Record Maintenance

Important Note: Study Start (Initiation) Date is the date on which the first participant is enrolled. "Enrolled" means a participant's, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.

When must a study record be updated?

The Responsible Party or designee is required to routinely monitor the record and take immediate action to address all problem messages.

The Responsible Party must keep the record up to date per regulations at 42 CFR 11.64. There are different requirements based on whether the Study Start Date was before January 18, 2017 or on/after January 18, 2017. Minimally, the record must be reviewed for accuracy and the Record Verification Date updated every 12 months.

Required Updates if Study Start Date before January 18, 2017

Within 30 calendar days of:

  • Overall Recruitment Status: any change
  • Primary Completion Date (PCD): reaching actual PCD 

Required Updates if Study Start Date on or after January 18, 2017

Within 15 calendar days of a change in:

  • Device Product Not Approved or Cleared by U.S. FDA

Within 30 calendar days of:

  • Study Start Date: first human subject enrolled
  • Intervention Name(s): non-proprietary name established
  • Overall Recruitment Status: any change
  • Individual Site Status: any change
  • Human Subjects Protection Review Board Status: any change in status.
  • Primary Completion Date (PCD): reaching actual PCD
    • PCD: change to “actual”
    • Enrollment: specify actual number enrolled
  • Study Completion Date: reaching actual study completion date
  • Responsible Party, including Official Title (in study record): any change
  • Responsible Party Contact Information, including Official Title (PRS user account information): any change

If subjects are notified of any changes from an IRB modification, updates to all data elements related to the modification must be submitted within 30 calendar days of IRB approval.

If the criteria related to expanded access described under “Study Type” in the Tip Sheet (link under “Registration” tab) come to apply during the course of a study, the following updates to the study record are required within 30 calendar days of:

  • Availability of Expanded Access: expanded access becoming available
  • Expanded Access Record: NCT number assignment to a newly created expanded access record

Expanded Access records only: Updates to Expanded Access Status and Expanded Access Type are required within 30 calendar days of any change.

Please note that it may be necessary, under certain circumstances (e.g., Responsible Party is leaving Pitt), to change the Sponsor Organization and/or Responsible Party to ensure that reporting obligations continue to be met.

 

When must a study record be corrected?

42 CFR 11.64(b)

Quality control. After clinical trial registration or results information has been submitted, including the updates specified above, the NLM may issue comments concerning apparent errors, deficiencies, and/or inconsistencies in the submitted information identified during procedures for quality control review. The responsible party must correct or address all apparent errors, deficiencies, and/or inconsistencies identified, not later than 15 calendar days for clinical trial registration information, or 25 calendar days for clinical trial results information, after the date of the electronic notification sent to the responsible party.

Other corrections. A responsible party who becomes aware of errors in any submitted clinical trial information, other than those identified as part of the QC review comments described above, shall have not more than 15 calendar days for clinical trial registration information, or 25 calendar days for clinical trial results information, to correct or address such errors.