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Good Clinical Practice (GCP) Workshop Content and Materials

Workshop Overview:

The Good Clinical Practice (GCP) workshop aims to provide participants with comprehensive knowledge and practical skills to conduct clinical trials ethically and in compliance with regulatory standards. This workshop covers the principles of GCP, roles and responsibilities, protocol adherence, data integrity, and more

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Introduction to Good Clinical Practice

- Definition and Importance:
- Overview of GCP principles.
- History and development of GCP.
- Ethical Foundations:
- Declaration of Helsinki.
- Belmont Report.

Regulatory Framework

- International Guidelines:
- ICH E6 (R2) GCP guidelines.
- National Regulations:
- FDA regulations (21 CFR Part 50, 56, 312).
- EMA and other regional guidelines.

Roles and Responsibilities:

- Principal Investigator (PI):
- Ensuring trial conduct and participant safety.
- Delegation of authority.
- Clinical Research Coordinator (CRC):
- Day-to-day trial operations.
- Data management and participant communication.
- Sponsor and CRO (Contract Research Organization):
- Study design, monitoring, and funding.
- Ensuring compliance and reporting.

Protocol and Study Design:

- Understanding the Protocol:
- Structure and essential elements.
- Deviations and amendments.
- Study Design Types:
- Randomized controlled trials, cohort studies, case-control studies.

Informed Consent Process:

- Ethical and Legal Aspects:
- Components of informed consent.
- Ensuring participant comprehension.
- Documentation:
- Recording and updating consent.

Recruitment and Retention of Participants:

- Strategies for Recruitment:
- Inclusion and exclusion criteria.
- Community engagement.
- Retention Strategies:
- Participant follow-up and engagement.

Data Management and Integrity:

- Data Collection and Recording:
- Source documents and electronic data capture.
- Case Report Forms (CRFs).
- Quality Assurance:
- Monitoring visits.
- Auditing and inspections.

Safety Reporting:

- Adverse Events (AEs) and Serious Adverse Events (SAEs):
- Identification and documentation.
- Reporting timelines and procedures.
- Safety Monitoring:
- Data Safety Monitoring Boards (DSMB).

Compliance and Quality Assurance:

- Monitoring and Auditing:
- Types of monitoring visits.
- Preparation for audits.
- Handling Non-Compliance:
- Identifying and addressing deviations.

Study Close-Out:

- Final Study Reports:
- Data lock and final analysis.
- Reporting results to regulatory authorities.
- Archiving:
- Storage of essential documents.
- Retention timelines.