Edit Checks

edit checks are validation rules that are associated with a data point the rules verify, confirm or authenticate data entered into the data point edit checks can also be used to verify the occurrence of an event and trigger an action, such as, displaying a query message the medidata rave edc system has extensive user programmable, edit check functionality value range checking cross checking values within a form and between forms global checks across all data internal programming language or direct import of c#, vbs, sql code value range checks question/rangechecks are used to test a collected value meets a simple set of criteria and are suitable for value = x ; value !=x x<= value <=y value = x, y, z ; value != x,y, z note a value range check only applies to the question (itemdef) it is attached to from the properties tab under range checks, click add specify the comparator for example, less than (lt), greater than (gt), equals (eq) select add and enter the data value (in, notin allows multiple data values) note this formal expression tab is not supported by rave select the error message tab set soft/hard soft checks allow the value to proceed hard checks do not allow the value to proceed enter the query message text click validate & update scroll down to the medidata rave properties and click add range check custom attributes group complete the following bypass during migration used to specify if the range check will be bypassed during crf migration defaults to “false” active used to specify if the range check is active defaults to “true” marking group used to specify the marking group for the query the options for marking group are configured in the master marking group property at asset group level require response used to specify if the query raised by the range check requires a response defaults to “false” require manual close used to specify if the query raised by the range check requires to be manually closed defaults to “false” when the als is exported, an edit check is created field edit checks field edit checks are the simplest type of edit check the following field edit checks can be configured for questions/fields auto query for required data entry auto query for non conformant data auto query for future date/time auto query for data out of range mark non conformant data out of range auto query for required data entry this edit check generates a query when the selected field is left blank and submitted by the user to set this property select the ‘mandatory’ checkbox next to the question in the section editor this populates the ‘isrequired’ column in the als fields tab to true note this property can also be set at field (itemref) level properties by selecting the ‘auto query for required data entry’ property auto query for non conformant data this edit check generates a query when the user enters data in a format other than what has been defined for the variable for example, if text is entered into a numeric field this property can be set at question level properties and field (itemref) level properties auto query for future date/time this edit check generates a query when the user enters a date in the future into a date field this property can be set at question level properties and field (itemref) level properties note the control type for the field must be defined as ‘datetime’ auto query for data out of range this edit check generates a query when the user enters data outside a defined range into a field at question level, this edit check is set using value range checks at field (itemref) level properties, it is set using the ‘auto query for data low’ and ‘auto query for data high’ properties note this edit check only applies to numeric variables (i e with data type ‘integer’ or ‘float’) mark non conformant data out of range this edit check automatically sets the field status to non conformant when the data entered in the field is outside a defined range at field (itemref) level properties, it is set using the ‘mark non conformant data out of range low’ and ‘mark non conformant data out of range high’ properties these values populate the “nclowerrange”, “ncupperrange” columns in the als fields tab note this edit check only applies to numeric variables (i e with data type ‘integer’ or ‘float’) edit check programming medidata rave has an internal programming language consisting of common arithmetic and logical operators, combined with function library rave edit checks are implemented as a series of programming statements, each returning a boolean value these statements are implemented in “postfix notation” or “reverse polish notation (rpn)”, common to scientific calculators “postfix” notation places the operators after the operands for example, 2 5 + , 10 2 ÷ , x y and this removes the need for parenthesis and provides an unambiguous formula suitable for machine processing edit checks are defined through conditions within the odm at metadata version level these are built up from a series of check steps and check actions see condition level properties edit check example this example shows how to create an edit check which opens a query on the 'age' field if the value entered is less than ‘18' create a condition details create a data value check step for the age variable create a constant check step for the value ‘18’ create a check function check step for ‘is less than’ create a check acton to display a message against the age question the 'folder' property within a data value, or within a data value derivation step, should not be populated if the 'form' property specifies the primary form