Method for the Provision of Clinical Trial Products

Abstract

The present invention relates to a method for the provision of clinical trial products and packaging of clinical trial products using RFID units in the context of clinical trials.

1 . A primary packaging for medicaments in the form of a blister comprising a RFID unit placed on a metal free area of the blister. 
   
   
       2 . The primary packaging according to a  claim 1 , wherein the blister comprises an aluminium layer and wherein part of the aluminium layer has been removed to form a metal free area. 
   
   
       3 . The primary packaging according to  claim 1 , wherein the RFID unit is connected to a tag, and the tag comprises a printable carrier material and a self-adhesive layer. 
   
   
       4 . The primary packaging according to  claim 1 , wherein the antenna of the transponder of the RFID unit is arranged in close or direct contact with the metal surface of the blister on the metal free area. 
   
   
       5 . The primary packaging according to  claim 1 , wherein the medicament is a clinical trial product. 
   
   
       6 . A method for the provision of clinical trial products in the context of clinical trials, comprising the following steps:
 (a) applying one or more RFID units to a primary packaging of a trial product,   (b) arranging one or more primary packagings, obtained after step (a), inside a secondary packaging,   (c) applying one or more RFID units to the secondary packaging obtained in (b),   (d) arranging one or more secondary packagings, obtained after (c), inside a common outer packaging,   (e) optionally applying one or more RFID units to the outer packaging, and   (f) recording all the packaging components by means of the RFID units,   wherein the primary packagings comprise a package according to  claim 1 .   
   
   
       7 . A test specimen shipper comprising an outer packaging which has an RFID unit and contains one or more secondary packagings, the secondary packagings each having one or more RFID units, the secondary packagings containing one or more primary packagings, and the primary packagings having one or more RFID units and wherein the primary packaging comprises a package according to  claim 1 . 
   
   
       8 . The test specimen shipper according to  claim 7 , in which one or more trial products are contained in the primary packagings.