- Do I have to submit the results of my study?
- You must report results for the following studies:
- All NIH funded clinical trials that require registration
- Results of “applicable clinical trials” (ACTs) need to be submitted. *ClinicalTrials.gov provides a checklist to help you determine if your study is an ACT: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
Other funding agencies may require results reporting. Check with your funder.
- When do I submit results?
- Results must be submitted within one year of completing data collection for the primary study outcome.
- Who will report the results of my study?
Study teams should register their studies in the Protocol Registration and Results Reporting System (PRS) at https://register.clinicaltrials.gov/. Contact the Yale ClinicalTrials.gov team if you need assistance.
- How do I report study results?
- ClinicalTrials.gov provides step-by-step guided tutorials to assist you with results reporting: https://prsinfo.clinicaltrials.gov/tutorial/content4/index.html#/
- Click on the “Help” and “Definitions” tabs in your study record for additional detailed guidance detailed guidance
- Our team is available to assist you and will review your study prior to submission to ClinicalTrials.gov.
- Are there other documents that I need to submit?
You must upload the study protocol and statistical analysis plan when submitting study results.
The study consent form must be uploaded if the study is supported by one of 20 Common Rule agencies or departments. Relevant agencies and departments include:
- Department of Health and Human Services
- Department of Veteran’s Affairs
- National Science Foundation
You can find the complete list here: https://en.wikipedia.org/wiki/Common_Rule
If you study is not supported by one of these 20 agencies, consent form submission is optional.
- How much time should I allot to enter the results of my study?
- Results reporting may take 10 to 45 hours to complete per Office of Management and Budget estimates: https://prsinfo.clinicaltrials.gov/omb-burden-statement.html
- What do I do when I have finished entering the results?
- Once you have entered the results, the study must be released for ClinicalTrials.gov review.
- If study involves an FDA-regulated drug, biologic, or device, the principal investigator (PI) is the responsible party and must release the study.
- The ClinicalTrials.gov team at Yale must release all other studies. Please let us know when the registration is complete.
- How long will it take for ClinicalTrials.gov to review my results?
- The review process may take up to 30 days.
- How will I know when ClinicalTrials.gov has completed its review of my study results?
- ClinicalTrials.gov will send an e-mail to the record owner (the PI of record) and to our ClincalTrials.gov Team at Yale.
- What feedback can I expect from ClinicalTrials.gov?
- In some cases, ClinicalTrials.gov will approve your results following its review.
- In other cases, ClinicalTrials.gov will provide comments and expect you to edit your registration before approval. You will be able to view the comments when you open your study record.
- Can I get help addressing comments?
- Yes, contact the Yale ClinicalTrials.gov team if you need assistance.
- When will my study results be made public?
- Results are posted within 30 days of submission. As it can take up to 30 days for ClinicalTrials.gov to complete its review, your results may be made public before you make the corrections that ClinialTrial.gov requested.