Keeping oversight of data management for Clinical Project Managers
About this course
Reasons to attend
This course provides you with the fundamentals of oversight of (outsourced) Clinical Data Management activities of a study if you are in a Clinical Operation or study management function.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- 1 webinar of 3 hours
Course Description
Clinical Data Management (CDM) is one of the Clinical Trial components that is frequently outsourced to CROs.Without a dedicated CDM function in your organisation, it is the responsibility of the Clinical Researcher (Clinical Project Manager, Study lead, Clinical Trial Physician, etc.) that CDM activities meet regulatory and operational requirements of a study and are properly described in Standard Operating Procedures (SOPs) and performance of oversight is documented in the Trial master File (TMF), such as :- Core documents (e.g., Case Report Forms, Data Management Plans)
- Systems used by Clinical Data Management (e.g., the Electronic Data Capture System)
- Relevant data capture and processing steps
Furthermore, oversight is an important element to ensure that you are receiving the relevant deliverables during study conduct and after database closure in a timely manner and according to the agreed quality requirements.
This course provides you with the fundamentals of CDM oversight. We will cover all relevant aspects of a study live-cycle. After this half-day course, you will have a clear picture for what to look at when working with a CDM provider and which documentation you should maintain in order to meet Sponsor oversight requirements when DM tasks are contracted out.
Programme highlight
- Vendor selection, qualification, and contracting from a CDM perspective
- Vendor governance and project management in CDM
- How standards in CDM can facilitate vendor oversight
- CDM documents – reviews and approvals
- Oversight of database development
- Oversight during study conduct – data quality oversight
- TMF content from a CDM perspective
- Understanding how risk management impacts CDM oversight
Learning objectives
- Get an understanding of Data Management specifics for vendor oversight
- Be able to define which processes should be in place and which documentation should be produced in order to be able to demonstrate oversight
- Helping you to integrate CDM oversight into your vendor oversight process
Who should attend
Clinical research professionals, including Leads of a Clinical Operation Function, Clinical Project Managers, Clinical Trial Physicians, and anyone involved with setting up and management of Clinical Data Management tasks that are outsourced to a CRO or vendor.
This course is not intended for Data Management specialists. An understanding of Data Management terminology and concepts as well as understanding Sponsor oversight requirements as defined in ICH-GCP is a prerequisite for this course.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (1)
- Study and Site Management (0)
- Data Management and Informatics (5)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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