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Quality Improvement Office - ClinicalTrials.gov

Compliance Program Documentation, Regulations, Policies & Guidance

The Indiana University, ClinicalTrials.gov Compliance Program documentation, policy and SOP provide the framework in which monitoring and auditing of registration, maintenance and results reporting in ClincalTrials.gov occurs. Regulatory and policy documentation informs the operations of the Indiana University, ClinicalTrials.gov Compliance Program.

Indiana University SOPs for Research Involving Human Subjects is available on the Human Subjects Polices & Guidance page.

ClinicalTrials.gov Resources

Federal Regulations, Policies and Guidance

Other Policies and Recommendations

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