Common findings

The following nine areas are routinely examined during our routine on-site review and IRB-requested audits.

In the past five years, the QI Program conducted more than 300 routine on-site reviews and about 70 IRB-requested audits. The occurrence of deficiencies identified during these reviews/audits are similar. The following table lists, in order of frequency, common deficiencies identified during 59 IRB-requested audits by the QI Program. Of the 59 audits conducted, 56 (95%) final reports were available for analysis. Percentages are based on a denominator of 56.

Regulatory Documentation
Signature log not on file or incomplete	68%
Delegation of Responsibility log not on file or incomplete	57%
CVs not on file, outdated, or unsigned	36%
No note-to-file re: location of centrally filed CVs	25%
Monitoring log/documentation not on file or incomplete	20%
Enrollment log not on file or incomplete	14%
Informed Consent Process
Study rep/subject date discrepancy	48%
Subject ID not on all pages	43%
Study rep signature missing	32%
Expired consent forms	30%
Study rep date missing	23%
Subject date completed by someone else	21%
Copy of consent given to subject but not documented	21%
Subject “options to choose” incomplete	18%
Signed consent forms not on file	14%
Signatures on wrong page or wrong line	14%
Unnecessary re-consent	14%
Consent by unauthorized staff	11%
Consent form(s) lack IRB approval stamp	13%
Copy of signed/dated consent form not given to subjects	11%
Subject date missing	11%
Handwritten changes to consent forms made without IRB approval	11%
IRB Documentation
IRB correspondence on file is incomplete	57%
IRB submissions on file not signed/dated	30%
Amendment not submitted to remove study staff who are no longer affiliated with the study	14%
Inaccurate, incomplete, or discrepant information submitted to IRB	14%
Protocol changes made without prior IRB approval	11%
Data Collection & Source Documentation
Signature(s)/date(s) missing from source documents or CRFs	50%
Data entry blanks	18%
CRF header information incomplete	11%
Documentation of Subject Selection
Eligibility checklist incomplete	23%
Eligibility checklist not in subject files	18%
No documentation of eligibility	11%
Reporting Protocol Violations
Protocol violations not reported to IRB	20%

	Regulatory Documentation
	IRB Documentation
	Subject Recruitment Procedures
	Documentation of Subject Selection
	Informed Consent Process
	Adverse Event Reporting
	Reporting Protocol Violations
	Drug / Device Dispensing Accountability
	Data Collection & Source Documents