Q. What is the role of quality assurance (QA) in clinical research?
Lakshmi Prasad Peesapati, Hyderabad
The QA person in a clinical trials responsible for:
● Continued maintenance of a clinical QA System with written standard operating procedures (SOPs)
● Preparation of quality assurance department SOPs
● Conduct of quality reviews of protocols, CRFs and supplemental study documentation
● Quality audits of tables, data listings, and study reports for data management projects
● Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and regulatory requirements
● Coordination and conduct of clinical research training programmes
● Identification of areas for continuous quality improvement and leading the organization in implementing these improvements
● Communication with management about quality issues or problems
● Interfacing with regulatory agency, sponsors and independent internal auditors.


Q. A group of investigators is planning to initiate a study with combination of marketed products in a new indication for academic purpose. Is it necessary to obtain DCGI and/or EC approval is required?
● Suresh Vaghela
As per the definition of Phase IV trial in Indian GCP, this will be considered a trial for a new drug.

Phase IV
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.

The Medical Council of India's (MCI) Code of Ethics Regulations 2002, which covers doctor's obligations towards various laws, suggests that the doctors have to follow Drugs and Cosmetics Act, 1940 and ICMR guidelines.

The relevant MCI code is:
1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940

7.22 Research:
Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy, which is not as per the guidelines, shall also be construed as misconduct.

It is clear from the above that a doctor conducting clinical research has to follow the ICMR guidelines, and Drugs and Cosmetic Act 1940 and other relevant laws.

ICMR guidelines, under the section on drug trials, refer to the new drug definition under Drugs and Cosmetic Act.

The ICMR guidelines stipulate that such trials can be carried out only after the approval of Drugs Controller General of India.

Q. How many IEC members should vote for the approval of a Clinical Research Study?
● Shiva
This depends on 1) total number of members 2) quorum.

Schedule Y recommends the following:
Ethics Committee
1. The number of persons in an Ethics Committee should be 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:

(a) basic medical scientists (preferably one pharmacologist).
(b) clinicians
(c) legal expert
(d) social scientist / representative of non-governmental voluntary agency /philosopher / ethicist / theologian or a similar person
(e) lay person from the community.

In any case, the Ethics Committee must include at least one member whose primary area of interest / specialization is nonscientific and at least one member who is independent of the institution / trial site.

This means that there should be at least 5 members present for quorum, who can vote. If the number is less than 5, the voting is invalid. If the investigator is present, he cannot be counted in quorum as he cannot vote on his own proposal. Besides, if non-scientific member and independent member are absent, the quorum is not complete.

Q. We are conducting a study with a site which has its own EC. Recently, I was told that the sponsor's representative cannot attend the EC meeting. If I am not wrong, as per the guidelines, the composition includes the management representative as well as member secretary. Is this correct?
● S. Gurunath,

No guideline describes specific composition i.e. inclusion of a management representative. The membership as per guidelines describes specific professions e.g. scientific / non-scientific / legal / medical person etc. Unless you are officially a member of the EC in one of the prescribed categories (see Schedule Y), you cannot attend the meeting.