4. INVESTIGATOR 研究者
4.6 Investigational Product(s)
试验药品
4.6.1 Responsibility for investigational product(s) accountability at the
trial site(s) rests with the investigator/institution.
在试验单位，试验用药品计数地责任归于研究者/研究机构。
4.6.2 Where allowed/required, the investigator/institution may/should assign
some or all of the investigator's/institution’s duties for investigational
product(s) accountability at the trial site(s) to an appropriate pharmacist or
another appropriate individual who is under the supervision of the
investigator/institution.
只要允许/需要，研究者/研究机构 可以/应当 将试验单位研究者地/机构 对试验用药品计数的责任部分或全部指派给在研究者/研究机构
监督下的合适的药师或其他适当的人员。
4.6.3 The investigator/institution and/or a pharmacist or other appropriate
individual, who is designated by the investigator/institution, should maintain
records of the product's delivery to the trial site, the inventory at the site,
the use by each subject, and the return to the sponsor or alternative
disposition of unused product(s). These records should include dates,
quantities, batch/serial numbers, expiration dates (if applicable), and the
unique code numbers assigned to the investigational product(s) and trial
subjects. Investigators should maintain records that document adequately that
the subjects were provided the doses specified by the protocol and reconcile all
investigational product(s) received from the sponsor.
研究者/研究机构 和/或受研究者/研究机构
指派的一名药师或其他合适的个人，应当保存试验用药品交到试验单位的记录，在试验单位的存货清单，每位受试者的使用记录，和未使用的药品交还给申办者或另行处置的记录。这些记录应包含日期、数量、批号/系列号、时效期(如有)、和分配给试验用药品和试验对象的特别编码。研究者应保持记载有按方案说
明给予对象药量的记录，并应与从申办者处收到的试验用药品总数一致。
