Table 2.

Good clinical practice inspection findings by deficiency areas included in data analysis

Deficiency area	Deficiency sub-areas
Protocol compliance#	Eligibility criteria
	Assessment of efficacy
	Safety reporting
	Reporting in case report form/diary as specified in the protocol
	Other protocol non-compliance not listed above
Trial management*	Data management
	Monitoring
	Document control
	Audit
Documentation#	Essential documents
	Source documentation
	Qualification and training
	Standard operating procedures
	Organization and personnel
	Facilities and equipment
	Randomization, blinding and codes of study drug
	Direct access to data
	Contracts and agreements
Study drug#	Drug accountability
	Supplying, storage, retrieving and destruction
	Prescription, administration and compliance
Human subject protection#,*	Informed consent • Presence of informed consent in the site • Informed consent process • Informed consent form content
	Independent ethics committee/institutional review board • Favorable opinion in the site • Opinion, amendments and notifications to the Independent Ethics Committee/Institutional Review Board • Composition, functions and operation
	Subject protection • Personal data protection • Safeguard of the safety and well-being of subject

*The findings in Trial Management were only included in the sponsor/contract research organization inspection analysis because it is the responsibility of sponsor or contract research organization. The findings in Human Subject Protection were only included in the clinical investigator inspection analysis because it is the responsibility of clinical investigator, according to the FDA regulations

^#Name modifications from EMA good clinical practice finding categories:

“Protocol Compliance” = “Investigational Site”

“Documentation” = “General”

“Study Drug” = “Investigational Medicinal Products”

“Human Subject Protection” = “Informed Consent” + “Independent Ethics Committee/Institutional Review Board” + “Subject Protection”