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Guidance and Resources

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Web Resources: 
UIC Clinical Research Finance Office (CRFO)https://research.uic.edu/compliance/clinical-trials/
FDA Formshttps://www.fda.gov/about-fda/reports-manuals-forms/forms?Page=5
FDA Regulations: Good Clinical Practice & Clinical Trialshttps://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
FDA Bioresearch Monitoring Program (BIMO) Compliance Programshttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-manual/bioresearch-monitoring-program-bimo-compliance-programs
Policy on Good Clinical Practice Training for NIH Awardees involved in NIH-funded Clinical Trialshttps://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
Schedules of Controlled Substanceshttps://www.ecfr.gov/current/title-21/chapter-II/part-1308
U.S. Department of Health & Human Services
Clinical Research Study Investigator’s Toolbox
https://www.hhs.gov/guidance/document/clinical-research-study-investigators-toolbox
Centers for Medicare and Medicaid Services
Medicare National Coverage Determinations (NCD) Manual
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS014961
Centers for Medicare and Medicaid Services
National Coverage Determinations (NCD) for Routine Costs in Clinical Trials
https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=1
Clinicaltrials.gov Registrationhttps://register.clinicaltrials.gov/
Clinicaltrials.gov
Protocol Registration and Results System (PRS) Guided Tutorials
https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/lessons/ZaiGS0D0DYHroTB-jJh6oLQlGYpvRiq1