Clinical Trials

Clinical Trials

• To determine if you are conducting a clinical trial review NIH Clinical Trial Decision Tree and NIH's Clinical Trial Definition and Basic Experimental Studies Involving Humans Research webpages.
• All personnel engaged in a Clinical Trial MUST complete CITI GCP training.
• All Applicable Clinical Trials must be posted to Clinicaltrials.gov.
  • FDA:https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
  • NIH:https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
  • Some journals may require posting even if you are not conducting an Applicable Clinical Trial:http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
• Registration on Clinicaltrials.gov:
  • Contact Kevin McCreary at kmccrea1@kent.edu to obtain credentials.
  • Adhere to clinicaltrials.gov's requirements and review the PRS User Guide.
• Clinical Trial and Biomedical Study Consent Template - (new 11/5/21) use this template for clinical trial and biomedical studies. 
• See also - Kent State User ID and Password Required Clinical Research SOPs
• KSU does not sponsor FDA regulated research and the KSU IRBs do not review FDA regulated research. Please contact researchcompiance@kent.edu for more information.