This two-day workshop is designed for Investigator Site Personnel who are involved in all aspects of clinical trials at the site level including study coordinators, research nurses, data managers, lab personnel, regulatory staff, quality assurance personnel, Sub-Investigators, and Principal Investigators.  Personnel who are new to research as well as experienced clinical staff will benefit from learning about the history of the drug development process and exploring the intricacies of conducting quality clinical trials at the site level.  Completion of this course will serve as evidence of a site’s commitment to ongoing training and continued quality process improvements, giving sites an advantage when competing for potential sponsors. 

Contract Research Organization (CRO) and sponsor staff who have not experienced research from a site perspective will benefit from taking this course to gain a hands-on understanding of site functions.

Learning Objectives

Knowledge gained from this workshop will give Investigators a competitive advantage as they present themselves as potential sites for sponsor studies.  Participants will become familiar with the processes required to conduct high-quality clinical research trials.  Furthermore, Investigators can use this course as ongoing training for experienced site staff, increasing the site’s preparedness for potential Industry Audits or Government Agency Inspections. 

This workshop will clearly identify the various roles and responsibilities of site staff, promote collaborative relationships between the sponsor/CRO and site staff, and will provide practical tips for new and experienced staff to ensure that all aspects of the clinical trial processes are done in accordance with Good Clinical Practices and in accordance with local laws and internationally recognized standards. 

This course will provide the attendees with an historical background to the drug development process in order to gain perspective on the existing patient protections that study subjects can rely upon today.  Participants will review protocol feasibility as well as recruitment and retention evaluations from a site perspective.  This will help attendees make determinations about whether or not to participate as a site on a particular study.  The mechanics of the entire clinical trial process will be discussed in detail, from initial exposure to a protocol through the study close out.  Special emphasis will be placed on ensuring quality data and inspection readiness at all times throughout the trial. 

Participants will improve their skills at collaboration and teamwork, both within the site and with   sponsor/CRO staff to ensure smooth conduct of a clinical trial and, above all else, maintain patient safety. 

The following issues will be discussed:

• Entities involved in clinical trials
• History of drug development
• Protocol feasibility
• Recruitment
• Patient safety and applicable laws, guidelines, and international standards
• Responsibilities prior to start up
• Responsibilities during the study
• Responsibilities after close out
• Preparation for audits and inspections

Participants will understand:

• How to explain the importance of clinical trials to potential participants
• How to determine whether or not a particular protocol is a “good fit” for his/her site
• The roles and responsibilities of a myriad of site personnel throughout the clinical trial process
• How to conduct quality clinical trials at his/her site
• How to protect patient rights and communicate patient responsibilities
• How to confidently consent patients onto a clinical trial
• Why it is important to follow applicable laws and comply with international standards of good clinical practice

With these tools, even experienced Investigators and site staff can be more confident that they are conducting studies with maximum efficiency in a manner that ensures patient safety, maintains data integrity, and fortifies partnerships with sponsors and CROs