Procedure [Responsibilities of individuals research team members] Principal Investigator (PI) /Co Principal Investigator (Co PI) Each research study will have a Principal Investigator (PI) who is the individual [and may have a Co PI] 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 is each fully responsible for: [and Co PI] 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
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
Study_Team_Responsibilities_SOP.docx