Per ClinicalTrials.gov the responsible party ensures that record information abides by any applicable laws, regulations or policies. The responsible party can either be the sponsor, the sponsor-investigator or a principal investigator (PI). The PI is only the responsible party if designated by the sponsor, and the sponsor is the institution that initiates the study.

The study record should be registered with the responsible party’s institution. Each institution has its own ClincialTrials.gov account and requirements.

Brown should be designated as the responsible party if the study is:

• a single-site study with Brown University IRB approval;
• a multi-site study and Brown is the prime awardee of the sponsored funding; or
• a multi-site study with no funding and Brown is the IRB of record for the collaborating institutions.

You can request a Protocol Registration and Results System (PRS) account on ClinicalTrials.gov after receiving an exemption from the Human Research Protection Program (HRPP) or approval from the Brown IRB, or after executing a reliance agreement.

Request a PRS account with Brown by emailing the Regulatory Advisory Unit at regulatoryadvising@brown.edu. In the email, please include the following information:

• Your full name
• Your Brown email address
• Your Brown phone number
• Your role in the research (PI, coordinator, research assistant, project administrator, etc.)
• Your approved Brown protocol number
• Your approved Brown protocol study title
• The name of the Brown PI (if different from the requestor)

Once a HRPP staff member has confirmed that a PRS account was created, you will receive an email from ClinicalTrials.gov with a temporary password that you should change after logging in for the first time.

The Brown PI will need to create a record on ClinicalTrials.gov so it is associated with their account. If the PI wishes to grant access to designated users, they can select “Edit” in the PRS, next to “Access List” in the Record Status box, and then check off boxes to any names of individuals to whom they would like to grant access to the grant.

How to Register Your Study on ClinicalTrials.gov

The ClinicalTrials.gov site is very user-friendly but it is highly recommended you refer to the Quick Start guide. The "Help" and "Definitions" links at the top left of the form take out the guesswork for data entry and formatting. Brown-specific guidance is provided below.

Protocol Section

Document Section

When uploading documents be sure to include a cover page with each document upload. The cover page should include: the official title, National Clinical Trial (NCT) number and document date. The document date is the date it was most recently approved by the IRB.

Results Section

Because the sponsor of the study is Brown University, under Certain Agreements indicate if the PI is an employee of Brown.

Once the study record is marked as “completed” it will take HRPP staff about two to five business days to provide a review and any changes or comments via email. Once the PI addresses this feedback, HRPP staff will approve/release the study for ClinicalTrials.gov staff review, which takes about three to seven business days (30 or more days for a results review). 

If ClinicalTrials.gov staff have additional comments or change requests, the PI must address them prior to the record being made public. Brown’s HRPP and ClinicalTrials.gov staff will then provide another review. If the edits require a revision to the approved study, you must wait to submit changes to the ClinicalTrials.gov record until the request has been reviewed and approved by Brown’s IRB.

The National Clinical Trial (NCT) number will be associated with the record once the study has been reviewed by both the HRPP team and ClinicalTrials.gov staff with no concerns or required edits. The PI will receive an email with the NCT number from ClinicalTrials.gov. The record and NCT number will then be available on ClinicalTrials.gov within two to five business days.

Once you receive an NCT number, update the study record in Brown’s electronic submission system (Huron) with this information. This should be done by adding a “Comment” to the study with “NCT#XXXXXXXX.”

The PI should review the record yearly and update the record each time a change is made to the study that affects the record. This update should be done after receiving IRB approval for this change.