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ePAR: The Next Frontier

ePAR: The Next Frontier. Elizabeth Wood WebCAMP Architect and Associate Director for Data Mgt and Operations Clinical and Translational Science Center The Weill Medical College of Cornell University. What is ePAR?. e lectronic P rotocol A uthoring and R eview

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ePAR: The Next Frontier

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  1. ePAR: The Next Frontier Elizabeth Wood WebCAMP Architect and Associate Director for Data Mgt and Operations Clinical and Translational Science Center The Weill Medical College of Cornell University

  2. What is ePAR? • electronic Protocol Authoring and Review • One of two main modules in WebCAMP: • Protocol Authoring and Review (ePAR) Provides full automation for protocol submission and review. • Census and Protocol Tracking Tracks activities and progress of approved protocols.

  3. What is WebCAMP? • A Web-based system, originally developed through NCRR funding to support administrative data management needs at GCRCs. • Now in use at approximately 40 sites nationwide, with about 20 additional sites preparing to go live. • These sites represent both GCRC and CTSA institutions. • Of the 24 funded CTSA institutions, 15 are using (n=12) or preparing to use (n=3) WebCAMP.

  4. Brief History • June, 2004 WebCAMP development started with 2-year plan to port FoxPro CAMP functionality to a Web(ColdFusion)-based platform. • September, 2004 ePAR development began at Weill-Cornell as a local initiative to automate the protocol application and review process. • April, 2005 ePAR launched at Weill-Cornell • September, 2005 ePAR incorporated into WebCAMP (in development) as 2nd module. • January, 2006 First non-Cornell production installation (Wake Forest) • January, 2006-November, 2007 ~40 additional sites “live”

  5. WebCAMP’s Technical Architecture • Front-end written in ColdFusion, HTML and Javascript • SQL-compliant back-end database options: • MS SQL Server • MySQL • Oracle • Database access is via standard SQL • Sites have full access to import and export data • Data dictionary is published within the software • Import/export routines can use any language that is able to issue SQL commands against a database.

  6. WebCAMP General Features • User-based privileges • Full audit trail of changes (v.1.2.0) • Configurable security settings • LDAP support • Open architecture • Easy to plug site-specific modules into WebCAMP menus • Database is accessible to non-WebCAMP code • System is distributed as source code; collaboration is encouraged.

  7. ePAR in a Nutshell • Comprehensive system for protocol authoring, submission and review. • Flexible support for attached files (e.g., IRB application, consents, etc.) • Support for revisions, amendments, re-reviews • Support for multiple review committees • Data on approved protocols transfers over to Census and Protocol Tracking for use in budget tracking, scheduling, etc.

  8. ePAR Setup • Identify your e-mail server (Data Setup) • Set up usernames for Advisory Committee and GCRC staff (System Setup). Identify those with administrative privileges in ePAR. • Identify committees, units and cores • Specify protocol flags (if any) • Identify Advisory Committee Members • Configure ePAR’s application sections to meet your site’s needs • Demo

  9. Protocol Submission Lifecycle As Supported by ePAR Request to submit new protocol (study team) Approval of request (protocol review coordinator) Protocol authoring and submission (study team) Scheduling, assignment of reviewers (protocol review coord) Electronic review (Advisory Committee members) Compilation of composite review (protocol review coord) Electronic response to review (study team) Review of response/revisions, if applicable (Adv Committee) Final approval; approved information is locked (no changes) Study team can initiate amendments to approved protocols Demo…

  10. Other Features of ePAR • Administrative notes

  11. Beyond Setup:Overriding Default Pages • WebCAMP supports override function, allowing you to replace default pages with your own versions. • Example: Replace summary page with a version that better suits your site’s needs (DEMO) • Recommendations: • Start with copy of existing page • Check with me regarding specific changes to ensure they don’t affect core functionality

  12. What’s in the pipeline… • Support for electronic pre-review sign-offs (e.g., biostatistician, budget reviewer) • Support for multiple application types (e.g., pilot award, computer-only, etc.) • Improved options to support site-specific alterations to built-in forms.

  13. Other information sources: • Today’s webinar is being recorded and will be posted at: ftp://ctsc.med.cornell.edu Username: gcrcdom\WebCAMPSite Password: ExtraDocs • This site also contains recordings of past webinars covering other WebCAMP areas

  14. Questions?

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