Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 5 · Duties Relating to Clinical Research Materials
17. Records of dealings with clinical research materials
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A sponsor must keep records relating to all clinical research materials that are put to some other use, disposed of or exported, as the case may be, under regulation 14, in order to permit proper evaluation to be made of the accountability of the material.
The records referred to in paragraph (1) include all of the following:
the proprietary name or description of the clinical research material;
the identification number of the clinical research material (including the control number, lot number, batch number or serial number);
the date on which the clinical research material was put to some other use, disposed of or exported;
the quantity of the clinical research material put to some other use, disposed of or exported;
the name and address of the person responsible for the putting to some other use, disposal or export, of the clinical research material.
Subregulation 1
A sponsor must keep records relating to all clinical research materials that are put to some other use, disposed of or exported, as the case may be, under regulation 14, in order to permit proper evaluation to be made of the accountability of the material.
Subregulation 2
The records referred to in paragraph (1) include all of the following:
the proprietary name or description of the clinical research material;
the identification number of the clinical research material (including the control number, lot number, batch number or serial number);
the date on which the clinical research material was put to some other use, disposed of or exported;
the quantity of the clinical research material put to some other use, disposed of or exported;
the name and address of the person responsible for the putting to some other use, disposal or export, of the clinical research material.