Interface software can markedly reduce time and improve accuracy for clinical trial data transfer from EMR to EDC: The results of two measure of work time studies comparing commercially available clinical data transfer software to current practice manual data transfer.

Abstract

1573 Background: Clinical studies and new drug approvals are delayed by slow data transfer and transcription errors from site entered data. These delays have been compounded by a shortage of data entry personnel at sites such that data entry approaches 10-30 days post visit. Data transfer is largely performed by manual keyboard entry from electronic medical records (EMR) into electronic case report forms (ECRF). Methods: We conducted two separate measure-of-work time studies to compare a commercially available interface software product, ProXimity to the current manual data entry. The clinical trial data from two different EMRs (ARIA and IKM G2) to an EDC (Medidata Rave). The EDC mirrored an IRB approved clinical study. Time to transfer data and error rates were the primary and secondary endpoints, respectively. For study 1 Aria EMR data from 3 subjects and 1497 data fields including demographics, vital signs, ECOG PS, physical findings, adverse events, and lab results including CBC, CMP, urinalysis, coagulation, serology were selected for visits from Screening and C2D1. For Study 2 IKM G2 data from 6 subjects and 834 data fields included demographics, vitals, and lab results. The data entry personnel were aware of the timed nature of the study. Results: Study 1 ProXimity took 13.2 min to transfer the data compared to 73.4 min for manual entry, with error rates of 0.8% compared to 3.5%, respectively. In Study 2 Proximity took 6.5 min compared to 29 min for manual entry, with error rates of 1.4% each due to non- conformant data (text). Conclusions: Software data transfer interfaces can markedly shorten the time for data entry, reduce error rates and reduce operational costs.