GCP WORKSHOP
NATIONAL & ONLINE
GOOD CLINICAL PRACTICE (GCP)
WORKSHOP
HELD ON - 20.02.2022, SUNDAY
9:00 AM - 06:00 PM IST
CHIEF GUEST
PROF.(DR.) SUHRITA PAUL
HONOURABLE VICE - CHANCELLOR
WEST BENGAL UNIVERSITY OF HEALTH SCIENCES
ADVISORS
DR. APURBA KUMAR MUKHERJEE
DR. SUBHANKAR CHOWDHURY
WORKSHOP FACULTIES
DR. PRADIP KUMAR MITRA
DR. RABINDRA NATH CHATTERJEE
DR. PINAKI CHAKRAVARTY
DR. AVIJIT HAZRA
DR. ANJAN ADHIKARI
DR. PAYODHI DHAR
LEARNING OBJECTIVES
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The importance of GCP, along with the historical issues &evolution of GCP.
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The method to design & conduct scientifically, the research involving humans.
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The issues related to safety of human in clinical research
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The pre-requisites for clinical research
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The steps to follow during clinical research
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The responsibilities of different stakeholders in clinical research.
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The significance & scopes of ethics in different scenarios during clinical research.
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The latest, international and national guidelines on clinical research.
PROGRAM TOPIC & SEQUENCE
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PRE-TEST
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OVERVIEW OF GCP
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ETHICAL DILEMMAS
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ROLES & RESPONSIBILITIES OF INVESTIGATOR
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ROLES & RESPONSIBILITIES OF SPONSOR
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MONITORING - INSPECTION-AUDIT: AN OVERVIEW
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DOCUMENTS TO BE SUPPLIED AT TRIAL SITE & INVESTIGATOR UNDERTAKING
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NEW DRUGS & CLINICAL TRIAL RULES 2019
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ROLES & RESPONSIBILITIES OF INSTITUTIONAL ETHICS COMMITTEE(IEC)
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ETHICAL DILEMMAS FACED BY IEC
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IEC APPROVAL LETTER
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ACADEMIC CLINICAL RESEARCH & ICMR ETHICS GUIDELINES
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INFORMED CONSENT IN CLINICAL RESEARCH
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DILEMMAS IN INFORMED CONSENT
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SAFETY REPORTING IN CLINICAL TRIALS
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EXAMINING SAFETY RELATED REPORTS OR ORDERS
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A SUMMARY OF GCP
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POST TEST
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Q & A with DOUBT CLEARANCE SESSION
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AFTER THE SUCCESSFUL COMPLETION OF THE WORKSHOP COURSE, WE GAVE THE CERTIFICATE ALSO.
DESCRIPTION:
Clinical Trials are research investigations in diseased person/ volunteer/ subject to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. It helps to determine if a new drug/ treatment/ intervention works, whether it is safe, and whether it is better than the drugs/ treatments/ interventions that are already available in the market. World Health Organization (WHO) defines Clinical Trial as - ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
What is actually Good Clinical Practice (GCP)?
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. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake. It is a guideline for conduction of biomedical and behavioural research, mainly Clinical Trial. But most importantly it is related to research work involving human participants. Three basic ethical principles of equal importance, namely respect for persons, beneficence and justice, permeate all other GCP principles. The principles of GCP help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training aims to ensure that the rights, safety, and well-being of human subjects are protected. All investigators and staff who are involved in the conduct, oversight or management of any form of clinical research or clinical trials are required to complete training in GCP and refresh this training regularly to update the knowledge and concept, consistent with principles of the International Conference on Harmonisation (ICH). In India, Indian Council of Medical Research (ICMR), New Delhi, made it essential for all clinical researchers. It is also a prerequisite for participation in any Institutional Ethics Committee (Clinical) in any capacity. So orientation with the concept and application of GCP is very important for all of us, who are regularly involved with clinical research and also for all professionals and students related to healthcare for their academic enrichment and career benefit.