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
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ A guidance document providing information on informed consent for IRBs, clinical investigators, and sponsors, 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 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
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
21 CFR Chapter I Subchapter H β Medical Devices β Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) πΊπΈ Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. 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 January 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on conducting medical device studies, covering topics like GCP and IDE, for IRBs, investigators, and sponsors. 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
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document on financial disclosure for clinical investigators, covering GCP and IDE, aimed at industry 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 August 10, 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
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for IRBs, clinical investigators, and sponsors on IRB responsibilities and GCP in reviewing qualifications and research sites. 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 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on data retention when subjects withdraw from FDA-regulated clinical trials. Topics 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 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
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
Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ Guidance document on transferring clinical investigation oversight to another IRB, providing considerations for IRBs, investigators, and sponsors. 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 May 7, 2020 Other (Public Domain) 0 reuses 0 favorites
Adverse Event Reporting to IRBs β Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for clinical investigators, sponsors, and IRBs on improving human subject protection in adverse event reporting. 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 May 6, 2020 Other (Public Domain) 0 reuses 0 favorites
IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on IRB continuing review after clinical investigation approval, targeting IRBs, investigators, and sponsors. 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 24, 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
Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) πΊπΈ An information sheet providing guidance on Good Clinical Practice (GCP) for IRBs, clinical investigators, and sponsors of medical 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 February 28, 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