Chapters follow on ICH, CRF design, data capture, planning, data validation, QA, performance metrics, data presentation, data coding including MedDRA (an ICH standard), database design for central laboratories, computer systems, software validation, reengineering the CDM process, working with CROs, and data management in epidemiology and pharmacoeconomics. Not much dust is allowed to settle there, and the ยฎnal chapter on the future revisited breathlessly ushers in the electronic age as it all but leaps over the threshold.
Already the world of clinical data management is moving the book towards a third edition, as the electronic data revolution, with and without the Internet, takes hold. There is plenty of reference to and advice on electronic data capture and transfer, electronic signatures, electronic document management and the like, but as yet little practical evidence of their successful implementation for the management of clinical research data, of their conversion to successful global product registration packages, or even of a reduction in the paper mountain. The digital age may be here, but utopia perhaps takes a little longer!
The book is one of very few such publications and the authors are masters of their craft. It is written with all clinical researchers in mind, be they in academia, industry or government, and regardless of where in the world they are practising or which professional group in the clinical research team they represent. As a work of principle and practice, this book should be made available to all of them ยฑ a deยฎnite buy.