Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding monitoring clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Describe the role of monitoring in clinical research
- Discuss the basic principles of Good Clinical Practice; International Conference on Harmonisation GCP guidance; Investigator’s responsibilities; Sponsor’s responsibilities; Monitor’s responsibilities; record retention; and basic requirements for conducting studies in Canada
- Describe the investigator recruitment process, identify key selection criteria, and discuss the conduct of a site selection visit
- Within the historical perspective of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, discuss the objectives of regulations pertaining to Institutional Review Boards and fi nancial disclosure
- Discuss regulatory requirements and ethical considerations involved in the informed consent process as well as the informed consent document
- Describe the activities involved in study initiation including budget and contract negotiation; planning and conducting investigator meetings; investigator selection; the conduct of study initiation visits; and preparing the site for study participation
- Assess the collection and evaluation of research data for completeness, compliance, and accuracy through periodic monitoring visits; discuss reporting and follow-up correspondence
- Compare and contrast the auditing and monitoring functions; describe the objectives of auditing; describe FDA inspections and how to prepare for them; review FDA warning letters
- Discuss mechanisms to implement and assure the quality of the processes and deliverables involved in clinical research
- Describe the essential elements of planning and preparing for and conducting a site closeout visit; site follow-up; and final documents for closure
- Describe site management techniques to manage expectations, facilitate site interactions, and improve subject recruitment and study conduct
- Discuss additional investigator responsibilities and monitoring of investigator-initiated studies