All health-related research requires a designated sponsor. The sponsor is an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical trial. An investigator who independently initiates and takes full responsibility for a trial automatically assumes the role of a sponsor. The sponsor may delegate certain activities or tasks to the study team. However, the overall responsibility for the quality and integrity of the data will reside with the sponsor. According to the New Drugs and Clinical Trial Rules, 2019 and the GCP guidelines, the following are some of the major responsibilities of a sponsor Before the trial commences the sponsor is responsible for:
During the trial the sponsor is responsible for:
Post-trial responsibilities of a sponsor:
Additional roles and responsibilities:In addition to the above-mentioned roles, some additional roles have been envisaged for the sponsor as part of GCP. These are: The sponsor must ensure that:
The Sponsor must arrange for the following:
The Sponsor must document and design the following:
Role of a foreign Sponsor or when a Contract Research Organization is involved:A foreign sponsor (an organisation situated outside India) should appoint a local representative or Contract Research Organisation (CRO) to fulfil local responsibilities as per the guidelines, and the transfer of duties must be documented. The ultimate responsibility of the quality and integrity of data resides only with the sponsor, even if a CRO has been involved. Investigator-initiated clinical trialsAcademicians often conduct research based on their observations in clinical practice or in response to a specific need of the patients. Such trials are also known as Investigator-initiated trials. These trials often do not have any funding support from external agencies. In such trials, the investigator or the host institution(where the research is conducted) will act as the sponsor for the trial, and will have all the responsibilities as described previously. References and Further Reading
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