Singapore legislation
Regulation 10
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 10
Records of dealings with clinical research materials
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 7, in order to permit proper evaluation to be made of the accountability and traceability 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.