General Information

What is ClinicalTrials.gov?: 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.