Pearls of Wisdom: Patient Case Review Debra Herzan, RN, BSN, OCN, CCRP Alliance Clinical Trials Auditor Alliance, Chicago Office
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Pearls of Wisdom: Patient Case Review
l Debra Herzan, RN, BSN, OCN, CCRP l Alliance Clinical Trials Auditor l Alliance, Chicago Office
Patient Case Review: Common Problems
l Incomplete or expired consent document signed by patient.
l Eligibility criteria are not met. l Treatment is not given per protocol instructions. l Cannot verify treatment adherence with oral medications. l Failure to evaluate response according to the protocol. l Failure to assess & report adverse events according to
protocol. l General data quality issues (timeliness, complete,
correct).
Incomplete or expired consent document signed by patient
l Pearl: Complete and Verify
Eligibility criteria are not met l Pearl: Source Documentation! If it’s not
documented, it didn’t happen.
Treatment is not given per protocol instructions
l Pearl: Review the protocol requirements and required AE assessments before each cycle
Cannot verify treatment adherence with oral medications
l Pearl: Do detective work
Failure to evaluate response according to the protocol
l Pearl: Review the Criteria for Response, Progression, and Relapse section of the protocol
Failure to assess and report adverse events according to
protocol l Pearl: Clarify, never guess!
General Data Quality Issues l Pearl: Complete→ Review→ Verify→ Submit
Pearls of Wisdom: Patient Case Review
Please save questions for the panel at the end of the presentations.
Related Documents
