Olympus Corporation of the Americas (OCA) is committed to advancing medical and scientific knowledge about Olympus products and contributing to the improvement of patient care by supporting investigator sponsored original research.
The IIT Committee makes decision pertaining to the support of IITs in the United States.
The IIT Committee assesses all requests for scientific merit and strategic interest and does not make decisions based upon past, present or future opportunities to generate business or goodwill from investigators.
Types of Studies Supported
The IIT Committee accepts the following types of proposals:
- Research related to Olympus’ published Research Areas of Interest
- Approved label studies using cleared/approved Olympus Products
The IIT Committee does not accept the following types of proposals:
- Non-human subject studies
- Studies using investigational devices or off-label uses
- Research topics outside Olympus’ published Research Areas of Interest
Types of Support Provided
Financial support and/or Olympus devices may be provided depending on the type of research.
The IIT Committee currently supports:
- Subject-related cost
- Research coordinator cost
- Data management expenses
- IRB review fees
The IIT Committee does not support:
- Educational and training activities
- Labor cost of investigators
- Purchase of capital equipment unrelated to the study or that would generate revenue
- Travel to conferences to present study results
- Manuscript writing
- Publication preparation and submission
- Idea or protocol development
The investigator and/or investigator’s institution assumes the roles and responsibilities of the study sponsor, including compliance of all regulatory requirements.
Research Areas of Interest
Frequently Asked Questions
What are the roles and responsibilities of an investigator participating in the OCA IIT Program?
An investigator is a single individual or institution that takes the roles and responsibilities of both a study sponsor and an investigator.
Supporter, Olympus of the Americas: Provides financial support and/or devices as outlined in the IIT agreement.
Sponsor, Physician/Institution: Has authority and controls over the study, including document management, data management, data analysis, publication, regulatory action, etc.
Investigator, Physician: Initiates and conducts the study according to a defined protocol and in compliance with Good Clinical Practice (GCP) guidelines.
Submission, Review, and Contracting
How long does the review process take?
A response is provided to the investigator within 60 days. If a submission is incomplete and/or missing required information, the review process would take longer.
What is the review criteria?
- Scientific soundness
- Novelty of research question
- Strategic alignment
- Investigator’s qualification
- Regulatory status
- Appropriateness of budget
What information is required to submit a proposal?
- Contact information
- Details about the proposed study (protocol synopsis or full protocol)
- Detailed request for support
- Research experience
- Investigator(s) CV (s)
- Current medical license
- Financial Disclosure Form
What is required for preparation of the contract?
- The finalized protocol
- The finalized study budget
Study Start-up and Study Management
Does OCA require IRB/EC protocol approval?
OCA must receive a copy of the Investigational Review Board (IRB) or Ethics Committee (EC) protocol approval letter before any support can be provided. If a waiver is granted by the IRB/EC, please submit a copy of waiver documentation.
What is required before the first study payment/shipment of product?
- IIT agreement signed and dated by all parties
- IRB/EC approval
- All payments are based on milestones outlined in the IIT agreement. Start-up payment may or may not be included as a milestone.
What is required during the study period?
Regular progress reports are required as outlined in the IIT agreement to document study progress and determine whether payment milestones have been achieved. If reports are not received in a timely manner as outlined in the IIT agreement, OCA may decide to discontinue support.
What happens if my study is delayed or has trouble with enrollment?
Please inform OCA of any delays to the study. If the study requires protocol changes, the investigator will be required to provide a report to OCA that summarizes the proposed changes, the cause of the delay, provides a justification of the change, and an explanation of what can be done to get the study back on track.
The IIT Committee will review the changes and make a decision on remedial action.
Should I register my study online?
Yes. The sponsor-investigator is responsible for registering the study. Moreover, in alignment with the International Committee of Medical Journal Editors (ICMJE), OCA requires that the study be registered before the sponsor-investigator enrolls the first subject.
The online clinical trial registration system may be accessed at: www.clinicaltrials.gov
Who is responsible for reporting adverse events occurred in the study?
The sponsor-investigator is responsible for reporting adverse events that occurr in the study as required by applicable laws and regulations.
The FDA defines specific responsibilities for investigators and sponsors.
Can OCA control or prevent me from publishing results and do I need to inform OCA?
Please notify OCA of intent to submit an abstract or manuscript as outlined in the IIT Agreement. OCA requires review of all publications prior to public disclosure to ensure technical accuracy and to protect our intellectual property. OCA will not prevent publication of results, but is permitted to request reasonable redrafting to protect proprietary information.