Identification: 120
Credits: None available.
With site evaluation visits, the adage, “presentation is everything” rings resoundingly true and applies to far more than mere facilities and equipment. It extends far beyond investigational staff interest and experience. Site evaluation includes the fundamental first impression/ first contact element, a cornerstone from which the sponsors/cro/site relationship is formed. How a site presents capabilities means everything; how enthusiasm is demonstrated, how information is communicated and how abilities/logistics are translated will most definitely influence site selection decisions. Considering that the key to a successful site evaluation is how the site is showcased to demonstrate experience, equipment, and patient access, it is paramount that an appropriate site representative facilitates this process. The investigational site representatives present during the site evaluation visit must be knowledgeable, with an essential balance of the clinical and personable. Anyone with sufficient understanding of the investigational site can answer the essential questions regarding site infrastructure, site research policy and process, site personnel and experience, and site equipment, facilities and access to ancillary departments required to fulfill study expectations. The savvy researcher charged with execution of site evaluation visits must possess the innate ability to do more than merely answer questions, but bridge the communication gap with enthusiasm, knowledge, and finesse to make a positive impression on the sponsor and strengthen site selection. This presentation will define the traits that investigational site staff need to effectively conduct the site evaluation visit.
Identification: 175
Credits: None available.
Quality Control Visits are conducted at Investigator Sites to assess the overall quality of trial sites. They are assessments performed by trial managers overseeing study-related activities at a country level. Quality Control Visits are conducted with the goal of proactively identifying risks, support continuous improvement of procedures and processes, and prevent recurrence of ICH-GCP non-compliance issues. These visits are not classified as routine monitoring visits or audits conducted by Sponsors. The presentation will include how these visits went from in-person to being conducted remotely, what the challenges have been, what the benefits are, and the proactive approach to quality improvement.
Identification: 105
Credits: None available.
This session will be addressing the challenge many sites face with showcasing their site performance and maintaining their competitiveness. This is important for the audience because they will learn what metrics to keep for their site/department that will assist them in telling their story. The audience will walk away with an understanding of the importance for tracking metrics and what metrics to track.
Identification: 157
Credits: None available.
This session addresses ACRP core competencies in Ethical and Participant Safety Considerations. Many education opportunities surrounding the topic of informed consent only address one element: the informed consent form. While the informed consent form is important, this neglects to teach research personnel about the informed consent discussion. This education gap is impactful, as the informed consent process is one of the most important periods of a participant's participation in a trial. However, participants tend to not understand crucial elements of informed consent (Thanh Tam et al., 2015). It is crucial for informed consent educational opportunities to focus on both the informed consent form as well as the informed consent discussion. In this session the audience will learn about elements of the informed consent form and also use the "questions method" (asking who, what, when, where, why, and how) to improve their informed consent discussions and increase subject understanding. In addition, this session will also walk through tricky consent scenarios. The audience should walk away with knowledge of the required elements of the informed consent form as well as increased confidence on how to complete an informed consent discussion that maximizes participant understanding. REFERENCE: Tam, Nguyen Thanh, et al. “Participants’ Understanding of Informed Consent in Clinical Trials over Three Decades: Systematic Review and Meta-Analysis.” Bulletin of the World Health Organization, vol. 93, no. 3, 2015, doi:10.2471/blt.14.141390.
Identification: 113
Credits: None available.
The Buck Stops with the PI... or Does It? Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. What happens when a coordinator goes rogue and is guilty of misconduct? This session will explore the definition of misconduct in clinical trials and the possible consequences of CRC intentional misconduct, violation of GCP and research ethics. Actual cases will be presented delineating CRC sanctions and punishments. Reasons for committing fraud will be explored.
Identification: 5065
Credits: None available.
Have you ever laid in bed thinking about where clinical research will be in ten years and how your team will navigate the evolving landscape of challenges to get there? If you are ready to share your story and ideas on what we need to do to build bridges to get there, this session will be for you. Our speakers will share a brief perspective on some of the most pressing challenges facing our sites today and facilitate a series of roundtable discussions on what we can meaningfully do to address these challenges. Each table will then be able to share their key themes and learnings with the group. The challenges will span topics of:
Identification: 151
Credits: None available.
Actionable insights to elevate their performance in clinical trials on an ongoing basis. - The Site Health Check (SHC) is a report developed to deliver simple key performance metrics to sites and give them early insights to where action is needed. - By using organized visuals on data, the report supports and drives collaboration between the Sponsor and Site.
Identification: 174
Credits: None available.
Today's methods of capturing prospective data typically happens either within the electronic health record or on paper source documentation records. As Electronic Health Records (EHRs) evolve, there is an opportunity to change how prospective data is captured at the point of care and delivered to the clinical trial sponsors to ease the burden of these processes on both sites and sponsors. This session will focus on: (1) tips and tricks to capturing prospective data within the EHR, (2) considerations for sponsors when receiving prospective data directly from EHRs, and (3) an overview of a case study where mod data was captured and transferred.
Identification: 101
Credits: None available.
Pediatric Enrollment and Retention within a large multi-site long-term observational study presents numerous challenges including; equitable treatment of all sites, navigating frequent coordinator turnover to minimize effects on enrollment and particularly retention, and proactively addressing subject transitions when pediatric subjects relocate or transition to adult care to successfully retain them in the study. We will present lessons learned from a large on-going study currently in its 9th year. We will share identified best practices and tips we have created to encourage enrollment, transition checklists to address coordinator turnover, and retention methods we have employed. Within this we will discuss barriers to enrollment and retention and how we have overcome them.