Data Management Essentials for Clinical Project Managers
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| 14/11/2024 | Data Management Essentials for Clinical Project Managers | Brussels | EUR 975.00 | 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 fundamental Clinical Data Management concepts to allow you to successfully understand, setup, and oversee Data Management activities of a study 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
- This course has been granted PharmaTrain Recognition
Course schedule
Classroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions of 3.5 hours |
Course Description
Clinical Data Management is one of the Clinical Trial components the most often outsourced to CROs. As such the Clinical Researcher (Clinical project manager, Study lead, Clinical Trial Physician, etc.) must ensure that the (electronic) Case Report Forms design and the used Electronic Data Capture (EDC) System, and other relevant data captures and processing steps meet regulatory and technical requirements of your study and that you are receiving the relevant deliverables during study conduct and after database closure.In that role, you will have to understand the basics of Clinical Data Management terminology, and concepts to properly define and oversee the expected deliverables, e.g. database build and ongoing Data Management activities. Poorly defined tasks and responsibilities can lead to unexpected delays, budget overrun, make analysis, report writing, and submission of the data difficult, and can increase inspection risk.
This course provides you with the fundamentals of key Data Management terminology, processes, and deliverables, the associated regulations, and what you should consider when selecting a Data Management CRO or EDC System, and where you should pay attention in setting up contracts and defining timelines.
After this course you will have a clear picture of what to look at during vendor selection and contracting of a DM provider, where your involvement as a Clinical Project Manager or Sponsor is essential, and what e.g., DMP, eCRF, DB Lock, CDISC SDTM, Data Transfer and reconciliation, Data Cleaning means and understand which areas are critical from study conduct and also what is relevant from a Sponsor oversight perspective.
Programme highlight
- Understand what Clinical Data Management is and its role in clinical research
- Get an overview and understand the core of relevant regulations, guidelines and standards applicable in Clinical Data Management
- Clinical Data Management processes and activities, e.g., CRF design, Database design & implementation, Data Management Plan development, Data Cleaning, Data Transfers & reconciliation, database lock and transfer
- Other important processes: Use of eCOA systems, SAE reconciliation, protocol deviations from a DM perspective
- Principles of using electronic/computerised systems in a clinical study – system validation requirements.
- Risk Management and Sponsor Oversight from a Data Management Perspective
- Essentials about Data Management vendor selection and oversight - Have a clear picture of where and how you should be involved as a Sponsor
- Understand a Data Management budget
Learning objectives
- Be able to select a Clinical Data Management vendor and understand what is relevant to set up an outsourced study
- Understand and apply Data Management deliverables and relevant Sponsor / CRO interactions for your study
- Be clear about your Sponsor responsibilities for outsourced Data Management tasks
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. This course is not intended for Data Management specialists.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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