Frequently asked questions.

  1. Are investigator initiated studies only available to investigators/sites that have done research with Janssen Scientific Affairs, LLC in the past?
    • No, any Health Care Professional (HCP) may submit an IIS proposal.

  2. What items do I need in the budget?
    • The budget should include the costs associated with each study procedure per patient.

  3. Can I include the cost of personnel in the budget?
    • The costs of staff (study coordinator, data manager, etc.) can be included in the initial budget. If so, the costs should be accounted for on a per patient basis, similar to the costs for study procedures. The Sponsor Investigator's costs should be accounted for in the cost of each procedure being performed.

  4. Can I include the cost of equipment in the budget?
    • No, the costs of purchasing equipment for the study cannot be included in the budget.

  5. Who is responsible for preparing the Protocol and Informed Consent Forms (ICF)?
    • The site is responsible for preparing its own ICF. Janssen Scientific Affairs will provide suggested standard safety language that details the risks associated with the use of our products.

  6. Is there specific language Janssen Scientific Affairs, LLC requires?
    • Janssen Scientific Affairs will provide suggested standard safety language that details the risks associated with the use of our products. This standard safety language can be used in the protocol and in the ICF.

  7. Can I do an IIS with another company? Is there any guidance regarding collaboration with another company?
    • If the study concept utilizes another pharmaceutical company's product and the site has an agreement with the other company, an IIS can still be supported by Janssen Scientific Affairs, LLC. Full disclosure between pharmaceutical companies would be required.

  8. Can I propose a study and conduct the study at several sites?
    • On rare occasions a study may be allowed to be conducted at multiple sites only if adequate need can be justified. You, as the sponsor would be responsible for monitoring the other sites and distributing study drug to them. You would also need to provide a Monitoring Plan to ensure Good Clinical Practices are being followed.

  9. I don't have a statistician; can I use one from the company?
    • No, we cannot provide statistical support for an IIS. You can budget for this and contract with a vendor for stats support.

  10. Do I have to make up case report forms (CRF) to conduct the study?
    • No. Sites can determine how they want to collect and organize their data for analysis. The site must ensure that the data collected/used is verifiable within the patients' source documentation, such as the medical records.

  11. Who is responsible for monitoring the study?
    • The site is responsible for ensuring that its data is clean and accurate. Janssen Scientific Affairs, LLC is not responsible for monitoring the sites.

  12. Can I use a central IRB?
    • Yes

  13. How will I be reimbursed?
    • After the concept and budget has been submitted and approved, a Clinical Trial Agreement (CTA) contract will be generated and payments will occur according to the agreed upon payment schedule in the CTA.

  14. Do you have a financial cap on IIS studies?
    • The budget for the study must be within fair market value.

  15. What types of studies are eligible for IIS consideration?
    • We will consider any study that involves XARELTO® or INVOKANA that addresses clinically relevant question/s regarding the use of our drugs.

  16. Can I request funding to attend a meeting/conference to present research findings?
    • No, funding to attend conferences to present the findings should not be included in the study budget.

  17. Do you supply placebo?
    • No. According to our policies, we cannot supply placebo for use in IIS studies. Funding to cover the costs of obtaining placebo used in the study can be included in the initial budget and will be evaluated on an individual basis.