Procedure [Responsibilities of individuals research team members] Principal Investigator (PI) /Co Principal Investigator (Co PI) Each research study will have a Principal Investigator (PI) [and may have a Co PI] who is the individual of a record who assumes authority and accountability for the ethical conduct of a research study in accordance with all applicable federal and state laws and state laws and regulations and with institutional policy. The PI [and Co PI] is each fully responsible for: The Investigator(s) shall be responsible for the conduct of the study according to the protocol; the relevant local and international guidelines good clinical practice guidelines (GCP) and for compliance purposes as per the undertaking given in Appendix [labelled according to group standardized nomenclature] The safety and welfare of participants in the [research study/trial] Reading and understanding all the information in the essential documents, the investigator’s brochure (IB), the informed consent, and the protocol. Informing all participants, including participants used as controls, that the investigational agents are being used for investigational purposes and following all requirements relating to obtaining informed consent. Preparing and submitting protocol documents for initial IEC review and approval. Conducting study activities only after IEC approval and in accordance with the approved protocol, and assuring that IEC requirements are met. Reporting Adverse Events (AEs) to the Sponsor as per protocol. Implementing modifications in approved research only after review and approval of the modification by the IEC, except where necessary to eliminate apparent immediate hazards to participants. Appropriate control, inventory, distribution, storage, record keeping and destruction or return of Investigational Product (IP). Prompt reporting to the IEC of all events that require prompt reporting. o Providing progress reports/annual report to the IEC in a timely manner. Assuring the disclosure of financial interest and arrangements to the sponsor and the IEC, and if required by the IEC, to participants, by any member of the research team that may present a conflict with the interests of participants in the study. While retaining knowledge of and overall authority for the conduct of all research studies, supervise members of the research team qualified by appropriate education and experience to
SOPs should be reviewed before any new clinical trial and every [second] year if trials are active during that period; however deficiencies in existing SOPs noted at any time (by any member of the [research group]) which require action are raised and dealt with at the earliest opportunity. New SOPs may also be suggested via email by any member of the [research group] for consideration by the [research group management]. The latter will facilitate a meeting of relevant key members of the [research group] to decide whether the new SOP is required and, if so, an outline for its contents and assignment of author/reviewer. In case of revisions, a summary of any changes are kept in the document history section. The revised SOP will be assigned a new version number/date according to a standard format. References 21 CFR 312.60 – General Responsibilities of Investigators Guideline Good Clinical Practice ICH Guidelines for Good Clinical Practice (E6) ICH Guidelines for Good Clinical Practice (E6) section 3.1 – Responsibilities Schedule Y : Responsibility of Investigator Document history Version no. Date Reviewer Details of changes 1 Not applicable, first version