REDCap Data Management

Transcription

1 REDCap Data Management How to begin using REDCap to collect and manage your research data CTSC Biomedical Informatics Program

2 What is REDCap? REDCap (Research Electronic Data Capture) is a secure web application for building and managing online databases for research REDCap is HIPAA-compliant, we will worry about data security and data compliance, you can focus on the research Worked with Research IT, IT Security, Compliance, Legal, and the IRB to launch REDCap

3 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

4 Kick-off Meeting Meet with CTSC Biomedical Informatics staff Discuss project workflow Discuss milestones and deadlines Researcher must complete a CTSC Application for Resource Use Researcher must sign the REDCap Project Level Agreement

5 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

6 Developing the Data Dictionary Variable / Field Name Form Name Section Header Field Type Field Label Choices Field Note Text Validation Type Text Validation Min Text Validation Max Identifier? Branching Logic Required Field?

7 Each data point Variable / Field Name Lowercase, no special characters, underscores allowed Form Name Section Header Field Label Choices All choices are coded (1, Choice 1 2, Choice 2, etc.) Although Choice 1 is selected, the value 1 is stored, useful during analysis Field Note

8 Sample Form Section Header Field Note Field Label Choices

9 Field Type text text box used to capture numerical values and text data notes large text box used to capture text data, usually for comments or notes dropdown drop down list used to select a single item from a predefined list of items radio radio buttons to select a single item from a predefined list of items checkbox checkboxes to select multiple items from a predefined list of items yesno radio button for simple Yes/No response

10 Validation For text fields number, min/max integer (whole numbers, no decimal places), min/max date (date_ymd, date_mdy, date_dmy), min/max time (datetime_ymd, datetime_mdy, datetime_dmy), min/max phone zipcode (5 digits)

11 Branching Logic Allows fields to be displayed when certain data is entered/selected If Female is selected as Gender, a question for Past pregnancy will be displayed [gender] = 0 would be entered into the branching logic column for the Past Pregnancy data point

12 Sample Dictionary

13 Resulting Form

14 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

15 Review Data Dictionary Research team will meet with informatics staff and a biostatistician to go over the data dictionary Informatics staff can communicate with the biostatistician regarding the data model Biostatistician can provide guidance to the research team on how certain data points should be captured to facilitate analysis

16 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

17 Requesting Access (this will only have to be done once) Submit a Lotus Notes Online Access Request Send a signed REDCap End User Agreement to the informatics staff working with you (fax, inter-office mail, or scan and ) Informatics staff will be using your data dictionary to create the database

18 User Permissions Matrix (per project)

19 Roles

20 Data Entry Rights Edit Read None

21 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

22 Final Database Review Research team will work with informatics staff to finalize the data dictionary, forms, and user permissions

23 Six Step Process to Using REDCap 1. Kick-off Meeting 2. Develop Data Dictionary 3. Review Data Dictionary 4. Create Database and Request User Access 5. Final Database Review 6. Begin Entering Data!

24 Post Processing Features All changes to the database are logged in accordance with HIPAA and other compliance regulations and policies

25 Post Processing Features Researchers can create custom reports

26 Post Processing Features Researchers will be able to export data into popular statistical packages, and into Excel

27 Where to Find REDCap From browser type --Redcap/

28 Citing REDCap and the CTSC in Publications Any publications resulting from the use of REDCap to collect and manage data should include the following CTSA acknowledgement: "This publication was made possible by Grant Number UL1 RR from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Information on NCRR is available at Information on Re-engineering the Clinical Research Enterprise can be obtained from Any publications resulting from the use of REDCap to collect and manage data should include the following REDCap citation: Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform Apr; 42(2):

29 Acknowlegements A joint project from the UC Davis CTSC and Health System IT Ayan Patel Kent Anderson Chris Lambertus and the IT Middleware group Monte Ratzlaff and the IT Security group Teresa Porter and the Compliance group Anna Orlowski and the Legal Office