- 23/06/2020 - 1 Formulier, 16 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Administrative, Serious Adverse Event, Serious Adverse Event (SAE) - Section 1, Serious Adverse Event (SAE) - Section 2 (Seriousness), Serious Adverse Event (SAE) - Section 3 (Demography Data), Serious Adverse Event (SAE) - Section 4 (If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?), Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s)), Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions), Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors) , Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications) , Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s)), Was treatment blind broken at investigational site?, Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments), Serious Adverse Event (SAE) - Section 11 (Narrative Remarks) , Investigator’s signature, Serious Adverse Event (SAE) - Additional/ Follow-Up Information
- 17/07/2019 - 1 Formulier, 13 Itemgroepen, 51 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Relevance, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Serious Adverse Event, Evaluation, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature

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