The responsibilities of the Chief Investigator
The person who takes overall responsibility of the design, conduct and reporting of the study if it involves one site or if the study involves multiple sites the person who take primary responsibility for design, conduct and reporting of the study whether that person is an investigator at any particular site.
For further information and a list of full responsibilities please see our Document Library.
The responsibilities of the Principle Investigator
In hosted organisations, each study will have a Principal investigator (PI) who has overall responsibility of the project for the following:
- The welfare of patients
- The medical care of trial subjects
- Informed consent
- Conduct of the study in compliance with the protocol
- Administration and management storage of investigational product as appropriate
- Ensuring that local management needs are met
- Obtaining local approval of e.g. Ethics Committee and Trust management / R&D
- Safety reporting e.g. Adverse Events and Serious Adverse Events to the sponsor
- The accurate and timely completion of trial data
- Training of the research team.
The responsibilities of researchers include:
- Developing proposals that are scientifically sound and ethical
- Seeking and obtaining a favourable opinion from an NHS Research Ethics Committee for each project
- Informing the Trust's R&D Office of all research being undertaken, and obtaining R&D approval before the research starts
- Conducting research to the agreed protocol (or proposal), in accordance with legal requirements and guidance
- Ensuring participants' welfare while in the study
- Feeding back results of research to participants
- Ensuring that students and new researchers have adequate supervision, support and training
- Ensuring that the findings from the research are opened to critical review through the accepted scientific and professional channels, are disseminated promptly, and fed back as appropriate to participants.
The responsibilities of the Trust, as host organisation for the research, include:
- Promoting a quality research culture
- Ensuring researchers understand and discharge their responsibilities
- Ensuring the research is properly designed, and that it is well managed, monitored and reported
- Ensuring that research using their patients, service users, carers or staff meets the standard set out in the Research Governance Framework for Health and Social Care
- Ensuring there is ethical approval for all research for which they have a duty of care
- Retaining responsibility for research participants' care
- Taking action if misconduct or fraud is suspected.