1. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org A simple, flexible tool for inexpensively building secure data capture systems Andy Arenson, Advanced IT Core Bob Davis, Biostatistics

2. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What is REDCap? Web-based software for data entry Originally for clinical research, but usable in other domains Developed by Vanderbilt. –267 institutional partners (as of 16-Sep-2011) –http://www.project-redcap.org

3. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org REDCap Consortium Worldwide: 21,160 studies; 30,060 end-users

4. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Who already uses REDCap? Statistics (as of 16-Sep-2011): –257 dbs (79 production, 76 development, 2 inactive, 18 archived, 82 practice) –294 active users –930 data entry forms; 23,288 data fields; 48,025 data records IU School of Medicine – many departments, divisions/sections; IU School of Nursing; IU School of Dentistry; Indiana CTSI; Purdue University; Regenstrief Institute; VA Medical Center; IU Health – Methodist; Wishard Health Services; Rehabilitation Hospital of Indiana

5. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Managing data on a small budget Custom programming is time-consuming and expensive Excel is quick and easy, but leads to data problems Imagine creating a database with the click of a button

6. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What do people like about Excel? It Just Works / It’s Familiar –It’s very easy to get going. Problems only come later You don’t have to wait for anyone else –You don’t have to get IT to do it for you

7. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What problems occur with Excel? Version Control –Who’s got the latest file? –Who changed what? –Has any of the data been lost? Data Consistency –How many ways can you spell Mississippi? –Is -37 an allowed value? –Is ‘Yes’ the same as ‘1’?

8. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org How can REDCap help? Get started fast –Entry forms, reports, etc. created automatically from a data dictionary. –Data dictionary created by anyone – from a spreadsheet or GUI Create data Consistency from the beginning –Apply type checking, range checking; Use coded/standard responses. –Begin with the end in mind – what will need to be analyzed?

9. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary - GUI

10. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary - GUI

11. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary – Resulting Form

12. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Export

13. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary – Spreadsheet

14. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary – Spreadsheet

15. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary – Spreadsheet Upload

16. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Data Dictionary – Library

17. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Demonstration: Start to Finish https://redcap.uits.iu.edu Create a database Data Entry Data Export

18. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What data can REDCap manage? Numbers, text, dates, files, lists (radio/checkbox/multiple), branching, calculations Simple Schemas –Designed for a single table of information –1:many relationship is possible, but tedious to create –Many:many only possible by using multiple REDCap databases. Electronic Protected Health Information (ePHI) –IU has put in place appropriate administrative, technical, and physical controls to protect data in accordance with the HIPAA security rule

19. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What data is not allowed in REDCap? When storing ePHI, you remain responsible for privacy, security, and compliance. You need IRB approval and a Data Management Plan. Technical and physical controls are provided, but you remain responsible for administrative controls. REDCap is for use only in support of academic research. Do NOT use REDCap for other uses, for instance to store official university business data, patient care data, or electronic health records (EHRs).

20. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Who can use REDCap? Anyone at an Indiana CTSI member organization (IU, Purdue, Notre Dame) plus any of their partners at other institutions. Register an IndianaCTSI HUB account: https://www.indianactsi.org/register Request a REDCap account: http://www.indianactsi.org/redcapacr

21. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org What else can REDCap do? Longitudinal data; Scheduling; Online reports; Simple online analysis; Data deidentification; Full audit trails and logging; Double data entry; Data access groups; Application Programmer Interface (API); Data Transfer Services REDCap Survey –More secure and fewer limits than Survey Monkey REDCap 4.0 – merger of REDCap and REDCap Survey; dozens of improvements.

22. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Longitudinal Data

23. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Calendar & Scheduling

24. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Online Reports

25. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Online Analysis

26. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org De-identification

27. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org De-identification

28. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Audit trails & Logging

29. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Advanced Functions Double Data Entry –Quality assurance for data entry – compare data entry by two different people Data Access Groups –Allow people at multiple sites to contribute to the same database, without seeing other people’s data.

30. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Advanced Functions Application Programmer Interface (API) –Web Services interface for reading and writing data and metadata Data Transfer Service –Separate software service, using the API, for incorporating data from other databases (typically a relational database) using an adjudication process –Commonly used to incorporate data from medical records systems

31. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Where is REDCap? Hosted on a physical server in the Bloomington Data Center Supported by the Indiana Clinical Translational Sciences Institute (CTSI) via a collaboration of staff from the Biostatistics Department and from the Advanced IT Core of the IU School of Medicine, which is part of Research Technologies/UITS

32. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Questions? hubsupport@indianactsi.org