Notify MHRA about a clinical investigation for a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. 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 2 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
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
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) 🇺🇸 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
Notification of Post Market clinical investigation with additional invasive or burdensome procedures From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notification of initiation of clinical investigations Post Market From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Clinical investigations with CE-marked devices From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Clinical investigations with CE-marked devices 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Clinical investigation authorization related to noninvasive Class I or Class IIa or IIb medical devices not bearing CE marking for intended use From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Authorization for clinical investigation of class IIa or IIb invasive or class III medical devices not bearing CE marking for intended use From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Medical devices - Requesting authorization for a clinical investigation From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Medical devices - Requesting authorization for a clinical investigation 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 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations with non-CE-marked devices From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Clinical investigations with non-CE-marked devices 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 7, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/EWP/89249/2004 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144533/2009 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 July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/1089/00 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human plasma derived von Willebrand factor products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/220/02 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/BPWP/410415/2011 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 July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/94033/2007 rev. 2 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/575/99 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 July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites