Is it necessary to have tripartite legal clinical trial agreement between sponsor, Investigator and representative from institute? or can we do away with two persons - sponsor and investigator signing the agreement? A problem arises when head of the institute becomes the principal investigator. Dr Sreevatsa The agreement between the sponsor, the investigator, and the institution is to ensure that the investigator and the institution conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) and with the protocol agreed to by the sponsor and given approval/favourable opinion by the IRB/IEC.
The GCP responsibilities of the investigator and the investigator are similar in most of the situations. However, in some situations the investigator must inform the institution e.g. SAE report to the head of the institution. Also, in case the investigator leaves the institution, institution would be responsible for GCP compliance. Even if the head of the institute is the investigator, the responsibilities for both these roles for regulatory compliance are different. So, it is desirable that there are two signatories from the hospital – the investigator and the head of the institute. If there is another person from the institution authorized to sign legal agreements, he/she could be the second signatory.
Indian GCP definition of contract mentions investigator and institution separately:
Contract: A written, dated, and signed document describing the agreement between two or more parties involved in a biomedical study, namely investigator, sponsor, institution. Typically, a contract sets out delegation/distribution of responsibilities, financial arrangements, and other pertinent terms. The “protocol” may form the basis of “contract”.
See also finance and insurance which mentions institution and the investigator separately.
Finance and insurance. The financial arrangement between the sponsor, the individual researcher(s)/manufacturer involved, institution and the investigator(s) in case such information is not stated explicitly.
The liability of the involved parties (investigator, sponsor/manufacturer, institution(s) etc.) must be clearly agreed and stated before the start of the study.
Can the principal investigator of the, EC & DCGI approved proposal be changed because of the non-availability of the PI. Under which guidelines PI position can be handed over to the other clinician and documents to be submitted? Dr Sreevatsa As per the checklist for application for global clinical trial 2019 following documents are to be submitted to CDSCO for approval. Checklist for (change in investigator (GCT) Covering letter Copy of CT permission letter Copy of previous protocol amendment approval letter, if any Trial site and reason for change: Undertaking by the investigators as per table 4 of third Schedule; CV including statement of qualification, CT experience, GCP training and copy of MRC; Name & address of the study sites. (private clinic/private hospital/nursing home/ Govt. hospital.); Details of the medical facility/hospitals: Number of beds, whether it is equipped with super specialty or multispeciality facilities and emergency facilities; Name, address and registration number of institutional ethics committee; and copy of ethics committee approval letter, if available.
Dr Arun Bhatt is a Consultant - Clinical Research & Development, Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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