Answer Posted / pnprasad

Hardcoding example:

data endstudy;
set endstudy;
if subjid = “xxxxxx” then
discterm = “Death”;
run;
it is known from non-database sources that at study
termination, subject
“xxxxxx” died.
With hardcoding there is no clear audit trail of data
change and CFR 21 – Part 11 controls might be considered
compromised.

Improved Hardcoding example;

data endstudy;
set endstudy;
**** HARDCODE APPROVED BY DR."nnn" AT SPONSOR ON 02/02/2008;
if subjid = “xxxxxx” and “&sysdate” <= “01MAY2005”d then
do;
discterm = "Death";
put “Subject “ subjid “hardcoded to termination reason”
discterm;
run;

For instance, there may be an upcoming data safety
and monitoring board (DSMB) or independent data monitoring
committee (IDMC)meeting where the clinical trial must be
monitored for safety information using the best
available data.

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