RQAP re-registration units: 4 GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionThis is a basic course providing an overview of the fundamentals of Good Clinical Practice. Exercises will be conducted including review of electronic documents. Topics include: Principles of GCP, Key Regulations and Guidelines, Audit Standards, and applying them to several types of GCP audits. A mock audit exercise will be conducted to give some hands-on experience.
ObjectivesAt the end of the course, the participants shall be able to:
- Define Good Clinical Practices.
- Identify the contents of GCPs.
- Find key regulations within 21 CFR and ICH GCP E6(R2).
- Describe 3-4 Activities to be performed during an audit.
Target AudienceThis course is for clinical auditors with less than 1 year experience, or GMP/GLP auditors with no GCP experience.
Agenda- Principles of GCP
- Key Regulations and Guidelines
- Electronic Records and eSignatures
- Protection of Human Subjects
- Institutional Review Boards / Ethics Committees
- Financial Disclosure
- Clinical Trial Essential Documents
- Drug Accountability
- Safety Reporting
- Investigator Site Audits
- Service Provider Audits
- Internal Audits
- Regulatory Inspections