2023-04-18T06:17:15
5.Accreditation
Any clinical trial of a new or existing drug or medical device needs to be carried out at a centre
where facilities for carrying out such trials exist, and the investigators carrying out the trial are
competent and have experience in the successful conduct of such trials. In addition, the institute
ethics committee (lEC) of the institute where the trial is to be carried out should understand the
ethics involved in clinical trials and should consist of persons from different walks of life.
When a clinical trial is carried out under such conditions, it gives confidence to the volunteer and
patients participating in the trial that they will not be subjected to any unjustified or hazardous trial.
It also gives confidence to the drugs regulator and the government that the trial is going to be wellrun, and a sense of confidence to the public and the civil society that the clinical trials being carried
out are justifiable, both on ethical and scientific grounds.
To ensure implementation of these concepts, it is proposed to introduce a system of accreditation for
the following:
a) Institute ethics committees (lECs)
b) Principal investigators (PIs) of clinical trials
c) Centres desirous of carrying out clinical trials.
Clinical trials will only be allowed to be conducted at those centres which have been accredited in
all three areas as above. These centres could be in the public or the private sector. Conducting
clinical trials at centres that have not been accredited would be illegal and will not be recognized by
the Drugs Controller General of India (DCGI).
The accreditation process will be supervised by a Central Accreditation Council (CAC). Details of
the composition and functioning of the CAC are given subsequently. The criteria to be followed for
accreditation of IECs, PIs and the centres where clinical trials are to be carried out are given below.
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