Course Overview
This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH.
You should expect to spend approximately 15 hours of study time to complete the course.
Course Details
4-Month Access
Course Rate: $590.00
Please have your credit card ready in order to complete registration.
Key Topics
- Regulatory Environment in the US
- International GCP Regulations
- Institutional Review Board (IRB)/Ethics Committee Responsibilities
- Investigator Responsibilities
- Sponsor Responsibilities
- The Protocol
- Sponsor Obligations
- Monitoring Responsibilities
- Clinical Quality Assurance (CQA) Group
- FDA Inspections
- Managing FDA Inspections
Educational Objectives
- Interpret FDA regulations and International Conference on Harmonization (ICH) guidelines pertaining to GCPs.
- Identify the regulatory, source documentation, and recordkeeping requirements for clinical trials.
- Describe the components of internal auditing systems.
- Explain the roles and responsibilities of sponsor, monitor, investigator, and regulatory authorities in ensuring the proper conduct of clinical trials.
- Apply GCP principles to the collection and reporting of adverse events.
Who Should Attend
- Quality assurance associates
- Regulatory compliance professionals
- Clinical research associates
- Medical monitors
- Pharmacists
Continuing Education Credits
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
Continuing Medical Education (CME)
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education (CPE)
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is a knowledge based CPE activity.