Self Studies
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February 2025 SOCRA Self StudyYou must log in to access content.
Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors - Part 5
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November 2024 Self StudyYou must log in to access content.
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors - Part 4
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August 2024 Self StudyYou must log in to access content.
Informed Consent: Guidance for IBs, Clinical Investigators, and Sponsors - Part 3
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May 2024 Self StudyYou must log in to access content.
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors - Part 2
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February 2024 Self StudyYou must log in to access content.
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors - Part 1
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November 2023 Self StudyYou must log in to access content.
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Part 2
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August 2023 Self StudyYou must log in to access content.
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Part 1
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May 2023 Self StudyYou must log in to access content.
Ethical Considerations for Clinical Investigations of Medical Products Involving Children (Part 2)
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February 2023 Self StudyYou must log in to access content.
Ethical Considerations for Clinical Investigations of Medical Products Involving Children (Part 1)
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November 2022 Self StudyYou must log in to access content.
Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices - Part 2
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August 2022 Self StudyYou must log in to access content.
Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices
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May 2022 Self StudyHumanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff (Part 2)You must log in to access content.
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February 2022 Self StudyHumanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration StaffYou must log in to access content.
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November 2021 Self StudyIRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human SubjectsYou must log in to access content.
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August 2021 Self StudyInformation Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572)You must log in to access content.
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May 2021 Self StudyConduct of Clinical Trials of Medical Products During the COVID-19 Public Health EmergencyYou must log in to access content.
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February 2021 Self StudyAdaptive Designs for Clinical Trials of Drugs and Biologics: Part 2You must log in to access content.
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November 2020 Self StudyAdaptive Designs for Clinical Trials of Drugs and Biologics: Part 1You must log in to access content.
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August 2020 Self StudyRisk Evaluation and Mitigation Strategies: Modifications and Revisions (Part 2)You must log in to access content.
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May 2020 Self StudyRisk Evaluation and Mitigation Strategies: Modifications and Revisions (Part 1)You must log in to access content.