Requirements and Procedures Q&A

1. Q: Who may apply and participate in Johnson & Johnson company funded IIS studies?
   A: Any qualified Investigator/Site wishing to study bona fide research questions that are of clinical relevance to Johnson & Johnson company products and/or related therapeutic areas.
2. Q: Am I required to apply online?
   A: All proposals must be formally submitted online for the IIS committee to render a decision.
3. Q: What types of studies are eligible for IIS consideration?
   A: Bona fide studies with valid study designs.
4. Q: How long does the application process take?
   A: We aim to provide a decision on submitted proposals as quickly as possible, but it could take 1 to 3 months depending on rounds of questions and any recommended study modifications.
5. Q: Who is responsible for preparing the Protocol, Informed Consent, Case Report Forms and Monitoring?
   A: The Investigator/Site is responsible for determining how to collect and organize data for analysis and ensuring that:
   • All data collected/used are verifiable within the patients' source documentation such as medical records
   • Data are clean and accurate
6. Q: Where can specific product safety language be found?
   A: It can be found in the Instructions for Use which are included with the product.
7. Q: Can a CRO, Central IRB, Biostatistician or other qualified suppliers be used by the site?
   A: Yes, if they meet the same rigor and requirements as presented in the protocol.
8. Q: Are IIS studies ever permitted to be conducted at several sites?
   A: Multicenter studies – IIS proposals for multicenter studies may be supported if (1) the therapeutic area and the study are such that there may be insufficient subjects at any one given study site to meet the target enrollment for the study; (2) there is a clearly identified need for gathering evidence in an expeditious manner that is best facilitated by a multicenter study; (3) the IIS is being conducted by a study group (e.g. cooperative group) of academic physicians headed by a lead investigator, who is selected for his or her established expertise and proven track record of clinical research; or (4) site-to-site variation is a factor that is under study or that may affect outcomes.

   NOTE: If a multicenter study is supported by a Johnson & Johnson medical device company, the lead investigator will be identified in the IIS contract as the party responsible for coordination of all sites involved in the study and for compliance with applicable laws, regulations, and guidelines at all participating study sites

   Budget and Contract Q&A

9. Q: Can you provide funding for an investigational device (i.e. device not yet approved or commercially available in the country)?
   A: Our IIS program does not provide funding for investigational devices.
10. Q: What is the IIS review and approval process?
    A: Investigator submits a request to the specific Johnson & Johnson medical device company
    • Company reviews application for relevance, qualification and funding
    • For full proposal submission, the company issues Approval or Denial to Investigator. The IIS committee may have questions that needs to be clarified before a decision is rendered.
    • For preliminary idea submission, the IIS committee will review the idea and provide general feedback to the investigator if the idea is of interest to the company. The feedback is not a guarantee of approval should the investigator decides to proceed with a full submission.
    • If approved, a contract, including budget with payment milestones, is executed by both Investigator and the company
11. Q: Can I reapply if my proposal is declined?
    A: Although denial of an application does not mean that the proposed research lacks value, we highly encourage investigators to pursue other sources of funding and welcome investigators to apply again with other study ideas.
12. Q: When will I receive funding or product(s) if my study is approved?
    A: Once a contract is fully signed, we will distribute funds, product(s) support, or both, to the investigators/sites based on the milestones established in the agreement. Payment may take up to 60 days upon initial set up of payment account. Note that the study should not start before the contract is fully signed. We will not be able to compensate for work performed before the contract is signed.
13. Q: What are the contracting requirements?
    A: The company will provide a contract template and payment schedule budget based on the project timeline, deliverables and associated costs.
14. Q: What are the budget requirements?
    A: The budget must show per patient, per procedure and all other research related cost as shown in the provided budget template located under the supporting documents tab.
15. Q: How is Fair Market Value (FMV) determined?
    A: Once the budget is submitted, a FMV review will be performed by the company based on industry-wide cost data. Additional information or clarifications may be requested. CVs for the primary research associates should be included with the application.
16. Q: What items are not reimbursable via IIS funding?
    A: The following are generally excluded from IIS funding
    • Procedural costs that are reimbursable through standard of care treatment
    • Site equipment
    • Capital or reusable equipment
    • Overhead for non-research related costs
    • Any costs which have not been included in the approved budget