Division of Research
How to Register a Brown Study on ClinicalTrials.gov
Identify the Responsible Party
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.
Create an Account with Brown
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 IRB manager (irb@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.
Create a Record and Register a Study
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.
Enter Information for the Record
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
Use the IRB protocol number, which can be found on any approval memo.
The Brief Title should match the IRB-approved study title.
The Secondary ID should be the complete grant or contract number. This should be listed if the clinical trial is funded in whole or in part by a U.S. government agency.
Designate the sponsor (Brown).
Include only general Brown IRB contact information (phone number, email, mailing address) and not a specific HRPP staff member’s information.
Brown University Institutional Review Board
350 Eddy Street, Box 1986
Providence, RI 02912
401-863-3050
irb@brown.edu
Use language from the Lay Summary in your protocol submission. Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
If the study received an IRB waiver of consent and there is no consent form to post, then it is recommended you include language in the “Detailed Description” section of the record that an IRB waiver of consent was received.
If the study received a HIPAA authorization waiver it is recommended this be mentioned in the “Detailed Description” section of the record.
Remove all personal pronouns. For example, change "we" to "the investigators" and "you" to "participants."
The Arm Description should be brief and include details about the intervention strategies administered or groups evaluated.
The Study Official is the person responsible for the overall scientific leadership of the protocol, such as the PI
If you plan to publish with the International Committee of Medical Journal Editors (ICMJE), you must select either “Yes” or “No” regarding plans to share individual participant data (IPD). ICMJE does not accept “Undecided.”
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.
Submit the Record for Review
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.”
Review and Update the Record
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.
Clinical Trial Reporting Requirements
All Brown University investigators conducting a clinical trial are required to comply with the consent form posting requirements included in federal regulations. The Human Research Protection Program (HRPP) team is responsible for general oversight and support of ClinicalTrials.gov registration and enforcement of Brown’s statement of compliance.