Answer / phani

hardcoding is explicitly stating the value of a symbolic
object or variable in a program

hardcoding is a bad proctice bcoz of 2 reasons:
1) it over rides the database controls in the clinical data
management systems and the CFR 21 Part 11 controls may be
compromised.
2) data often change in a trial over time and the hadcode
that is written today may not be valid in the future.

Answer / saurabh gupta

It's a best practice not to hardcode values in code until
or unless it's not very necessary. Always try to use
dynamic variables in your code it will increase the
felxibility of the code.

Ex let say you have to run one of your code every year and
one of your condition needs a date which is begning of the
year and you hardcoded your value like this
%Let YBEG = '2007-01-01'

Then every year when you have to run this code you have to
change the date but if you use daynamic variable it will
resolve automatically.
ex YBEG = Y_BEG_0.

Answer / 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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