Does my study need to be registered? | Who should be the Responsibility Party? | How to request an account with Brown | How to register a study | Record requirements | Record review process | FAQ | Who to Contact with Questions

ClinicalTrials.gov Records and Registration

WHEN DOES A STUDY NEED TO BE REGISTERED?

Please refer to Brown University’s clinical trials webpage for more information on registering and reporting requirements.

Brown University allows any Brown University IRB approved clinical trial to be registered on ClinicalTrials.gov regardless of this being a requirement for the study.

RESPONSIBLE PARTY

What is a Responsibility 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. The principal investigator is only the Responsible Party if designated by the sponsor, and the sponsor is the institution who initiates the study.

Why does the Responsible Party need to be determined prior to registration?

The study record should be registered with the Responsible Party’s institution. Each institution has their own ClincialTrials.gov accounts and requirements.

Should Brown University be designated as the Responsible Party?

Brown should be designated as the Responsible Party if:

• This is a single site study with Brown University IRB approval.
• This study is a multi-site study and Brown is the Prime Awardee of the sponsored funding; or
• This study is multi-site with no funding and Brown is the IRB of Record for the collaborating institutions.

CREATING AN ACCOUNT WITH BROWN

Requesting a Protocol Registration and Results System (PRS) account on ClinicalTrials.gov:

1. Request your account after receiving Brown IRB Approval, HRPP Exemption, or Reliance Agreement Execution.
2. Request a PRS account with Brown by emailing IRB Manager, Alana Chetlen. In the email please include your:
   1. Full name
   2. Brown email address
   3. Brown phone number
   4. Role in the research (PI, coordinator, research assistant, project administrator, etc.)
   5. Approved Brown protocol number
   6. Approved Brown protocol study title
   7. Brown PI’s name (if not the requestor)
3. Once HRPP has confirmed that a PRS account has been created, you will receive an email from ClinicalTrials.gov with a temporary password that should be changed after logging in for the first time.

CREATING A RECORD/REGISTERING A STUDY:

How to create and edit a registered study:

1. The Brown PI will need to create the record so it's associated with their account.
2. Directions for registering a study on ClinicalTrials.gov can be found here.
3. If the PI wishes to grant access to designated users, they can click the blue "Edit" button next to "Access List" in the Record Status box and then check off boxes next to any names of individuals to whom they would like to grant access to the record.

RECORD REQUIREMENTS:

Protocol Section:

• Resources:
  • The 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.
• Unique Protocol ID:  should be the Brown protocol number. This information can be found on any approval memo.
• Brief Title or Official Title: should match the Brown IRB approved study title.
• 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. Federal Government agency.
• Responsible Party: Designate the Sponsor (Brown).
• Human Subjects Review: 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 St, Box 1986
Providence, RI 02912
(401) 863-3050
[email protected]

• Detailed Description and Brief Summary: it is recommended that you 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, please change "we" to "the investigators" and "you" to "participants."
• Arm Description: this should be brief and include details about the intervention strategies administered or groups evaluated.
• Study Official: this is the person responsible for the overall scientific leadership of the protocol, such as the principal investigator.
• Plan to Share Individual Participant Data (IPD): must be 'Yes' or 'No' to satisfy the International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration  Policy IF you plan to publish with ICMJE  ('Undecided' is not accepted).

Document Section:

• When uploading documents be sure to include a cover page with each document upload. The cover page should include: the official title, NCT number and document date. The document date is the date it was most recently approved by the IRB.
• See Brown University's Clinical Trials webpage for Consent Form posting requirements.

Results Section:

• Certain Agreements: the sponsor of the study is Brown University, so indicate if the PI is an employee of Brown.

RECORD REVIEW PROCESS

Once the record has been approved and released by Brown’s HRPP, it will receive an internal review through ClinicalTrials.gov and either be accepted or returned for further modifications. If it is accepted, then the record will be made public.

All edits to the record will need to be reviewed by Brown’s HRPP and then ClinicalTrials.gov before they are made public. 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.

Once a National Clinical Trial number (NCT #) is received, update the Huron IRB Electronic System study record with this information. This should be done by adding a “Comment” to the study with “NCT#XXXXXXXX.”

FREQUENTLY ASKED QUESTIONS (FAQ)

How long does it take to have a record made public?

When do you receive the National Clinical Trial number (NCT #)?

Do all changes need to be reviewed by both Brown’s HRPP and ClincialTrials.gov staff?

How often should the PI update and review the record?

What information should be in the IRB submission about registering the study on ClinicalTrials.gov?

How long does it take to have a record made public?

Once the study record is marked as “completed” it will take Brown’s HRPP about 2-5 business days to provide a review and any changes/comments via email. Once the PI addresses this feedback, HRPP will approve/release the study for ClinicalTrials.gov staff review, which takes about 3-7 business days (30 or more days for a Results review). If there are comments/requested changes 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 there are no more concerns, then the study will be made public 2-5 business days after the ClinicalTrials.gov staff review is completed.

When do you receive the National Clinical Trial number (NCT #)?

The NCT # will be associated with the record once the study has been reviewed by both Brown’s HRPP and ClinicalTrials.gov staff with no concerns or required edits. The PI will receive an email with the NCT # from ClinicalTrials.gov. The record/NCT # will then be available on ClinicalTrials.gov within 2–5 business days.

Do all changes need to be reviewed by both Brown’s HRPP and ClincialTrials.gov staff?

Yes, all changes to the record require these reviews before they are made public.

How often should the PI update and review 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.

What information should be in the IRB submission about registering the study on ClinicalTrials.gov?

Include in the submission to HRPP for IRB review that this study is a clinical trial. Be sure to also refer to Brown’s Education Instructions webpage and Additional Consent Language documents for other clinical trial submission requirements.

QUESTIONS OR CONCERNS?

If you have any questions or concerns please refer them to Alana Chetlen or [email protected].