Clinical research course
Data Management Essentials for Clinical Project Managers
Become familiar with the key words & terminology, the associated regulations and the processes used in Clinical Data Management.
Dates and booking
Choose your date.
No dates are scheduled right now. Join the waiting list below, ask us about the next session, or ask about an in-house course for your team.
Join the waiting list
Leave your details and we will email you as soon as new dates are published. No commitment.
Who it’s for
Is this course for you?
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.
What you’ll learn
About this course.
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.
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
Programme highlights
- 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
Your trainer
Your trainer.
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
Keep learning