Guide to Good Clinical Practice

Introducing the Guide to Good Clinical Practice - a new resource available from the Himmelfarb website's E-Texts and E-Databases/MEDLINE page. The Guide to Good Clinical Practice provides sponsors, institutional review boards, clinical investigators, monitors and study site staff with the information and tools they need to conduct quality clinical trials of new drugs, devices and biologics. From explanations of laws, federal regulations and international harmonization efforts to an analysis of accepted good clinical practices, this resource will assist clinical researchers in avoiding errors and gaining faster product approval. Included in the Guide are sample checklists for conducting quality assurance audits, FDA forms, industry guidance documents and information sheets.

When users access the Guide, in addition to the full-text of the resource, they will have access to Recent Updates, which lists additions, updates, or changes to the Guide's content; the Guide's monthly newsletter; Newsbriefs, which lists short segments of recent news pertaining to clinical research; and the Additional Resources section. There is a wealth of information here, in the Additional Resources area, including access to Clinlaw, the online database of state and federal clinical trial requirements; court cases; FDA Compliance Guides; legal reference documents; and the Office of Regulatory Affairs Inspections Guides.

We invite you to explore this new resource. Please contact the library's reference department with any questions you might have, at 202-994-2850.