Subject_MedicalHistory data set

Data Series Title Description Location in Oracle Argus Safety
MedicalHistory_Name Condition, disease, or surgical procedure in the patient's medical history. Map to the user-entered verbatim or to the encoded MedDRA lower-level term. Case Form / Patient / Other Relevant History / Description
MedicalHistory_MedDRA Version Version of MedDRA used to code the medical history name if the medical history name is mapped to a lower-level term.

Note:

If MedicalHistory_Name is mapped to a text field entered by the user, do not map this field.
For items to be encoded in Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in the Oracle Argus Safety.
MedicalHistory_StartDateTime Start date of the condition, disease, or surgical procedure. Case Form / Patient / Other Relevant History / Start Date
MedicalHistory_Continuing Indicator Whether the patient still has the condition or disease (Yes, No, Unknown). Case Form / Patient / Other Relevant History / Ongoing
MedicalHistory_EndDateTime End date of the condition, disease, or surgical procedure. Case Form / Patient / Other Relevant History / Stop Date
MedicalHistory_Comment Description of the relevant medical history for the patient. Used when more structured information, such as dates and terms, is unknown. Case Form / Patient / Other Relevant History / Note