谢谢。作者: shiyiming 时间: 2006-1-20 03:47 标题: CDM, CRA, Biostatistician 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.作者: shiyiming 时间: 2006-2-6 08:57 标题: 请问OC如何 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？作者: shiyiming 时间: 2006-2-6 23:40 标题: OC 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 -->作者: shiyiming 时间: 2006-2-7 08:20 标题: EDC 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？作者: shiyiming 时间: 2006-2-8 01:27 标题: OC 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.作者: shiyiming 时间: 2006-2-8 01:33 标题: OC 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作者: shiyiming 时间: 2006-2-9 18:15 标题: to oooh SFDA is State Food and Drug Administration. 国家食品药品监督管理局
一看你就是久居海外，要不怎么会不知SFDA
我们的EDC系统是基于xml编写的。后台数据库也使用了oracle，通过联网http访问。这个系统的最大的一个好处就是可以将检验结果直接导入。不用手工录入。当然评价性的内容还是要人工录入(double entry)。操蛋的是这个公司竟然按项目收费，就是说没做一个临床试验都要让他设计一次，且交一次费用。不知你们是否也是这样？作者: shiyiming 时间: 2006-2-9 21:56 标题: to maurice 1, State Food and Drug Administration. 国家食品药品监督管理局 - 我还以为是 National xxx or Chinese xxx。 State 感觉是北京地方的机构？ <!-- s:shock: --><img src="{SMILIES_PATH}/icon_eek.gif" alt=":shock:" title="Shocked" /><!-- s:shock: -->
2，很多软件都是‘借’的，象SAS. or 'leasing'，你可以自己修改。另一种是‘外包’，eg: MoSS is service provider, u use them to design the entry screen for ur company?
3，我们的还没有看到，是一家加州的公司。
4，我们只要是internet key in，你们有cellphone, pda or portable pc key in?
5, lab data都可以batch load.作者: shiyiming 时间: 2006-2-12 21:47 标题: ?? which note do you want?作者: shiyiming 时间: 2006-2-15 07:11 标题: to maurice i can't find the post <!-- s:shock: --><img src="{SMILIES_PATH}/icon_eek.gif" alt=":shock:" title="Shocked" /><!-- s:shock: -->
the one u said u can't post online...作者: shiyiming 时间: 2006-2-15 14:27 标题: to oooh 我已经把那个pdf文件发给你了。上次想上传上来，但是文件过大。管理员同志还好心的给了我一个ftp帐号，可惜我不太会使。如果你能把文件上传到这个版，请帮个忙，谢谢！作者: shiyiming 时间: 2006-3-1 21:22 标题: ff i forward ur pdf to shiyiming. he will help upload the file.
cheers!作者: shiyiming 时间: 2006-3-6 10:17 标题: 秩和检验-Hills Armitage.pdf 上传完毕