Research Electronic Data Capture

Transcription

1 Research Electronic Data Capture Data Management and Survey Tool Lynn Simpson, MPH Research Analytics & Data Service Manager Partners HealthCare Enterprise Research Infrastructure & Systems Harvard Catalyst The Harvard Clinical and Translational Science Center

2 1

3 FREE license from Vanderbilt U. Medical Center REDCap Consortium = 2051 Institutions, 107 Countries 2

4 Overview Free, Licensed from Vanderbilt U. Medical Center Secure, Hosted by PHS IS Research Computing o No purchasing, downloading software, or storing data locally Web-based application o PC and Mac compatible o Mobile device, Smart-phone friendly o Accessible via internet (no VPN, remote access required) o Compatible with all popular web browsers Safari, Internet Explorer, Chrome, Firefox 3

5 Overview Fully customizable - You are in total control of shaping your database or survey. Define: Question / Field types Validation for text fields (dates, numbers, ranges) Calculations Branching logic: hide/display fields based on data entered Piping: display data entered across forms / visits No limit to number of data fields or forms you can program Mid-study modifications - Modify projects as needed during the course of your study. 4

6 Support Model 1.5 FTE : 8,876 Projects : 10,450 Active Users 1-2 Business Days for most responses 2-5 Business Days for some requests edcsupport@partners.org Self Service Module: Help & FAQ Getting Started website: Knowledgebase: Guidelines, How-To Articles, Feature Highlights. Test site: This is open access to internal Partners users - do not enter real research or clinical study data. 5

7 Online Form Editor Q: How much experience with programming, networking and/or database construction is required to use and design EDC tools in REDCap? A: No programming, networking or database experience required. Use Point-and-Click interface to design your EDC tool(s). 6

8 Database Design: Data Dictionary Or use Off-line Excel.csv File to build forms 7

9 Project Home > Other Functionality 8

10 Benefits: Shared Library REDCap Library: Accepting requests for open domain assessments REDLOC: - Builds Forms - Obtains Licensing Requirements 9

11 Project Settings There are two data collection instrument types: 1. Data Entry Forms: Data entry by study team 2. Survey: Data entry performed by subjects, participants 10

12 Data Collection (1) Data Entry by Project User REDCap Account Required 11

13 Survey (2) Data Entry by participants subjects SURVEY No log in required. REDCap generates unique URLs 12

14 Project Settings There are two data collection instrument types: 1. Data Entry Forms: Data entry by study team 2. Survey: Data entry performed by subjects, participants There are two data collection formats: 1. Classic: One record per patient (WIDE) 2. Longitudinal: One record per patient per event, with the possibility of defining multiple arms (LONG) 13

15 Wide vs Long Design Traditional VS Longitudinal 14

16 Wide vs Long Design Each FORM will create fields in database - Data model by REDCap is EAV Single Table Projects with multiple visits executed two ways (1) Traditional Format: (WIDE) - Create unique forms for each Visit - Data saved as one row with distinct fields 15

17 Traditional Design Wide (multivariate) Example Each record is a row in data export Each Lab Visit variable is unique: alb_b, alb_v1, alb_v2, alb_v3 Limitations: To search for all Albumin > 10, must parse through all alb_ variables List of forms may get unruly if you have a lot of forms / visits; Useful for trials with less time points 16

18 Wide vs Long Design (2) Longitudinal Format (LONG) - Create 1 Form for each measure - Create Events for each visit - Designate FORM to multiple EVENTS - Data saved as multiple rows with same field As # of EVENTS increase this option easier to execute 17

19 Longitudinal Design Raw Data Representation Green dot denotes that data has been entered for event A new record is created for each event ALL data collected for a single event appears in one record Un-utilized Events do not generate records 18

20 Wide vs Long Design Traditional VS Longitudinal 19

21 Data Management Applications Calendar - View and edit project calendar for scheduling and event tracking Data Exports, Reports, and Stats - Extract data fields from database to Microsoft Excel, SPSS, SAS, R, STATA software (Ability to de-identified data sets), View Plots (graphical representations) and Descriptive Statistics for data entry forms; view, edit, copy, delete custom reports; query database in real time and display data in a table format. Data Import Tool - Add and edit data by importing data into database from a Microsoft Excel file Data Comparison Tool - Compare database records entered by designated data entry persons (double data entry) Logging - View and export a list of all changes made to the database, including data exports, data changes, and the creation or deletion of users File Repository - View, upload, and download project files; view and download previous data exports (data and syntax stored files) Data Access Groups (DAGs) - Restrict access to database records by group, users in the same Data Access Group can access records created by that group. Record Locking / Locking Mgmt Lock records to disable changes API Allows external applications to connect to REDCap remotely; automate imports and exports REDCap Mobile App Collect data offline (no internet access) to sync back to project 20

22 User Rights Customize Each User: Application Rights Data Entry Rights 21

23 Export REDCap Data Export Export to Excel, SPSS, SAS, STATA, R Numerous de-identification options - Removal of fields that contain PHI - Automatic removal of date fields; date shifting Exports include corresponding syntax files Maintain record of entire export history 22

24 Reports Graphical Views & Stats 23

25 Data Quality 24

26 Add / Edit Records 25

27 Surveys - Public URL vs Participant List vs Designate an Address - Anonymous - Multiple Surveys linked to specific Participant - Automated Survey Invitations 26

28 Survey Settings - Survey Title - Survey Instructions - Logo - Size of survey text - Font of survey text - Survey (color) theme - Question Numbering - Question Display Format - Require Field options - Survey Expiration Date - Save & Return option - End of Survey Options: Auto-Continue to next survey Redirect to a URL Survey completion text 27

29 Longitudinal Example Survey Settings Advantages - Can designated certain instruments at certain events - Can track which surveys have been completed Limitations - Save&Return option may not be as intuitive to manage because each survey has it s own link; Participant only receives 1 st survey link. 28

30 Public URL vs Participant List vs Designated Public Survey URL: Single survey link for your project which all participants Link can be copy and pasted into: The body of an message in your own client Posted to web pages. Limitations: allows for the possibility of participants taking the survey multiple times. Advantages: Participants can forward or resend the link to other participants. Participant List: Send s and track who responds to your survey Identify an individual's survey answers by providing an Identifier for each participant. Limitations: Must know addresses Advantages: Tracks Responders / Non-Responders 29

31 Public URL vs Participant List vs Designated Designate an field : Example field designated: (" address"): Capture addresses for sending survey invitations on a form/ survey Any records with entered address will have that address show in the Participant List Limitations: address saved to record Advantages: First instrument does not have to be a survey 30

32 Anonymous Surveys Truly Anonymous = Public Survey Link Honest Broker = Coded Participant List Behind the scenes link Information is provided to investigators in such a manner that it would not be reasonably possible for the investigator or others to identify the corresponding patients-subjects directly or indirectly. REDCap/REDCap Admins have access to the key to the code. Public Survey Link or the Participant List For either method, the survey questionnaire must not contain any questions asking the participants for identifying data What is your ? name? address? Participant Contact List Do not enter unique values into the "Participant Identifier field Links the address to the survey responses. 31

33 Automated Survey Invitations 32

34 Getting Started Partners HealthCare Access: Partners users can log in with their Partners usernames and passwords External users: contact EDC Support Language for grant and IRB submission: Getting Started website: Training: There is no formal training required to use REDCap. Video tutorials and Help&FAQ page in REDCap contain a lot of useful information. Test site: This is open access to internal Partners users - do not enter real research or clinical study data. 33

35 Contacts Contact Information for Harvard Catalyst REDCap Support Staff Lynn Simpson, MPH Jeremy Alphonse MGH, BWH, Spaulding & McLean BIDMC, Children s & Joslin edc@bidmc.harvard.edu For support for other Harvard schools or affiliated academic health care centers, contact edcsupport@partners.org 34