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Bioequivalence study should not be conducted in illiterate volunteers


Wednesday, March 3, 2021, 08:00 Hrs  [IST]

Can we enrol an illiterate volunteer in bioequivalence study?
Dr Ramesh Ranade

Bioequivalence study is a non-therapeutic study. Indian GCP defines non-therapeutic study as a study in which there is no anticipated direct clinical benefit to the subject(s). Such studies, unless an exception is justified, should be conducted in patient(s) having a disease or condition for which the investigational product is intended.

Indian GCP recommendation 2.4.3.3. pertains to informed consent in non-therapeutic study and mandates as follows:
In case of a non-therapeutic study the consent must always be given by the subject. Non-therapeutic studies may be conducted in subjects with consent of a legal representative or guardian provided all of the following conditions are fulfilled: The objective of the study cannot be met by means of a trial in subject(s) who can personally give the informed consent; The foreseeable risks to the subject(s) are low; Ethics Committee’s written approval is expressly sought on the inclusion of such subject(s); and Objectives of bioequivalence study can be met by a study in volunteers are literate. So, such studies should not be conducted in illiterate healthy volunteers.

What would constitute adequate training for site team?
Suchitra Bhattacharya
The US FDA guidance on investigator responsibilities recommends the following: The investigator should ensure that staff are familiar with the purpose of the study and the protocol; Have an adequate understanding of the specific details of the protocol and attributes of the investigational product needed to perform their assigned tasks; Are aware of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects; Are competent to perform or have been trained to perform the tasks they are delegated; Are informed of any pertinent changes during the conduct of the trial and receive additional training as appropriate.

We are conducting a medical device study, which requires video recording of  the procedure. What are regulatory expectations for such procedures?
Dr Vijay Raman

Regulatory agencies would require the following documentation/process for devices studies, which require video recording:
•    The protocol should describe in detail all aspects of the study especially the medical/device procedure and the video recording procedure.
•    The Ethics Committee should review and determine 1) whether there are adequate provisions  to protect the privacy of subjects and to maintain the confidentiality of data and 2) approve the plan of video recording of the study participants and procedure.
•    The informed consent documents should describe 1) the need for procedure of video recording the medical procedure / device procedure and 2) a statement describing the extent to which confidentiality of records identifying the subject would be maintained.
•    If the video images are part of the protocol required source data and are used to assess endpoints - safety or efficacy, then the images should be available for review during an audit/ inspection.

Dr. Arun Bhatt is a Consultant - Clinical Research & Development, Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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