- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Study Start-Up Consultation
OHSP-QI has demonstrated that providing study-specific training to study teams the SSU service increases overall compliance in human subject research. Study teams who utilized this service had fewer high-risk findings and improved ratings upon internal review compared to those who did not. For further details on this project, refer to our ‘Quality Improvement Study Start Up Consultations Improve Protocol Compliance’ poster.
To assist Investigators and study staff in their ability to achieve compliance with the regulations, policies, and guidelines applicable to their specific study and to further protect subjects who participate in research.
At the request of the Principal Investigator, the OHSP-QI staff is available to conduct a Study Start-Up consultation. This service would typically occur after IRB approval but prior to initiating study conduct (consenting and enrollment of subjects).
The OHSP-QI staff will evaluate study documentation (e.g. regulatory binder, data collection forms) and will collaborate with the Investigator/site staff to ensure understanding of the applicable regulations, policies, and guidelines specific to the research study. Study Start-Up Consultations are free and fully customizable to study team needs.
OHSP-QI provides educational materials/references, support, study tools, and a post-consultation written assessment.
OHSP QI SSU Consultation Information Memo
If you'd like to discuss or schedule a consultation, please contact: