Gennia Michlin, Clinical Data Management Systems (CDMS) Project Leader Mar 2010 New RDC features training

2 RDC new features overview 1.Bugs corrections 2.New enhancements 3.Reference field 4.New site set up process 5.Introduction to site assessment tool 6.Future glance

3  Group approval / verification - Failures while approving / verifying a large number of CRFs were resolved  Review tab - Error messages received when working on discrepancies in Review Tab were resolved Corrections of bugs

4  Manual discrepancies on Log CRFs (relevant for AE, MED, COMMENTS) –  A manual discrepancy created on a repeating question in Log CRFs, was automatically closed when the discrepancy or data on another row were modified  In addition, a manual discrepancy created on a repeat with data, was automatically closed when the data on the same row was deleted  These issues were resolved Corrections of bugs

5  CRF printing: When printing CRF additional blank pages were added, this issue was resolved. Currently page setup can be adjusted:  IE6: Click File and then select Page Setup. On the bottom right of the dialogue window set the margins to the minimum. Then print the CRF.  IE7: Right-click on the HTML Data Entry window and select Print Preview. Navigate to Settings and select Shrink to Fit. Then print the CRF. Note that Shrink to Fit does not always print correctly: You may have to manually adjust the Zoom setting. We found 70% Zoom worked well in the test environments.  IE8: Ensure IE8 Browser Mode is set to Internet Explorer 7 and Document Mode is set to Internet Explorer 7 or Quirks. Right-click on the HTML window and select Print Preview. Navigate to Settings and select Shrink to Fit. Then Print the CRF. Note that Shrink to Fit does not always print correctly: You may have to manually adjust the Zoom setting. We found 70% Zoom worked well in the test environments. Corrections of bugs

6 The Reference Field is used for:  Displaying additional subject identifiers  Enabling advanced search options  Distinguishing between Screening failures and Randomized Subjects when randomization is performed (For SF subjects the Reference field will remain empty) Reference field general description

7 Using only percent in the Reference field, will filter only subjects with a Reference Value – randomized subjects Reference field - Advanced search for Randomized subjects

8 Visible with Subject Identifiers Enabling search options basic and advanced Reference field - Customized search

9 Tooltip including all relevant information when pointing mouse over the subject icon Enabling search options basic and advanced Reference field – Casebook functionality

10  The Reference field will be updated automatically once a day following the night  Data required in order for the update to take place:  Subject’s initials was updated  Demographic CRF was saved as complete  Subject’s Randomization number was updated (For Studies with Randomization)  Enrollment CRF was saved as complete (For Studies with Randomization)  Options for reference field data:  For Studies with Randomization (no transformation – new studies): - : AFT –  For Studies with Randomization (with transformation – old studies): - : AFT – Reference field – when will it be updated?

11  Performance issues improvements:  Navigation within the system between Tabs  Navigation between studies and sites  Data refresh time after performance of selections and searches (e.g. after "Go" button is clicked)  Internet Explorer version 8 - RDC is now certified to work with Internet Explorer version 8 New enhancements

12  Site Assessment Tool:  CRA will use the site assessment tool link ( is.ness.com/) before or after the site was selected (e.g. during pre study visit) is.ness.com/  Site’s PCs Technical data will be received automatically and stored in the service desk database for future use  Collecting data & updating CTMS  CRA will update CTMS with the following data  RDC readiness flag (mandatory)  IT details  Site staff details  Collect info about RDC physical location  Planned SIV date Update RDC Site set-up process and assessment tool

13  HelpDesk Site Assessment  Once RDC readiness flag checked in CTMS the service desk will assess the site information received.  In case all requirements are met the service desk will contact the CRA/Site IT in order to implement RDC on the site’s PC.  In case not all requirements met the service desk will contact the CRA/Site IT in order to provide with solution for RDC implementation at the site. Update RDC Site set-up process and assessment tool

14 RDC Site Assessment tool   New studies - RDC site set-up process:   Should be used during the pre-study visits in order to assess the site readiness for RDC   Ongoing studies sites:   Assess ongoing sites performance

15  Future Glance - RDC Portal  RDC user's portal is now under construction and will replace our current Web Based Training website. Our portal will provide unified and user friendly interface in order to perform activities such as:  One location to Log in to all SSL/VPN gateways (RDC)  Receive live updates on applicative or technical issues  Downloading training materials  Future Glance - Training movies  Tired of navigating through RDC training presentations?  Short training movies focusing on main Investigator and CRA activities in RDC will be released soon. Each movie will be between 2 and 3 minutes long. The movies will focus on the main activities that should be performed and will use the assistance of visual instructions and clarifications.  The movies will assist you to perform the initial training and quick refreshments. Future glance