Investigator-Initiated Research Roles and Responsibilities

Through research and discovery, we advance patient care.

At Philips, we challenge the status quo. We are dedicated to supporting Investigator-Initiated Research. In pursuit of excellence, we partner with physicians and institutions worldwide to discover what’s next in treating the challenges of cardiovascular health.

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

	INDUSTRY SPONSORED	INVESTIGATOR SPONSORED
PROTOCOL OWNERSHIP	The company owns the protocol and invites investigators to participate	The sponsor institute owns the protocol and can submit to multiple funding sources for support
DATA	The company manages data with subject consent; the investigator typically has access to their data only	The sponsor institute manages data with subject consent and gives company rights to use the data
MONITORING	The company is responsible for conducting appropriate monitoring and may monitor the data to ensure validity	The sponsor institute is responsible for study conduct and data validity
INTELLECTUAL PROPERTY	The company typically has rights to all intellectual property developed from the study data	The intellectual property is negotiated by study protocol
DELIVERABLES	Usually determined by the company	The investigator and company determine as part of any research grant agreement
PUBLICATION	The company and steering committee determine authorship	The investigator determines authorship

Definitions:

SPONSOR	PRINCIPAL INVESTIGATOR (PI)
An individual, company, institution, or organization that takes responsibility for the initiation, management, and / or financing of a clinical trial. Note: The regulatory/legal definitions of “Sponsor” and associated indicators of sponsorship may vary by geography.	An individual who is responsible and accountable for conducting the study at a study site. The PI assumes full responsibility for the treatment and evaluation of the Clinical Subjects and for the integrity of the research data and results at the respective study site. Note: The Principal Investigator may also be the Sponsor of the clinical study.

Responsibilities:

Sponsor (ISO 14155 ):

Clinical quality assurance and quality control
Clinical investigation planning and conduct
Selection of clinical personnel
Preparation of documents and materials
Conduct of clinical investigation
Monitoring
Safety evaluation and reporting
Clinical investigation close-out

Principal investigator (ISO 14155)

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, MedTech, Eudamed (European Commission) (pending 2022) requirements, local, laws, and guidelines.

Please refer to the ClinicalTrials.gov Protocol Registration and Results System Final Rule Information website. https://prsinfo.clinicaltrials.gov/ and/or Eudamed website (pending 2022) European Commission, official website (europa.eu)
Design the protocol and conduct the scientific investigation.
Gain approval through Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
Register study with Clinicaltrials.gov  https://clinicaltrials.gov/ct2/manage-recs/how-register and/or Eudamed. Click this link to learn how. https://clinicaltrials.gov/ct2/manage-recs/how-register Eudamed (pending 2022).
Control study protocol and manage the data generated during the study.
Submit study status updates to the company 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 about the IIR Principal Investigator/Site Roles and Responsibilities, please contact us at IIRStudy.IGTDevices@philips.com

Apply

Questions?

If you still have questions after reviewing the content on this site, please contact us at IIRStudy.IGTDevices@philips.com.