DataFax F.A.Q.
Q: How is DataFax licensed?
A: A DataFax license is based on the number of simultaneous active users. So if the maximum number of users active at a given point is 8 users, you will need an 8-seat license.
Q: We are a University research group and have limited budget; does DataFax have an Academic discount?
A: As DataFax roots from a University, we have a very attractive discount for Academic and not-for-profit Organisations.
Q: What if we have a single study, do we need to pay the full price?
A: No, we have a special arrangement for this.
Q: Is it difficult to export the CRF images?
A: DataFax allows to export (a selection of) the CRF images into a PDF file. This PDF will be automatically bookmarked and can also be encrypted.
Q: Which data export options are available?
A: DataFax includes export procedures to migrate all clinical data to a relational database (Oracle, PostgresSQLl or MySQL). A separate utility called DFsas allows to transfer data into SAS datasets or CDISC/SDTM Domains.
Q: Some of our sites are using MAC’s, does DataFax support Apple hardware for EDC studies?
A: Yes, the EDC client software is available for MacOS X, Windows, Linux and Solaris.
Q: Some of our sites require a System Administrator to install the iDataFax client tool; is there a way to avoid this?
A: Yes, actually we have a zero-footprint solution which avoids installing software on the client PC.
Q: As a CRO, we would like to grant our sponsor viewing access to the clinical data, is that possible?
A: DataFax has a fine grain security system, so it is no problem to allow any kind of secured access to any external party.
Q: Is there a limitation on the size of a study?
A: Hardly, the current limitation is 2,000,000,000 patients or a maximum of 2,000 clinical sites, so that will be difficult to reach.
Q: Is your software CFR 21, part 11 compliant?
A: As a vendor, we feel it is all too easy to state that we are compliant. However, the DataFax user community organizes a bi-annual audit. Their conclusion from the last audit was: “DataFax version 3.8 was developed and manufactured with adequate level of quality for application in clinical operations governed by Good Clinical Practices (GCP), Code of Federal Regulations, (CFR) Chapter 21 Part 11 (Electronic Records and Signatures), and other applicable regulations, guidelines and standards listed in section 3.1 of this report.”. This is a link to the 2007 DataFax User Group Vendor Audit Report.
|
