Abstract
ObjectiveBarriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible. MethodsFive hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected.ResultsThirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV. ConclusionsBecause each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.
Highlights
Large randomized controlled trials (RCT) are the gold standard for evaluating the risk/benefit profile associated with new medical therapies
Accuracy, and efficiency of previsit remote source document verification (SDV) by study monitors followed by on-site verification compared to traditional on-site SDV by study monitors by randomizing study subjects participating in one ARDS and one ChiLDREN clinical trial who were scheduled for an upcoming on-site monitoring visit (Figure 1)
The specific case report forms and specific data values within case report forms verified were based on which forms had been monitored in previous visits and patient status
Summary
Large randomized controlled trials (RCT) are the gold standard for evaluating the risk/benefit profile associated with new medical therapies. Many processes in the conduct of clinical trials are inefficient, thereby prolonging the time for evaluation of therapies and increasing their cost. Ensure appropriate communication between the principal investigator (PI) and the sponsor 3. Verify proper adherence and conduct of the protocol 6. Verify compliance with the written informed consent document process for subject participation (*) 7. Ensure that the PI and study staff are adequately informed about the trial 8. Verify that the PI in enrolling only eligible subjects (*) 9. Communicate protocol deviations and develop an appropriate plan to prevent their recurrence 13. Ensure accuracy and completeness of the case report form (CRF) entries through source document verification (SDV) (*) From [17] Items noted with '(*)' are amenable to being performed using remote access technologies.
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