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IIS Research Program Details

What is an Investigator-Initiated Study?

An independently-initiated study sponsored by one or more healthcare professionals or scientists who have an interest in examining the effects of a drug product in a particular setting and/or on a particular population and/or in a particular form. In this type of study, the healthcare/research professional assumes both legal and regulatory responsibilities and performs the role of both the sponsor and the investigator and assumes the role of S-I. The role of S-I can sometimes be assumed by an institution. IIS may be supported by Janssen in the form of product and/or funding.

Who is a Sponsor-Investigator?

An individual (or entity, where permitted) who both initiates and conducts, alone or with others, a clinical study, and under whose immediate direction the drug product is administered to, dispensed to, or used to treat a patient. In the case of a non-interventional/observational, human biological sample, or non-clinical study, an individual (or entity where permitted) who initiates designs and implements, alone or with others, a research effort, and under whose immediate direction the scientific systematic investigation is conducted. In all cases, the obligations of an S-I include both those of a sponsor and those of an investigator in accordance with applicable laws and regulations.

What are the responsibilities of the Investigator?

  • Designing and conducting the scientific investigation.
  • Complying with institutional requirements where the study will be conducted and all relevant laws, regulations and guidelines for research.
  • Reporting safety data to regulatory authorities and Janssen, as required.
  • Registering the clinical study on a public website such as www.clinicaltrials.gov, as required.
  • Publication of results in peer-reviewed journals and/or presentation at a scientific congress.

What is needed for submission?

  • A completed Research Application
  • Investigator Curriculum Vitae
  • Budget (when funding is requested)

What information is required for an application?

  • Click here to download an example template of the Clinical Research Worksheet
  • Click here to download an example template of the Non-Clinical Research Worksheet
NOTE: All submissions must be via the website. Email submissions are not accepted.

How do I submit an application?

  • Create an account
  • Create your user profile
  • Complete the online Research Application
  • Click here for a Website Overview
NOTE: The Janssen IIS Review Committee requires all application submittals to be made in English.

What is the review process?

Each request will go through Janssen internal review which consists of a cross-functional team composed of personnel from Regulatory, Clinical and Medical Affairs, Statistics, and Health Care Compliance. A decision is based on criteria in the areas of, but not limited to, scientific merit, strategic fit with the business plan of Janssen, investigator research experience, and adherence to Good Clinical Practice / Good Laboratory Practice.

What happens after my application is reviewed?

You will be notified via e-mail of the decision. If your Research Application is approved you will be asked to submit study documents for final review. These documents include:

  • Full protocol
  • Informed consent form, if applicable
  • Itemized budget (when funding is requested)

Once these documents have been approved and a research agreement has been fully executed, agreed-upon funding and/or product will be released according to the terms in the research agreement.