October 2020: What’s New on ClinicalTrials.gov PRS

The below update has been posted on the What’s New section of ClinicalTrials.gov PRS Test, which will go live on October 01, 2020:

Record Information Download

For administrators only, information about all of an organization’s records can now be downloaded as comma-separated values (CSV) for input to spreadsheet applications such as Excel. An extensive list of fields is available with summary and status information from the PRS Home page record list, the Public Site Report, the Planning Report and the PRS Review Comments List page. Additionally, Sponsor, Collaborators, Initial Public Release Date and other fields are available. The additional fields have also been added to the Record Information application program interface (API).

The Record Information Download function is accessed via the PRS Home page Records menu. Administrators may wish to use auto-formatting features of their spreadsheet applications to make the information easier to read.

Field Length Changes

Maximum field lengths have been increased for the following Protocol Section data elements:

  • Why Study Stopped?: 250
  • Arm/Group Title: 100
  • Eligibility Criteria: 20,000

Maximum field lengths have been increased for the following Results Section data elements:

  • Participant Flow: Pre-assignment Details: 500
  • Participant Flow: Recruitment Details: 500
  • Participant Flow: Arm/Group Title: 100
  • Participant Flow: Arm/Group Description: 1500
  • Participant Flow: Period(s): Started: Comments: 500
  • Participant Flow: Period(s): Completed: Comments: 500
  • Participant Flow: Period(s): Additional Milestone(s): Comments: 500
  • Participant Flow: Period(s): Additional Milestone(s): Milestone Title: 100
  • Participant Flow: Period(s): Reason Not Completed: Other Reason: 100
  • Baseline: Arm/Group Title: 100
  • Baseline: Arm/Group Description: 1500
  • Baseline Analysis Population Description: 500
  • Baseline Measure Information: Category or Row Title: 100
  • Baseline Measure Data: NA (Not Available) Explanation: 500
  • Outcome Measure: Arm/Group Title: 100
  • Outcome Measure: Arm/Group Description: 1500
  • Outcome Measure: Analysis Population Description: 500
  • Outcome Measure: Category or Row Title: 100
  • Outcome Measure Data: NA (Not Available) Explanation: 500
  • Outcome Measure: Statistical Analyses: Method of Estimation: Confidence Interval: NA (Not Available) Explanation: 500
  • Adverse Event Information: Arm/Group Title: 100
  • Adverse Event Information: Arm/Group Description: 1500
  • Overall Limitations and Caveats: 500

June 2017: India Regulatory Update

June 30, 2017: According to the CTRI bulletin, all trials are flagged according to the status at the time of registration. For prospective registration at the time of trial submission, patient enrolment should not have begun. Otherwise, the trial will be flagged as ‘Trial Registered Retrospectively’. Once a trial is registered, flagging cannot be changed.