Updates | ClinRegs

UK Profile Updated in ClinRegs

Mar 20, 2020 - The United Kingdom (UK) profile in ClinRegs has been reviewed and updated with the following: Updated information on the UK’s withdrawal from the European Union and its impact on clinical research (See Scope of Assessment) Updated information on electronic communication ...

United States: FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19

Mar 18, 2020 - FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19 On March 18, 2020, the Food & Drug Administration (FDA) issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to assist sponsors in assuring the safety of trial participants, ...

United Kingdom: MHRA Issues Guidance for Clinical Trials Impacted by COVID-19

Mar 18, 2020 - On March 12, 2020, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued Advice for Management of Clinical Trials in relation to Coronavirus that provides information related to protocol deviation, sites, and participant safety.

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 ...