Record Maintenance

SOP: Record Maintenance

SOP: Record Transfers

Caution:

Avoid the appearance of outcome reporting bias (i.e., outcome switching). Any interested party can easily compare publicly available listings of study outcome measures for consistency, including: the public study record (all outcome changes tracked), the uploaded protocol document, and the manuscript, as applicable. The study record should be updated concurrent with implementation of changes to outcome measures. Updates submitted after the Study Start (Initiation) Date should include brief explanations (in Protocol/ Detailed Description) when:
  • Modifying any pre-specified outcome measure entry, beyond minor editorial changes.
  • Adding an outcome measure entry.
  • Removing an outcome measure entry. NOTE: Do not delete an outcome measure that has not been formally removed from the study protocol and analysis plan.
Likewise, it is recommended that the record be updated concurrently to reflect any material changes to the design information (i.e., Study Design, Arms & Interventions, Eligibility modules), including a brief explanation in the Detailed Description.

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. 
  • Please note that it may be necessary, under certain circumstances (e.g., Sponsor or Investigator is leaving Pitt), to change the Sponsor, Responsible Party or Sponsor Organization (i.e., transfer the record). Contact CTgov@pitt.edu for assistance.  
  • The Responsible Party must keep the record up to date per regulations at 42 CFR 11.64. Minimally, the entire record must be reviewed for completeness and accuracy, and the Record Verification Date updated, every 12 months and at the time of the initial results submission

More Frequent Updates 

All Records
 
Within 30 calendar days of:
  • Overall Recruitment Status: any change
  • Primary Completion Date (PCD): reaching actual PCD
    • PCD: change to “actual”
    • Enrollment: specify actual number enrolled
Required Updates if Study Start Date on or after January 18, 2017
 
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.
 
Within 30 calendar days of:
  • Study Start Date: first human subject enrolled
  • Intervention Name(s): non-proprietary name established
  • Individual Site Status: any change
  • Human Subjects Protection Review Board Status: any change in status.
  • 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
  • (For Expanded Access Records) Expanded Access Status and Expanded Access Type: any change

Within 15 calendar days of a change in:
  • Device Product Not Approved or Cleared by U.S. FDA
 
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
 
Required Updates if Primary Completion Date on or after January 18, 2017 (for Applicable Clinical Trials of unapproved or uncleared device products)
 
Within 30 calendar days of:
  • Intervention Name(s): non-proprietary name established
  • Study Completion Date: reaching actual study completion date

Are there other updates that may be required or helpful?

If the study is a clinical trial subject to the Revised Common Rule (“2018 Rule”), an IRB-approved informed consent form version used to enroll subjects must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Refer to the Study Documents page for further information.
 
If a plan to share individual participant data (IPD) from a clinical trial originates or changes after registration, the IPD Sharing Statement should be updated in the record, per the ICMJE Clinical Trial Data Sharing Statement Policy. Once available, references to IPD sets and supporting information, and to publications of the clinical study results, may be provided in the References module of the study record.

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.

How do I update a study record?

Refer to How to Edit Your Study Record on ClinicalTrials.gov and to the SOP linked at the top of this page for further information.