Transcript REDCap Training - Pennsylvania State University

REDCap Introduction
Your gateway to compliant data management.
Presented by:
Terri Shkuda
Research Informatics
Information Technology Department
What is REDCap?
REDCap is a secure web-based
application that supports data capture and
management for research studies.
 Users will be able to quickly and
intuitively build and manage research data
forms and surveys.
 It is an electronic Case Report Form
(eCRF) that is compliant with Penn State
Hershey policies.

9/24/13
2
The REDCap Story…
REDCap was initially developed at
Vanderbilt University, through a CTSA
grant and now has collaborative support
from a wide consortium of over 700
domestic and international partners who
actively serve to contribute, prioritize,
test and support the application.
 REDCap has been made available at no
charge to institutional partners.

9/24/13
3
Features











Create forms for data entry and surveys
Enter data with workflow for managing the
project
Surveys delivered to participants electronically
Reuse of forms for multiple events/arms
Data export to common statistical packages with
de-identification tools
Data import from Excel
Record locking and e-signatures
Real time quality rule checks and post collection
data query resolution
Double Data Entry for data quality improvement
Access for multi-site studies
Full audit trail
9/24/13
4
Form Development
9/24/13
5
Field Types and Validation
Define Field Type
Determine validation
9/24/13
6
Data Entry
9/24/13
7
Reporting & Exporting Data
•
Exports to most common statistical packages
• De-identification Options
o Automatic removal of pre-specified identifiers
o Date Shifting
o Automatic removal of text and note fields
• Develop quick reports for quality control
9/24/13
8
Security & Integrity




Audit logs
Role-based user rights
Annual Risk Analyses
Developed Standard Operating Procedures for:
◦
◦
◦
◦



Training
Access
Risk Management
Test Plans
Regularly scheduled network security scans
Data stored in the Data Center and backed up nightly
Currently working on a system validation to ensure
that REDCap is 21 CFR Part 11 capable for those
studies that wish to be compliant.
9/24/13
9
REDCap Advisory Group
The REDCap Advisory Group is an multidisciplinary team
who meets monthly to decide on acceptable uses,
processes, delivery, data safety and security issues.
Members:
 Phil Canakis – Research Informatics
 Liz Galgocy – Research QA
 John Graybeal – Neuroscience Institute
 Rebecca Jenkins - CTSI
 Terry Novchich – non-cancer CTO office
 Bill Pogash – Research QA
 Rosanne Pogash – PHS Data Management
 Jim Robertson – Research Informatics
 Terri Shkuda – Research Informatics
 with support from Matt Solovey for initial marketing.
9/24/13
10
Collaboration & Support

REDCap Consortium (>700 institutions)
REDCap
Consortium
REDCap
Liaisons
REDCap
REDCap
Admin
Admin
Informatics
Core Tools
REDCap
Advisory
Group
Researcher
Electronic
Data
Warehouse
CTSI
REDCap
User Group
9/24/13
11
Training
Training is required for access to REDCap and
to be compliant with 21 CFR Part 11.

REDCap Introductory Session
◦ Offered biweekly at HMC and monthly at UP
(video conferencing is available)
◦ Required for at least one project member

Vanderbilt tutorials
◦ Available free on web (www.project-redcap.org)
◦ Excellent step-by-step instructions through all
modules

Peer Training
9/24/13
12
More information
Visit our website at ctsi.psu.edu and click
on REDCap.
 Vanderbilt University’s website for
REDCap www.project-redcap.org
 For further information, contact:
[email protected].

Questions…
9/24/13
13