GCP Queries

Understanding the overall issues in GCP and adopting procedural norms as per national and international guidelines becomes imperative in present times, especially for India which is turning out to be the hub of clinical research activities. There are many imponderables, both for the sponsors and investigators. Doubts and queries, even in the simplest of procedures which could have been taken for granted in the past, can arise. To enlighten readers on such issues, Dr Arun D Bhatt, well known clinical pharmacologist from Mumbai will answer queries raised on this subject.

How do we select a central laboratory? - Dr Kavita Singh, Hyderabad
Central Laboratory Services are a paramount component of a clinical trial. Although there is no regulatory requirement for central laboratory, the requirements of ICH GCP (data quality, documentation of procedures and document control) mean that central laboratory facilities are useful as part of integrated clinical trial procedures.

The criteria for selecting central laboratory are:

• Adherence to Good Laboratory Practice (GLP)
• Accreditation by a reputed international organisation eg. College of American Pathologists (CAP)
• Accreditation in India by National Accreditation Board for Testing and Calibration Laboratories (NABL)
• Quality assurance
• Staff training
• Efficiency of processing samples
• Speed of services
• Networking and transport of samples
• Past track record/ experience in a clinical trial.

We have made a minor change in clinical trial design. We plan to send a letter to inform the Ethics Committee (EC) of this change. Is this in compliance with GCP? - Dr Ashish Nandi, Kolkata

No. The change in trial design is not a minor change. Only logistical or administrative changes eg. change in personnel, change of office does not require prior approval of EC. It requires an amendment to the protocol. It would be necessary to submit to ethics committee 1) the reason for change in design 2) amended protocol and request its approval for the amendment.

The relevant guideline from ICH-GCP is cited below:

ICH GCP 4.5.2: ‘‘The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/ favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (eg. change in monitor(s), change of telephone number(s)).’’

We have a potentially eligible patient who is illiterate. How do we obtain his consent for the trial? - Dr Kamlesh Kumar, Lucknow

If the patient is unable to read or write, the investigator or his designated staff should read out the patient information and explain the process of the consent in detail to the patient. However, the consent process should be conducted in presence of the patient’s legal representative. It is necessary to inform the patient’s legal representative about all pertinent aspect of the trial and obtain the legal representative’s signature and date the consent form. The relevant guideline from ICH-GCP is cited below:

ICH GCP 4.8.5: ‘‘The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject’s legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.’’

If the patient and his legally acceptable representative are illiterate, can we ask a staff member of the hospital to be a witness for the consent? - Dr Narendra Mehta, Ahmedabad

No. A staff member of the hospital even if he/ she is not connected with the trial, can become a witness. The witness has to be independent of the trial. The witness should be a person who cannot be influenced by the investigator and his team.

The staff member from the hospital will not be an impartial witness as he is likely to be influenced by the investigator or his staff. The relevant definition from ICH-GCP is cited below:

ICH GCP 1.26: Impartial Witness: ‘‘A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject."

Send in your queries to Dr Arun D Bhatt at: arun_dbhatt@hotmail.com. All queries should ideally reach him by the 15th of each month.