WHO sponsored workshop on
Good Clinical Practice
for
Ethics Committee Members
an orientation to the workshop
B.Gitanjali
Organizing Secretary
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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
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1. Bhatt A. Clinical trials in India: Pangs of
globalization. Indian J Pharmacol 2004;36:207-8.
All gave
some
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Some gave
all…
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.
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Schedule Y
Legal
Issues
Ethics
committees
Investigator &
Sponsor
Responsibilities
GCP
Serious
Adverse
Events
SOPs
Informed
consent
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Special
Issues
Publication
Issues
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
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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.
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Rapporteurs for the workshop
Day 1
Day 2
Reba Kanungo
Sheila Ananda Kumar
Dinesh Mahale
Rathinam Sivakumar
S.Pradeep
J.Yuvaraj
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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
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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
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Meal timings
Breakfast 07.30-08.30 hrs
Lunch 13.00-14.00 hrs
Dinner 20.00
Refreshments during the workshop.
All meals at the JIPMER community Hall.
Inform reception desk for bed coffee/tea
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