Скачать или смотреть Complete GCP Workshop by PRF, API WB Branch

GCP Workshop – 5 Hours Online Program

Organized by:
Physician Research Foundation (PRF), API West Bengal Branch

Under the Aegis of:
Association of Physicians of India (API), West Bengal Branch

Program Overview:
The Good Clinical Practice (GCP) workshop aimed to provide a comprehensive overview of GCP guidelines, ensuring participants understood the ethical and scientific quality standards necessary for conducting clinical research. It was tailored for clinical investigators either already involved or planning to engage in clinical research.

Topics included core GCP principles, investigator roles and responsibilities, and essential documentation for regulatory compliance.

Date: 19th April 2024
Platform: Online
Target Audience: Clinical Investigators, Researchers, Physicians

Workshop Agenda:

Welcome Address and Context Setting:
1. Dr. Jyotirmoy Pal – President, API
2. Dr. Partha Sarkar – Chairman, API WB
3. Dr. Uttam Paul – Chairman, PRF - API WB
4. Dr. Ashish K Saha – Secretary, API WB

Lecture 1: Introduction to Good Clinical Practice (GCP) and Its Importance
Speaker: Dr. Shambo Samrat Samajdar
Overview of GCP guidelines
Ethical framework for human research
Importance of GCP adherence

Lecture 2: Investigator Responsibilities and Roles in Clinical Research
Speaker: Dr. Sucheta Kurundkar
Key responsibilities
Participant safety
Clinical trial team management

Lecture 3: Informed Consent Process: Best Practices and Documentation
Speaker: Dr. Pradeep Narayan
Essentials of informed consent
Legal/ethical considerations
Case studies

Lecture 4: Sponsor’s Role and Responsibility in Clinical Trials
Speaker: Dr. Sujoy Ghosh
Sponsor’s responsibilities
Regulatory adherence
Sponsor–investigator collaboration

Lecture 5: Managing Adverse Events and Safety Reporting in Clinical Trials
Speaker: Dr. Avijit Hazra
Definition of AEs and SAEs
Reporting guidelines
Managing unanticipated risks

Lecture 6: Data Integrity and Monitoring in Clinical Trials
Speaker: Dr. Sandhiya Selvarajan
Accurate data practices
Monitoring, auditing, and QA
Tools for site monitoring

Lecture 7: Essential Documents for Clinical Trials and Regulatory Compliance
Speaker: Dr. Santanu K Tripathi
Study documentation (Protocol, CRFs, IB)
Preparing for audits and inspections

Final Session: Open House Q&A
Moderator: Dr. Nandini Chatterjee
Panelists:
Dr. Santanu Tripathi
Dr. Sujoy Ghosh
Dr. Avijit Hazra
Dr. Pradeep Narayan

Participants discussed queries and concluded the event with reflections on applying GCP in routine clinical practice.

Closing Remark: Dr. Asish K Saha, General Secretary, API WB