DAIDS Good Clinical Laboratory Practice Guidelines

On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.

In DAIDS sponsored clinical trials, DAIDS aims to ensure the safety and optimal management of participants, obtain reliable laboratory-based data critical for the meaningful interpretation of trial findings, ensure the safety of those who perform the laboratory testing, and achieve accurate reconstruction of a trial to allow its submission to a regulatory body such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), or South African Health Products Regulatory Authority (SAHPRA). To attain these goals, as well as allow data to be pooled and/or comparable regardless of where they are generated, DAIDS has developed the DAIDS Good Clinical Laboratory Practice (GCLP) Guidelines.

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /