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SPONSOR's INTERNAL AUDIT RECORDS OF CLINICAL INVESTIGATIONS

Executive Summary

SPONSOR's INTERNAL AUDIT RECORDS OF CLINICAL INVESTIGATIONS "generally" will not be inspected by FDA, Associate Commissioner for Regulatory Affairs John Taylor told Ciba-Geigy in an Oct. 25 letter. Responding to comments on the IND Rewrite submitted by the firm in June 1987, Taylor said that FDA believes "the current regulations give it the authority to inspect all records relating to a clinical investigation, including all auditing records. However, in general, records maintained by clinical trial auditors are not examined as part of our surveillance inspection program." Ciba-Geigy had written FDA to clarify whether the language of the IND Rewrite allows FDA to examine a sponsor's records of internal Good Clinical Practice audits as well as audits conducted by clinical trial monitors. The provision allowing FDA to access audit records was contained in the final IND Rewrite, published in March 1987, but not the proposed rule, the firm noted. Ciba-Geigy said that the rule could be read as allowing FDA to examine internal audit records, and that such capabilities would undermine the intent of internal audits. "This lack of clarity is of serious concern in that we and many other companies also have groups which perform Good Clinical Practice audit functions which are completely separate from the monitoring efforts conducted during a clinical trial," the firm said. "Ciba-Geigy is opposed to disclosure of our GCP audit records since they are not the result of routine monitoring efforts. . . . To encourage complete and candid problem reporting, this internal assessment system must be afforded a high degree of confidentiality," the firm added. Responding, Taylor noted that although the IND Rewrite allows FDA to access all records relating to clinical investigations, the provision does not really reflect a change in agency policy. "The agency does not view the revised language in ]the IND Rewrite[ as signaling a change in . . . policy and you can expect, as a routine matter, that audit records will not be inspected on a surveillance basis," he said.
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