Good Clinical Practices (GCP) Training
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights and assuring the credibility of trial data.
All training programs can be customized to meet your company’s specific needs. We have provided sample agendas for your review. We can develop a training program that selects topics from various agendas, or we can incorporate topics that are important to your team’s needs.
Based on the number of topics chosen, the courses can be anywhere from 2 hours to multiple days.
Examples of 483s, Warning Letters or other official action will be included, as appropriate.
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FOUNDATION GCP TOPICS
- History of FDA and EMA regulations and guidelines
- New drug development process overview
- Underlying principles of ICH-GCP compliance
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
- SOPs for GCP compliance
- US FDA trial audits – triggers, and current industry-wide findings
- Essential monitoring responsibilities
- Roles and responsibilities of Clinical QA
- Review of regulatory documentation (1572, Informed Consent, HIPAA, etc.)
- Control of clinical supplies by the sponsor, CRO and site
- Preparing for FDA audits
ADVANCED GCP TOPICS
- 21 CFR Part 11 (electronic) compliance
- FDA Form 1572
- Documentation control and security
- FDA regulations vs. guidance documents
- Investigator-sponsored INDs
- Investigator and sponsor responsibilities
- Scientific misconduct, detection and response
- Clinical QA audits: most common findings
- Post-marketing safety
- Post-audit actions and responses to the FDA
- The roles and functions of the IRB and Ethics Committees
- FDA and IRB approval
- Informed Consent
- Clinical Supplies: receipt, storage, documentation, accountability
- Risk Evaluation and Mitigation Strategies (REMS)
- Pharmacovigilance (PV)
GCP TRAINING FOR CLINICAL MONITORS AND REGULATORY STAFF
- Identifying investigational sites
- Site initiation visit, strategies and tactics
- Selection of investigators and monitors
- Interim monitoring visits, a training approach
- Auditing techniques for monitors
- Documenting the monitoring visit
- Site close-out visits
- Errors in GCP documentation
- Source document review for adverse experiences
- Scientific fraud, detection and response
- Multicenter program planning, issues and options
- Study medication accountability
- Drug sample retention requirements
- Auditing techniques for monitors
- TMF and eTMF audits
- Shortening the queries process
- Premature termination: when, why, and how
- Post-marketing safety tracking of AEs and SAEs
- Investigator responsibilities
- Prohibition of promotion and other practices
- Significant risk device determination