Paragraph 25 Storage and retrieval
(1)
Archives should be designed and equipped for the accommodation and the secure storage of—
(a)
the study plans;
(b)
the raw data;
(c)
the final reports;
(d)
the reports of laboratory inspections and study audits performed according to the quality assurance programme;
(e)
samples and specimens.
(2)
Material retained in the archives should be indexed so as to facilitate orderly storage and rapid retrieval.
(3)
Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.