Once the investigators and institutions have been identified and selected, the sponsor must enter into a legal agreement or contract with the site, where the trial is to be conducted. This is most often referred to as a Clinical Trial Agreement. The agreement should cover the following terms:
- Roles and responsibilities of the various stakeholders involved (sponsor, investigator, Contract Research Organization, any laboratory, etc.)
- Conduct of study in compliance with Good Clinical Practices (GCP), applicable regulatory and ethical guidelines, and the approved protocol
- Compliance with procedures for data recording and reporting
- Terms of confidentiality and non-disclosure
- Details of insurance and indemnity (compensation details)
- Permission for monitoring, audit and inspection of the trial site. The contract should explicitly state that the CRO or monitor should be given access to the trial sites, source data and documents, and reports. The agreement should also state that the institution or site should allow access to the regulatory authorities (if needed) for an inspection.
- Agreement to retain all essential documents (related to the trial), until the Sponsor informs the site that the documents are not required (archiving)
- Proposed communication plan
- Details of the financial support, payments, honorariums and fees, etc.
- Grounds for termination of contract
- Publication policy
The allocation of roles and responsibilities, should also cover the following, in the agreement (as applicable):
- Data processing
- Breaking of the code
- Statistical analysis
- Preparation of the study report
- Preparation and submission of materials to the Ethics Committee, regulatory authorities and other oversight committees
- Reporting of Adverse Drug Reactions, Adverse Events, Serious Adverse Events
- Quality Control and Quality Assurance systems with written Standard Operating Procedures (SOPs).
An Investigator’s Undertaking is one of the documents submitted to Central Drugs Standard Control Organization (CDSCO) with an application to request permission to conduct a clinical trial in India (along with other documents). The IU is a legal document, in which the investigator commits to conduct the trial in accordance to the applicable regulatory, ethical and Good Clinical Practice guidelines. Table 4 of Third Schedule as per the New Drugs and Clinical Trial Rules, 2019 (Page 217) provides a format for developing the IU. This document can be used as template for IU.
- 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 03.04.2019).