CRO Oversight
CRO Oversight
To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.
Course outline HERE
INTERACTIVE DEMO AVAILABLE BELOW
This is a topic that is important to all Sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product development. Sponsors outsource for many reasons, including but not limited to, meeting the temporary need for a large expanded workforce, additional and sometimes unique expertise, technology, and quality systems. To make these partnerships work, Sponsors must have systems in place to oversee the quality of the CRO’s work for the protection of study participants and also the reliability of the data. The training provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting. It also includes information about the global regulatory landscape regarding CRO management, primarily focusing on EMA, FDA, and ICH E6(R2).
Course Length: 60 minutes
INCLUDES:
Unlimited access to the content for 45 days from your initial day of purchase.
Case scenarios
Helpful resources
Certificate of completion
Knowledge Checks after each content area
Post assessment
LEARNING OBJECTIVES
Describe the Sponsor regulatory requirements for oversight of CROs.
Recognize key components for effective Sponsor CRO oversight.
Identify adequate CRO oversight procedures, oversight plans, and documentation management.
AUDIENCE
A foundation training applicable for all sponsor clinical team members and contractors. A customized course with therapeutic area specific scenarios can be developed for sponsors for in person or online workshops.
INTERACTIVE DEMO:
