ICH guideline E8 (R1) on general considerations for clinical studies From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr* 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance for industry on implementing diversity action plans to enhance enrollment of underrepresented populations in clinical studies. 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 July 3, 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) 🇺🇸 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
Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for the FDA and industry staff on medical devices related to weight loss, including clinical study and benefit-risk considerations. 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 September 14, 2023 Other (Public Domain) 0 reuses 0 favorites
Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for conducting clinical studies on medical devices to improve glycemic control in patients with type 2 diabetes. 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 5, 2022 Other (Public Domain) 0 reuses 0 favorites
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on involving patients in the design and execution of medical device clinical studies. 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 25, 2022 Other (Public Domain) 0 reuses 0 favorites
MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Points to consider when using real-world data in clinical studies 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 December 16, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Provisional determination eligibility criteria From Therapeutic Goods Administration (TGA) 🇦🇺 Update to currency of data required for criteria assessment 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 August 26, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Leadless cardiac pacemaker therapy: guidance from an MHRA Expert Advisory Group From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Recommendations on leadless cardiac pacemaker therapy from MHRA Expert Advisory Group 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 January 28, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on adaptive designs for medical device clinical studies, covering topics like GCP, IDE, 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 October 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on clinical study designs for catheter ablation devices used to treat atrial flutter. 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, 2020 Other (Public Domain) 0 reuses 0 favorites
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document by the FDA for pre-clinical and clinical studies on neurothrombectomy devices, focusing on GCP and premarket requirements. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Recommended Clinical Study Design for Ventricular Tachycardia Ablation From Food and Drug Administration (FDA) 🇺🇸 A guidance document outlining the recommended study design for ventricular tachycardia ablation in clinical settings. 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 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Evaluation of Sex-Specific Data in Medical Device Clinical Studies" for the FDA and industry staff. It covers topics such as 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 March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for conducting early feasibility medical device clinical studies, including first in human studies, for FDA staff and industry. 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
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document by the FDA on clinical study designs for surgical ablation devices used in treating atrial fibrillation. 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
Handling on the Scope of Situations where “Documents related to Clinical Study Results” is Necessary on Medical Devices (Operations based on Measures through Pre-and Post-Marketing Phases) From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PSEHB/MDED Notification No.1117-1 PSEHB/SD Notification No.1117-1 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 November 17, 2017 Other (Public Domain) 0 reuses 0 favorites
Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-04201. The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device… 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 25, 2013 Other (Public Domain) 0 reuses 0 favorites
Handling of clinical study data on medical devices which was carried out in foreign countries From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PFSB/MDE Notification No. 0331006 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 31, 2006 Other (Public Domain) 0 reuses 0 favorites
Provision No. 4457/06 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 Conformation to be carried out by the Permanent Evaluation and Advisory Committee of Clinical Trials of Medical Technology Products, in relation to modifications to clinical studies already authorized. B.O. 08/23/06 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 January 1, 2006 Creative Commons Attribution 4.0 0 reuses 0 favorites