Pre-Conference Workshops
Enhance your conference experience by attending a Pre-Conference Workshop*. Explore a single topic in-depth in a full-day or a half-day workshop.
Full-Day Pre-Conference Workshops
Friday, April 23
8:00 am - 5:00 pm
W002: Auditing Clinical Investigators
This course will describe the auditing process for conducting clinical investigator audits and inspections. Advanced auditing skills and techniques will be detailed in seven areas of proficiencies including: data techniques, observation skills, communication skills, interviewing skills, writing skills, legal expertise, and organizational skills.
Speaker(s): Deidra Poucher, RN, MSHS, CCRC; Tamera Smith, PhD, MT(ASCP)
Topic Area: Regulatory Compliance
Level: Advanced
W003: Best Practices in Clinical Study Project Management
Clinical research professionals frequently aspire to management as the next step in their career. Improving skills and knowledge in the role and responsibilities of both project and people management will support these goals. This session will provide practical knowledge in several of the key areas in clinical study project management.
Speaker(s): Laurie Halloran, BSN, MS, CCRA
Topic Area: Clinical Study Management and Delivery
Level: Intermediate
Half-Day Morning Pre-Conference Workshops
Friday, April 23
8:00 am - 12:00 pm
W007: How to Build Quality Into Your Site and Prepare for an Audit
This workshop will provide information on how to build quality into a clinical trials program. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with Good Clinical Practice expectations.
Speaker(s): Michael Hamrell, PhD, RAC
Topic Area: Regulatory Compliance
Level: Intermediate
W015: Facing the Ethical and Regulatory Challenges of Investigator Initiated Research
IIR studies require the investigator to assume the regulatory responsibilities of the investigator and the sponsor. Investigators may also have real or perceived conflicts of interest that must be managed to protect the integrity of the research and the welfare of patients and study participants. Successfully conducting an ethically and scientifically sound IIR study requires expertise in clinical research methodology, study management, and regulatory compliance throughout the research process.
Speaker(s): Ernest Prentice, PhD; Susan Odum, MEd, CCRC
Topic Area: Physician Investigator Issues
Level: Intermediate
W019: Data Manager and CRA Collaboration in an eClinical Environment - Working Together for Quality Data
This tutorial will be focused on things that the clinical research professional, from both the data management and clinical monitoring arena, can do together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked. Often times, these two groups do not collaborate as much or as often as they should, and as a result, practices are not employed which could lead to a reduction in “toe stepping,” data quality issues and, overall, a better and more productive working relationship.
Speaker(s): Jonathan Andrus, MS, CQA, CCDM
Topic Area: Clinical Study Management and Delivery
Level: Intermediate
Half-Day Afternoon Pre-Conference Workshops
Friday, April 23
1:00 pm - 5:00 pm
W009: Site Quality System Approach for Meeting Investigator Supervisory Responsibilities
Meeting FDA expectations of investigator supervisory responsibilities should be top of the list of research sites for audit readiness. This workshop presents study management that combines FDA requirements with a quality system approach to ensure drug/device site superior performance.
Speaker(s): Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP; SAM Sather, MS, BSN, CCRA, CCRC
Topic Area: Regulatory Compliance
Level: Advanced
W010: Responsible Conduct of Research with Human Subjects
Responsible conduct of research is the foundation for research. The federal regulations to protect human subjects are the minimal standards. The education and training of the principal investigators, research coordinators, monitors, and auditors in the responsible conduct of research knowledge ensures safe and effective clinical trial.
Speaker(s): Adil Shamoo, PhD; Ernest Prentice, PhD
Topic Area: Ethics
Level: Intermediate
*Please note there are additional registration fees for Two-Day ACRP Education Courses, Pre-Conference Workshops, and Post-Conference Workshops.