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Is it essential to submit a copy of signed Clinical Trial Agreement (CTA) before ethics committee (EC) gives approval?
Dr Ravindra Sainani
New Drugs and Clinical Trials Rules 2019 mandate that the EC should review Investigator's agreement with the sponsor. Ideally, the signed CTA should be reviewed. However, before CTAs are finalized, the sponsor and institution/investigators and their legal experts would review and may give suggestions for amendments. Similarly, the EC and its legal expert may also seek clarifications and suggest amendments. Hence, the process of finalizing CTA would be time consuming. It would be pragmatic for the EC to review draft CTA, seek clarification, and request submission of final CTA after incorporation of EC suggested changes, if applicable, without waiting for final signed CTA. The EC could request submission of final signed CTA before the investigator initiates screening and enrollment of participants.
Can CTA be signed between CRO, investigator & institution? Is sponsor’s signature essential on CTA?
Dr Ravindra Sainani
Contract Research Organization (CRO) is defined as a person, or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
As per ICH-GCP, all references to a sponsor in ICH-GCP guideline apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a sponsor.
A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
When a CRO signs the CTA, it assumes the responsibilities of the sponsor in ensuring conduct of clinical trials as per protocol, GCP and regulations. Hence, the sponsor’s signature is not essential on the CTA.
Can EC insist on the insurance for clinical trial?
Dr Ravindra Sainani
As per ICH-GCP 5.8.1. If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.
New Drugs and Clinical Trials Rules 2019, the EC is supposed to review insurance policy or compensation for participation and for serious adverse events occurring during the study participation.
Indian GCP, which is the law as per New Drugs and Clinical Trials Rules 2019, recommends:
2.3.1.12. d. Study subjects should be satisfactorily insured against any injury caused by the study.
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.
In view of these rules and guidelines, the EC can insist on insurance policy to ensure that the insurance is available to cover compensation for serious adverse events.
We plan to conduct a study of cough sounds in predicting Covid-19 infection by employing artificial intelligence-machine learning. Does this require regulatory approval?
Anuradha Jaiswal
As per Ministry of Health and Family Welfare S.O. 648(E) of 2020, all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of - (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder. (ii) diagnosis, monitoring, treatment, alleviation, or assistance for, any injury or disability. (iii) investigation, replacement or modification or support of the anatomy or of a physiological process.
(iv) supporting or sustaining life. (v) disinfection of medical devices; and (vi) control of conception.
As artificial intelligence-machine learning is used to diagnose a medical condition, it would be considered a medical device. Use of such device for diagnosing a highly transmissible agent - SARS-CoV2 - could be considered high risk and could regulatory approval for a clinical study.
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