As part of The ISMMS CTSA ConduITS mission to streamline and centralize the infrastructure needed to accelerate translational research across an ever-expanding research enterprise, ConduITS and the Office of Research Services directs Investigators to resources and support related to scientific regulatory and reporting requirements which also includes the Research Roadmap.
As public awareness increases, more people are looking at clinical trials outcomes for information regarding efficacy and safety of therapies. The importance of posting of clinical trial information in a timely manner allowing for transparency of research study outcomes, broadening scientific knowledge for providers and other researchers, as well as enabling public trust of patients and volunteers cannot be underscored enough.
In the summer of 2020, Pre-Notice of Noncompliance letters were sent to Principal Investigators for studies registered on ClinicalTrials.gov, which is managed by NIH/NLM, who did not comply with their legal reporting obligation. In April 2021, the FDA issued about 40 Notice of Noncompliance letters giving responsible parties 30 days to meet their obligations or face penalties which can include, but are not limited to, monetary penalties, withholding of current or future grants, rejection of manuscripts for journal publication, and notice of noncompliance posted to the FDA’s website and on ClinicalTrials.gov.
During this period, nationwide, research institutions have improved in compliance with number of trials registered increasing and number of trials with unreported results decreasing. At ISMMS, investigators are involved in robust research clinical trials across all specialties and understand the importance of reporting results for the benefit of colleagues, the research community, and the public.
Please refer to the Research Roadmap for step-by-step guidance on ClinicalTrials.gov requirements or if you have questions please a Research 411 help desk ticket with The Office or Research Services.
ConduITS is supported by NCATS of the NIH’s CTSA Program. Any use of CTSA-supported resources requires citation of grant number UL1TR001433 awarded to ISMMS in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.
