November 2024 SOCRA Source Journal - Journal - Page 59
References
1 Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors. https://www.fda.gov/
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2 Code of Federal Regulations (Drugs) - 21 CFR 312. https://www.ecfr.gov/current/title-21/chapter-I/
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3 Code of Federal Regulations (Devices) - 21 CFR 812. https://www.ecfr.gov/current/title-21/chapter-I/
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4 E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.
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7 ClinicalTrials.gov Protocol Registration Data Element De昀椀nitions for Interventional and Observational
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11 U.S. Food and Drug Administration Bioresearch Monitoring (BIMO) Fiscal Year 2022 Metrics.
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12 Guidance for Industry E3 Structure and Content of Clinical Study Reports Questions and Answers
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13 Good documentation practice in clinical research. https://www.ncbi.nlm.nih.gov/pmc/articles/
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