Answer to query (Paribhush)
abhijit vaidya
-If we go as per the schedule Y and ICH GCP it has been clearly mentioned that
there has to be 1 Priniciple Investigator and his responsibility is
the patient safety
at his site and also at various different sites.But in practice you
wont find Prinicple
Invesigator at the site because these are generally very busy
doctors with their
tremendous experience.So they are like a consultant or a medical expert at the
site.The amount of experience which they have come to use when there is a ADR
or SAE.
-Now about the Ethics committe there are 2 types of ethics committe
1.Institutional Review Board which generally,each site is associated
with and the
review of the study related document and periodic meeting,
inspection(if required)
is being carried out by them.
2.Independent ethics committe these are totally independent body who can take
the responsibility of safety and review of the documents of more then
2 site.IF "The
Trial site may accept the approval granted to the protocol by the
ethics committee
of another trial site or the approval granted by an independent
ethics committe
provided that the approving ethics committe is/are willing to accept their
responsibility for the study at such trial site and trial site is/are
willing to accept
such an arrangement and their protocol versionis same at all the trial site"
(Ref: Schedule-Y Requirements and guidelines for permission to import and / or
manufacture of new drugs for sale or to undertake a clinical
trial----2. Approval for
clinical trial(i) 3rd sentence)
-In India there are 179 Institutional Review Board and only 40 of them
have been
constituted according to ICH-GCP guidelines.
-Along with that their are some 4 Independent ethics committe in
India(as per my knowledge i can even be wrong with the data) located
at delhi,banglore,mumbai,ahmedabad.
If we talk about Europe countries there are two kind of bodies
governing over their
LREC(local research ethics committe- 250 in Number) and MREC (Multicentric
Centric research ethics committe- 10 in number).So for getting
approvals on trial in
different countries of europe you have to approach LREC if it is in
one country or
you can approach MREC if it has to be conducted in different coutries
of europe.
(This saves a lot of time,Money and extra documentation).But yes these ethics
committe take their time in giving approval to your documents related to trial.
This is the most simplest way i can solve ur query and the most
important thing to
remember is that ScheduleY is like a bible for us of regulations for
conducting
clinical trials in India.
Abhijit Vaidya
Research Associate
Cipla Ltd.
Raj Plaza Vikroli-W
Mumbai
Mob: 9820474986