Clinical Data Management by Richard K. Rondel, Sheila A. Varley, Colin F. Webb

By Richard K. Rondel, Sheila A. Varley, Colin F. Webb

Broadly revised and up to date, with the addition of recent chapters and authors, this long-awaited moment version covers all elements of scientific information administration. Giving info of the effective scientific facts administration approaches required to fulfill either company ambitions and caliber audits by way of regulatory specialists, this article is well timed and an incredible contribution to the literature.

The volume:

* is written by way of famous and skilled authors during this area

* presents new methods to significant issues in medical facts management

* includes new chapters on platforms software program validation, database layout and function measures.

It could be valuable to a person within the box in the pharmaceutical undefined, and to all biomedical pros operating in scientific learn.

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Additional info for Clinical Data Management

Example text

Patient profiles and domain profiles may be provided as part of the submission. Patient profiles are defined as all study data collected for an individual patient organised by time. Domain profiles are defined as patient line listings and consist of all data collected for a single CRF domain from one study. Patient profiles should be provided as Adobe PDF files and domain profiles may be provided by either Adobe PDF or SAS transport files. The reviewing division should be contacted to determine the preferred method for domain files.

The information collected on this topic is a powerful study management tool and should be shared with the study team on a regular basis. 3 ‘Missing values represent a potential source of bias in a clinical trial. ’ This point emphasises the importance of data coding conventions, the monitoring of protocol deviations and the importance of raising data queries to the site (rather than assuming data are missing) when it is not clear if the data were generated or not. 2). They are of interest to clinical data management groups as they provide specific instructions to companies seeking compliance with the ICH requirements.

They are of interest to clinical data management groups as they provide specific instructions to companies seeking compliance with the ICH requirements. Discussion of these seven documents and their consideration by sponsor clinical data management groups will follow. Directive of the European Parliament and of the Council of the EU This definitive proposal for the first ever EC Directive on Clinical Trials forms part of a legislative framework being developed in Europe which will eventually mandate for ICH GCP being followed.

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