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楼主: BLUE_KAIKAI

[分享] 新手经验不够的进来。《ICH-GCP英文版加中文版》

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 楼主| 发表于 2009-3-8 22:09 | 显示全部楼层
Title of Document
Purpose
Located in Files of
Investigator/
Institution
Sponsor
8.3.14
SIGNED, DATED AND COMPLETED
CASE REPORT FORMS (CRF)
To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded
X
(copy)
X
(original)
8.3.15
DOCUMENTATION OF CRF CORRECTIONS
To document all changes/additions or corrections made to CRF after initial data were recorded
X
(copy)
X
(original)
8.3.16
NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with 4.11
X
X
8.3.17
NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION
Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in accordance with 5.16.2 and 4.11.2
X
(where required)
X
8.3.18
NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
Notification by sponsor to investigators of safety information in accordance with 5.16.2
X
X
8.3.19
INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3
X
X
(where required
 楼主| 发表于 2009-3-8 22:10 | 显示全部楼层
Title of Document
Purpose
Located in Files of
Investigator/
Institution
Sponsor
8.3.20
SUBJECT SCREENING LOG
To document identification of subjects who entered pre-trial screening
X
X
(where required)
8.3.21
SUBJECT IDENTIFICATION CODE LIST
To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject
X
8.3.22
SUBJECT ENROLMENT LOG
To document chronological enrolment of subjects by trial number
X
8.3.23
INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE
To document that investigational product(s) have been used according to the protocol
X
X
8.3.24
SIGNATURE SHEET
To document signatures and initials of all persons authorised to make entries and/or corrections on CRFs
X
X
8.3.25
RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)
To document location and identification of retained samples if assays need to be repeated
X
X
 楼主| 发表于 2009-3-8 22:11 | 显示全部楼层
8.4 After Completion or Termination of the Trial
After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the following
Title of Document
Purpose
Located in Files of
Investigator/
Institution
Sponsor
8.4.1
INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE
To document that the investigational product(s) have been used according to the protocol. To documents the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor
X
X
8.4.2
DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION
To document destruction of unused investigational products by sponsor or at site
X
(if destroyed at site)
X
8.4.3
COMPLETED SUBJECT IDENTIFICATION CODE LIST
To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a confidential manner and for agreed upon time
X
8.4.4
AUDIT CERTIFICATE (if available)
To document that audit was performed
X
8.4.5
FINAL TRIAL CLOSE-OUT MONITORING REPORT
To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files
X
8.4.6
TREATMENT ALLOCATION AND
DECODING DOCUMENTATION
Returned to sponsor to document any decoding that may have occurred
 楼主| 发表于 2009-3-8 22:11 | 显示全部楼层
Title of Document
Purpose
Located in Files of
Investigator/
Institution
Sponsor
8.4.7
FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)
To document completion of the trial
X
8.4.8
CLINICAL STUDY REPORT
To document results and interpretation of trial
X
(if applicable)
X
发表于 2009-3-10 15:46 | 显示全部楼层

临床试验管理规范指导原则

请问此“临床试验管理规范指导原则”是什么时间开始施行的?
发表于 2009-3-11 09:10 | 显示全部楼层
楼主人太好了,还把内容都贴出来,辛苦了。
发表于 2009-3-13 11:05 | 显示全部楼层
谢谢,真的很佩服版主啊!
发表于 2009-3-13 16:02 | 显示全部楼层
厉害 可爱的LZ,大家有空没空就来顶顶
发表于 2009-3-14 14:51 | 显示全部楼层
谢谢,斑竹辛苦辛苦.谢谢. 顶顶啊.
发表于 2009-3-14 16:04 | 显示全部楼层
楼主真的太善良了,居然还把贴了具体内容,再次感谢啊
最近正好需要了解一下这个,好好学习一下
发表于 2009-3-17 22:57 | 显示全部楼层
好人好事,怎能不顶
发表于 2009-3-25 15:08 | 显示全部楼层
真是个好人呀!感激了!谢谢楼主了!
发表于 2009-3-27 10:27 | 显示全部楼层
辛苦楼主了,呵呵,都发上来了,楼主的经验应该比较多了,发了这么多。幸好楼主不是恶意灌水的,开个玩笑。
发表于 2009-4-2 16:56 | 显示全部楼层
太厉害了,居然贴了具体内容,感谢感谢
发表于 2009-4-24 00:29 | 显示全部楼层
非常谢谢楼主~~~本人是新手。希望以后多多指教!
发表于 2009-5-7 19:04 | 显示全部楼层
新手入门,感谢楼主分享
发表于 2009-5-11 14:03 | 显示全部楼层
楼主的奉献精神很值得学习,赞一个!
发表于 2009-5-11 14:39 | 显示全部楼层
辛苦大家了      
发表于 2009-5-14 09:20 | 显示全部楼层
LZ辛苦了~

内容都贴出来了,专为为新手准备的

知道俺们经验不够没法下载。。。

LZ真好人!!
发表于 2009-5-18 17:33 | 显示全部楼层
楼主辛苦了! 多谢提供的资料
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