Updates | ClinRegs

South Africa Profile Updated in ClinRegs

Nov 5, 2021 - The South Africa profile in ClinRegs has been reviewed and updated to include the following: The 3rd edition of the South African Good Clinical Practice: Clinical Trial Guidelines Updated safety reporting timeframes, including for foreign reports of safety issues in multi-country ...

China Profile Updated in ClinRegs

Oct 28, 2021 - The China profile in ClinRegs has been reviewed and updated with the following information: New Personal Information Protection Law to ensure the safety of the personal information processed during clinical trials (See Definition of Sponsor and Quality, Data & Records ...

Thailand Regulatory Fees Information Updated

Oct 19, 2021 - The Thailand profile in ClinRegs has been updated to reflect the applicable fees listed in the July 26, 2017, Thai Food and Drug Administration fees notification, which is currently in force. See Regulatory Fees for more information. Sources Revised During this Update: (Regulation) Notification ...

Guinea Profile Updated with Revised CNERS Application

Oct 14, 2021 - The Guinea profile in ClinRegs has been updated to include version 7 of the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) Application Form for the Ethical Evaluation of a Research Project, which was issued in July 2021. ...

Sierra Leone Profile Updated

Oct 13, 2021 - The Sierra Leone profile in ClinRegs has been reviewed and updated with the following information: Updated Pharmacy Board of Sierra Leone (PBSL) guideline for clinical trial applications and authorization (See Regulatory Authority, Clinical Trial Lifecycle, and Investigational Products ...

Guinea: CNERS Issues Updated Application Form

Oct 1, 2021 - In September 2021, the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) posted version 7 of the Application Form for the Ethical Evaluation of a Research Project (July 2021). The ClinRegs team will review the ...

UK: HRA Issues New Final Report Form

Sep 17, 2021 - On September 15, 2021, the Health Research Authority (HRA) implemented changes to final study reporting requirements, which will apply to all UK studies that require ethics approval and have not yet submitted a final report. The new final report form must be completed within 12 months of the ...