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
Good clinical practice for clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. 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 July 22, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ICH Guideline for Good Clinical Practice From Therapeutic Goods Administration (TGA) π¦πΊ This guideline is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Good Clinical Practice (GCP) Inspection Program From Therapeutic Goods Administration (TGA) π¦πΊ Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program. 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 June 5, 2024 Other (Non-Commercial) 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
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
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
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" for the industry and FDA staff. It covers topics such as clinical studies, good clinical practice, labeling, and premarket evaluation. 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry on the scope and application of Part 11, covering topics like compliance, electronic submissions, and good clinical practice. 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
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
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
Oversight of Clinical Investigations β A Risk-Based Approach to Monitoring: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry on a risk-based approach to monitoring clinical investigations, focusing on administrative and procedural aspects and good clinical practice. 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 November 21, 2022 Other (Public Domain) 0 reuses 0 favorites
Australian clinical trial handbook From Therapeutic Goods Administration (TGA) π¦πΊ Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods 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 August 21, 2021 Other (Non-Commercial) 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
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
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
Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on Humanitarian Use Device (HUD) Designations, covering topics like Good Clinical Practice and Premarket. 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 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Electronic Source Data in Clinical Investigations: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Guidance document providing industry guidelines on electronic source data in clinical investigations, covering administrative and procedural aspects and 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 29, 2020 Other (Public Domain) 0 reuses 0 favorites
Pharmacogenomic Data Submissions: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry on pharmacogenomic data submissions, covering administrative and procedural aspects and good clinical practice. 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 27, 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