Subject identification, e.g. 1.014(5)
1.	Number of location
014	Number of subject
(5)	Number of schema

 

Data entry
	A	Form absent
	L	Form present but empty
	D	Form present, but only a date
	I	Form present, but no date
	T	Form present, date complete and at least one item

 

Data entry comments
	T	No special attention needed (default)
	A	Attention of data manager required
	I	Attention of investigator required

 

Data modification
	C	Data modified on Case Report Form
	I	Data not modified on CRF: modification of data entry

 

Data validation checks
	T	No special attention needed (default)
	A	Attention of data manager required
	I	Attention of investigator required