Kendle Implementation of CDASH - PhUSE Wiki

Kendle Specification Examples• Conditional Rule– CMENDTC: Yes - if CMONGO is NULL• Comment– AETOXGR: Either AESEV or AETOXGR must appear on the CRF. Some studiesmay mandate the collection of both.Note: Completion of CTCAE grade is a mandatory field for cancer studies. In allother types of studies this is an optional field.– AEREL: It may be necessary to collect Relationship Type (e.g. Study TreatmentOnly, Device Only, Both Study Treatment and Device, or other types). If so, thevariable AERELTP should be included on the CRF, with a codelist of AERELTP13N N o o r r t t h h A A m e e r r i i c c a a •• E u r r o p e • A s i a / P a c i f i c • L a t t i i n A m e e r r i i c c a a • • A A f f r r i c i c a a