请教Clinical Data Manager中文翻译

shiyiming

请教Clinical Data Manager 的中文翻译，此职位在临床试验中的地位，对SAS的要求？
什么是data validation，data management operational plan，有什么资料可以参考，中英文都可以，website or white paper都可以。

shiyiming

在我们公司叫做数据管理员吧.医药公司和CRO公司临床试验中数据处理的一个重要环节.
DATA VALIDATION.也就是数据合法性的检验和更正的过程,
data management operational plan,对数据进行操作的一个计划吧,比如在不同的软件和库中转换.非法性检验的步骤等等.
资深的人懂SAS,也有很多不用SAS的.因为我们公司专业的软件很多.
做一样就是用一样软件. ORACLE CLINICAL ......
不是有的地方,SAS打天下.

shiyiming

在临床试验中地位低于统计师，主要负责数据库的建立核查。

参考资料：Cody's Data Cleaning Techniques Using SAS Software

shiyiming

谢谢 ahuige and collen 的解答。这几天忙于完成一个报告，回答晚了。
根据我的观察，大体上有以下职位 (不包括 project manager, marketing etc)
1， CRA: Clinical Research Associate
2， DM: Data Manager/Clinical Data Coordinator
3， Biostatistician
4， Statistical programmer*, 部份工作可有2，3分担
5， MDR: Medical Data Reviewer
感觉3 人数少，1最多。如果从就业方面，2也不错。

我现在用OC, Oracle Clinical v4.5。有兴趣的朋友，大家可以交流交流。
有OC 教程也可交流和切磋。

谢谢。

shiyiming

Clinical Data Manager
Supervises and coordinates all aspects of clinical data. Assists in standardizing data management procedures such as documentation for departmental operating procedures. Requires a master's degree/Ph.D in area of specialty and 2-4 years of experience in the field or in a related area. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Clinical Research Associate I
Analyzes and evaluates clinical data. Ensures compliance with protocol and overall clinical objectives. May require a BS, RN, or BSN degree or equivalent and 0-3 years of experience in the field or in a related area. Knowledge of FDA regulatory requirements is required. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.

Biostatistician I
Prepares analysis plans and writes detailed specifications for analysis files, consistency checks, tables, and figures; communicates with clients regarding statistical analysis issues. Interprets analyses and writes statistical sections of study reports. Requires a master's degree in area of specialty and 0-3 years of experience in the field or in a related area. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Typically reports to a supervisor or manager.

shiyiming

早就听说过Oracle Clinicle。据说是价值连城，但不知道他的功能究竟如何强大。我们这里最近请一家外国公司设计了一个EDC系统，用于E-CRF的制作。我自己感觉OC的适用范围更广，不仅局限于EDC。不知可否介绍一下？

shiyiming

OC has four main parts:
1, Oracle Clinical
2, TMS - thesaurus managment system
3, AERS - adverse event reporting system
4, RDC - remote data capture

据我所知，很少有公司能覆盖全部4个产品, except PhaseForward。比如很多EDC公司只提供输入界面，不提供数据管理和数据库的支持。但是他们的界面 比Oracle, more user-frinedly.

You EDC should be similar to RDC, so-called paperless CRF. Could I know which company's product you are using, if you don't mind <!-- s:D --><img src="{SMILIES_PATH}/icon_biggrin.gif" alt=":D" title="Very Happy" /><!-- s:D -->

shiyiming

我们使用的是一个叫做MOSS的日本公司的产品。它是FDA认可的。目前，SFDA还没有关于Paperless CRF或E-CRF的规定。所以各公司现在都有自己的EDC系统以及E-CRF格式。不知今后是否会统一。

OC究竟是一个DB还是DBMS？

还有，针对不同的试验方案OC能够很方便产生不同的数据库吗？

shiyiming

1, to my knowledge, FDA just publish Part 11, it's the company's responsibility to conform to these regulations.
there are tons of IT companies now doing EDC <!-- s:D --><img src="{SMILIES_PATH}/icon_biggrin.gif" alt=":D" title="Very Happy" /><!-- s:D -->, eg in California
the problem to use Japan products is that it may conform to Japan regulations, not the FDA regulations? - I have no idea. hehe
- we will use an EDC product next month. Maybe we can share some info?

2, OC is a clinical data management system which is based on Oracle databases. Oracle call it OPA, Oracle Pharmaceutical Application

3, OC can generate views, and you can access these views using SAS or other software.

Qs:
1, what's SFDA?
2, can paste some snapshotshere, or to my email? i can paste OC ones.

shiyiming

On February 4, 2003, FDA withdrew the draft guidance Electronic Copies of Electronic Records and on February 25, 2003, they withdrew the Validation, Glossary of Terms, Time Stamps, and Maintenance of Electronic Records.  Six months later, on August 28, 2003, a revised guidance was released to the general public to describe how Part 11 would be enforced until the regulation itself could be revised.

see how FDA work! hehe