MCCRSCC Clinical Research Operations Reflection Discussion

Instructions: Write a 1-page reflection essay about what was learned in the Clinical Research Operations Class. Each paragraph should have a minimum of 5 sentences each. This doesn’t have to be in APA format as this is a relective essay.

Please see the following topics that were reviewed in the class:

Learning Objectives

By the end of this module, students will be able to:

• Refer to ICH guidelines and summarize GCPs for conducting clinical trials.
• Describe the site selection process including investigator and site qualification.
• Create a site feasibility checklist for site evaluation.
• Differentiate Responsibilities of the Sponsor and Investigator.
• Review Site Standard Operating Procedures (SOP)

Learning Objectives

By the end of this module, students will be able to:

• Describe the importance on industry contracts
• Identify and define the key components of clinical trial contracts
• Identify resources available to research professionals related to contracts

Learning Objectives

By the end of this module, students will be able to:

• Analyze a sample study budget to determine study feasibility
• Identify common study expenses
• Create a budget
• Negotiating effective clinical trial agreements and study budgets

Learning Objectives

By the end of this module, students will be able to:

• Define and describe proper recruiting methods
• Identify strategies to successfully retain study subjects.
• Describe industry best practices for recruitment and enrollment of study subjects.

Learning Objectives

By the end of this module, students will be able to:

• Summarize and explain the FDA monitoring requirements
• Describe risk-based monitoring and discuss when it is an appropriate monitoring tool
• Describe and apply strategies for successful sponsor-site interactions

Learning Objectives

By the end of this module, students will be able to:

• Identify study close-out requirements at the site-level