Author Archives: Sjouke
Clinical Trial Portals using Web 2.0 Technologies
In 1790, with a good horse, it took from four to six days, depending on the weather, to travel from Boston to New York. And nobody complained. In 1890, it took the fastest steamship six days, four hours, and five … Continue reading
CRF Design using Adobe Indesign
In a previous Blog-post, I have discussed the different requirements for (DataFax) CRF design for studies using paper forms compared to Electronic Data Capture (EDC). Especially when using DataFax as Clinical Data Management System (CDMS), it is equally possible to … Continue reading
Remote Virtual Desktop opens up new Possibilities
The new ‘Remote Virtual Desktop’ (RVD) service offered by Thorin to our Pharma clients, opens up a whole range of new opportunities. To trigger your mind, it is as if the user is actually working within a fully controlled environment, a … Continue reading
DataFax eCRF Design
Perhaps not everybody realizes that using Electronic Data Capture (EDC) as method for data collection in a DataFax study, might impose some new Options and Requirements regarding CRF Design.
Page Flow in a DataFax EDC study
The order of Forms in the Patient Binder in iDataFax does not always coincide with the actual order of Forms or CRF pages. While this might not be a big issue in a Paper based trial, it becomes more of … Continue reading
Edit Checks for EDC usage
Didn’t we say that you can use the same Edit Checks for both data collection from paper CRFs and for Electronic Data Collection (EDC) ? Eh yes, technically speaking, you can use the same Edit Checks. However, there are certain … Continue reading
CRF Annotation: A boring Necessity or a part of the QA process ?
Automated creation of an Annotated CRF, and including meta information, can make it a useful part of the QA process. Continue reading
Minimizing Number of Queries
Proper Edit Check programming can avoid sending needless queries to Sites. Continue reading
From DataFax to CDISC/SDTM
One of the more recent projects for a client was to export all data from DataFax into CDISC’s Standard Data Tabulation Model (“SDTM”). In this Blog, I want to share some of our experiences with this SDTM export.
Quality is in the Person, not in the SOP
Having supported DataFax for over 15 years, it sometimes looks as if SOPs are used as an excuse NOT to focus on Quality. If I am convinced of one thing, it is that SOPs are not a guarantee for Quality.