Gitanjali 1 WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members an orientation to the workshopB.Gitanjali Organizing Secretary

Gitanjali 2  By 2010, clinical trials to the tune of $ billion will be performed in India. 1  Schedule Y  CDSCO, Govt. of India & WHO initiative to train all major stakeholders in GCP 1. Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol 2004;36:207-8.

Gitanjali 3 All gave some Some gave all…

Gitanjali 4 Aim of the workshop  To create awareness among individuals who serve on ethics committees, on the various aspects of GCP with special emphasis on the current Indian regulations and guidelines for clinical trials.  To provide the knowledge and skills required for a member of the EC to review and monitor trials according to local and international GCP requirements and safe guard the wellbeing and interests of the trial participants.

Gitanjali 5 Informed consent Ethics committees Schedule Y Publication Issues GCP Legal Issues Serious Adverse Events Investigator & Sponsor Responsibilities SOPs Special Issues

Gitanjali 6 Objectives of the workshop  At the end of the workshop the participant shall :  Understand and apply relevant portions of GCP guidelines  Understand the procedures to be adopted for safeguarding the rights, safety and wellbeing of subjects participating in clinical trials  Understand ethical review of essential documents of a clinical trial  Be able to conduct a risk benefit assessment of the protocol prior to giving approval

Gitanjali 7 During the workshop  Please be on time. Sessions start at 8.30 A.M.  Do not hesitate to ask questions, voice your opinions or disagree with the resource person.  There may be more than one correct answer for a question.  Some questions may not have an answer as yet.  Try to finish the given task within the allotted time.

Gitanjali 8 Rapporteurs for the workshop  Day 1  Reba Kanungo  Dinesh Mahale  S.Pradeep  Day 2   Sheila Ananda Kumar   Rathinam Sivakumar   J.Yuvaraj

Gitanjali 9 Course Material  Inside your bag:  ICMR guidelines  Schedule Y  ICH guidelines  Spiral bound copy – objectives of all sessions, Helsinki Declaration, CIOMS guidelines, Belmont Report, all the group tasks, operational guidelines EC from WHO and ICMR  Before you leave – collect the CD & certificate

Gitanjali 10 Arrangements for the three days   Bus will pick you up from Surguru at 7.15 A.M.sharp. To take you to the JIPMER community Hall for breakfast.   Transport provided   Bus will pick participants from Guest house at 7.40 P.M. for dinner at Anandha Inn.   Dinner at 8.00 P.M.   Collect TA & DA at the community hall during lunch tomorrow

Gitanjali 11 Meal timings  Breakfast hrs  Lunch hrs  Dinner  Refreshments during the workshop.  All meals at the JIPMER community Hall.  Inform reception desk for bed coffee/tea

Gitanjali 12