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NIS Essentials for Investigators – narrated and read-only tracks, suitable for both inexperienced and experienced investigators and their teams (takes approx. 25 mins).
Fantastic rates available for groups of 5 or more participants
This training provides an understanding of the general obligations of researchers when undertaking non-interventional studies.
• Personalized – the participant is addressed by their first name.
• Users can choose between a narrated or read-only (no sound) track.
• The training is divided into key sections, each with interactions.
• A short test at the end of the training consolidates knowledge.
• The course can be set up to have a pass or simply certification for completion.
• Content is based on Good Pharmacoepidemiology requirements, Declaration of Helsinki, data protection principles.
• Definition of non-interventional
• Types of study
• Key factors affecting NIS
• Ethics and consent
• Heath authority approval
• Data privacy
• Protocol and its content
• Current medical practice
• Safety data collection
• Study contracts
• Data access
• Study reports
• Publication of results
• Glossary of terms and abbreviations
• Short quiz