinicalTrials.gov information: especiallyhttp://prsinfo.clinicaltrials.gov Elaboration of Definitions of Responsible Party and Applicable Clinical Trial FDAAA related information: For specific questions or comments: Office of Extramural Research (OER): Frequently Asked Questions for NIH Grantees: Instructions for Authors sections of ICJME journals all have information regarding clinical trial registration Office of Regulatory Affairs: Diane Lehman Wilson ;

THANK YOU. Diane Lehman Wilson, MPP, JD Office of Regulatory Affairs University of Michigan Medical School Administration 14 Developed by: U-MIC