EDC repository database This is just an alternative to the Reporting Database. Because of the human time and system resources required, the Reporting Database is very selectively set up, meaning there are several live trials that do not have this set up. To date, the refresh process has caused a lot of problems because of the required system resources. The data is refreshed asynchronously from the transactional database on a schedule determined by IS, usually daily. It is the responsibility of the IS department to set up the schema for each trial. Each trial has it's own schema in the database. PATH 1: data entry -> transactional database -> Reporting Database PATH 2: data entry -> transactional database -> EDC Repository Database Reporting Database This database is set up by Inform software. There are two paths that data can flow, and the two final destinations are very important to distinguish. Where is the EDC data stored All of the data is stored on Oracle databases maintained by DFCI/Partner's IS. Main Contact: Marina Nillni( ), Project Manager C. They are resposible for creating and refreshing the reporting database(more about that later). They also build and install the EDC trials onto the servers. This includes maintaining the web servers and database servers, upgrading the Inform or Oracle software when necessary, and providing DBA support for the databases. Main Contacts: QACT data analysts for form design, change requests, and data requests Danny Quinn( ) for SAS tools Information Systems They do everything related to hardware and software outside of the Biostatistics Unix server. For data extraction into SAS, Danny Quinn is the primary contact. The data analyst can also give access to the front-end EDC application or the COGNOS reporting tool. They write the specifications for the EDC trial and send them to IS, then IS builds and installs the trial onto the servers. Who's in charge of EDC Two DFCI departments play the biggest roles in the EDC system: QACT The QACT data analysts are the primary contacts for the statisticians and the study teams regarding form design, change requests, and data requests. Pulling Data from Inform EDC Trials into SAS of 9 B. As a data analyst, statistician, or programmer this affects you because you need to know how to access the data and understand what you're getting from the system. Eventually all new trials will go up on the system. This Electronic Data Capture(EDC) system is intended to replace the paper-to-Ingres system used for DF/HCC initiated trials. The name of the software is Inform and is produced by Phase Forward Incorporated. What is EDC? Back in late 2004 Dana-Farber licensed a new software product which allows collection of clinical trials data via the web. Similarities and Differences between the old and new systems A. ![]() pftransatts - find attributes of tables (including literal values for codes) D. pfprotdata - locate the SAS library for your trial B. %pfgetdata - SAS macro to create data set from a trial table III. pfccodes - find literal values for codes E. ![]() pfcprots - find database names and schema owners B. The old (but still valid) system for data extraction A. Pulling Data from Inform EDC Trials into SAS of 9 Pulling Data from Inform EDC Trials into SAS D.Quinn Updated OctoAudience: Biostatisticians, Data Analysts and SAS Programmers on DF/HCC clinical trials with data collection in the Inform EDC.
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