Good Documentation Practices for Clinical Trials
- Product Id : FDB1114-REC
- Category : Food, Drugs & Biologics
- Presenter : Dr. Mukesh Kumar
- Duration : 60 Minutes
This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices.
To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.
The documentation requirements including a set of SOPs with key elements to be contained in the SOP will be discussed.
In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs – sustainable compliance and patient safety.
Areas to be Covered:
Statutes, Regulations and Definitions
Regulatory Requirements for INDs and IDEs.
Clinical Investigators (CI)
Institutional Review Boards (IRBs)
Sponsors and Monitors
Contract Research Organizations (CROs)
List of SOPs and Adequate Documentation
Key Elements in the SOPs
Common GCP Deficiencies in EU and US
Who will Benefit:
Anyone Interested in the Topic