Investigator-Initiated Study

Investigator-Initiated Study (IIS) Principal Investigator’s (PI) / Institution’s Roles and Responsibilities as Sponsor

With this IIS application you agree to take the roles of Sponsor and Principal Investigator as per ISO 14155:2020.

Sponsor (ISO 14155:2020): Individual, company, institution or organization taking responsibility and liability for the initiation and management of a clinical investigation and arranging the financial setup.
Sponsor Responsibilities (ISO 14155:2020):
9.1 Clinical quality management

9.2 Clinical investigation planning and conduct
9.2.1 Selection and training of clinical personnel
9.2.2 Preparation of documents and materials
9.2.3 Conduct of clinical investigation
9.2.4 Monitoring
9.2.5 Safety evaluation and reporting
9.2.6 Clinical investigation close-out

Principal Investigator (ISO 14155:2020): Qualified person responsible for conducting the clinical investigation at an investigation site.
Principal investigator Responsibilities (ISO 14155:2020):
The role of the principal investigator is to implement, oversee the management of the day-to-day conduct of the clinical investigation as well as ensure data integrity and the rights, safety, and well-being of the subjects involved in the clinical investigation.
The principal investigator is responsible for ensuring adequate training and qualification of the investigation site team and for maintaining oversight of their activities. The principal investigator may delegate tasks to qualified members of the investigation site team but retains responsibility for the clinical investigation. This also applies when activities are outsourced to an external organization by the principal investigator in which case he/she shall implement procedures to ensure the integrity of all tasks performed and any data generated by this external organization.

10.1 General  
10.2 Qualification of the principal investigator
10.3 Qualification of investigation site
10.4 Communication with the Ethics Committee (EC)
10.5 Informed consent process
10.6 Compliance with the Clinical Investigation Plan (CIP)
10.7 Medical care of subjects
10.8 Safety reporting 

If you have questions on the IIS Principal Investigator’s/Site’s Roles and Responsibilities, please contact us at IISStudy.PD@philips.com