The in- and exclusion criteria in a protocol specify the conditions under which a subject can be included or when he/she has to be excluded. Therefore, by definition, the screening must contain “measurements” that correspond to the in- and exclusion criteria. (This measurement can be anything, an age, gender, the answer to a certain questions, the score on a questionnaire, the result of a blood analysis, etc.)
The measurement will provide a result, and this result will be checked against the in- and exclusion criteria. In Promasys, the measurement is defined by the definition of the corresponding parameter. Thus, for each in- or exclusion criterion, you need at least one parameter which is used in screening.
During the study definition, you will define the parameters that are related to in- and exclusion criteria. These parameters can only do their work, if they are used in a validation rule. Only then can Promasys check the result of the related screening measurement and provide the answer whether or not a subject can be included.
For instance if you want to exclude subjects with a stomach ulcer, you first make a parameter to “measure” this. This could be a parameter called GI_Ulcer, of the yes-no datatype. Next you have to make sure that ther parameter is used during screening, by connecting it to a timepoint in the screening timetable.
The next step is to make a validation rule that makes use of this parameter. You want to make an exclusion for all subjects for who the result of the GI_Ulcer measurement is Yes. Go to module Study Definition, tab Validations.
Click Add, specify a rule name, e.g. GI_Ulcer, make it an Exclusion, and write a description. Then click the When button, click the Add button, select the Ex_GI_Ulcer parameter, Aggregate Every value, Opreator =, Value Yes, click Save, Done and Save.
Now you have completed the validation rule for the exclusion of subjects with a stomach ulcer, and Promasys will not allow subjects into the study if they have a Yes value for the GI_Ulcer measurement.
