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Data Collection Forms in Clinical Trials

Data Collection Forms in Clinical Trials


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About the Book

This book explains how to design and utilize data collection forms to obtain complete and accurate data in clinical trials and provides a library of designed forms that can be modified for a specific clinical trial. The first part of the book offers guidelines on choosing modules, designing forms, preparing the data collection form package, reproducing and assembling forms, using remote date entry forms and data processing and storage of completed forms. The authors then provide examples of data collection forms for every type of data needed in a clincial trial, including times and events schedules; demographics; medical histories; inclusion and exclusion criteria, vital signs; physical examinations; psychological and psychiatric tests; laboratory tests; radiology and pathology reports; dosing and dispensing of drugs; assays of biological levels; efficacy; compliance; patient diaries; patient termination and global clinical impressions.

Table of Contents:
Part 1 Creating data collection forms: an overall approach - building a library of forms; types of forms; choosing modules and designing forms; preparing the data collection form package; reproducing and assembling forms; remote date entry forms; data processing and storage of completed forms; selected issues. Part 2 Examples of data collection forms: background of a clinical trial; instructions for completing data collection forms; times and events schedules; demographics; medical history; specific types of medical histories; medication history; inclusion and exclusion criteria. Part 3 Physical and other examinations: physical examinations; vital signs; neurological and ophthalmological examinations; psychological and psychiatric tests. Part 4 Other specialized physical examinations, laboratory tests and evaluations: clinical chemistry and hematology tests; radiology and pathology reports; electrocardiograms; urine, microbiology, virology, neurological, immunological and endocrinological tests; pulmonary function studies; other laboratory tests; adverse experiences. Part 5 Medicines and assays of biological levels - dosing and dispensing: records; concomitant medications; pharmacokinetic samples to assay. Part 6 Efficacy: evaluations; compliance; patient diaries. Part 7 Patient termination and miscellaneous forms: termination and premature patient discontinuation; global clinical impressions; additional and unscheduled visits; comment log and investigator verification.


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Product Details
  • ISBN-13: 9780881677591
  • Publisher: Lippincott Williams and Wilkins
  • Publisher Imprint: Lippincott Williams and Wilkins
  • Height: 279 mm
  • Width: 216 mm
  • ISBN-10: 0881677590
  • Publisher Date: 01 Jul 1991
  • Binding: Hardback
  • Weight: 2130 gr


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