Selection of Trial Sites

As data obtained from clinical trials will facilitate the use of new medical products in an evidence-based manner, the credibility of such data is very important. The site of the clinical trial must enable researchers to obtain high-quality results and monitor subjects adequately.

Over the years, site selection has been increasingly influenced by numerous factors such as the economic and social climate of the chosen country. This course teaches participants the basics of site selection for clinical trials. You will also learn how to bring a substandard site to a standard level where accurate results can be obtained and proper documentation and archiving ensured.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

• Setting Up of the Clinical Site

Lesson 1: Considerations for Successful Site Selection

• Patient Enrollment Capabilities
• Staff Qualification
• Commitment
• Competition
• Facilities and Equipment
• Geographical Location
• Cost

Lesson 2: Site-Selection Strategies

• Think About the Patient Recruitment Approach Before Site Selection
• Locate Sites That Have Conducted Trials in Your Condition Area Before
• Find Sites That Use Up-To-Date Technology
• Experienced Staff
• Understanding Site Startup Cycle Times

Lesson 3: Site Selection – Identifying High Performing Clinical Sites

• Key Insights
• Site Feasibility
• Enrolment
• Site Selection
• Site Selection Questionnaires

Lesson 4: Effective Clinical Site Management

• Find the Technology for Clinical Site Management
• Look for Site-Focused Software
• Generate a Central Hub for Clinical Trial Site Management
• Conduct Remote Monitoring Visits
• Communicate Often With The FDA and Other Regulatory Bodies

Lesson 5: Challenges Associated with Site Selection for Clinical Trials

• Common Issue and Challenges
• Participant-Related Factors
• Contextual and Environmental Factors
• Research Related Factors
• Identify Clinical Barrier
• Common Site Selection Mistakes

Lesson 6: Improving Site Selection in Clinical Trials

• Improving Clinical Site Performance

Conclusion

Glossary