Investigator-Initiated Research (IIR) Principal Investigator (PI) / Site Roles and Responsibilities as the Sponsor

Definitions:

Sponsor (ISO 14155 – 2011): Individual or organization taking responsibility and liability for the initiation or implementation of a clinical investigation.

Principal Investigator (ISO 14155 – 2011): Qualified person responsible for conducting the clinical investigation at an investigation site.

Responsibilities:

Sponsor (ISO 14155 – 2011):

8.1 Clinical quality assurance and quality control

8.2 Clinical investigation planning and conduct

8.2.1 Selection of clinical personnel

8.2.2 Preparation of documents and materials

8.2.3 Conduct of clinical investigation

8.2.4 Monitoring

8.2.5 Safety evaluation and reporting

8.2.6 Clinical investigation close-out

Principal investigator (ISO 14155 – 2011)

• The role of the principal investigator is to implement and manage 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. Understand and act in accordance with FDA and MedTech requirements, guidelines and laws.
• Please refer to the ClinicalTrials.gov Protocol Registration and Results System Final Rule Information website. https://prsinfo.clinicaltrials.gov/

• Design the protocol and conduct the scientific investigation.
• Gain approval through Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
• Register study. Click this link to learn how. https://clinicaltrials.gov/ct2/manage-recs/how-register
• Control study protocol and manage the data generated during the study.
• Submit study status updates as required in the study agreement.
• Notify the company of significant study milestones as required in the study agreement
• Provide a draft manuscript and study data upon completion of the study.
• Report safety data to regulatory authorities, the IRB/IEC, and the company.
• Understand and comply with any and all requirements of institution(s) which are associated or which research will occur.

If you have questions on the IIR Principal Investigator/Site Roles and Respsonsibilities, please contact us at IIRStudy.IGTDevices@philips.com