#Patient Registration
- presence of required fields. Taken from Study parameters.
- Study exists in OC,
- Site exist in the study
- uniqueness of Study Subject ID (SSID) within file
- width of SSID max 30 characters
- gender is either "m" or "f"
- uniqueness of PersonID in the Study
- date format of Date of Enrollment
- Width of Secondary ID max 30 characters
- Date of birth format. Has to be in the past.
#Event Registration
- presence of required fields. Taken from Study parameters.
- Study exists in OC,
- Site exist in the study
- uniqueness of Study Subject ID (SSID) within file
- width of SSID max 30 characters
- Location width max 4000 characters
- date format of Start Date
- correct start time, between 0:00 and 23:59
- correct end time, between 0:00 and 23:59. End time after start time
- date format of End Date. End Date after Start Date
- repeat number is an integer bigger than 0
- repeat numbers form consecutive numbering from 1 to n where n is the highest value
#Data
- presence of required fields. Taken from Study parameters.
- Study exists in OC,
- Site exist in the study
- uniqueness of Study Subject ID (SSID) within file
- width of SSID max 30 characters
- Events used in the data are present in the study
- Event repeat higher than 0, integer
- CRF used in the data exists and is registered in given event
- CRF version exists
- Item name exists
- group repeat is a positive integer
- checks
- validation rules
- hidden/shown plus display-rule
Patient Registration
Event Registration
Data File
Data checks
And don't forget the:
ignore empty fields or overwrite with empty data