Updates | ClinRegs

Peru: REPEC Issues Communication Related to COVID-19's Impact on Clinical Trial Procedures

Mar 18, 2020 - On March 18, 2020, as a result of the COVID-19 outbreak, the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) issued a communication regarding the current suspension of administrative procedures until March 31. Clinical trial initiation, ...

Peru Profile Updated in ClinRegs

Mar 10, 2020 - The Peru profile in ClinRegs now includes the following updates: Regulations and revised application forms that modify clinical trial application submission requirements (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle and Sponsorship topics) Legislation ...

Brazil: COVID-19 Research Protocols Must Be Reviewed by CONEP

Feb 27, 2020 - Brazil’s National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) has issued a requirement that all coronavirus disease 2019 (COVID-19) research protocols must go to CONEP for expedited review. This requirement will continue as long as the World Health ...

US Profile Updated in ClinRegs

Feb 6, 2020 - The United States profile in ClinRegs has been reviewed to ensure all information is up to date. Links to two recently released FDA guidelines have been added: The Guidance for Industry: Adaptive Designs for Clinical Trials of Drugs and Biologics, a new guide providing ...

Australia Profile Updated in ClinRegs

Jan 28, 2020 - The Australia profile in ClinRegs has been reviewed and updated to reflect current requirements, including: The Management of Data and Information in Research, a new guide supporting the implementation of the Australian Code for the Responsible Conduct of ...

Mexico Profile Updated in ClinRegs

Jan 10, 2020 - The Mexico profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include: Revised 2019 version of Pharmacovigilance Guide for Safety Notifications or Any Safety Problem Related to the Use of Medicines and Vaccines, which ...