Rescuing an EDC Study

• Published in: Applied clinical trials Vol. 18; no. 8; p. 34
• Main Author: Chappell, Eric
• Format: Journal Article
• Language: English
• Published: Monmouth Junction MultiMedia Healthcare Inc 01.08.2009
• Subjects: Audit trails; Corporate sponsorship; Documentation; Legacy systems; Online instruction; Training
• ISSN: 1064-8542; 2150-623X

While the transition process is relatively straightforward for a paper-based trial, this is not the case for an Electronic Data Capture (EDC) trial. This is true even more so if the legacy and new EDC platforms are different. Detailed up-front planning and collaboration are required for a successful transition. The transition itself is often the most challenging aspect of the study. Once the new database and eCRFs have been fully designed and tested, the system is ready to be populated with the legacy data. Depending on the volume of data entered into the legacy system, there are two approaches one can take. In either case, the legacy vendor must be able to supply the data within a reasonable time frame following site access restriction. The first approach is a relatively low tech one that simply involves manual entry of the data into the EDC platform. This would be the ideal approach for a study that does not have a large volume of data entered into the legacy system. The legacy vendor should be able to supply paper versions of the subject eCRF data. A quality control plan should be in place to assure that the data were entered correctly. If possible, a programmatic comparison of the two data sets is preferable to a manual one. Once entered, the data can be source document verified by clinical research associates. The second approach would apply to studies in which a large volume of data exists in the legacy system, precluding a manual repopulation of the new EDC platform. In this case, a series of data integrations would need to be programmed and validated to populate the EDC platform. If at all possible, the integrations should seek to include any "flags" (Source Document Verification complete, Data Management Review complete, Safety Review complete) from the legacy system into the new one. This will alleviate the need to remonitor the legacy data, saving time and cost. A second strategy would be for the sponsor to require the EDC vendor to provide routine electronic data transfers on an ongoing basis. These transfers ideally should be on media (CD or DVD) and must also include the electronic audit trail. This should be considered a "data safety net" and will assure that at least some of the data is available. Depending on the capabilities of the vendor, these transfers should ideally be provided as an ASCII version of the normalized data (one row per patient per field).