RESPONSIBILITIES OF INVESTIGATORS

  1. to be free to participate in the research and not subject to any regulatory or misconduct litigation or investigation by the MHRA, EMEA, GMC or any other regulatory body or institution, the host organisation or employing institution
  1. to disclose any conflicts of interest that arise prior to or during the course of this research, and ensure that all staff involved in this research are aware of their responsibilities to disclose conflicts of interest

3.to conduct the study in accordance with ICH GCP, the DoH Research Governance Framework and the international and national laws and statutes that relate to the study, and any local requirements as may be specified by their host institution

  1. to ensure that all staff involved in research are familiar with all relevant legislation, policies and guidelines and are able by knowledge, training and experience to undertake the roles assigned to them
  1. to have sufficient time to properly conduct and complete the study and not serve as an investigator or significant participant in other research projects if such activity might adversely affect ability to perform obligations under this agreement

6.to maintain a Site File containing the essential documents set out in section 8 of ICH GCPensuring the site file is available for inspection if requested by the Sponsor

7.to conduct the study in accordance with the protocol “except where necessary to eliminate an immediate hazard(s), or when the change(s) involve only logistical or administrative aspects of the trial …” ICH GCP 4.5.2. These circumstances must be reported to the Chief Investigator, the Sponsor, the research ethics committee and STH Research Department

8.to inform the Chief Investigator, Sponsor and relevant research ethics committeeof any deviations or amendments to the protocol necessary for patient safety and to request approval from the relevant Ethics Committee and Research Department for protocol amendments

9.to document, with the involvement of Pharmacy, the supply, handling and accountability of trial drugs

  1. to use all reasonable efforts to ensure that all data collected and reported are accurate, complete and identifiable at source and that record keeping, data transfer and storage procedures adhere to the Data Protection Act 1998 and the principles of ICH-GCP

11.to monitor the study in accordance with the arrangements outlined in the submission to the Sponsor

12.to report all Serious Adverse Events to the Sponsor as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004

  1. to supply documentation and reports as deemed necessary by the Sponsor and STH Research Department to fulfil their obligations
  2. to inform the Research Department of any impending audits, monitoring visits or inspections by external institutions
  3. to cooperate with audits or inspections undertaken by the host institution, the Sponsor and regulatory authorities including the MHRA, and the Department of Health informing the Research Department of the outcome
  4. to alert the Research Department to any concerns relating to potential research misconduct
  5. to assist investigations into any alleged research misconduct undertaken by the Trust in its role as Sponsor or host of research
  6. to make the necessary provision for archiving essential documents

DECLARATION
Protocol Title______
Sponsor Reference. ______REC Reference ______
Chief Investigator______
I accept the responsibilities set out above.
Name ______
Signature ______Date ______