I just wanted to share what i knew and understood about Data Validation Procedures.
Data Validation Procedures: Validations are set of programs to validate the data entered into the database (both paper and RDC). It checks the data points (questions defined in the body of Case Report Form) whether each data point meets the criteria as defined in the program.
Validations can be of three types.
i)Procedures checking data points within the form (Age violates protocol range).
ii)Procedures checking data points between the same form (AE form Vs AE forms)
iii)Procedures checking data points between forms (AE reported with Hospitalization, validation should check is there any hospitalization reported for the specified AE in the Hospitalization form).
Standard Procedure: Procedures are of three types (as per my knowledge), standard, indication specific and study specific. Standard procedures are the ones which can be used across therapeutic areas - Example age is validated against protocol specification.
Indication specific procedure is the one which can be used for a specific therapeutic area - example: validations related to pain assessment scale in arthritis studies, i.e. entered values should be within the range of pain assessment scale.
Study specific: Within the therapeutic area, for a particular study / for a particular drug, program has been changed to check the range specified in the protocol, which is a deviation from the Therapeutic are level. Example: Pain score scale range is 0 to 10 for Musculo skeletal studies, which has been defined by MS research scientists. If we use the value as 0 and 10 then it is Indication specific, if we change it to 0 to 8 (because for this particular study, protocol changed the range from 0 - 10 to 0 -
, then it is study specific.
Validation works: After data entry, SAS programs took values stored in the questions (Example: Age) into their variables (Example: Agex), and validate it against the values defined for them in the data base. For example, in this case the min and max of agex has been defined in the study start up as 18 and 60, if the age is entered as 61, the validation will fail.
Project specific Procedure: This is otherwise called as project specific procedure (Explained above).
Backend process (I explained the little what i know above topic "Validation works").
Thanks a lot in advance: You are always welcome and its my pleasure to share the things what i knew.
Request: Please correct me if any of my understanding about the above topics is wrong and do share more about this.