TrialScope is part of Informa Pharma Intelligence, a division of Informa Business Intelligence, Inc. (IBI). IBI is a wholly-owned subsidiary of Informa PLC.

This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Tips to Comply with Final Rule Clinical Trial Disclosure Requirements

Francine Lane

April 17, 2017

APRIL 17, 2017

April 18, 2017 is the date that your studies must comply with the Final Rule… are you ready?

Tips to prepare for April 18…

Know which studies are in scope for this compliance date

The April 18 compliance date applies to studies with a study start date on or after Jan. 18, 2017 that are Applicable Clinical Trials or ACTs. This means that the study must meet the criteria for an ACT as described in the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial that the NIH has posted on its website.

Clinical trial results for studies with a Primary Completion Date on or after Jan. 18, 2017 must comply at the earliest by January 18, 2018, or a year after the Primary Completion Date, so there is still time to prepare for the results compliance date.

Verify your data

  • Verify that new data fields, and newly required data fields, have the required data – see also the Changes from Current Practice Described in the Final Rule on the NIH website.
  • Required data will change from Warning to Error messages, and must be resolved before the record can be released.
  • Check the Problem Report and the Planning Report provided by in the Protocol Registration and Results System (PRS) to find out which of your studies have errors.

Address reviewer comments

  • Reviewer comments must be addressed within 15 days for comments on protocol registration and within 25 days for results disclosure data
  • Comments will be identified as Major and Advisory starting on April 18. Major comments must be addressed.

Keep data up to date

  • Specified data elements must be updated within 30 or 15 days
  • There are several data elements that must be updated within 30 or even 15 days of a change

Changes requiring update within 15 calendar days of change:

  • Device Product Not Approved or Cleared by U.S. FDA: after a change in approval or clearance status has occurred

Changes requiring update within 30 calendar days:

  • Study Start Date: after the first subject is enrolled (if the first subject was not enrolled when the study was first registered)
  • Intervention Name: after the nonproprietary name is established
  • Availability of Expanded Access: after expanded access becomes available and 30 days after the NCT number is assigned to a newly created expanded access record
  • Expanded Access Status: after a change to the availability of expanded access
  • Expanded Access Type: after a change in the type(s) of expanded access that is available
  • Overall Recruiting Status: after a change in the overall recruitments status for the study
  • Site Recruiting Status: after a change to an individual site status
  • Human Subjects Protection Review Board Status: after a change is status by the review board
  • Primary Completion Date; after the study reaches its actual primary completion date
  • Enrollment: at the time the primary completion date is changed to actual
  • Study Completion Date: after the clinical trial reaches its actual study completion date
  • Responsible Party, by Official Title: after a change to the responsible party or the official title of the responsible party
  • Responsible Party Contact Information: after a change to the responsible party or the contact information of the responsible party

Verification Date

  • In addition to these updates that are required when changes are made, the full record must be reviewed at least once a year to update the verification date

About the author

As Vice President of Global Transparency for TrialScope, Francine is responsible for helping customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. She also serves as chair of the Drug Information Association (DIA) Clinical Trial Disclosure Community.