Avera Research Integrity Conference

Participant Registration Fee:

Avera Employees: $0
Non-Avera Participants: $0
Students: $0

AVERA EMPLOYEES:  Please help us be good stewards of Avera's financial resources by notifying us if you're unable to attend the event.  We kindly ask for cancellations at least 5 business days prior to the event at [email protected].

This conference will not be provided via videoconference.

1. Identify the importance of choosing courage over comfort
2. Define the three sequential processes required to hold an individual accountable for their actions within the research site environment.
3. Differentiate errors from deliberate noncompliance, falsification and fraud.
4. Recognize fraud, waste and abuse in clinical research settings and understand the options available to you to best protect yourself, the research, and your facility/company.
5. Evaluate Investigator and Research Coordinator competencies
6. Identify specific and unique ethical, regulatory and cultural aspects of conducting research with Native American Communities
7. Prepare for and what to anticipate during an FDA inspection
8. Discussion of hypothetical (but realistic) scenarios in which a researcher must make a difficult decision will help participants understand that not all situations are black and white. Participants will be better prepared to interpret “gray area” situations and apply best practices for research integrity.
9. Discuss ways for assessing and improving readability, while keeping the consent form comprehensive and informative. 
10. Select the right investigation methods and tools to identify root cause
11. Examine the impact of the most recent ICH Guidance regarding the approach to GCP audit applications.
12. Identify the benefits of mentoring and stages of the mentoring process.
13. Identify how mentees can contribute to the process and reap the greatest benefit from a mentoring exchange.
14. Discuss challenges faced by both small companies and academic settings with participants.
15. Introduce and review the objectives and process undertaken in creating a study assessment and start-up training program at Mayo Clinic to help minimize competency gaps.
16. Identify the critical steps of developing a CAPA plan.
17. Identify security risks associated with research data
18. Select appropriate security measures for data protection
19. Describe the importance of mentor training in the biomedical research enterprise.
20. Describe the resources available to provide mentor training

1. see above

Avera is accredited by the Accreditation Council for Continuing Medical Education to provide continuing education for physicians. Avera designates this educational activity for a maximum of 8.00 AMA PRA Category 1 Credit per session. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Avera is an Approved Provider of continuing nursing education by the Alabama State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. A total 8.00 contact hours can be received upon completion of this activity. Attendance at the entire educational activity is required to receive contact hours.

Friday, April 17, 2020