Investigator-
Initiated Study
Overview
Motus GI believes that clinical research data is generated in many important avenues such as sponsored trials, investigator-initiated studies (IIS) and real-world evidence endeavors. Each avenue contributes in different ways and specifically, investigator-initiated research allows for industry and the medical community to pursue equally important ideas in a collaborative environment. The value of the scientific research produced by investigators is key to complementing sponsored research and Motus GI is committed to supporting investigator led initiatives.
What is an Investigator-Initiated Study (IIS)?
Motus GI defines an IIS as a clinical study conceptualized, developed and executed by an independent third-party sponsor. Each IIS must be unsolicited, conducted without the participation of Motus GI, and be conducted with the highest manner of scientific rigor.
Additional Resources
IIS Application Form
ClinicalTrials.gov
Good Clinical Practice (GCP)
AdvaMed Code of Ethics
Qualifications of Investigators & Sponsors of IISs
Motus GI will only undertake IISs with investigators that are qualified, and able to demonstrate sufficient experience and clear evidence of high ethical and scientific standards as it relates to clinical research in human subjects as stipulated by the applicable regulations and international standards.
- Investigators undertaking IISs will have to provide evidence of ethical standards and/or Good Clinical Practices (GCP)
- Investigators must have adequate resources including staff and facilities to conduct the proposed study.