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[[Reference:+]] [[HasDocument::Document:USA 45 CFR Part 160 09-Apr-2025]]
[[Reference:+]] [[HasDocument::Document:USA 45 CFR Part 46 09-Apr-2025]]
[[Reference:+]] [[HasDocument::Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018]]
[[Reference:+]] [[HasDocument::Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)]]
[[Reference:+]] [[HasDocument::Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998]]
[[Reference:+]] [[HasDocument::Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023]]
[[Reference:+]] [[HasDocument::Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018]]
[[Reference:+]] [[HasDocument::Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs â€” Improving Human Subject Protection Jan-2009]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations â€” A Risk-Based Approach to Monitoring Aug-2013]]
[[Reference:+]] [[HasDocument::Document:USA FDA Guidance for Industry Investigator Responsibilities â€” Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009]]
[[Reference:+]] [[HasDocument::Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998]]
[[Reference:+]] [[HasDocument::Document:USA NIH - Glossary 27-May-2025]]
[[Reference:+]] [[HasDocument::Document:USA FDA Information - Observations and citations 20-Mar-2024]]
[[Reference:+]] [[HasDocument::Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023]]
[[Reference:+]] [[HasDocument::Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024]]