Key points

What is ? REDCap (Remote Electronic Data Capture) is a secure, web-based application for building and managing surveys and databases online. Developed by Vanderbilt University, used by multiple institutions world-wide Each institution installs and can customise its own instance of REDCap

Why ? Feedback from other sites currently using: Data entry screens are easy to navigate Saves time! More room to report text fields Text is always legible No scanning, emailing or faxing forms in initial submission or query corrections. More self checks which will hugely reduce queries. Easier for sites, SCC and ICC.

eCRFs and Worksheets Data collection is via eCRFs using REDCap Each eCRF has a corresponding worksheet that may be used as a tool to help complete the eCRFs Screening Worksheet Screening eCRF

Accessing REDCap (1) Access REDCap from the Member Area of the INSIGHT website redcap.ccbr.umn.edu Go here Click here

Accessing REDCap (2) FLU-IVIG has its own instance (copy) of REDCap that must be used for this study Click here

Note different graphic from other REDCap Accessing REDCap (3) Log in with your secure REDCap password Note different graphic from other REDCap

Accessing REDCap (4) Click on “My Projects” Click on “FLU-IVIG”

Adding a new patient Sites don’t create new PIDs. SDMC pre-load these to REDCap

The Record Status Dashboard

What do the different colored radio buttons mean? Status/Color REDCap calls it… For INSIGHT it means… Clear/blank   Default status – the form has never been opened for the PID selected Red Incomplete The form for the PID has been opened - there may or may not be data in the form Yellow Unverified Can be used to indicate data has been entered and needs to be reviewed Green Complete Instrument has been completed by the site and submitted to the SDMC

How to set the form status (colour): At the bottom of each form, you will see: “Unverified” (yellow) is a good choice for a form you have started entering but that still needs something. If you save a form without changing its status, it keeps the status most recently set. Changing the status to “Complete” and saving the CRF submits it to the SDMC.

Choosing a form using the sidebar Major forms in UPPER CASE (capital letters) Additional forms associated with the major form are in mixed case (capital and small letters) Forms for events that may occur multiple times

REDCap is limited in its ability to specify formatting for text fields: It cannot restrict these fields to a small number of characters (i.e. to 3 letters) It cannot force entry of upper-case letters or convert lower- to upper-case Note that REDCap text fields are case-sensitive: aaa ≠ AAA, and REDCap will identify these as not matching when it checks the 3-letter code across forms.

NOTE: Saving does not submit a eCRF to the SDMC NOTE: Saving does not submit a eCRF to the SDMC! You must change a CRF/section’s status to “Complete” and then save it to submit it.

Using the Lock/Unlock button:

Use the mouse to move around in a eCRF If you use the <enter/return> key while you are entering data: The CRF/section is saved You are taken to the “home page” for that CRF/section. The <tab> key may also function in unexpected ways in REDCap. For these reasons, it is best to use the mouse to move between fields. Stay away from the <enter/return> key. The <tab> key may do things like skip fields, so use with care!

Send a message to the SDMC: If you need to “write a note in the margin of the CRF” to explain why a value is missing or odd (and so likely to generate a query), you can do so in REDCap: - Be specific about section & item number. - State why items missing or unexpected There is a box at the top of each CRF that you can use for this

Queries in REDCap Can occur at 2 points: When you complete a field and move to the next one Data in the wrong format Data out of range Lead-in and follow-on item mismatch When you save a record Required items missing Other data quality edits

Data formats Dates can be typed in, but you must use the English 3-letter abbreviation for the month. You can also click on the calendar button to select a date

Data out of range If the value entered is correct: click on the “X” to stop the range check from running again on this item. You will not be queried again on this out-of-range value in REDCap or in the queries on the website If the value entered is incorrect: click on “Close,” enter the correct value, and continue completing the CRF.

If you miss a required item.. Click OKAY or ‘X’ to go back and complete missing item Clicking on either “Ignore…” button saves the record with the item missing. If you re-open the record and save again, the missing items check will run again and alert you to the missing items.

Submitting a CRF in REDCap: To submit a CRF to the SDMC, set its status to “Complete” and save it All sections of a form must be ‘complete’ before whole visit is sent to SDMC. (e.g., for FLU IVIG STUDY DAY 7, you would need to do this for 3 Sections, STUDY DAY 7, Safety labs- Day 7 and Symptoms- Day 7) The next day, any queries identified by the SDMC will be posted to the INSIGHT website as usual for your review & action. eCRFs for ALL study visits MUST be submitted to SDMC via REDCap within 3 days of the visit date.

Deleting a form in REDcap If you have submitted a REDCap form to the SDMC and wish to delete it: Change each data item to be blank Make sure the “Form Status” is “Complete” then save YOU MUST DO THIS FOR EVERY SECTION THAT MAKES UP A FORM (e.g., for FLU IVIG STUDY DAY 7, you would need to do this for 3 Sections, STUDY DAY 7, Safety labs- Day 7 and Symptoms- Day 7) The SDMC will then remove the form from the database, and reset “Form Status” to “Incomplete” for all instrument

Resources Use Training slides Chapter 3 of FLU-IVIG PIM REDCap training videos found under ‘training resources’ in REDCap Contact your SCC