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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 +
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 +
USA CTCAE -
Common Terminology Criteria for Adverse Events v5.0 (2017) +
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
USA FD&C Act -
Federal Food, Drug, and Cosmetic Act 30-Sep-2023 +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):
Guidance for Industry March 2018 +
USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
USA FDA Guidance for Clinical
Investigators,
Sponsors, and IRBs
Adverse Event Reporting to IRBs —
Improving Human Subject Protection Jan-2009 +
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
USA FDA Guidance for Industry
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
USA FDA Guidance for Industry -
Computerized Systems Used in
Clinical Investigations May-2007 +
USA FDA Guidance for Industry -
Computerized Systems Used in
Clinical Trials 13-Apr-2015 +
USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
USA FDA Guidance for Industry -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
USA FDA Guidance for Industry -
Electronic Source Data in Clinical Investigations Sep-2013 +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 +
USA FDA Guidance for Industry -
Oversight of Clinical Investigations —
A Risk-Based Approach to Monitoring Aug-2013 +
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
USA FDA INFORMATION SHEET -
Recruiting Study Subjects,
Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
USA FDA Information - Observations and citations 20-Mar-2024 +
USA Informed Consent -
FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 +
USA NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS
FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 +
USA NIH -
SCORE Manual N.A. +
USA NIH -
SCORE Manual: Appendix Source Documents Requirements Rev 01
16-Aug-2025 +
USA NIH - Glossary 27-May-2025 +
