Hi All,
I've three different versions of the protocols in my study where one of the exclusion criteria test(IETEST) is slightly different in the text from other versions compared to the first version but it has the same testcds in all of the protocols. All other Exclusion criteria were exactly same except for the above one . So which exclusion criteria should be included in IE domain for IETEST. Will we include both tests(IETEST) with same IETESTCD or shall we consider the latest version of test(IETEST). Do we get any pinnacle error if we include both tests(IETEST) with same IE code (IETESTCD). Please provide your inputs. BElow is the data with IETEST with the different versions:
IETEST IETESTCD version
Has current illness other than renal disease EXCL2 1
or any other medical condition considered
by the investigator likely to interfere with
the subject compliance or the interpretation
of study assessments
IETEST IETESTCD version
Has medical condition considered EXCL2 2
by the investigator likely to interfere with
the subject compliance or the interpretation
of study assessments
IETEST IETESTCD version
Has medical condition considered EXCL2 4
by the investigator likely to interfere with
the subject compliance or the interpretation
of study assessments
Has per above data what version of protocol test(IETEST) will be included either 1 version or 4 version or both . please provide your inputs. thanks in Advance
IETEST IETESTCD VESRION
? EXCL2 ? ( 1 or 3) or both
