Table 3. Requirement for site data quality control.

DATA checked	Percentage of sampling	Details
Patient initials and date of birth	100% of DCFs	The presence of source documents with medical records corresponding to this patient will be checked.
ICF	100% of DCFs	The completeness of ICF signed by the patient or authorized designated surrogate will be checked.
Inclusion and exclusion criteria	100% of DCFs	The eligibility of all patients will be checked.
All other data	At least 5% of DCFs in 40% of the sites	It means 1 out of 20 DCFs with corresponding source documents and medical records will be 100% checked in 2 out of 5 sites. The top recruiting sites take priority to monitor.
		In sites with less than 20 enrolled patients, at least 1 DCF will be entirely cross-checked with source documents and medical records.

DCFs, data collection forms; ICF, informed consent form.