Can a CRA view (to listen and to see) the AV recording (CD)? If yes, to what extent? Can a person independent from the study - QA person - can view this AV recording proof during a quality visit?
Dr Yashodha Madhu
The CRA should follow the monitoring process for informed consent as in case of written ICF. For written ICF, the CRA checks the signed ICF and source notes. For AV consent 1) subject’s written consent for AV recording and 2) source document of AV recording process is adequate. If CRA wants to listen to AV recording, there could be practical issue of language and understanding by CRA. If CRA wants to view AV recording, there will be violation of principles of patient’s privacy and confidentiality as required by CDSCO 2014 Guideline.
For a person, independent from the study, the issues will be similar to what would be faced by a CRA.
GCP inspection checklist dated Sept 1, 2016: The check points mentioned in checklist under Section B.1 sounds that these check points should be ensured in AV recording. How to ensure these from CRO/sponsor perspective?
Dr Yashodha Madhu
These check points are from the CDSCO 2014 Guidance. The investigator should ensure that these are followed during AV recording. The CRO/sponsor should check the availability of appropriate room, and video recording equipment and train the investigator about these requirements during Investigator Meeting/ Site Initiation Visit. The investigator should document the AV consent process in source notes. These should be checked by CRA/QA person.
Can Managing Trustee of an NGO act as a “lay person from the community” in EC meeting for reviewing the clinical trial protocols? Or act as a social scientist? What should be the minimum educational qualification of lay person?
Recently ICMR has revised the ethical guidelines. This recommends the following qualification/experience for the lay person on EC.
A literate person from the public or community who is
• not qualified in medical/health sciences
• not pursued a medical science/health related career in the last 5 years
• is aware of the local language, cultural and moral values of the community
• indulges in social and community activities
• is willing to read and review the research proposal, specifically the informed consent document.
So, an NGO person can serve as lay person provided she or he fits these criteria.
If one makes new formula from multiple plant source involving use of herbal extract or try powder intended to be used for any ailment like diabetes, what is guidelines for registration of such product? Is it mandatory to register these trials with CTRI?
In India, Ayurveda, Yoga & Naturopathy, Siddha, or Unani (ASU) drugs have been under purview of Department of Ayush.
Herbal extracts are covered under Ayurvedic formulations.
In Indian regulations, the major class of Ayurveda, Siddha, or Unani (ASU) drugs included are:
a) Classical ASU drugs as mentioned in the authoritative books of ASU system drugs, which are manufactured and named in accordance with the formulations described in the authoritative texts. For this category, issue of license to manufacture is based on citation in authoritative books and published literature, unless the drug is meant for a new indication, when proof of effectiveness is required.
b) Patent or proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation, or invention to manufacture products different from the classical medicine. For this category issue of license to manufacture requires proof of effectiveness, based on pilot study as per relevant protocol for ASU drugs.
In 2010, Department of Ayush introduced Rule 158(B) which made requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine. Dept. of Ayush released GCP guidelines for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine.
Herbal product which you have referred would be classified as patent or proprietary medicine. This does not come under purview of DCGI. Also, there is no formal process of clinical trial approval/registration of product by Dept. of Ayush. The investigator has to follow Ayush GCP guidelines. However, the herbal product should have received manufacturing license from State Ayurvedic FDA.
Registration in CTRI is voluntary except for clinical trials of new drugs approved by Drugs Controller General of India.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
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