问题 多项选择题 X型题

在新药临床试验中如发生严重不良反应事件,研究者应采取什么措施()

A.立即对受试者进行适当治疗

B.报告药品监督管理部门、卫生行政部门、申办者和伦理委员会

C.研究者在报告上签名并注明日期

D.与受试者及其家属讨论赔偿

E.向上级部门申请中止临床试验

答案

参考答案:A, B, C

解析:在新药临床试验过程中发生严重不良事件,研究者应在获知消息后24小时内通过电话或传真向申办者报告;随后,申办者应按相关程序向研究者搜集该严重不良事件的详细资料;研究者应确保向申办者全面、详细地提供严重不良事件的有关情况;同时研究者有义务向国家药品监督管理局报告严重不良事件。此外如发生严重的与试验用药品相关且以前未知的不良反应,研究者也应向伦理委员会报告。

单项选择题 A1/A2型题
阅读理解

根据短文内容,从短文后的选项中选出能填入空白处的最佳选项。选项中有两项为多余选项。

__小题1:__ Scientists and experts have proved the uniqueness of finger-prints and discovered that no exactly similar pattern is passed on from parents to children, though nobody knows why this is the case.

The ridge(隆起) structure on a person’s fingers does not change with growth and is not affected by surface injuries. Burns, cuts and other damage to the outer part of the skin will be replaced in time by new one, which bears a reproduction of the original pattern. __小题2:_ Some criminals make use of this fact to remove their own finger-prints but this is a dangerous and rare step to take.

Finger-prints can be made very easily with printer’s ink. They can be recorded easily. __小题3:_ Because of the simplicity and economy of this system, finger-prints have often been used as a method of solving criminal case. A suspected man may deny a charge but this may be in vain. __小题4:_ When a suspect leaves finger-prints behind at the scene of a crime, they are difficult to detect(察觉) with the naked eye. __小题5:__ Some of the marks found are incomplete but identification is possible if a print of a quarter of an inch square can be obtained.

A.Special techniques are used to “develop” them.

B.A fingerprint is an impression of the friction ridges of all part of the finger.

C.It is only when the inner skin is injured that the arrangement will be destroyed.

D.With special methods, identification can be achieved successfully within a short time.E. A latent(潜在的) print is the chance reproduction of the friction ridges deposited on the surface of an item.

F. His finger-prints can prove who he is even if his appearance has been changed by age or accident.

G. Every human being has a unique arrangement of the skin on his fingers and this arrangement is unchangeable.