The arguments to set-up your own Clinical Data Management department are various. You want to learn something new. You can do Clinical Data Management yourself because you could allocate resources for it. Conducting Clinical Data Management in-house could get you more in control of your clinical study data.
ABSTRACT Much effort goes into the specification, development, testing and verification of programmatic edit checks to ensure that the error rate in clinical trial data is sufficiently low as to have no statistically significant effect on the overall trial results. An analysis of several thousand clinical trials, containing over 1.1 billion data values and 1.1Continue reading “Complexity and effectiveness of edit checks”
Important part of the data management job is to verify received data. Checking for inconsistencies and unexpected patterns. Verifying that the data is complete, legible, logical and plausible. However, how to perform data verification? You could regard the data verification job as completing a couple of puzzles. Each puzzle is one subject participating inContinue reading “Data verification puzzles”
A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials. There are some defiance in implementingContinue reading “CDISC/CDASH Standards at your Fingertips”
How to write queries unambiguously expressing what is asked for? Using short, polite sentences? Objectively explaining the underlying inconsistency? First of all my general guidelines. My preference is to use no more capitals then needed. Capitals in the middle of a query text, e.g. for CRF fields or for tick box options, could distract fromContinue reading “How to write query texts – 6 template sentences”
Steps towards a successful CTMS: Exploring the benefits of clinical trial management system (CTMS) The benefits of mapping and developing an enterprise wide solution include6: Centralizing decentralized departments Optimizing institutional review board (IRB) functionality Realizing real-time data available to both investigators and leadership Decreasing bottlenecks in knowledge transfer between various entities involved in research ReducingContinue reading “Choosing a Successful Clinical Trial Management System [CTMS]”