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- 2019-03-11 - 1 Formulär, 6 Item-grupper, 55 Dataelement, 1 Språk
Item-grupper: Case data, Medical Department data, Diagnosis details, Procedure Details, PIA-Documentation of services, Modell project
- 2018-11-14 - 1 Formulär, 2 Item-grupper, 27 Dataelement, 1 Språk
Item-grupper: Form Header, Treatment Discontinuation
- 2018-04-18 - 1 Formulär, 16 Item-grupper, 60 Dataelement, 1 Språk
Item-grupper: Laboratory Reference Ranges, Laboratory Reference Range, Serious adverse event, Section 1, Section 2, Section 3 - Demography Data, Section 4, Section 5 - Causes of SAE, Section 6 – Relevant Medical Conditions, Section 7 - Other relevant risk factors, Section 8 – Relevant Concomitant Medications, Section 9 – Details of investigational product(s), Section 10 – Details of relevant assessments, Section 11 – Narrative remarks, Section 12 – SAE additional / follow-up information, Administrative data
- 2017-10-09 - 1 Formulär, 7 Item-grupper, 123 Dataelement, 1 Språk
Item-grupper: lnvestigational Product Run-in, lnvestigational Product Treatment Period 1, lnvestigational Product Treatment Period 2, Pharmacogenetic Research, Concomitant Medications, Non-Serious Adverse Events, Serious Adverse Event