Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document covers various studies, focusing on clinical trials. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the content, management and archiving of the clinical master file (paper and/or electronic) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018 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 July 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Requirements for Clinical Trials of Medical Devices (MDS-REQ 2) From Saudi Food and Drug Authority (SFDA) 🇸🇦 Requirements related to clinical trials of medical devices. 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 July 28, 2024 Other (Public Domain) 0 reuses 0 favorites
Good clinical practice for clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 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
Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - FDA-2019-D-0359 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 July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH Guideline for Good Clinical Practice From Therapeutic Goods Administration (TGA) 🇦🇺 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) 🇦🇺 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
Guideline on missing data in confirmatory clinical trials From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CPMP/EWP/1776/99 Rev. 1. 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 June 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on clinical trials in small populations From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/EWP/83561/2005. 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 June 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical trial notification (CTN) form - user guide From Therapeutic Goods Administration (TGA) 🇦🇺 The user guide for the Clinical Trial Notification (CTN) form has been updated to reflect the recent updates to the online CTN form 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Investigator’s brochures for medical device clinical trials From Therapeutic Goods Administration (TGA) 🇦🇺 A sponsor’s guide to the expectations for the contents of an Investigator’s Brochure. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical trials From Therapeutic Goods Administration (TGA) 🇦🇺 Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants. 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 May 29, 2024 Other (Non-Commercial) 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) 🇺🇸 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
Roles and responsibilities for clinical trial safety reporting of significant safety issues and urgent safety measures From Therapeutic Goods Administration (TGA) 🇦🇺 Summarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs). 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical Trial Significant Safety Issue/Urgent Safety Measure safety reporting form (SSI/USM) From Therapeutic Goods Administration (TGA) 🇦🇺 This form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA. 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Common issues identified during clinical trial applications From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them. 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 6, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on collecting race and ethnicity data in clinical trials, aimed at industry and FDA staff. Covers GCP and IDE 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 August 10, 2023 Other (Public Domain) 0 reuses 0 favorites