Healthcare Research Compliance Academy
Las Vegas, Nevada, United StatesAgenda
Monday |
|
Registration and Continental Breakfast (provided) | 7:30 – 8:00 am |
Welcome / Introduction | 8:00 – 8:15 am |
Research Compliance 101 • A high level overview of key research compliance issues • Human research protections, scientific misconduct, conflicts of interest, research billing, effort reporting, and more • Integration of research compliance into the corporate compliance program |
8:15 – 10:00 am |
Break | 10:00 – 10:15 am |
Healthcare Compliance 101 • An overview of general compliance topics focusing on the elements of an effective compliance program |
10:15 – 11:15 am |
Lunch (provided) | 11:15 am – 12:15 pm |
Human Research Protections • Overview of Federal Regulations governing investigators, institutions, IRBs |
12:15 – 1:45 pm |
Break | 1:45 – 2:00 pm |
FDA-Regulated Research • Guidelines for determining whether research is regulated by FDA and, if so, by which component |
2:00 – 3:30 pm |
Break | 3:30 - 3:45 pm |
Conflicts of Interest • Identifying a potential conflict of interest that may introduce bias into the design, conduct, or reporting of research |
3:45 - 5:00 pm |
Tuesday |
|
Continental Breakfast (provided) | 8:00 - 8:30 am |
Scientific Misconduct • Introduction to concepts of Research Misconduct: What it is and what it isn’t |
8:30 – 9:45 am |
Break | 9:45 – 10:00 am |
Certified in Healthcare Research Compliance (CHRC)® Exam Information | 10:00 – 10:15 am |
Research Billing • In-depth review of rules for billing payors for clinical research services |
10:15 am – 12:00 pm |
Lunch (provided) | 12:00 – 1:00 pm |
Research Billing (Continued) • Review the impact of budgets and clinical trial agreements on billing compliance |
1:00 – 2:00 pm |
Break | 2:00 – 2:15 pm |
Animal Research • Overview of the main regulators/regulations in the animal research arena |
2:15 – 3:30 pm |
Break | 3:30 – 3:45 pm |
Research Documentation and GCP • Understand what is the research record |
3:45 – 5:00 pm |
Networking Event (optional) | 5:30 pm |
Wednesday |
|
Continental Breakfast (provided) | 8:00 – 8:30 am |
Conducting a Research Risk Assessment • What is a risk and what does it mean to assess it? |
8:30 – 10:00 am |
Break | 10:00 – 10:15 am |
Auditing and Monitoring • Key elements of a successful healthcare research auditing and monitoring plan |
10:15 – 11:30 am |
Lunch (provided) | 11:30 am – 12:30 pm |
Grants Management • Discuss the basic requirements for grants management |
12:30 – 1:45 pm |
Break | 1:45 – 2:00 pm |
Data and Safety Monitoring Issues • Understand the criteria for establishment of a Data Monitoring Committee (aka DSMB) |
2:00 – 3:15 pm |
Break | 3:15 – 3:30 pm |
Research Compliance Hot Topics & Watch List • Important research compliance issues and trends not otherwise covered in the Academy |
3:30 – 5:00 pm |
Thursday |
|
Continental Breakfast (provided) | 8:00 – 8:30 am |
Conducting an Internal Research Investigation • Being prepared is a key to conducting a good investigation |
8:30 – 10:00 am |
Break | 10:00 – 10:15 am |
Privacy and Security Issues in Research • Overview of the basics of privacy and security in research |
10:15 – 11:45 am |
Academy Ends | 11:45 am |
CHRC Exam Check-In Time | 12:45 pm |
Exam Time — Certified in Healthcare Research Compliance (CHRC)® (optional) The CHRC exam is optional. You must apply and pay for the exam separately from the Academy. To apply online, visit: hcca-info.org/Certification/ApplyforCCBCertification.aspx. PLEASE NOTE: If you are not present at the specified "Exam Check-in Time" as listed above, and as determined by the exam proctor, you will not be allowed to sit for the exam. Actual exam duration is 120 minutes, per the Candidate Handbook. The time range, listed at left, includes mandatory exam procedures and proctor instructions. |
1:00 – 4:00 pm |