Choice question check

Check the value of a choice question.

Rule description: if injection site is "Other" for Study Vaccine Administration, issue a query.

Rule expression

if(getStringFromChoice(INJSITELOC)==='Other')
{
   return false;               //System sends query when return false condition is met
}
else
{
   return true;
}

Query Message: Potential Protocol Deviation: The Injection is not administered in a recomended muscle. Please reconcile or complete Protocol Deviation CRF.

Definitions

INJSITELOC: Corresponds to Injection Site choice question from the rule description.
getStringFromChoice( ): Convert the label of the seleceted choice from a drop-down, radio button or check box into a string or comma-separated value. Takes in the question item variable as parameter.

Return value

Boolean: Returns either true or false. System raises query when return false condition is met.

Usage tips

Use this only for choice question types.

Verification steps

Using a subject for testing, go to the given visit and form containing the iems to check, in this example the Injection site for study vaccine administration <INJSITELOC> .

Update the form item INJSITELOC as in the following table and verify the result is as listed:

Step	Result
a. Select `INJSITELOC` as 'Other'.	Query
b. Select `INJSITELOC` as any value other than 'Other'.	No query
c. Select `INJSITELOC` as 'Other'.	Query
d. Clear `INJSITELOC`.	No query
e. Select `INJSITELOC` as any value other than 'Other' and different to the one selected in step b.	No query

Note:

Repeat the above steps if the form is present in multiple visits.

Other examples

Example 4-4 If Stop Date is present, then Outcome must be Recovered/Resolved, Recovered/Resolved with Sequelae, or Fatal

if(stpdt!==null)
{
   if(getStringFromChoice(outcm).contains('Recovered/Resolved') || getStringFromChoice(outcm).contains('Recovered/Resolved with Sequelae') || getStringFromChoice(outcm).contains('Fatal'))
   {return true;}
   else{return false;}
}
else
{    return true;}

Query message:You have entered a Stop Date but the Outcome is not RECOVERED/RESOLVED, RECOVERED/RESOLVED WITH SEQUELAE, or FATAL. Please change the Outcome or remove the Stop Date.

Example 4-5 If Were Height and Weight collected? on VS form is No, issue a query

if (getStringFromChoice(VSYN)==='No')
{
    return false;
}
else
{
    return true;
}

Query message: Potential Protocol Deviation: Height and/or Weight was/were not assessed as schedule at Screening. Please reconcile or complete Protocol Deviation CRF.

Example 4-6 If Standard Toxicity Grade is Grade 4 or Grade 5, then Is AE Serious? must be Yes

if(getStringFromChoice(toxicity).contains('Grade 4') || getStringFromChoice(toxicity).contains(Grade 5'))
   {
      if(getStringFromChoice(aeser)==='Yes')
	  {return true;}
	  else{return false;}  
  }
else
{    return true;}

Query message: Standard Toxicity Grade is selected as either Grade 4 or Grade 5. Please assess whether this AE meets seriousness criteria. If no, please confirm. If yes, please change Is AE serious? to Yes and report SAE.

Example 4-7 If Outcome is Fatal then the answer to Is AE Serious? must be Yes

if(getStringFromChoice(outcm).contains('Fatal'))
   {
      if(getStringFromChoice(aeser)==='Yes')
	  {return true;}
	  else{return false;}  
  }
else
{    return true;}

Query message: Outcome is FATAL, but Is AE Serious? is No. Please correct outcome or seriousness.

Example 4-8 If Hypersensitivity Reaction Term is Other then (Other) Specify must be completed

 if(getStringFromChoice(reacterm).contains('Other'))
   {
      if(othspec!==null)
	  {return true;}
	  else{return false;}  
  }
else
{    return true;}

Query message: Other is selected; however the (Other) Specify field is blank. Please correct or clarify.

Example 4-9 Fire Query if Pregnancy Test is Positive

if(getStringFromChoice(pregtest)==='Positive')
   {    
	 return false;
   }  
	else
	{
	 return true;
	}

Query message: Pregnancy Test Result is recorded as Positive. If this is correct, please report immediately to the Sponsor Safety Team.

Parent topic: Electronic Data Collection (EDC) examples