Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.47 · Good Clinical Practice And (S.L. 458.47)

S.L. 458.47 Art. 17Archives.

In KraftAmtlicher Text

(1) The sponsor shall appoint individuals within its organisation who are responsible for archives.

(2) Access to archives shall be restricted to the named individuals responsible for the archives.

(3) The media used to store essential documents shall be such that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request.

(4) Any alteration to records shall be traceable.