4. INVESTIGATOR 研究者
4.3 Medical Care of Trial Subjects
试验对象的医疗
4.3.1 A qualified physician (or dentist, when appropriate), who is an
investigator or a sub-investigator for the trial, should be responsible for all
trial-related medical (or dental) decisions.
作为一名研究者或次级研究人员的合格医生(或牙医)应当对与试验有关的所有医学(牙科)决定负责。
4.3.2 During and following a subject's participation in a trial, the
investigator/institution should ensure that adequate medical care is provided to
a subject for any adverse events, including clinically significant laboratory
values, related to the trial. The investigator/institution should inform a
subject when medical care is needed for intercurrent illness(es) of which the
investigator becomes aware.
在对象(受试者)参加一个试验期间或以后，研究者/研究机构应当保证为对象(受试者)的任何不良反应，包括与试验有关的临床上有意义的实验室测定值提供合宜的医疗保健。研究者知道并发疾病需要医疗保健时，研究者/研究机构应当通知对象(受试者)。
4.3.3 It is recommended that the investigator inform the subject's primary
physician about the subject's participation in the trial if the subject has a
primary physician and if the subject agrees to the primary physician being
informed.
如果受试者有初级医生并且受试者同意让初级医生知道，建议研究者将受试者参加试验的事通知受试者的初级医生。
4.3.4 Although a subject is not obliged to give his/her reason(s) for
withdrawing prematurely from a trial, the investigator should make a reasonable
effort to ascertain the reason(s), while fully respecting the subject's
rights.
尽管一名受试者没有义务给出他/她中途退出试验的理由，研究者仍应当在充分尊重受试者权利的同时作出合理的努力确认其退出理由。
