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
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
Conformity assessment, Essential Principles and consent to supply From Therapeutic Goods Administration (TGA) π¦πΊ Conformity assessment, Essential Principles and consent to supply Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on February 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Operational Information Sharing From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process. 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 January 2, 2024 Open Government Licence 2.0 (United Kingdom) 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
Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1 Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Essential Principles: consent for non-compliance From Therapeutic Goods Administration (TGA) π¦πΊ New features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal 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 February 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Consent for non-compliant Medical Device(s): Frequently Asked Questions From Therapeutic Goods Administration (TGA) π¦πΊ Consent to import, supply or export a medical device that does not comply with the Essential Principles - frequently asked questions. 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 November 23, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Viewing and responding to a notification on the consent for non-compliance dashboard From Therapeutic Goods Administration (TGA) π¦πΊ How to view and respond to notifications related to an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs). 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 October 6, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for completing an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles From Therapeutic Goods Administration (TGA) π¦πΊ New feature added to the consent application form on TBS portal. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on October 6, 2022 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of oral digital medical device standardization technology focal point unit of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-164 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry From Therapeutic Goods Administration (TGA) π¦πΊ Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia. 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 November 5, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Exculpatory Language in Informed Consent From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the use of exculpatory language in informed consent, 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 July 21, 2021 Other (Public Domain) 0 reuses 0 favorites
Application for consent to import, supply or export goods that do not comply with standards - section 14/14A From Therapeutic Goods Administration (TGA) π¦πΊ Application form to import, supply or export a therapeutic good that does not comply with standards. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 10, 2021 Other (Non-Commercial) 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
Database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19 From Therapeutic Goods Administration (TGA) π¦πΊ Records of special decisions made to help deal with COVID-19-related delays. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on November 12, 2020 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of the national medical device clinical evaluation standardization technology focal point of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Consent to import, supply or export goods that do not comply with standards From Therapeutic Goods Administration (TGA) π¦πΊ New database available Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on October 13, 2020 Other (Non-Commercial) 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
Questions and Answers on Informed Consent Elements, 21 CFR Β§ 50.25(c): Guidance for Sponsors, Investigators, and Institutional Review Boards From Food and Drug Administration (FDA) πΊπΈ A small entity compliance guide providing guidance on informed consent elements in clinical trials under 21 CFR Β§ 50.25(c). 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 19, 2019 Other (Public Domain) 0 reuses 0 favorites