Gitanjali 1 WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members an...

Gitanjali Gitanjali 11

WHO sponsored workshop onWHO sponsored workshop on

Good Clinical Practice Good Clinical Practice forfor

Ethics Committee MembersEthics Committee Members

an orientation to the workshop

B.GitanjaliB.Gitanjali

Organizing SecretaryOrganizing Secretary

http://www.aarogya.com/legalitiesandinformatics/ethics/index.asp


By 2010, clinical trials to the tune of $250-300

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.


All gave some

Some gave all…


Aim of the workshopAim of the workshopTo create awareness among individuals who To create awareness among individuals who

serve on ethics committees, on the various serve on ethics committees, on the various aspects of GCP with special emphasis on the aspects of GCP with special emphasis on the current Indian regulations and guidelines for current Indian regulations and guidelines for clinical trials. clinical trials.

To provide the knowledge and skills required To provide the knowledge and skills required for a member of the EC to review and for a member of the EC to review and monitor trials according to local and monitor trials according to local and international GCP requirements and safe international GCP requirements and safe guard the wellbeing and interests of guard the wellbeing and interests of the trial participants.the trial participants.


Informed consent

Ethics committees

Schedule YSchedule Y

Publication Issues

GCPLegal Issues

Serious Adverse Events

Investigator &Sponsor

Responsibilities

SOPs

SpecialIssues


Objectives of the workshopObjectives 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


During the workshopDuring 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.


Rapporteurs for the workshopRapporteurs for the workshop

Day 1Day 1

Reba Kanungo

Dinesh Mahale

S.Pradeep

Day 2Day 2

Sheila Ananda Kumar

Rathinam Sivakumar

J.Yuvaraj


Course MaterialCourse MaterialInside 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


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


Meal timingsMeal timings

Breakfast 07.30-08.30 hrsLunch 13.00-14.00 hrsDinner 20.00Refreshments during the workshop.All meals at the JIPMER community Hall.Inform reception desk for bed coffee/tea

Gitanjali 1 WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members an...

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