We aim to improve the lives of people around the world through education and research. To achieve this goal, Philips Hospital Patient Monitoring (HPM) partners with investigators and institutions worldwide to discover what’s next for patient monitoring.
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If you have questions, please contact us at IISStudy.HPM@philips.com
Thank you for your interest in submitting an IIS application. Below are the steps for applying:
Step 1: Complete the IIS application
Step 2: Upload a current CV of the principal investigator
Note: All sensitive information should be removed prior to submission, for example, date of birth
Step 3: Submit the IIS application
The IIS application will be reviewed against specific qualifications to ensure it meets scientific, legal, and regulatory requirements and aligns with the Philips Hospital Patient Monitoring IIS strategy and budget. Satisfying all criteria does not guarantee the study will be supported by Philips.
The applicant will be contacted once the review committee has made a decision or more if information is required. We aim to contact the applicant within 45 days of submission.
Clinical Measurements in Acute Care
Clinician Experience in Acute Care
Digital Health in Acute Care
Wearables and Continuous Monitoring
Patient Safety
Investigator-Initiated Study (IIS) Review Qualifications
We mindfully review all IIS requests with a detailed assessment by a cross-functional review board. IIS requests will be assessed with the following criteria:
IIS strategy alignment
Scientific merit
Investigator and site qualifications
Compliance with national and international regulations and guidance relating to the protection of human subjects
Satisfying all criteria does not guarantee the study will be supported by Philips.
Principal Investigator and Study Site Roles and Responsibilities as the Sponsor
In Philips Hospital Patient Monitoring, an investigator-initiated study is original research that is created, designed, and executed by a non-Philips sponsor-investigator. The investigator is responsible for independently managing all aspects of the study. The submitting investigator will be the designated sponsor for the study according to the definition as described in the Code of Federal Regulation section 812.40 and ISO 14155: 2020.
| Industry Sponsored | Investigator Sponsored | |
| PROTOCOL OWNERSHIP | The company is responsible for the protocol with the support of the investigators | The sponsor-investigator is responsible for the protocol |
| DATA | The company is responsible for data management with subject consent | The sponsor-investigator is responsible for data management, with subject consent. The sponsor-investigator shares data with the company in alignment with the contract/data sharing agreement |
| MONITORING | The company is responsible for participant and data monitoring | The sponsor-investigator is responsible for participant and data monitoring |
| INTELLECTUAL PROPERTY | The intellectual property is negotiated during contracting. The company typically has rights to intellectual property coming from the study | The intellectual property is negotiated in the contracting phase |
| DELIVERABLES | The company determines deliverables | The sponsor-investigator and company determine deliverables during contracting |
| PUBLICATION | The company determines authorship | The sponsor-investigator determines authorship |
With this IIS application, you agree to take the roles of Sponsor and Principal Investigator 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. [Note: The regulatory/legal definitions of “Sponsor” and associated indicators of sponsorship may vary by geography.]
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. [Note: The Principal Investigator may also be the Sponsor of the clinical study.]
Principal Investigator Responsibilities (ISO 14155:2020):
The role of the principal investigator is to implement the study, oversee management of the day-to-day conduct of the clinical investigation, and 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 Additionally, the principal investigator shall:
Q: Who can apply for IIS support from Philips Hospital Patient Monitoring?
A: Principal investigators who wish to participate in a study aligned with the HPM IIS strategy
Q: How do I apply for support for my IIS study?
A: Complete the application in the Application tab.
Q: Am I required to apply online?
A: Yes.
Q: What is the IIS application submission and review process?
A: Click here to read the IIS application submission & review process.
Q: How long does the application review process take?
A: Our goal is to review each IIS request and provide a rapid response. It may take up to three months to review and provide a final decision on the application. Timelines are subject to change.
Q: What are the roles and responsibilities of the principal investigator and study site?
A: Click here to review a detailed list of roles and responsibilities
Q: What types of studies are eligible for IIS consideration?
A: Studies with a cleared or approved product indication and a valid study proposal are eligible for IIS consideration.
Q: What are the Hospital Patient Monitoring areas of interest for investigator-initiated studies?
A: Click here to see the current list of examples. Please note that this list is not exhaustive.
Q: Where can I find specific product information?
A: All product indications for use and specific safety information can be found in the Instructions For Use. General product information can be found here on the Philips website.
Q: What if my IIS request is denied?
A: If your IIS request is denied, this does not indicate the study lacks scientific significance, but the business will not be moving forward with supporting your study proposal. However, we welcome you to reapply in the future with other study ideas.
Q: If my IIS request is approved, will I receive a contract?
A: If your IIS request is approved, Philips Hospital Patient Monitoring will provide Philips form of a draft contract.
Q: Does my study need approval from an independent ethics committee or institutional review board?
A: It is the responsibility of the sponsor-investigator to follow all applicable regulations related to conducting clinical research. This requires approval or an exemption from an independent ethics committee or institutional review board.
Q: When will I receive funding, product(s), or support if my study is approved?
A: Once an IIS contract is fully executed, meaning the contract is signed by all parties involved, and the study is approved by the IRB or IEC. Philips will distribute funds, product(s), and/or provide the agreed upon support to the investigators and sites based on the milestones established in the contract. Payments can range depending on the timeline identified in the contract and must comply with fair market value regulations and Philips compliance standards.
Q: Am I required to provide a study budget?
A: Initial submissions require an estimated budget. Before the application is officially approved, Philips will ask for a full budget breakdown. Agreement on budget is subject to Philips compliance and regulatory requirements.
Q: What items are not reimbursable via IIS funding?
A: The following list includes examples of excluded items from IIS funding:
Q: Is it possible to receive products if requested for an IIS study?
A: Yes.
Q: Will payments be reported in alignment with transparency reporting requirements?
A: Yes, transfers of value to covered recipients will be reported for Philips Hospital Patient Monitoring complies with all mandated transparency regulations.
Please click here to submit your application.