Monitoring/ Monitoring Effectiveness

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2022 Agenda

Friday, September 16, 2022 at 11:00 am to 11:45 am ET                                                          Track: Monitoring / Monitoring Effectiveness

Best Research Practices (GCP, GDP, ALCOA-C): Tips, Tricks and Tools From a Monitoring Perspective

Research is a complicated endeavor with a steep learning curve for new staff. This need for accelerated knowledge, coupled with a high clinical research staff turnover rate, necessitates the importance of training and guidance on how to conduct clinical trials. The most basic and important tool in a new research staff employee’s toolbox is research recordkeeping, the foundation on which research is built.

Good Clinical Practice (GCP), Good Documentation Practice (GDocP), and ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, Complete) principles are fundamental to data integrity and reliability and are essential to ensuring the safety, efficacy, and quality of drugs/ devices, and the ability to protect subjects and their data.

Information contained in this presentation will cover the basics of good recordkeeping practices, as well as more advanced tips, tricks and tools, to provide new and experienced research staff with information that will help them pass any inspection, whether by monitors, auditors, or the FDA. 519
Presenter: Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS, Interim Director, Clinical Research Monitoring Unit Manager, UAMS Office of Research Regulatory Affairs

Friday, September 16, 2022 at 11:50 am to 12:35 am ET                                                         Track: Monitoring / Monitoring Effectiveness

The Crucial Skills That CRAs Are Missing

In the heavily regulated world of clinical research, CRAs are getting all the needed training in hard skills that they need to understand their role, but that's about it. What is missing is training in soft skills that will help them deal with the demands of the job, increase each CRA's job satisfaction, and reduce churn, all the while allowing CRAs to have a healthy work/life balance. Examples of crucial soft skills include assertiveness, communication, listening, and task efficiency. Ms. Finlayson will present two pictures of a CRA's life; one without these crucial soft skills, and one with soft skills training. This will encourage the audience to understand why it is time to pay attention to soft skills and offer CRAs the appropriate soft skills training along with all the hard skills training available at present. 521
Presenter: Agnieszka Finlayson, MSc, MA, Founder and Director, White Wisteria Academy