临床试验听听看 ▎ICH-GCP 3.2.3-3.2.6

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3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established.

确定其组成(成员的姓名和资格)和授权。

3.3.2 Scheduling, notifying its members of, and conducting its meetings.

安排时间，通知其成员，举行会议

3.3.3 Conducting initial and continuing review of trials.

对试验进行初始审评和继续审评

3.3.4 Determining the frequency of continuing review, as appropriate.

酌情确定继续审评的频度

3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.

依照适用的管理要求，为已经获得IRB/IEC批准/赞成的正在进行的试验的较小修改提供快速审评和批准/赞成意见。

3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial.

说明在IRB/IEC书面签署对试验的批准/赞成意见之前不得接纳受试者进入试验。

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