Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Process for Handling Referrals to FDA Under 21 CFR 50.54" that provides additional safeguards for children in clinical investigations. It focuses on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ A draft guidance document outlines the process for referring research involving children to the FDA and OHRP, focusing on pediatric product development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for institutions and IRBs on conducting and documenting minutes of IRB meetings, focusing on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on live case presentations during IDE clinical trials, covering GCP, IDE, and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) πΊπΈ An information sheet providing guidance for Institutional Review Boards and Clinical Investigators on Good Clinical Practice (GCP) FAQs. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on informed consent for studies using leftover human specimens, aimed at sponsors, IRBs, and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 22, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 814 Premarket Approval of Medical Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 814 Premarket Approval of Medical Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations From Food and Drug Administration (FDA) πΊπΈ Document number 2023-27935. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when aβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs From Food and Drug Administration (FDA) πΊπΈ A guidance document providing written procedures for Institutional Review Boards (IRBs) and institutions, focusing on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on pivotal clinical investigations for medical devices, covering topics like GCP, IDE, and premarket considerations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for Institutional Review Boards and Clinical Investigators on the expedited review procedure for research involving human subjects. Topics covered include Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for Institutional Review Boards, Clinical Investigators, and Sponsors on disqualification actions in clinical investigations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Protection of Human Subjects and Institutional Review Boards From Food and Drug Administration (FDA) πΊπΈ Document number 2022-21088. The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections ofβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 28, 2022 Other (Public Domain) 0 reuses 0 favorites
Frequently Asked Questions - IRB Registration: Guidance for Institutional Review Boards (IRBs) From Food and Drug Administration (FDA) πΊπΈ A guidance document for Institutional Review Boards (IRBs) on Good Clinical Practice (GCP) and frequently asked questions about IRB registration. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 21, 2021 Other (Public Domain) 0 reuses 0 favorites
FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This is a guidance document by the FDA for sponsors, investigators, and review boards on IDE clinical investigations and premarket devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Use of Electronic Informed Consent in Clinical Investigations β Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Use of Electronic Informed Consent in Clinical Investigations β Questions and Answers". It falls under the topic of "Administrative / Procedural". Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions: Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ FDA provides guidance on categorizing Investigational Device Exemption (IDE) devices to assist CMS with coverage decisions. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on exceptions to informed consent requirements for emergency research, focusing on Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards From Food and Drug Administration (FDA) πΊπΈ Draft guidance document by FDA for industry, sponsors, and review boards on using investigational IVDs in clinical investigations of therapeutic products. Covers GCP, IDE, and labeling. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) πΊπΈ Non-local IRB Review: Guidance for IRBs and Investigators on Good Clinical Practice (GCP). Information Sheet. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 21, 2020 Other (Public Domain) 0 reuses 0 favorites