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15 sie 2023 · This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations.
- Download The Final Information Sheet
Information Sheet Guidance For IRBs, Clinical Investigators,...
- Download The Final Information Sheet
complete the Statement of Investigator form (Form FDA 1572). The Food and Drug Administration (FDA or agency) has received a number of questions about Form FDA 1572.
1 lut 2022 · This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products.
On August 15, 2023, FDA published a final guidance entitled, “Informed Consent, Guidance for IRBs (Institutional Review Boards), Clinical Investigators, and Sponsors.”. This final guidance supersedes the September 1998 guidance entitled “A Guide to Informed Consent” and replaces the July 2014 draft guidance “Informed Consent ...
FDA highlights the critical role the IRB plays in review and approving consent forms and the consent process for compliance with FDA regulations to safeguard the rights and welfare of human subjects. The guidance outlines specific areas to take into consideration when carrying out their responsibilities including:
The Statement of Investigator, Form FDA 1572 (1 572), is an agreement signed by the investigator to provide certain information to the sponsor and assure that helshe will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors. Frequently Asked Questions About Medical Devices. Additional copies are available from: Office of Good Clinical...
