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Selected Regulations and Guidance for Drug Studies

As of:

FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

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Part 50: Protection of Human Subjects

Subpart A – General Provisions
§50.1 Scope
§50.3 Definitions
Subpart B – Informed Consent of Human Subjects
§50.20 General requirements for informed consent
§50.23 Exception from general requirements
§50.24 Exception from informed consent requirements for emergency research
§50.25 Elements of informed consent
§50.27 Documents of informed consent
Subpart C – [Reserved]
Subpart D – Additional Safeguards for Children in Clinical Investigations
§50.50 IRB duties
§50.51 Clinical investigations not involving greater than minimal risk
§50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects
§50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition
§50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
§50.55 Requirements for permission by parents or guardians and for assent by children
§50.56 Wards

Subpart A – General Provisions
§50.1 Scope
§50.3 Definitions
Subpart B – Informed Consent of Human Subjects
§50.20 General requirements for informed consent
§50.23 Exception from general requirements
§50.24 Exception from informed consent requirements for emergency research
§50.25 Elements of informed consent
§50.27 Documents of informed consent
Subpart C – [Reserved]
Subpart D – Additional Safeguards for Children in Clinical Investigations
§50.50 IRB duties
§50.51 Clinical investigations not involving greater than minimal risk
§50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects
§50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition
§50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
§50.55 Requirements for permission by parents or guardians and for assent by children
§50.56 Wards

Selected Regulations and Guidance for Drug Studies

As of:

FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency