Subject_SuspectDrug_ReactionRelatedness data set

Note:

If you want to send causality information from Oracle InForm to Oracle Argus Safety, you must map the SuspectDrug_AssessmentResult and SuspectDrug_ReactionID to items on the AE form. If this is a multiple drug study, you must also map the SuspectDrug_DrugName to items on the AE form.

All fields mapped in the Subject_SuspectDrug_ReactionRelatedness data set must be on the AE form. However, they do not all need to belong to the same itemset.

Data Series Title	Description	Location in Argus Safety
SuspectDrug_AssessmentSource	Source of assessment (for example, investigator). Note: The value of the item mapped to the SuspectDrug_ AssessmentSource data series for an adverse event that has been coded determines whether the reaction relatedness data for the adverse event specified in the SuspectDrug_ReactionID and SuspectDrug_MedicinalProductName data series appears as Determined Causality or Reported Causality in Argus Safety. PHARMACEUTICAL COMPANY—As Determined Any other value—As Reported	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_AssessmentMethod	Method of assessment (for example, global introspection).	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_AssessmentResult	Result of assessment (for example, related, possibly related).	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_ReactionID	MedDRA lower-level term (LLT) for the reaction that was assessed for relatedness to the drug.	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_Name	If the study contains multiple investigational products, you need to create an itemset for entering causality for the AE. It is best to use a codelist for the product name. Map this to the item in the itemset that collects the product name the site user is entering the causality (AssessmentResult) for. Note: If this item has a codelist attached, Oracle InForm Publisher always sends the code stored in the database for items with a codelist and not the label shown on the screen. Note: In order for the relatedness to come over correctly, the study designer should use the same codelist on all forms where the study drug name is entered. If the study designer chooses to have the end user enter free text for the Drug Name, the causality they intend may not be what is sent over to Oracle Argus Safety.	Case Form / Events / Assessments / Causality / As Reported, As Determined