ClinicalTrials.gov is a web-based database of clinical trial information geared toward both the general public, who may wish to find opportunities for research participation, and for other researchers, who may wish to learn about studies that have already been conducted in a particular area and their results. ClinicalTrials.gov records are created and edited through the Protocol Registration and Results Reporting (PRS) platform and then moved to the public-facing website by NIH’s National Library of Medicine (NLM) staff, who manage the ClinicalTrials.gov site. Study registration and/or results reporting on ClinicalTrials.gov may be required by a funder, by FDA regulations, and/or as a condition of future publication.
Because a study can only appear on ClinicalTrials.gov once, it is important to identify who will complete the registration process. The study sponsor is typically responsible for this action. In the absence of an industry sponsor, the grant awardee or lead institution may be responsible. Once the “responsible party” is identified, the study will be registered in that Organization’s PRS account. When IU is the sponsor, IU assigns the responsibility party role to the Principal Investigator. The PI must then ensure that registration and results reporting requirements are met for each impacted trial. Of note, the timing of study registration may vary. Studies that require registration under FDA regulations or NIH policy must submit the ClinicalTrials.gov record for registration within 21 days of the first participant’s enrollment, while studies that are being registered to comply with ICMJE publication requirements must submit the ClinicalTrials.gov record for registration prior to the first participant’s enrollment.
When the posting of results data is also required, results must be submitted in the PRS no later than one year after the last participant interactions for the study’s primary and secondary outcomes, respectively. This requirement prevents extended timelines for data analysis and seeks to ensure that results are publicly disseminated in a timely manner after a trial’s completion. If a study is terminated early, any data collected towards the primary and secondary outcomes—for any subject(s)—must still be analyzed and reported on the site. In this scenario, the one year “due date” is still calculated based on the last participant’s data collection dates and not on the date of the termination decision. As such, studies with slow enrollment should be proactively considered for delayed results requests. Such requests are reviewed by the National Library of Medicine and are only granted for “good cause” (as defined by NLM).
For questions about whether a study should be registered, which Organization’s account should be used to register a study, to request an IU PRS user account, and/or to discuss eligibility for delayed results requests, please contact ctgov@iu.edu. Additional resources are also available on the IU HRPP website and within the PRS Help menu.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For interventional studies that involve Cancer Center patients and are directly or indirectly funded by NCI (National Cancer Institute), additional reporting requirements may be required. Please reference Study is Evaluated for OnCore Requirements for more information.
Registering your study with Clinicaltrials.gov is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.