Frequent Questions

What would constitute adequate inspection of the ongoing study? Would an audit of the protocol or of data records be adequate?

At least one inspection must be conducted while the study is in progress. Under GLPS, the QAU monitoring of protocols, data records, or other documentation phases of a study are important just as is directly observing the experimental phase of the study. However, the GLPS state at 40 CFR 160.35(b)(3) that inspections must be done at intervals adequate to ensure the integrity of the study, and further, at 40 CFR 160.35(b)(4), that periodic status reports noting problems and corrective actions be submitted to management.

An audit of a study protocol would be of very limited utility since the subsequent reporting would be to management which, in all likelihood, has already reviewed the protocol. Data record audits would also be of very limited utility since they may occur after all experimental work is completed--in short, too late for any corrective actions to be taken. This problem also applies to protocol audits conducted after the experimental phase is completed. Thus, reliance solely on such types of audits would not meet the GLP requirements as stated at 40 CFR 160.35.
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