Thank you for your interest in submitting an IIS application. Below are the steps for applying:
Step 1: Complete the IIS application
Step 2: The following documents are required for submission. Please provide those in a PDF format:
Once submitted, the IIS application is reviewed for completeness.
The IIS request will be reviewed against a specific qualifications list to ensure its scientific merit as well as alignment with our strategy and available budget. The IIS application will also go through legal and regulatory review.
The applicant will be contacted directly once a Review Committee decision is made.
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:
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.
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 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
If you have questions, please contact us at IISStudy.PD@philips.com
Q: Who can apply for IIS support from Philips Computed Tomography (CT)?
A: Principal Investigators/Institutions wanting to partake in a research study of clinical relevance to Philips CT products and/or related therapeutic areas are eligible to apply.
Q: Am I required to apply online?
A: Yes, in order for your IIS application to be reviewed for potential funding, all grant requests must be formally submitted online.
Q: What is the IIS application submission and review process?
A: Please review the ‘Submission & Review Process’ above.
Q: How long does the application review process take?
A: Our goal is to review each IIS request and provide a rapid response. Note that depending on questions or additional information, it may take one to three months to review and provide feedback on the IIS application.
Q: What are the Principal Investigator’s (PI) / Institution’s Roles and Responsibilities?
A: Please review the ‘Roles and Responsibilities’ above.
Q: What types of studies are eligible for IIS consideration?
A: Studies with an on-label product indication and a valid study proposal are eligible for IIS consideration.
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 included within the product packaging. General product information can be found here on the Philips website.
Q: Can I apply for funding for an investigational device (i.e., device not yet approved or not commercially available in the country)?
A: No. The Philips CT/AMI IIS program does not support investigational devices/off-label use
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 will provide a contract proposal.
Q: When will the contract become valid?
A: The contract will only be valid when the contract is signed by all parties defined in the contract.
Q: Does my study need approval from an independent Ethics Committee?
A: Yes. You must get approval from the Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
Q: When will I receive funding or product(s), if my IIS applications approved?
A: Once an IIS contract is fully executed, (contract signed by all parties involved) and the study is approved by the IRB or IEC. Philips will distribute funds, product(s) support, or both, to the Principal Investigators/Institution based on the milestones established in the contract. Payments will be according to Philips standard payment terms and depending on the timeline identified in the contract.
Q: Am I required to provide a study budget?
A: When the IIS application requires funding, a full budget breakdown is mandatory.
Q: What items are not reimbursable via IIS funding?
A: The following items are excluded from IIS funding:
Q: Do you provide products if requested for IIS study?
A: Yes, we do have the option to provide Philips CT products for the purpose of the study and during review this request will be considered.
Q: Will payments be reported on the physician financial transparency reports?
A: Yes. Philips complies with all mandated transparency regulations.
Questions?
If you still have questions after reviewing the content on this site, please contact us at IISStudy.PD@philips.com.
Click here to submit your research request application.