04 Aug CRES Event: Think Like an Auditor
THINK LIKE AN AUDITOR: CONSTRUCTIVE RESPONSES TO REAL STUDY PROBLEMS
Do you feel confident when you consider how an audit of your research study might unfold?
In this quarter’s CRES event, Mandy Morneault, ITHS’ Manager of Regulatory Knowledge and Training, will describe the goals and common triggers of creating quality systems to assure data integrity and regulatory compliance. Attending this event will help to:
- Learn a framework to turn problems into audit-proof processes
- Explore real case studies that illustrate the framework
- Strategize a quality assurance plan for a case
- Learn from other groups as they share back their case and plans
This event is applicable to Research Coordinators at all levels who work in a clinical research environment. The case study topics will include applicability of regulatory policy, protocol adherence, consent issues, confidentiality and data integrity, falsification of data, loss of records and adverse event reporting. For those joining via webcast, a handout of the quality assurance framework and sample case studies will be provided to facilitate conversations at your own site.
A version of this event was presented at the ITHS Networking to Enhance Development Conference in May 2015. If you were not able to attend, or want to experience it again, please plan to join us on September 24 at Fred Hutch.