Keeping oversight of data management for Clinical Project Managers
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|23/10/2023||Keeping oversight of data management for Clinical Project Managers||Webinar||EUR 425.00||Book|
|If you would like to have this course as an in-house session click here|
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.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
- 1 webinar of 3 hours
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.
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