Automatic Pre-filling of DataFax CRFs Name: Company: Email: Mark Williams Vice President CIO Applied Clinical Intelligence, LLC. mwilliams@a-ci.com Why Pre-fill Forms? When clinical electronic data and/or Information exists outside of the normal DataFax CRF collection and validation process Diagnostic Data, (Lab, ECG, etc.) Electronic Patient Dairy Data. When you require the non-datafax data to be reviewed, assessed and signed off by Investigational site personnel or a clinical expert (Cardiologist, etc.) 1
ACI s Case Study ACI performs Centralized ECG interval and Morphology interpretation of Digital or Paper ECGs ECG Analysis Process First, Interval wave forms are measured either by a digitizing tablet and measurement puck (Paper ECG) or using on- screen calipers (Digital ECG). Next, a Cardiologist provides a morphology diagnosis of the ECG waveforms by carefully reviewing the waveform pattern and the interval measures previously recorded 2
Challenge Hybrid CRF ECG SQL Server ECG Measures Signature & Date Morphology Diagnosis DataFax What We Needed A tool that could read values stored in any arbitrary database (SQL Server, Oracle, Excel, etc ) and electronically populate a typical Datafax CRF Page. Since we design the CRFs in Adobe FrameMaker, could we create a Adobe Acrobat file of the CRF and using Acrobat s Form technology, link the database values to the Acrobat form? 3
Tools We evaluated a number of Database to Acrobat form software tools. Some were UNIX based and some Windows based. We settled on PF-Merge from Pureforms, inc. (http://www.pureforms.com) What We Had to Decide Do we only want to report the values from the ECG SQL Database onto the ECG Hybrid CRF? Meaning: we would not set up the Datafax plate to capture and validate the ECG interval values only the Cardiologist s morphology diagnosis codes, date and signature. Or did we want to set up the DataFax database to ICR and validate the ECG intervals AND the Cardiologist s morphology diagnosis codes, date and signature? 4
What We Did Since it was necessary at times to reconcile a given ECG Interval measure value with a given Morphology diagnosis and have the ability to query both types of data It was decided to set up the DataFax database to capture ALL data on the form. Hybrid ECG CRF (2 Zones) Automatic population Of ECG Interval Measurement Values Manual Completion By Cardiologist 5
Setting up Acrobat Form Fields for ICR Now for the Filling Using PF-Merge we would open a SQL Server database View of the ECG interval measures. A specifically designed view that displayed a field for every corresponding field entry box on the ECG form. Example: If the QTcB value was 425 milliseconds Then this value was represented as: QTcB1 QTcB2 QTcB3 QTcB4 0 4 2 5 6
PF-Merge Next the Acrobat Form would be opened. For every single record in the ECG Database View table, PF-Merge would create a single ECG DataFax ready CRF page in Acrobat format. One acrobat file per ECG or one multiage Acrobat file for all ECGs at time of batch merge). So: the database view structure is one-record per ECG per time point. How it Works Database Window Acrobat Form Window 7
How It Works Continued How It Works Continued 8
How It Works Continued Voila! Pre-filled Form Ready for Cardiologist PF-Merge ECG SQL Server 9
Form Completed by Cardiologist and Sent to DataFax Cardiologist Implications Hybrid CRF ECG SQL Server Clinical Lab Data Patient Diary Data Other Diagnostic Data Signature & Date 10
Questions? 11