Abstract
Rapid acquisition of clinical data, “cleaned” and entered during the trial, is a critical factor in reducing time between study completion and analysis. For a study whose results were needed quickly, a five-part no carbon required (NCR) case record form (CRF) was designed on a “per visit” basis. After each visit, Part 3 was sent overnight for review. Corrections were requested by phone, then Part 4 was expressed for immediate data entry. Part 4 blocks entries from Part 5; data appearing on Part 5 are changes made after removal of Part 4. These changes, regularly added to the database, resulted from source document discrepancies found during monitoring, and the addition of adverse event stop dates. A movable “tracking tool” was developed to locate ongoing adverse events and concurrent medications. The following are discussed: 1) construction of the CRF and the tracking tool including paper weights, widths, and chemical coatings, 2) cost differential compared to the standard three-part form, and 3) project outcomes.
Get full access to this article
View all access options for this article.