Patient monitoring investigator initiated studies

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.

Table of Contents

Investigator-Initiated Study (IIS) Application Submission & Review Process
Areas of Interest
Review Qualifications
IIS Roles and Responsibilities
Frequently Asked Questions
Application Form

If you have questions, please contact us at IISStudy.HPM@philips.com

1. Investigator-Initiated Study (IIS) Application Submission & Review Process

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.

2. Areas of Interest

Clinical Measurements in Acute Care

Real-world performance of patient measurement technology, particularly for oxygen saturation, non-invasive and invasive blood pressure, and electrocardiography
Performance of multiparameter patient monitoring in identifying a clinical condition

Clinician Experience in Acute Care

Clinical workflow optimization strategies
Addressing alarm fatigue through smart alarms, multimodal approaches, implementation science, and mixed methodology or ethnographic study designs

Digital Health in Acute Care

Artificial intelligence, decision support, visualization, and situational awareness tools
Prediction models, particularly studied in a prospective methodology
Bidirectional communication of devices, particularly as it relates to impact on workflow or alarm management

Wearables and Continuous Monitoring

Clinical studies assessing device performance measures, clinical outcomes, workflow improvement, staff and patient satisfaction, and data fidelity of innovative monitoring devices in general care, obstetrics, hospital-to-home, or hospital-at-home settings

Patient Safety

Care strategies or tools to improve patient safety during monitoring

3. Review Qualifications

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

Alignment with Philips Hospital Patient Monitoring therapeutic areas of interest and IIS strategy
The proposed budget or resource request is reasonable and meets Philips compliance and regulatory regulations

Scientific merit

The methods are clear and concise with an appropriate sample size, timeline, endpoint(s), and statistical plan
The proposal is unique, not duplicative to existing literature, and will provide valuable insights for clinical practice
The study aims to yield valuable information regarding clinical outcomes, health economics, clinical workflow, or other scientifically relevant topics
There is a publication and communication plan

Investigator and site qualifications

The principal investigator has adequate research experience
The institution has adequate infrastructure and study personnel to conduct the study

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.

4. IIS Roles & Responsibilities

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:

For clinical investigations in the European Union, apply all appropriate EU MDR regulations, as applicable, including but not limited to:
Alignment with Articles 82, 62, or 74. Most IISs will fall under Article 82
Notification to- or approval of- the study by the competent authority
Each member state’s Medical Device Act
Register study in databases such as Clinicaltrials.gov at https://clinicaltrials.gov/ct2/manage-recs/how-register or the European Clinical Trials Register at https://euclinicaltrials.eu/ctis-for-sponsors/, as appropriate.
Develop the study protocol and manage the data generated during the study.
Submit status updates to the company per the contract.
Notify the company of significant study milestones per the contract.
Understand and comply with all institution(s) requirements, the ethical principles stated within the Declaration of Helsinki, Good Clinical Practice, and all applicable regulatory requirements

5. Frequently Asked Questions

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:

Reimbursable procedural costs through standard of care treatment
on-study overhead or non-study related costs
Costs not approved in the budget within the contract

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.

6. APPLICATION

Please click here to submit your application.