TRACS INSTITUTE CLINICAL DATA MANAGEMENT. Clarence Potter Clinical Data Management Team

Transcription

1 TRACS INSTITUTE CLINICAL DATA MANAGEMENT Clarence Potter Clinical Data Management Team

2 Now a word from our Sponsor NC TraCS The North Carolina Translational and Clinical Sciences (NC TraCS) Institute NC TraCS is the home of the UNC CTSA Infrastructure grant Funded May 08, it s Renewal Time ~ 260 faculty/staff + involved across multiple cores, programs and services Involved from beginning of an idea (navigators) to community involvement (state wide) to data collection to business planning Work with and support over 2,000 members across the state and the country

3 NC TraCS is Here to Help TraCS wants to help ease the burden of clinical research administration by offering a variety of Services & Resources such as but not limited to: A new Clinical Research Management System (CRMS) Tools to help recruit study participants Access to and support of Clinical Research Professionals and resources at UNC Clinical and Translational Research Center (CTRC) resources Educational and Training opportunities Carolina Data Warehouse Health REDCap / CDART

4 TraCS Data Challenge Data Done Right Secure Consistent Easily accessible Affordable Data is not carried around on memory stick EXCEL

5 Background Previously EpiInfo Access / Excel Currently, REDCap/CDART REDCap create by Vanderbilt Open Source - php, mysql Supported by consortium of ~400 instituions 1000 s of projects around the world TraCS has hosted the service since 2009 Over 150 projects at UNC More info: project-redcap.org

6 Key Tools for Data Capture REDCap Light, Quick, DIY smallmed and multicenter Web-based Secure Simple to use / modify Easy to access Audit logs User access controls Simple field validation Skip patterns/logic Data imports Easy export to standard analysis

7 CDART Key Tools for Data Capture All of REDCap plus more Heavy duty, multi-center trials Build forms with XML (ie not DIY) CSCC uses it for all of their projects Shared with CTSA Very detailed dependencies / validations Every field comes with comment capability Preserves versions Repeat forms as needed

8 Without REDCap Find someone to build the database Computer / office space for them Secure place to store your data Apply Current data security policies and regulations Time to build it Worry about what to do when that person left

9 With REDCap, you just need a little time. Discuss project time / events / key data 1 hour Meet with research team create a data form 1 hour Research team creates list of data elements, with choices, value limits 1 hour Upload list of data 10 minutes Live, secure data entry on the web Improve / Test hours Production review 1 hour READY TO COLLECT DATA < 12 hours

10 DIY - What, Why, How Loaded with Features ONYEN / Local accounts Individual user permissions by form / by process Edit Checks / Validation Export SAS, SPSS, R, STATA, Excel Import Data dictionary Numeric coding Online editor

11 DIY - What, Why, How SECURE Better Data Controls Access? Excel? Easy to create Quick to go live Simple to use

12 DIY - What, Why, How Define your data requirements / time frames Create a list spreadsheet Upload the spreadsheet Review errors Set user permissions Collect Data Export for analysis / reports

13 Create Data Dictionary

14 Data Dictionary (cont d)

15 Data Form Navigation- Simple

16 Data Form Navigation - Longitudinal

17 User Permissions

18 REDCap Charges for Service NIH Mandate to become self supporting: The more you do yourself the less it costs Hourly fee for hands on help Monthly hosting fee covers: servers updates, software updates, backups, etc.

19 In Conclusion (REDCap) REDCap is a great DIY tool for researchers TraCS Data Management service will help make your data more consistent better research more grants

20 Contact TraCS to learn more about the services offered: NC TraCS Institute UNC - CH 160 N. Medical Drive Brinkhous-Bullitt Building, 2nd Floor CB 7064 Chapel Hill, NC nctracs@unc.edu (toll-free) 22