In an ethics committee meeting, the required quorum was met as per ICH-GCP and schedule Y. However, among the members present, the physician was the PI and did not vote. Will this approval be invalid for audit purposes?
Dr. Indrani Banerjee
USFDA recommends:
The quorum is the count of the number of members present. If the number present falls below a majority, the quorum fails. The regulations only require that a member who is conflicted not participate in the deliberations and voting on a study on which he or she is conflicted. The IRB may decide whether an individual should remain in the room
If the quorum requirements are met, the approval would be acceptable.
We have a site in Thailand which is not familiar with English. They have difficulty in completing source notes / other documents in English. Can a CRA / Study Manager complete the source notes?
Amit Nasa
A CTM or CRA does not work for the investigator site. Hence he/she cannot write source notes for the site. The responsibility of complete source notes should be defined in the site signature log. Usually, this task is completed by site personnel. A better alternative is to locate a local SMO / site coordinator who is comfortable with English and local language. This person can support the site in all such documentation activities.
Suppose in a blinded trial, a patient has to consume one tablet from each from two bottles (one bottle contains active medicine and 2nd bottle contains matching placebo of comparator). And if one of the patients experiences SAE and later investigator comes to know that patient has consumed tablets only from one bottle, then what should be written as a suspected drug?
Shruti Kulkarni
It appears from the description that when patient experienced SAE, the investigator was not aware that from which bottle the patient took the tablet. Hence, the initial report will contain the suspected drug as was the suspicion at the time the patient experience SAE. The second report i.e. after the investigator became aware of that the suspected drug came from a particular bottle, will be described in the follow-up report.
While forming the Ethics Committee, which guideline should be followed - ICMR guidelines or Indian GCP guideline? While the former suggests 8-12 members, Indian GCP recommends 5-7 members. Can you please advise?
Rajendra Dobriyal
In India, the IEC composition is governed by Schedule 2005. ICMR 2006 refers to this for quorum. Schedule Y recommends:
# The number of persons in an Ethics Committee should have at least seven members. Ethics Committee should appoint, from among its members, a Chairperson (who is from outside the institution) and a Member Secretary. Other members should be a mix of medical/non-medical, scientific and non-scientific persons, including lay public, to reflect the different viewpoints.
For review of each protocol the quorum of Ethics Committee should be at least 5 members with the following representations:
# basic medical scientists (preferably one pharmacologist).
clinicians
# legal expert
# social scientist / representative of non-governmental voluntary agency / philosopher / ethicist / theologian or a similar person
# lay person from the community.
Schedule suggests at least 7 members. You can have more than 7 members. But the crucial thing would be overall composition and quorum. The convention for quorum is ½ (total number of members) + 1. As Schedule Y recommends minimum 5 members in quorum, it would desirable to have at least 9 members in the EC.
When the AUDLT subject is illiterate, is the signature of his legal representative is required? or only then the signature of an impartial witness is necessary?
Eileen Kan
If an adult subject is illiterate, you need his/her thumb impression and signature of an impartial witness
Does the Ethics Committee require any registrations or approvals from any regulatory authorities?
Javeed Mohammad
At present, there is no formal requirement for registration of EC. However, CDSCO has prepared draft guidance on registration of EC. Once finalized, the EC will need to register with CDSCO.
Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd, Mumbai. Readers can send their queries at: arunbhatt@clininvent.com