1. REDCap Version 5 By K. Essmyer

2. Why Use REDCap? Provides researchers a tool that.. – Defines forms/data – Controls user access to data – Captures data entry – Validates fields – Checks/Queries data – Stores data – Exports data for analysis …Researchers are good people, give them a good tool and they will do good things….

3. REDCap Publications Researcher Statistical Analysis Write Conclusion Define Forms/Data Define Procedure/Events Set User AccessCapture DataQuery/Correct Data Spreadsheet / Custom DB Find Problem Fix Problem Eventually $$$

4. File Server Host Server WEB Server Uploaded Files Installation Files WEB Server WU Campus Sidedoor Server https://redcapsurvey.wustl.edu... REDCap Survey Data Entry /Admin MySQL Server MySQL Slave Server Data Sync Biostatistics Secure Domain Authenticated Access Public HTTPS Survey Access

5. WUSM REDCap Servers (http://www.biostat.wustl.edu/redcap)http://www.biostat.wustl.edu/redcap Development “Trying it Out” HIPAA Secure server REDCap User Request form (Fax or email) – Sponsoring PI – Username /password – Open access to the Development server Off-campus Access – Sidedoor security certificate – Access from any “capable” Internet connection (world wide) Development “Trying it Out” HIPAA Secure server REDCap User Request form (Fax or email) – Sponsoring PI – Username /password – Open access to the Development server Off-campus Access – Sidedoor security certificate – Access from any “capable” Internet connection (world wide) Production “Data Collection” REDCap Project Request form (Fax or email) – Sponsoring PI – IRB Approval or Waiver – Only PI or Project Admin can create projects Production “Status” – Data Dictionary Changes saved Review of submitted changes to avoid unintended data corruption Delete all records function disallowed

6. Current Usage Costs Offered as an Investigator Resource for Washington University Institute of Clinical and Translational Sciences(ICTS) and Siteman Cancer Center (SCC) members. No charge for data or file storage. – Individual upload file size currently limited to 32MB per file – No limit on number of upload files No limit on the number of projects per study. Basic technical support and usage guidance provided by REDCap administators. – Study design and analysis services provided via appropriate Division of Biostatistics Consulting Mechanisms

7. Existing REDCap Features Calendar Scheduling tool Online Graphical Form designer Multiple data types supported Built-in data validation for special text fields (phone, email, SSN, numeric, …etc.) Branching Logic to conditionally show/hide fields Calculation Fields Configurable user permission levels Record Locking User grouping for multi-site data access restrictions Double Data Entry support Report Builder Graphical data viewing tool Simple data Import / Export mechanism Data quality query system for checking data integrity API interface for integration with other data systems. Detailed logging routines for monitoring data creation, modification, deletion and viewing. Integrated software instructions, FAQ, video tutorials. Curated Shared Forms Library Treatment Randomization Module

8. New Features Projects – Templates – Expanded Automated Design Change Approvals in Production Mode – Project Deletion-30 Day delay option – Record Status Dashboard – Data entry trigger Surveys – Multiple Surveys Per project – Survey Email Scheduler – Response Driven Survey – Participant Email Field

9. Project Templates Create new project based on existing templates REDCap Administrator can create templates as requested. Templates open for general use by all users with project creation rights.

10. Templates

11. Several default templates will be available immediately. Projects can be modified once created.

12. Expanded Automated Design Change Approvals in Production Mode Data field changes will only be considered critical if – Data has already be entered into the field for the project – Multiple choice fields, changes to options that have not been selected in the project will no longer be flagged as critical. – Built in email tool for requesting change verification.

13. Project Deletion-30 Day delay option Deleted projects may now be restored at any time within 30 days of their "deletion". Immediate deletion available via REDCap Administrator request

14. Record Status Dashboard

16. Data Entry Trigger Automated HTTP Post to URL Address – Form Submitted Trigger – Record ID | Form | Event |Form Completed Status – Not Activated by Data import – Remote system must determine appropriate response to data trigger

17. Data Entry Trigger Remote System REDCap Server Data Entry Data Trigger URL Actions Pre-determined Notifications… Rule based Query Project for Condition (API) Actions Pre-determined Notifications… Rule based Query Project for Condition (API) Data trigger event occurs on every form submission

18. REDCap Surveys

19. Multiple Surveys Projects First Form must be enabled as Survey – Anonymous Survey – Participant Invitation List Follow Up Surveys – Existing Record – Participant List or Designated Email address Field

20. Multiple Surveys Projects Survey Server Event 1-First Form Anonymous Link Participant List Invitation Creates Participant Record Follow Up Surveys Designated Email Field Participant List Email Address Adds Data to Existing Record Multiple Surveys Per Event Asynchronous Requests Scheduled Email Logic Trigger Data Event Schedule Unique Survey URL

21. Online Designer Changes Enable instrument as survey Survey instructions and Acknowledgements. Automated invitation conditions – Event specific

22. Automated Survey Invitation Conditions

23. Survey Participant Management New survey activity log view page – Date Time invitation was sent – Survey/Event – Response Status – Invitation Status

24. Survey Participant Email Use designated field to capture/enter email address for future survey invitations Participant List email address supersedes email field Enable in Project Setup Survey not the First Instrument of the Project. – Participant List cannot only be used – Participant record must exist

25. FEATURE CHANGES Creating a REDCap project

26. Alternate “From” Email Address Add up to 2 alternate email address. Primary email address used by REDCap for alerts and notifications

27. Logic Restrictions Tighter logic and F(x) restrictions – Branching Logic – Calculated Fields – Data Queries Barred use of Javascript Libraries – Only Built-in REDCap Functions may be used Legacy queries exempt unless security issue detected Rules apply to New or Updated equations Why??? – More secure and easier to debug equation errors.

28. GETTING STARTED Creating a REDCap project

29. Getting Started Create Project (On Production Server) – Select Usage – Cross-sectional or longitudinal – Options: Scheduling, Existing Template Create Forms – Online designer to graphically create forms – Spreadsheet template for advance and large form changes – Forms per event designations User Rights – Data access, Import/Export Rights, Data Access Groups – Form level access Tests forms (Thorough testing will help avoid deployment delays) Move to Production “Status” Start Collecting Data.

30. Project Creation Flow Chart Create Project –Project Name, Longitudinal or Cross-Sectional/ Survey Excel Spreadsheet Or Online Form Designer Data Entry Forms Add Users and Set User Rights Test Forms Move to Production Status and start Data Collection Define Study Events (Longitudinal) add Schedule (optional)

31. “?!!?” User Rights Branching Logic Scheduling API Data Dictionary Data Validation

32. REDCap Lifelines Built-in tutorial videos Built-in Frequently Asked Question (FAQ) guide Demonstration Databases (Some Online, more to come, on demand) WUSM Biostat REDCap Email Help Queue – [redcap@rt.biostat.wustl.edu] – Monitored by 4 to 5 Administrators

33. REDCap Email Support redcap@rt.biostat.wustl.edu

34. REDCap Goals Easy to use Metadata Driven Adaptable Features Data entry validation Self service tool Questions?

35. Acknowledgements Phil Miller – Director of ………many……many…things…………… – ……………………, and the WUSM REDCap Installation REDCap Administrators – Jack Baty[redcap@rt.biostat.wustl.edu] – Yu Tao[redcap@rt.biostat.wustl.edu] – Ningying Wu [redcap@rt.biostat.wustl.edu]