DFUG 2008 Information

When preparing to run an EDC study, training is of utmost importance. Site personnel, CRA's and Data Management staff must be fully trained on the EDC system and eCRF completion guidelines. Training should be completed and documented prior to entering the live database.

In the DataFax community, many companies have standardized on SAS for developing reports for internal and external use. At DF/Net Research, we've started to develop our own reports using R and Star Office for presentation on our data web portal. The reports are automatically refreshed each night, and posted as a time-stamped PDF available for secure download. Clients can view or print reports at any time, without having to contact our office. Our administrator can restrict permissions for different sections of the web portal, providing complete control over who views content.

The 2007 Vendor Audit Team visited CDSI on May 1-2 and conducted a follow-up visit on August 14, 2007. At the end of this process, the audit team concluded that DataFax version 3.8 was developed and manufactured with an adequate level of quality for application in clinical operations governed by applicable regulatory and industry standards. During this presentation the team will summarize its findings as well as the company's response and discuss options for the future of the vendor audit process.

Edit checks are easy to hate. Too many of them are written to match staff- or client- specific QC message preferences, and they all do the same thing. No one knows if the edit check they need has already been written, and if it has, where it is stored. Changes to one copy of an edit check never make it to other copies being used in other studies. And validation is repetitive, tedious, and time consuming.

This paper will share our experience of evaluating and selecting a clinical data management system. DataFax 3.8 was one of the two CDM systems selected from over dozen CDM systems. The two systems were scored and compared against our selection criteria. This presentation will review DataFax's strength, scrutinize its weakness, and focus on the functions and capabilities needed to meet the demand for standardization and integration in the future. It will review FDA's proposition on adopting a standard and discuss how to make a CDM system CDISC compliance. The CDISC standards such as ODM, SDTM, CDASH, and FDA JANUS data models will be reviewed briefly.

We will describe the unique benefits of utilizing DataFax in a 40 country global study for Primary Efficacy and Endpoint Adjudication. In our opinion no other system could have met the unique data capture or data turnaround requirements of this study.

At DFUG 2000, Betty Carr and Scott Horton demonstrated a new system for implementing MedDRA Adverse Event Coding within DataFax. At DFUG 2005, Betty updated the user group on the status of this system, but a lot has happened since then.

The DataFax R-based Reporting Tools (DfRTools) package is a collaborative project between FSTRF-Madison and Factory CRO to develop modules using the R-Project statistical software environment for creating data management reports revealing patterns, trends or discrepancies, and providing study metrics in a comprehensible fashion. At the DFUG-2007 meeting, we demonstrated the DfRTools prototype and presented examples of standard DataFax reports and their DfRTools equivalents, and showed some additional DfRTools reports not available from DataFax. The success of this prototype has motivated us to continue development of the DfRTools package, focusing on end-user functionality and usability, and improving technical features of the package. We began by deploying the DfRTools package within a prototype test study developed at Factory CRO, and then in at least one actual study for both FSTRF and Factory. Based on this experience, parts of the DfRTools package were adjusted and partially rewritten. Specifically, more consistent naming conventions for the functions within the package and directory structures within DataFax studies. Also, increased portability of the package by eliminating LaTeX requirement; DfRTools can now output the reporting tables in either LATEX or HTML format. In addition, it now uses simple ANT (http://ant.apache.org/) build files to create package and do other tasks, and the distribution files include better R-package installation documentation. Finally, the visit-schedule report required modification to accommodate its dependency on DFvisit_map for a given study.In this presentation, we will demonstrate updated and new functionalities in the DfRTools package , and how we deployed this package within the DataFax and as a batch reporting system. We are fairly close to the first release candidate of DfRTools for public use under the GPL-license. Some of the presentation will include our near future goals, such as integration with Open Office. We hope that our presentation will generate user feedback and start new collaborations with DFUG users to extend functionality and usability of the DfRTools package within DataFax system.

We plan to discuss some communication techniques that we use to facilitate our DataBase lock. Describing:

• CRF design workshop (a 4-6 hour meeting that includes the study coordinator, statistician and clinical staff)
• Reducing the number of CRF drafts (CRF useful for all customers)
• CRF training workshop for study coordinators (using a mockup subject chart for coordinators in group)
• JITIs (Just In Time Information) for study coordinators and clinical monitors (short powerpoint presentations) used in webex/telecoms at different study stages:
  • Monitor communication with data management
  • Monitor visit timing
  • Monitor query tracking form
  • Final count page
  • Site initiation
  • Site closeout
  • Monitor changeover

Delivering CRF information to researchers can be daunting and time-consuming task. Finding a delivery system that is productive, user-friendly, and seamless is a challenge. The Seattle Biomedical Research Institute would like to share their solution to this problem.

Internet-based data management has the potential to be a valuable tool in data collection. It offers clinical sites an electronic format to enter, review and modify data; a method of immediate feedback on data quality; and a shift in focus for central data management from data entry to the ability to assist sites to avoid and rapidly address data queries. However, in order to be an effective tool at both the site and centrally, various strategies and procedures need to be developed and implemented.

The DataFax Publication Tool (DFPT) is an application that allows modifications to be made to a DataFax database in a development environment and published to a production environment. Using the DFPT greatly reduces the amount of downtime required when implementing database modifications. The DFPT can be used to decrease the time to open a traditional DataFax, iDataFax or SynCapture database, by allowing only necessary portions of the setup to be transmitted as completed.