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, following are some of the major responsibilities of a sponsor
Before the trial commences the sponsor is responsible for:
- Selection of appropriate investigator(s) and site(s) and if required CRO (Contract Research Organization)
- Formal contract with the investigator for all research related activities and responsibilities (Clinical Trials Agreement).
- In case of a CRO, document the transfer of trial related duties in the form of an agreement or contract, between the two parties.
- Ensuring that only qualified personnel are involved throughout the trial process.
- Development of detailed SOPs (to ensure compliance).
- Confirmation of review by an Ethics Committee (registered in case of regulatory clinical trials). The sponsor should obtain the documented approval, re-approval, withdrawal or suspensions, etc.
- Development and provision of essential documents including Investigator’s Brochure and Investigational Product handling and safety information.
- Designation of qualified medical experts / personnel who are available to advise on trial related concerns and issues, supervise the overall conduct of the study, etc.
- Ensuring that the trial site(s) has adequate supply of the Investigational Product (IP), and that the team is trained to handle and store the IP as per recommendation.
- Setting up a Data Safety Monitoring Board (DSMB) also known as Independent Data Monitoring Committee (IDMC), to assess the progress of a clinical trial, etc.
- Sponsor may also consider reimbursement to be paid to the participants for their time and expenses incurred. All such reimbursements have to be approved by the Ethics Committee.
During the trial the sponsor is responsible for:
- Submission of status report (of the trial) in cases of regulatory trials to CDSCO at the prescribed frequency
- Implementation and maintenance of appropriate Quality Control and Quality Assurance systems in order to ensure data validity and integrity.
- Communication of all Serious Adverse Events (SAE’s) to CDSCO and other investigators within 14 calendar days, as per the format provided in in Table 5 of the Third Schedule (page 218) in New Drugs and Clinical Trial Rules, 2019. This format may be used for reporting SAEs in a clinical trial or Bioavailability or Bioequivalence study.
- Study management, data handling and record keeping
- Monitoring (risk-based, centralised / remote / on-site) and auditing (relevant SOPs and personnel).
- Ongoing safety evaluation of the Investigational Product. Notification to investigators, regulatory authorities and institutions of findings that could potentially impact participant safety, conduct of the trial, or alter the EC’s approval.
Post-trial responsibilities of a sponsor:
- Submission of a Summary Report – in case of premature discontinuation or termination of the trial – within 3 months (report should include brief description of the study, number of participants exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study).
- Study reports (Clinical Study Report / Study Report)
- Appropriate archival of study related documents
- Appropriate disposal of left-over Investigational Product
- Post-trial access must be granted under specific circumstances, when the investigator has recommended it, and it has been approved by the Central Licensing Authority (i.e. CDSCO) and the Ethics Committee, and the with the participant’s consent (please refer to Rule 27 of Chapter V (page 157), in the New Drugs and Clinical Trial Rules, 2019). If applicable, it is the responsibility of the sponsor to provide post-trial access of the investigational drug to the participant, free of cost.
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:
- All sites follow the relevant regulatory principles, protocol, GCP guidelines, SOPs, etc.
- The study at all sites start and end simultaneously.
- The SOP includes the roles and responsibilities of the coordinating committee (Trial Steering Committee / Project Management Group) – if such a committee has been set up.
The Sponsor must arrange for the following:
- Training of all staff members (including the site staff).
- Facilitate communication between the various site investigators (in case of a multicentre study).
- Appropriate design of the Case Record Forms (CRF) – considering the data that has to be collected.
The Sponsor must document and design the following:
- The Ethics Committees that have to be consulted.
- Roles and responsibilities of the coordinating investigator.
- Roles and responsibilities of the Contract Research Organisation (CRO) – if it has been contracted.
- Randomisation procedure.
- Standardisation and validation of methods of evaluation, and analyses of data (at each site).
- Structure and function of a centralised data management set-up.
- Adverse Event Reporting – the Sponsor must ensure that the safety reporting is done as per the regulatory requirements.
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 trials
Academicians 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
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
- National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed 05.07.2019).