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Pediatrics / Research / Pediatric Clinical Research Office / Clinical Research Quality Assurance Review Process

Clinical Research Quality Assurance Review Process

  • Memo sent to principal investigator via email indicating tentative date and time that a study under their auspices is scheduled for review. If original date/time is not convenient, an alternate, mutually agreed upon date/time will be arranged.
  • Accompanying the notification of review memo is a Pre-Audit Information Worksheet that the Principal Investigator/Study Coordinator is requested to complete and forward to the PCRO QA Coordinator prior to the date and time of the review.
  • Once notification is received by the Principal Investigator, a pre-review meeting can be established at the Investigator’s request to discuss the plan and purpose of the review as well as answer any questions. At any time during the review, the Principal Investigator can request to meet with the PCRO QA Coordinator to discuss the status of the review.
  • The review is conducted over a sufficient period of time necessary to conduct a through and comprehensive review. This could be from one day to a week, depending on the amount/volume of records to be reviewed. The PCRO QA Coordinator will make every effort to minimize Principal Investigator/Study Staff time.
  • Records can be reviewed on-site at a  location where the records are stored, at a location requested by the Principal Investigator, or reviewed in the PCRO QA Coordinator office in 4-7219B.
  • If a deficiency(s) are noted during time period of the review, the PCRO QA Coordinator will endeavor to substantiate whether or not the deficiency(s) exist with the Principal Investigator/Study Staff. If the Principal Investigator can substantiate that a deficiency(s) does not exist, the deficiency(s) will be removed from the review findings.
  • Upon completion of the review a Draft Review Summary will be completed and reviewed by the Director, Operations, PCRO and the Director, PCRO.
  • Upon internal PCRO review of the Draft Review Summary, it will be forwarded to the Principal Investigator for review, comments, additions, clarifications, etc. If no revisions are noted, a Final Review Summary will be submitted to the Principal Investigator.
  • If the Principal Investigator requests incorporation of a revision(s) to the Draft Review Summary for the purpose of clarification, as a response to a deficiency(s) noted, to respond to steps taken to correct a deficiency(s), etc., the revision(s) will be incorporated into the Final Review Summary and submitted to the Principal Investigator.