Reviews the history of the GCPs from Tuskegee to Nuremberg, Helsinki to the current 21 CFR and other protections, demonstrating the evolution of the regulation's current status. Particular focus will be on constraints, including requirements for informed consent and the disposition of samples. Several illustrations of recent violations will be provided, along with the consequences.

Areas Covered

Who Should Attend

• Analysts
• Directors
• Managers
• QA officers in GCP labs 

Why Should You Attend

This webinar will describe the history of what is considered GCP protections and the rights of study participants, review informed consent in relation to participation in the study, and control and governance of samples and their components. 

This is intended to provide awareness of the GCP and informed consent in order to minimize risk to the study due to any failure of observance.

Topic Background

Clinical Study samples under GCP have distinct and limiting constraints that may or may not be covered in the clinical protocol. Subjects are covered under individual orders such as informed consent, release or guarded use of the sample and associated results, even extending to future use of the sample and release of property rights associated with the sample and the patient. Absent the awareness of these issues, the lab and the analyst may jeopardize the study, the lab, and the career.