Good Clinical Practice (GCP) - As Applied To The Regulated Bioanalytical Lab

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.

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 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 are 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.

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

Who Will Benefit:

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