Q. Is QA certificate mandatory after completion of audit of every site? Is it obligatory to issue QA certificate after resolution of all queries raised by Quality Assurance or can we issue QA certificate only to be evidence that visit has been performed by QA persons?
● Gurbinder Tuli

It is not mandatory to issue the audit certificate after completion of site audit. Audit certificate is issued when it is required by the applicable law/regulations of the country the audit is being performed or requested by the sponsor for contracted audits. In practice, you can issue audit certificate along with the audit report.

In India Schedule Y requires audit certificate to be appended if available to clinical trial report. (Appendix II Structure of Clinical Trial Reports item 16 audit certificate).

Similarly ICH E3 guidelines for Clinical Trial Report require an audit certificate to be appended, if available (appendix 16.1.8).

Q. Can a doctor (BHMS or MBBS) CRC write source notes/hospital files (of a clinical trial patient) if he is designated to do so by the principal investigator?
● Dr Amrut Jadhav

Yes. This is allowed if the doctor is authorized by the investigator to do so. The investigator should ensure that the designated doctor is trained in completing source notes.

A recent FDA guidance "Guidance for Industry Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators" discusses such issues. FDA cautions researchers on delegation of study tasks and advises that the investigators should be very careful in delegating clinical trial responsibilities.

The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience to perform the delegated task. Appropriate delegation is primarily an issue for tasks that would be considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing part of the medical care provided to subjects during the course of the study. Most clinical/medical tasks require formal medical training and may also have licensing or certification requirements. Clinical investigators should take such qualifications/ licensing requirements into account when considering to whom it would be appropriate to delegate specific tasks. . The investigator is also responsible for overseeing the work of any staff members who are not directly employed by the site, such as employees of site management organizations.

The investigator should ensure that staff:

● Have a general familiarity with the study and the protocol
● Have a specific understanding of the details of the protocol and the investigational product, relevant to the tasks they will be performing
● Are aware of regulatory requirements and acceptable standards for the conduct of clinical trials, both in respect to conduct of the clinical trial and human subject protection
● Are competent to perform the tasks that they are delegated
● Are informed of any pertinent changes during the conduct of the trial and educated or given additional training as appropriate

Q. If any violation during the study (in house) what will be the compensations and / after completion of the study if the subjects expire what will be the compensation?
● Amitava Roy

Please see Indian GCP guidelines on compensation.

2.4.7 Compensation for Accidental Injury.

Research subjects who suffer physical injury as a result of their participation in the Clinical Trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from IEC. In case of death, their dependents are entitled to material compensation.

2.4.7.1.Obligation of the sponsor to pay.

The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research begins, to provide compensation for any serious physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.