Compliance Program

Objective: The CHRISTUS Health Research Compliance Program is committed to advancing the highest standards of ethics, integrity and honesty, and to compliance with all applicable laws, regulations and policies governing research, privacy and conflict of interest. The Program strives to promote best practices and ethical behavior and to deter activity contrary to these standards by (a) anticipating risk, and (b) encouraging strong stewardship and management accountability at all levels, in collaboration with institutional colleagues responsible for compliance implementation.

CIIACC Research Compliance Policies (downloadable)

Auditing & Monitoring

Types of Audits

  • Routine: Routine audits involves randomly selecting studies from any of our ministries and reviewing them for compliance. This audit is Non-punitive, rather, it creates an interactive forum to help refine our processes.
  • For Cause: For-cause audits are not a routine compliance review and are usually triggered by the following events:
    • Participant Complaint
    • Whistleblower
    • IRB request due to new information that might affect the rights and welfare of research subjects
  • Directives: This is when the IRB or Institutional Official feels that there is a need to probe further to determine if a particular trend found at a site or with a specific study necessitates an audit.

Audit Process

  1. Send out Intent to Audit Letter
  2. Collect documents from site
  3. Conduct Audit
  4. Review Initial Audit findings with site (This step is to give sites an opportunity to clarify any issue and ask questions)
  5. Conduct final audit review with site
  6. Send post audit letter to site
  7. Follow-Up with corrective action if necessary

Writing an Effective Corrective Action Plan

Contact Us

P. Everage Headshot

IRB Director

Phyllis Everage, CIM
Phyllis.Everage@christushealth.org
(469) 282-2671

P Ratti headshot

Institutional Official

Pukar Ratti, MSChE, MSHCM, CIM, CCRP, FACMPE
Pukar.Ratti@christushealth.org
(469) 282-2220