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All observational plans, with two exceptions, contained information on the planned total study duration.
This has involved detailed image simulation work and efforts to produce a set of observational plans to tackle specific scientific questions.
Through this study, we conclude that ecosystem modeling is a powerful tool to help design future iron-enrichment experiments and observational plans.
The quality of the observational plans was rated using a specially developed scoring system.
Our results only show the findings based on variables for which information was provided in the observational plans.
This study evaluated the quality of NIS by analyzing the content and quality of their respective observational plans.
Similar(47)
The legal basis for such notifications did not include the obligation to also submit the observational plan.
Since then, pharmaceutical entrepreneurs are also obliged to submit the observational plan together with the notification of a NIS [ 27].
An NIS could only be scored if data on a score item was presented in the observational plan.
Furthermore, they contain advice on quality management, content and function of the observational plan, analysis of the results and reimbursement of the participating HCP [ 21].
A medical condition in the observational plan was specified in 93%% of NIS protocols which complied with the marketing authorization conditions specified by the SmPC in all instances.
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