MR investigator initiated studies
At Philips MR, we challenge the status quo. We are dedicated to supporting clinical discovery through Investigator-Initiated Studies (IIS). In pursuit of excellence, we partner with physicians, scientists, and institutions worldwide to discover what’s next in MR diagnosis and MR guided procedures to help caregivers decide, guide, treat, and confirm the right therapy for each patient.
1. Application submission and 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: The following documents are required for submission. Please provide those in a PDF format:
• Draft protocol or clinical research study synopsis: preliminary data (if available), study design, methods, statistical plan, study timeline (expected start date/first patient in, end recruitment/last patient out, database lock, final report/publication)
• Current CV signed and dated (Note: All sensitive information i.e., DOB, Social Security Number should be removed prior to submission by the applicant)
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.
2. Areas of interest
Early diagnosis, multi-center studies, clinical guidelines, neurodegenerative disease, cardiovascular disease, oncology, liver disease, musculoskeletal disorders, pediatrics, AI enhanced imaging and diagnosis, treatment response, neuroscience and novel MRI methodology.
3. 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:
• Clinical and scientific merit
• Realistic sample size, timelines, budget, and statistical plan
• Compliance with international regulations and guidance documents relating to the protection of human subjects, national standards, and compliance with medical device regulation
• Alignment with therapeutic/diagnostic areas where Philips has an interest and with the business strategy
• Research should address new ideas, new fields, explore gaps in existing knowledge. Proposal is unique (unnecessarily duplicative)
• Principal Investigator (PI) adequate research experience and Institute’s infrastructure to conduct the clinical research study
• Research resulting in valuable information regarding clinical outcomes, health economics or reimbursement possibilities
4. Roles and responsibilities
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):
- Clinical quality management
- Clinical investigation planning and conduct
- Selection and training of clinical personnel
- Preparation of documents and materials
- Conduct of clinical investigation
- Monitoring
- Safety evaluation and reporting
- Clinical investigation close-out
Principal Investigator (ISO 14155:2020): 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.
- General
- Qualification of the principal investigator
- Qualification of investigation site
- Communication with the Ethics Committee (EC)
- Informed consent process
- Compliance with the Clinical Investigation Plan (CIP)
- Medical care of subjects
- Safety reporting and 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
Click here to submit your research request application.
If you have questions, please contact us at IISStudy.PD@philips.com.