OpenClinica Global Forum 2010. Demonstrating an a coding application written in Corel Paradox!

1. A Low Cost Approach to Coding OpenClinica Data rick.watts@ualberta.ca 780-248-1170

2. The terminology is free for coding non-commercial studies. MedDRA adds significant ‘value’ to verbatim free text data items. Academic researchers are often unaware of the existence of MedDRA. Coding software is expensive and out of reach of small grant funded studies. MedDRA in an Academic Environment

3. Should MedDRA coding be included in OpenClinica? Pros: Open source solution would remove the cost barrier associated with coding solutions. Increased uptake for academic research Single point of entry for clinical data collection and coding Integrated coding and discrepancy management MedDRA and OpenClinica

4. Should MedDRA coding be included in OpenClinica? Cons: Coding functions should be limited to a small number of trained individuals. Site access to coded data is a data manager’s worst nightmare. Dictionary searches result in large data volumes passing over the network. Potential performance issues. MedDRA and OpenClinica

5. 1997 - Application required to code investigator initiated studies Stand-alone COSTART coding application developed in Corel Paradox. Adapted for MEDDRA 1.5 MEDDRA 1.5 was: Developed by the UK’s Medicine Control Agency Provided free to interested parties Now supports MedDRA 11, WHO-DDE and custom dictionaries. Zero Cost coding

6. Support for multiple tables within multiple studies Multiple MedDRA versions Basic auto-coding Manual coding Term splitting Codes any ODBC data Reads and writes SAS data via ODBC SAS 9.2 ODBC drivers do not work well with Paradox. Features

7. Export data into SAS Generate a unique key SAS MD5 function Write data to a supported format (DBF) Date variables display as dates, not numbers Code the data Export coded data Merge coded data back into original SAS data set for data management and analysis. Coding OpenClinica Data

8. Medication coding with WHO-DDE. Custom Dictionaries For instance laboratory test names. Additional Features

9. Given time and money: Redevelop using a more widely supported development tool not a desktop database. Open Source project? Java? C#? Visual Basic? RAD Tool? Where Next?

10. Demonstration

11. Rick Watts rick.watts@ualberta.ca 780-248-1170 Contact