- What is ClinicalTrials.gov?
- Is the largest online trial registration and results reporting repository in the world
- Includes published and non-published studies
- What is Yale’s policy on clinical trials registration and reporting?
- You can find Yale’s policy here: https://your.yale.edu/sites/default/files/hrpp-policy-1000-clinicaltrialregistrationandresultsreporting18apr2017.pdf
- Why should I register my study/report results?
- Trial registration and reporting:
- Fulfills regulatory requirements
- Fulfills ethical obligations to study participants, the public and the medical/scientific community
- Reduces publication bias and disseminate crucial scientific information
For more detail see: clinicaltrials.gov/ct2/manage-recs/background
For data comparing Yale with other major universities on ClinialTrials.gov reporting requirements see: UAEM | Clinical Trials Transparency - The role of universities in a more equitable biomedical R&D system (altreroute.com)
- What study information does ClinicalTrials.gov require?
When registering your study, you will be asked to:
- Describe the study and timeline
- List relevant personnel and their contact information
- Identify the design, outcomes, eligibility criteria
When reporting results, you will be asked to:
- Describe the patient flow
- Present participants’ baseline characteristics
- Complete analyses for primary and secondary study outcomes
- List serious and other adverse events
- Upload the study protocol, including the statistical analysis plan
- Upload consent documents if required by the funder. See “Are there other documents that I need to submit?” below.