„Kontrola sprovođenja kliničkog ispitivanja je postupak kojim Agencija kontroliše da li određeno kliničko ispitivanje teče u skladu s Protokolom, odnosno Smernicama Dobre kliničke prakse, na mestu izvođenja kliničkog ispitivanja leka, na lokaciji sponzora, kod drugog pravnog
ili fizičkog lica na koje je predlagač ugovorom preneo ovlašćenja ili deo ovlašćenja u kliničkom ispitivanju leka, ili po potrebi na drugim relevantnim mestima;”

„A for-cause audit is an in-depth examination of all components of a research study, including all records and documents, observation of research procedures, and interviews with investigators, research staff members and participants to determine if participants’ rights, safety and welfare are being upheld according to national and international ethical and regulatory standards.”

There are two types of audits, routine audits and for-cause audits. Audits are often performed by the sponsor, IRB,FDA or internal quality assurance department (...) For-cause audits, may be conducted if during the monitoring process a sponsor has continual documented accounts of possible noncompliance, data discrepancies or concerns over the ethical conduct of the study by the investigator (https://ccts.osu.edu/education-and-training-programs/researc...

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