GCP and Investigational Product Management for Clinical Research Pharmacists
Course Description
This comprehensive course equips clinical research pharmacists with the foundational knowledge and practical skills needed to manage investigational products (IPs) in compliance with Good Clinical Practice (GCP) standards. Participants will explore the full lifecycle of IP management - from receipt, handling, storage, and dispensing to documentation, accountability, and destruction - across all phases of clinical trials. By the end of the course, pharmacists will be prepared to apply best practices in IP management, navigate real-world challenges including inspection findings, and uphold the regulatory and ethical standards essential to clinical research.
Learning Objectives
- Discuss the development of Investigational Products (IPs), Phases and types of studies
- Define Good Clinical Practices (GCPs) in relation to Investigational Product (IP) receipt, handling, and storage
- Evaluate documentation, dispensing, and accountability best practices
- Review types of randomization systems and staff expectations for double blind and single blind trials
- Examine areas of common problems and challenges in Investigational Product (IP) Management in the pharmacy
- Define Good Clinical Practices (GCPs) in relation to Investigational Product (IP) dispensing, dosing and documentation
- Review types of source documents related to Investigational Product dosing and accountability
- Explore the causal relationship between Investigational Product and Adverse Events
- Discuss end of study requirements for return, destruction, and final accountability processes
- Examine areas of common problems and challenges in Investigational Product (IP) Management based on regulatory observations
Course Outline
- Module 1: Introduction to clinical trials and investigational product management
- Module 2: Investigational Product documentation, accountability, handling, dispensing and management
- Module 3: Dispensing, dosing and documentation
- Module 4: Destruction, return, and challenges including inspection findings
Instructor
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Click here for complete trainer biographies
Accreditation
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.0 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.
ACPE#: 0778-0000-26-001-L99-P Released: 5/26.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
