1.1. Packaging and numbering of study IMP

进行研究时试验用药品（IMP）的包装和编号

Packaging and distribution of IMP will be conducted by LC2 for all sites.

采用LC2对所有地点进行试验用药品的包装和发运。

The IMP will be supplied as 100 mg and 200 mg non-divisible capsule-shaped orange coated tablets, packaged in polyethylene bottles. Tablets are packaged by 30 units, with a tear-off part of the label to be removed by the investigator or the pharmacist when providing the IMP to the patient and to be attached in the respective section of the IMP dispensation form. Dispensed IMP number will be reported in the eCRF.

试验用药品供应形式为剂量100mg和200mg的不可分胶囊状橙色包衣片，采用聚乙烯药瓶包装。片剂以30单位进行包装。标签带有可撕掉的部分，研究者或药师在对患者进行给药时撕掉这部分标签粘贴到试验用药品给药形式的相应部分。所分配的试验用药品编号应在eCRF中有记录。

The allocation of masitinib bottles to patient is performed via IWRS. The IWRS User Guide outlines the protocol for site staff, pharmacist and CRA for the respective roles of initial shipment request, reception, and eCRF allocation. The system determines the dose, the bottle numbers and the number of bottles

通过中央随机化系统（IWRS）将masitinib药瓶分发给患者。中央随机化系统使用指南中为场地人员、药师和临床监察员（CRA）提供了概要方案，说明了其在首批货物需求、接收和eCRF分配中各自的职责。由系统确定剂量、瓶号和瓶数。



1.2. Shipment, storage and accountability发货、储存和职责

The initial supply of IMP should be arranged by the AB Science CRA/CPM via IWRS. The investigator or pharmacist is responsible for the safe and proper handling of the IMP at the site. Storage conditions and temperature logs will be checked by the CRA during MV and reported. In case of storage temperature deviation, the Monitor must inform immediately AB Science Pharmaceutical Operations Department for appropriate actions.

首批试验用药品的发货应由AB Science的临床监察员或临床项目经理通过中央随机化系统进行。研究者或药师应负责在研究场地安全、恰当地处理试验用药品。由临床监察员在监察时检查储存条件和温度日志并进行报告。如果储存条件发生偏离，监测人员必须立即告知AB Science的制药操作部门已便采取相应的措施。



Temperature logs will be filed in the Study Centre File and Investigator Site File. The monitor will check during MV the records on delivery, receipt, use, return, loss or other disposition of the IMP, as well as available stock on site.

应将温度日志归档至研究中心档案和研究者场地档案中。监测人员应在监察时检查有关交付、接收、使用、退回、损失或其他对试验用药品处置的记录，以及场地中可用的药品存货信息。