Document Verification Research Articles

Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study

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.

Document Verification and Traceability Through Image Quality Analysis

The age of digital printing has complicated the task of forensic document examination in two significant ways. In the case of document falsification and verification, the widespread availability of sophisticated hardware and software tools (and knowledge to use them) for imaging, manipulation, and duplication has made it difficult if not impossible to detect counterfeiting without equally powerful equipment and know-how. Where a document has been identified as a fraud, or where the pedigree of a valid one is required, traceability to the printing source is critical for successful prosecution. The equivalent of a fingerprint for the printer must be identified, and matched to the source from either a database or the suspect device.Objective, quantifiable image quality analysis provides a means to achieve these objectives. Powerful image analysis algorithms combined with flexible imaging hardware and instrumentation offer the tools required to analyze documents and establish defensible curricula vitae.

A Review of the Source Document Verification Process in Clinical Trials

Confirming that accurate and reliable information has been reported by the investigator to the sponsor during clinical trials is a fundamental requirement of good clinical practice (GCP), and there can be significant implications if this is not undertaken appropriately. Yet, there is still much uncertainty surrounding this process, generally referred to as source document verification (SDV). This paper attempts to identify and discuss the main considerations to enable an effective and appropriate SDV system to be implemented.The responsibilities of both the investigational team and the sponsor in SDV must be made clear at the outset of the trial. Considerations such as access to data and confidentiality must be fully addressed, so that there are no misunderstandings or surprises when SDV is undertaken. Records of what was done and found, including an evaluation of the findings, must be made, in the same way as for any other aspect of the trial. There must also be a recognition that SDV really adds value t...

A Review of the Source Document Verification Process in Clinical Trials

A Review of the Source Document Verification Process in Clinical Trials