How to design a database for electronic data capture in 1 Outline • REDCap background • REDCap features - System features - Database design features - Data Entry(DE) & management features • Real-Bme CRF creaon • CRF creaon using a template • DE overview • REDCap modules overview 2 • Research Electronic Data Capture (REDCap) Background – secure web-based applicaon – designed & developed exclusively for research studies by Vanderbilt University (VU) (www.project-redcap.org) – available at no cost to REDCap consorum partners – Currently 228 consorBum partners 3 Data from REDCap Consor8um 4 Features of REDCap System Features • Secure and web-based - Input data or build database from anywhere - secure web connecBon with authenBcaon & data logging. - Installed on server(s) & configured for intranet and/ or internet access. • 21 CFR part 11 Capable - server can be configured to ensure compliance 5 • Fully customizable - total control to shape database and features - wriRen in php – source code available to partners - Support RDBMS but for opBmal performance MySQL database is recommended. • Well Supported by partners - Online mailing lists/ forum - Weekly web-seminar/ conferences - Online tutorials 6 Database Design Features • Stream-lined process for rapidly building a database - Point/Click & drag for real-Bme CRF Creaon - Or upload from csv file. • Database changes easily implemented - database field(s) can be modified or added when study is in progress. 7 Data Entry & Management Features • Supports following Advanced features: - Auto-validaon (Range/ data checks) - Branching/skip logic - Data calculaon (e.g. can automacally calculate value for Body Mass Index (BMI)) - File uploading and sending of files (links) from REDCap database with link expiring opBon - Can set database to allow double data entry 8 • MulI-site access - Researchers from mulBple sites and insBtuBons can access same database. • Export data to common staIsIcal packages - Exports raw data and syntax files to SAS, Stata, R, and SPSS. 9 REDCap Database design Summary Point/Click Drag (Ajax) For Real-8me CRF Crea8on or Uploading from csv file. Op8onal Longitudinal Create Blank CRF Mapping database with no eCRF Oponal Par8cipant Scheduling Setup Screens 10 New Database name 11 Click To Start eCRF Design 12 eCRF name 13 Field type on eCRF Field type in database if Text Box 14 database field name Queson on eCRF 15 defining range check and data type validaon Defining field note to aid clarity during DE 16 defining coded response for radio buRons 17 defining coded response for drop- down list 18 creang check responses 19 creang auto- calculaons 20 Using date difference and rounding funcons in calculaons 21 defining branching or skip logic (quesBon available when condiBon is true) 22 creang field that allows to upload files 23 Allow value to be retrieved from REDCap or other database based on query e.g. pull list of medicaons from SPINE 24 Define Secon heading on eCRF 25 csv data dicBonary file opened in Excel 26 csv data dicBonary upload module 27 Data Entry Overview eCRFs 28 PDF download opBon for eCRF with or without Data eCRF ready for DE 29 pop-Up Calendar 30 radio buRons drop-down list check Boxes 31 file upload dialogue 32 data check pop-up message during DE (value no with range) 33 data check pop-up message during DE (required field values not specified) 34 completed eCRF buon for viewing data field history 35 giving reason for change 36 data field history/ log 37 Only sends download link for specified file 38 REDCap modules overview REDCap Modules - Dynamic project status - ParBcipant scheduling - Data Export and Import - Data Comparison Tool 39 - User rights & acBvity Logging - File Repository - Data visualizaon/ Cleaning and Reports - Record locking & e-Signatures - API & Shared Library - Online Tutorials & CiBng REDCap in publicaons 40 Dynamic project status A user can only view project(s) for which s/he has Read/ Edit rights 41 Dynamic database stasBcs 42 43 Selecng field for Export 44 Data Export + De-ID Tools Embedded De-Iden8fica8on Tools 46 47 48 REDCap Project Owners Autonomously Control Access To THeir Applica8ons REDCap Module Access eCRF access rigHts Database expiraon date 50 51 Login account Reason(s) for data field changes 52 Project File Repository Project-Specific Files Uploaded Here Project-Specific Files Downloaded Here 53 Data Export Files Auto-Saved 54 55 Data Visualizaon / Cleaning Automa8cally GrapHs Categorical & Con8nuous Variables Primary Use Case: Data Cleaning 56 -- Requires R-Apache Server Connecon 57 58 • REDCap API - allows programmers to customize REDCap tasks like Export/ Import of data using programming plaorms of choice e.g. php, .Net, Python. 59 Repository for REDCap eCRFs that can be used by other insBtuBons 60 Online Video resource accessed through Internet 61 How to cite REDCap in Study manuscript that used it for DE & DM 62 • Acknowledgements - Paul Harris, Vanderbilt University (www.project-redcap.org) - REDCap project (www.project-redcap.org) Thank you 63 .