该指南旨在协助机构审查委员会(IRBs)、临床研究者及申办方遵守临床研究中的知情同意规定,取代了1998年的指南《A Guide to Informed Consent》,并最终确定了FDA于2014年7月发布的名为《Informed Consent Information Sheet》的指南草案。当前的指南概述了知情同意过程、FDA对知情同意的要求和讨论,知情同意相关各方的责...
[1] U.S Food and Drug Administration. FDA Briefing Document Oncologic Drugs Advisory Committee Meeting (2022-02-10). [2] U.S Food and Drug Administration. Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors (2014-07). [3] U.S Food and Drug Administra...
• whether informed consent documents were signed by the subject or the subjects’ legally- authorized representative prior to entry in the study (i.e., performance of any study- related procedures); • whether authority to conduct aspects of the study was delegated, and if so, how the co...
[1]U.S Food and Drug Administration. FDA Briefing Document Oncologic Drugs Advisory Committee Meeting (2022-02-10). [2]U.S Food and Drug Administration. Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors (2014-07). [3] U.S Food and Drug Administration...
to reflect the new information, the IRB should determine whether the investigator should provide currently enrolled subjects with the new information either with the revised informed consent document or an alternative method such as a consent addendum or information sheet describing the new information. ...
study involving human subjects that it either was conducted in compliance with the institutional review board regulations in Part 56, or was not subject to the regulations under section 56.104 or section 56.105, and that it was conducted in compliance with the informed consent regulations in Part ...
[17] FDA. Frequently Asked Questions — Statement of Investigator (Form FDA 1572) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs [EB/OL]. (2021-05-19) [2023-08-23]. https://www. fda. gov/media/148810/download. [18] FDA. Use of Electronic Informed Consent: ...
FDA Releases Draft Guidance for IRBs, Clinical Investigators, and Sponsors on Informed Consent Information Sheet
For clinical studies, study start date (SSTDTC) is the earliest date of informed consent among any subject that enrolled in the study 提交完整的ts.xpt时,请参阅附录部分,了解在与临床研究相关的研究中应提交的研究参数列表。除附录中列出的参数外,还可以包括其他参数。对于临床研究, 研究开始日期(SSTDTC...
Informed consent and safeguards for children in research in 21 CFR Part 50, Institutional Review Board (IRB) requirements in 21 CFR Part 56, Investigational Device Exemptions (IDE) requirements in 21 CFR Part 812, Financial Disclosure for Clinical Investigators requirements in 21 CFR Part 54,以及 ...