Transcription of Effective Date: 09/28/19 Document No.: MAN-A-OD-001
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Effective Date: 09/28/19 Document No.: MAN-A-OD-001
DAIDS Guidelines for Good Clinical Laboratory Practice Standards Public Health Serv ices National Institutes of Health Bethesda, Mary land 20892 Site Principal Investigator and Laboratory Director: All National Institutes of Health, National Institute of Allergy and Infectious Diseases, division of aids - supported clinical trials involving human subjects must ensure compliance with f ederal regulations including procedures to protect the safety of all participants. These studies must be conducted in a manner to assure the sponsor a nd regulatory agencies that all data submitted are a true reflection of the results obtained during a study and that this data can be relied upon when making risk and/or safety assessments of study products. DAIDS has dete rmined that Good Clinical Laboratory Practices (GCLP) a re the minimal requirements that clinical research laboratories should follow, as GCLP embraces b oth the research/pre- clinical and clinical aspects of Good Laboratory Practices (GLP).
DAIDS Guidelines for Good Clinical Laboratory Practice Standards The development of these GCLP standards was a collaborative effort between PPD and the Division of AIDS (DAIDS). The authors that have contributed to this document are listed below: PPD, Inc.: DAIDS: Global Government andPublic Health Services, Laboratory DAIDS Clinical Laboratory
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