In the mutli-site cinical studies, it is quite common that one or more sites in several coutnries become high enrollers. These sites require more attention and support from the clinical research team (CRA, PM, Regulatory, Medical Monitoirs). If the clinical study was organized and managed at theses sites as required by the protocol, REB, regulatory authorities and ICH/GCP - these sites generate large amounts of valid, verifiable data - which is so important for sponsors and for future patients. If however, amount of attention ans support to the high-enrolling sites is not adequate - these sites often deviate from the protocol, study guidelines and even ICG/GCP. In this presentation we will review most common errors made by the sites' staff, and the sponsor's representatives. We will also review successful strategies that allowed high enrolling sites become high quality standards sites and be able to pass various inspections and audits.
Description of the topic:
Managing high enrolling sites - from a perspective of a lead CRA who has several years experience of managing high enrolling sites on different protocols.
Areas Covered in the Session:
- Definition of a high-enrolling site
- Types of high-enrolling sites
- Most common problems encountered at high enrolling sites
- Case review
- Strategies implemented to ensure the high enrolling sites remain compliant and involved
-Importance of properlty managing high enrolling sites.
Who will benefit:
Clinical research Manager
Clinical research Associates
Quality Assurance professionals
Alex Aptovcov MD, MBA & CCRP Consultant based in Ontario, Canada. Alex holds the degrees of Doctor of Medicine from the National Medical University, Kiev, Ukraine and Masters of Busines Administration, Victoria, British Columbia, Canada. Alex has more than fifteen years of clinical research experience - as sub-Investigator in Ukraine, Patient Recruitment Consultant in New York and as Clinical Research Consultant (Canada, USA). For the last five years, Alex has worked on complex studies with a number of high enrolling sites
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