Non-Compliance Citations

DO NOT TAKE STUDY RESPONSIBILITIES FOR GRANTED…INVESTIGATORS HAVE BEEN CITED BY THE FDA FOR:

CO-INVESTIGATORS

INFORMED CONSENT

CORRECTIONS TO STUDY DOCUMENTS

PROGRESS REPORTS TO IRB /CONTINUING REVIEW

DOCUMENTATION OF RESPONSIBILITY

RECRUITMENT

DRUG STORAGE/REFRIGERATION

STUDY RELATED DUT IES

FDA INSPECTION

SUBJECT ELIGIBILITY

CO-INVESTIGATORS

	Entries were written over in the CRF
	White correction fluid was used to obscure entries on the CRF
	Handwritten note without a date; inserted at the top of the first page of the consent form with no IRB approval of this consent form modification
	Progress notes for subject, contained changes that were not initialed or dated, and were illegible
	Numerous mark-overs and obscuring of original data
	Crossed out data without dates or initials; indicating who corrected the forms or when the corrections were made

	Start and stop dates not recorded for study personnel
	Study visits conducted by personnel not medically qualified to evaluate the subjects' disease status; including the study coordinator
	Unauthorized personnel dispensed investigational product and an unauthorized nurse administered the investigational product
	Subjects enrolled were not seen by the investigator or sub-investigator at any time during their participation
	Conducting too many studies; unable to remember specific study details
	Failure to provide research staff members with direct supervision resulting in inadequate communication and lack of accountability

	Failure to ensure that the refrigerator used to store the investigational product maintained the proper temperature as required by the protocol
	No twenty-four hour temperature recording system to verify that the required temperature was maintained
	Failure to ensure that study drugs were stored at the required temperature to ensure the drugs maintained their specified characteristics
	No documentation to show that the study drugs were in a refrigerator maintained according to protocol

	Failure to permit an FDA officer to have access to records and reports relating to a clinical investigation
	Failure to acknowledge the seriousness of violation/actions

	Notations in the informed consent document that it had been read to the subject over the telephone; no consent forms signed
	Failure to provide a copy of the informed consent to subjects
	Someone other than subject entered the date next to the signature line
	Informed consents signed at the time of the prescreening phase were discarded
	Investigator signed consent prior to the subject
	Informed consent document lacked a principal investigator signature
	Signed consent forms approximately one month after the patients signed them

	Failure to submit annual progress report to the IRB
	Failure to provide documentation that the IRB had approved continuation of the study
	Conducting the study without continuous IRB approval

	Failure to obtain IRB approval for recruitment materials prior to enrolling subjects in the study
	Failure to indicate that the device is investigational in recruitment materials
	Failure to obtain IRB approval for media advertisement used to recruit and enroll subjects

	Signed consent forms approximately one month after the patients signed them
	Safety data such as lab tests not reviewed and signed off until weeks/months after the tests are performed

	Subject enrolled into the study although they did not meet the inclusion criteria
	Failure to perform the required pregnancy test for all female subjects enrolled
	Data important in determining subject eligibility for enrollment, differ from corresponding source documents

Human Research Quality Improvement Program 2004