In this example, a CRF module occurring at several visits asks whether or not nausea, vomiting, or diarrhea occurred.
The responses to the probing questions (Yes, No, or Not done) will be represented in the Findings About (FA) domain [see Section 6.4 - FA Domain].
If “Yes ” the investigator is instructed to complete the Adverse Event CRF.
In the Adverse Events dataset, data on AEs solicited by means of pre-specified on the CRF will have an AEPRESP value of Y.
For AEs solicited by a general question, AEPRESP will be null.
RELREC may be used to relate AE records with FA records.