Overview

Thank you for your interest in working with Terumo BCT. The External Research Program (ERP) supports studies with scientific and medical merit developed and sponsored by independent investigators or academic sponsors around the globe. An investigator-initiated study (IIS) may be a clinical or nonclinical study conducted without the participation of Terumo BCT.

For an IIS, the researcher functions both as the sponsor and investigator for the study and is responsible for study conception, design and operational execution; data handling, analysis and interpretation; subsequent reporting and publication; and compliance with all local laws and regulations.

IIS Proposal Application Package:

• Required supporting documents in English
  • Principal investigator’s curriculum vitae
  • Protocol synopsis must include:
    • Study title
    • Background/significance of the study
    • Objective and rationale
    • Study design
    • Primary endpoints
    • Secondary endpoints
    • Description of study population
    • Summary of study procedures
    • Statistical methodology
    • Projected timeline
  • Full protocol – optional
  • Full budget – required in USD, if monetary support is requested

About the External Research Program

We have established an internal cross-functional review process when considering support for investigator-initiated studies. Submissions are reviewed by our external research committees.

Terumo BCT supports external clinical research with investigators who are able to demonstrate clear evidence of high ethical and scientific standards as they relate to clinical research in human subjects as stipulated by the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP).

Investigators undertaking nonclinical studies must provide evidence of adherence to established processes and laboratory procedures.

Investigator-Initiated Studies (IIS)

Investigator-initiated studies are studies with scientific and medical merit developed and sponsored by an independent investigator/sponsor. An IIS may be clinical or nonclinical and is conducted without Terumo BCT participation. The IIS investigator/sponsor may request Terumo BCT to provide any or all of the following: funding, medical device(s), laboratory device(s) and training.

Responsibilities of the investigator/sponsor:

• Study design and conduct
• Data analysis and interpretation
• Publication
• Compliance with laws, regulations and guidelines
• Reporting to regulatory authorities

Other responsibilities include:

• Meeting specific milestones
• Submitting updates to Terumo BCT External Research Program
• Authoring final study report