The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
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ICH Guideline for Good Clinical Practice<br />
E 66, Chapter 8: in TMF before the trial commences<br />
From the Sponsor (or Vendor):<br />
-Investigator brochure, protocol, CRF<br />
-<strong>Master</strong> <strong>Master</strong> Informed Consent, Consent subject<br />
materials, and advert<strong>is</strong>ements<br />
-Contractual and Insurance documents<br />
-Central Laboratory y documents<br />
-Sample drug labels and drug/trial<br />
supplies handling instructions,<br />
Certificate of Analys<strong>is</strong><br />
-<strong>Drug</strong> <strong>Drug</strong> shipment documents<br />
-Health Author<strong>it</strong>y (HA) approval<br />
documents<br />
-Randomization codes, , Decoding g pproc.s<br />
-Pre-study and In<strong>it</strong>iation v<strong>is</strong><strong>it</strong> reports<br />
-HA/MS specific forms or documents<br />
www.diahome.org<br />
From the Investigator:<br />
-Protocol signature page<br />
-S<strong>it</strong>e-specific S<strong>it</strong> ifi ICF, ICF subject bj t<br />
materials, and advert<strong>is</strong>ements<br />
-IRB/EC approval documents<br />
-Local Laboratory documents<br />
-PI & SI Curriculum V<strong>it</strong>ae (CV)<br />
and/or other documentation of<br />
qualification f<br />
-<strong>Drug</strong> shipment documents<br />
-HA/MS specific documents<br />
(such as GCP statements or<br />
Form FDA 1572)
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