Navigating the New 21 CFR 11 Guidelines
March 1st 2004When FDA commenced discussions on the use of electronic records in lieu of paper records in 1991, it embarked upon a six-year consultation exercise culminating in the issuance of the final rule "21 CFR 11,"1 which came into force on 20 August 1997. The final rule itself is succinct (approximately 2000 words), but has given rise to massive amounts of commentary and interpretative text. The latest guidance aims to address issues with these secondary texts rather than the rule itself.
Transforming EDC-The Emerging eR&D Model
February 2nd 2004As so many articles have noted,1 the uptake of electronic data capture (EDC) and associated technologies has continued to be disappointing. Even though 20 years ago experts predicted that electronic case report forms (CRFs) would replace paper as a natural consequence of the introduction of computers, this has not been the case.
Conducting Clinical Trials with Plasma-derived Products
January 1st 2004The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.
Data Warehouses: Your Company's Future in the "Stars"
December 1st 2003Somewhere in a closed conference room, the IT wizards are plotting the data strategy of your company or institution. They are wrestling with the vast amount of raw data that is being collected and the challenges of making that data available as information to help in making decisions.