The regulations do not specifically address this issue. Section 58.195(g) requires contract
laboratories that go out of business to transfer all raw data and records to the sponsor.
Likewise, Section 58.190(b) permits raw data and study records to be stored elsewhere
(other than the contract laboratory location) provided that the contract laboratory’s
archives have reference to the other locations and provided that the final study report
identifies the other locations as directed by Section 58.195(a)(13).
Consequently, it is permissible for the sponsor to retain all raw data and records from the
date of termination of the nonclinical laboratory study. Common sense dictates, however,
that the contract laboratory keep copies of the material that has been forwarded to the
sponsor.
