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Improving quality assurance in clinical trials (CT) through standardization: A review of source documentation practices at a large Canadian cancer center.

e16577 Background: Deficiencies pertaining to the accuracy, completeness and maintenance of source data remain the most prevalent regulatory finding reported during site inspections. The Princess Margaret Hospital (PMH) enrols @ 25% of patients in treatment-based CT. As a quality initiative, source documentation practices (SDP) of clinical research nurse coordinators (CRNC) were evaluated to determine compliance with institutional, professional and regulatory requirements.


METHODS
A review of SDP from CRNC was conducted using required criteria in 6 practice areas: informed consent (IC), adverse event (AE), concomitant medication (Con Med), drug administration, eligibility, and general documentation. Compliance was classified as yes, no, or n/a. Practice areas were reviewed to determine methods utilized: checklists (CL), clinical notes (CN), study specific templates (SPT) or other. Compliance within each practice area was summarized using the median and inter-quartile range. Group differences were tested using the non-parametric Wilcoxon test.


RESULTS
20 reviews were conducted. Although overall median compliance was considered acceptable (table 1), the variability in each practice area varied widely, from 6% for Con Med to 69% for IC. Methods utilized also varied across the practice areas: range in frequency of use (n=20): CL(12-16), CN(4-10), SPT(6-9), other(1-3). Comparing % compliance to method use, only 3 findings were significant: Con Med: CL(100) vs. no CL(71) p = 0.03, Con Med: SPT(86) vs. no SPT(100) p = 0.01, general documentation: CN(75) vs. no CN(63) p = 0.05.


CONCLUSIONS
Variation in SDP was identified as an important quality control initiative. Standardized source documentation templates and guidelines for IC, AE and Con Med have been developed and implemented across the program to improve compliance with institutional, professional and regulatory requirements. [Table: see text].