Analysis of samples supporting a clinical trial requires familiarity with the clinical protocol, at least at the sample management and bioanalytical PI level. This understanding improves lab efficiency and regulatory and legal compliance.

Areas Covered in the Webinar:-

• Understanding GCP
• FDA and EMA regulations for GCP
• The informed Consent Forms
• Patient Directives for Samples
• Exceptions to Informed Consent
• HIPAA requirements
• GDPR requirements
• Blinding requirements
• Suggestions for rectifying issues with Clinical Staff
  • Variances with informed Consent/ Sample Disposition
  • Blinding Issues- Accidental Unblinding
  • Personal Information on Sheets or Tubes

Why Should You Attend:-

Familiarity with the clinical protocol permits resource allocation (reagents, instruments analytical, QA, and QC personnel) to ensure efficient and timely analysis and reporting. In addition to the resources, attention to the specific informed consent, and sample directives reduce the risk of facing regulatory and legal issues. This is to ensure not only that reported results are in the correct format, but also to understand what the subject has agreed to in terms of sample handling, disposition, storage, and use.

Application of a patient’s sample to something not agreed upon in the protocol or specifically proscribed in the protocol can lead to personal charges against the clinical trial sponsor and FDA findings of non-compliance. This presentation will discuss the responsibilities of the lab in supporting subject requests and orders.

This review will cover the development, evolution, and application of Good Clinical Practice, (GCP) and will discuss responsibilities of lab personnel in maintaining GCP, observing and enforcing specific blinding protocols, maintaining the integrity and privacy of personal health information under HIPAA and GDPR.

Because bioanalytical personnel is not generally the drivers, the approach suggested is to identify possible issues and to discuss with the clinic approaches to minimize risk- for example assigning accession numbers to samples and associated documents such that the lab does not “see” or record any personal identification which can be traced and identify trial participants. Specific attention will also be directed at understanding patient directives regarding results and samples.

Who Will Benefit:-

• Clinical Personnel
• Lab Personnel including
  • Principal Investigators
  • QA/QC
  • Sample Management/Receipt
  • Laboratorians