The differences between validated and non-validated import

Import functionality might need to be enabled by UMC. For assistance, contact UMC

Validated import

Requires that the ICSRs in the file capture some administrative and basic information, such as:

• Report type

• Reporter identifier

• Designation/Qualification of the reporter

• Patient identifier

• At least one reaction/event – MedDRA coded

• At least one suspect drug

Non-validated import

This option has no requirements for administrative and basic information to be captured in the ICSR.