Honoraria - Leveraging Enhanced EDC Integrated CTMS
Functions
Implementation approach one - articulation with manual process
CellTech deployed a 370 patient 57 site hypothesis generating registry in 2004, and retained MedNet Solutions to provide enhanced EDC with integrated CTMS functions to support the initiative. It was determined that efficiencies could be achieved through reduction in process steps and articulation with the existing system. Essentially, this approach allowed the system to manage data submission and capture, validate that data, and then produce a series of reports designed to support a manual process of financial system check request and generation. Compare and contrast the fully manual process in figure 1 with that representative of the CellTech/MedNet EDC/manual articulation process depicted in figure 2 below (note: italics indicate system (non-human) process).
Figure 2: Enhanced EDC articulation with manual process
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Reports were run on a monthly basis and served up summary information for processing in the manual system. Online "drill down" capabilities were provided for dispute resolution and error checking. EDC systems inherently populate their databases directly from data entry (unchangeable once signed by the investigator) eliminating double data-entry and opportunities for mis-keying. Other altered process steps include elimination of the human validation elements; those steps as seen in figure 1 were eliminated and replaced with a system level check - replicating the human work of checking for completion and appropriateness at computer level speeds of millions of instructions per second (MIPS). As with any enhanced EDC, the validations were derived from a data dictionary describing field, variable type (alpha/numeric, characters), high/low cutoffs, cross-form/visit delta variance checks, etc. and may be of hard (i.e. preclude entry) or soft (i.e. prompt user for confirmation at time of entry) types. In some instances, apart from speed and accuracy, advanced elements such as delta variance* checks cannot be performed by any but the most highly skilled human operators, and, even if detected, require significant time to resolve: in this implementation such checks are performed real-time and error rates are reduced.
Figure 3: Monthly Honoraria report for manual processing
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© Timothy Pratt 2005
