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Appendix A. Null flavor specification

In PV, some form fields of ICSR support the null flavor selection per ICH E2B (R3) standard.

Code

Name

Definition

NI

No Information

No information whatsoever can be inferred from this exceptional value. This is the default and most general exceptional value.

MSK

Masked

There is information on the item available, but it has not been provided due to security, privacy, or other reasons. There could be an alternate mechanism for gaining access to this information.

Keep in mind that using this null flavor can be considered a breach of confidentiality, even though no detailed data is provided. Its primary purpose is for those circumstances where it is necessary to inform the receiver that the information does exist without providing any detail.

UNK

Unknown

A proper value is applicable, but not known.

NA

Not Applicable

No proper value is applicable in this context (for instance, the last menstrual period for a male).

ASKU

Asked But Unknown

Information was sought but not found (for instance, a patient was asked but did not know the answer).

NASK

Not Asked

This information was not sought (for instance, a patient was not asked).
In this section:

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An ICH standard of electronic transmission of individual case safety reports (ICSRs) data elements and message specification that must be incorporated according to ICH's Implementation Guide.