1. Development, Testing and Audit Findings of an eConsent Process in REDCap
Stephanie Oppenheimer, MS
SUCCESS Center
Erica Ellington, CRA, CHRC
University Compliance
SCTR Lunch ‘n’ Learn
May 23, 2017

2. What did the stakeholders request?
The process should be able to………….
retain flexibility of the Word version, i.e. its role in the application process
retain consent approval process workflow
mitigate potential audit findings
allow for version control

3. How do you access the template?
Create a Project Page

4. What are the features?
Project Setup Page

5. What are the features?
Project Setup Page

6. What are the features?
Online Designer Page

7. Participant Information Form
What are the features?
Participant Information Form

8. Consent Form – Section 1: The Document
What are the features?
Consent Form – Section 1: The Document

9. Consent Form – Section 2: Participant Signature
What are the features?
Consent Form – Section 2: Participant Signature

10. Consent Form – Section 3: Consenter Signature
What are the features?
Consent Form – Section 3: Consenter Signature

11. Consent Form – Section 4: Pro# Statement
What are the features?
Consent Form – Section 4: Pro# Statement
Adds the study Pro# to the signature page
Helps with data collection

12. How does it work? Create the record
Enter data to set up the documents for this record

13. How does it work?

14. How does it work?

15. How does it work?

16. How does it work?

17. How does it work?

18. How does it work?

19. What if you amend the consent?
Export and save the consent report to secure location

20. What if you amend the consent?
Download the instruments w/ data (signed documents)
Save the file to a secure location

21. What if you amend the consent?
Archive the expired project (remove from active project list)
Create a new project
Append new project’s title with eIRB amendment tag

22. Acknowledgements SUCCESS Center Research
Stephanie Gentilin, MA, CCRA Matthew Carpenter, PhD
Amy Boatright, BS
Inst. Review Board Amy Wahlquist, MS
Stacey Goretzka, CIP
Compliance
Erica Ellington, CRA, CHRC

23. eConsent: A Compliance Perspective
SCTR Lunch and Learn
University Compliance Office
Erica Ellington, CRA, CHRC| |Phone:
May 23, 2017

24. eConsent Compliance So….
A compliance audit is intended to be constructive, service oriented process conducted for several positive reasons….
The large majority of studies selected for audit are random, however more effort is spent on new PI’s, investigator initiated, vulnerable populations and high enrolling studies.
Ultimate goal = to help improve the quality of human subjects research
So….
Try to think of us as
Partners not
Adversaries
To ensure full compliance with the laws, policies and standards governing human subjects research
To identify potential problem areas to be addressed
To educate on standards and expectations of research practices and promote Good Clinical Practices
This is our premise – that audits should be constructive. We’re trying to achieve several things….

25. eConsent Compliance These are the main components of every audit…..
Review of all Informed Consent Documents and HIPAA authorizations to verify subjects have been properly consented
Review of the Regulatory Binder for essential documents
Review of Individual Subject Data Records for protocol adherence, safety and confidentiality
Verification of data storage and security
Overall site operations
These are the main components of every audit…..

26. eConsent Compliance
65% of findings involve the consent document and/or HIPAA authorization
Audits 64
Subject Files Reviewed
3,270
Findings
2,077
830 consents
519 HIPAA Authorization

27. eConsent Compliance: Common Consent Process Findings
Dating errors
Incomplete dates (portion of the date missing)
Person obtaining consent (POC) writing in dates for subjects
Incomplete sections
Checked instead of initialed
Options left empty
Signatures
Person obtaining consent or subject did not sign the consent
Person obtaining consent and subject signature are reversed
Subject signs incorrect signature line
Incorrect versions of the consent used
Crossing out information or writing notes on the consent document
Photocopying signatures
Older version of HIPAA authorization (privacy notice not initialed)
These type of errors could lead to a loss of data!

28. eConsent Compliance: Audit Process
eConsent Audit
Reviewed each consent to ensure completion
21 Subjects
17 electronic (0% error rate)
4 paper (75% error rate)
Checked future contact section instead of initialing as instructed in the consent document
Reviewed audit logs

29. eConsent Compliance: Takeaways
Improves record retention (reduces the number of lost consents and HIPAA authorizations)
Documents are immediately and automatically saved to REDCap server upon completion
eConsent reduces the risk of informed consent noncompliance by providing better management and documentation of the consent process
When properly implemented the eConsent document can not be completed until required fields are completed
Provides audit trial

30. eConsent Compliance: Considerations
IRB Application Policy: eConsenting process must be included in the protocol and IRB application as part of the consenting process1

31. eConsent Compliance: Considerations
Set Up
Make sure study team has been appropriately trained on eConsent process
Make sure the correct version of the consent is being uploaded to REDCap (only approved system at this time)
When setting up eConsent use required fields ONLY
Use REDCap consult if you have questions about how to set up your eConsent
Follow SCTR Standard Operation Procedures when setting up eConsent
Test REDCap eConsent multiple times prior to use

32. eConsent Compliance: Considerations
Consenting Process
Policy: IRB approved study team member must be present when consenting subjects1
Ensure subject signature is legible
Policy: Provide subject with a signed copy of the consent/HIPAA authorization (paper or electronically)1,2
Document the consenting process
Document changes in the field comment log when study team accesses consent document
Double check eConsent database to ensure consent was properly saved to database prior to the end of encounter with subject
Save pdf versions of eConsent on a MUSC secure drive
1Policy: Informed Consent to Participate in Research Policy and Procedures (HRPP 6.1); 2 45 CFR Part 164

33. Questions?