Author Topic: Good Clinical Data Management Practices  (Read 6423 times)

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Offline kufun

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Good Clinical Data Management Practices
« on: Thu, 18 Sep 2008 »
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Dear all,

I'm looking for the latest version of GCDMP. So could anyone give me a copy for reference only?

Many thanks!


_____________________________From Wiki:______________________________________________
Good Clinical Data Management Practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The FDA and ICH have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development.

The Society of Clinical Data Management (SCDM [1]) has created a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is entitled Good Clinical Data Management Practices (GCDMP) and version 4.0 was most recently published in May 2007.

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Offline ilikecdm

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Re: Good Clinical Data Management Practices
« Reply #1 on: Thu, 18 Sep 2008 »
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Dear Kufun,

GCDMP is chargeable document of SCDM. Eventhough it might be available with someone but it should not be posted in forum due to Copyright Act.

I hope you understand the situation. ;)

I Like CDM  :)
"The postings on this site are my own and do not necessarily represent my organization's positions, strategies or opinions."

Offline pnreddy

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Re: Good Clinical Data Management Practices
« Reply #2 on: Thu, 18 Sep 2008 »
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I totally agree with I Like CDM.

We cannot post any information which might violate copyright act. Infact, our endeavor should also be not even to copy paste information from other websites. Our effort should be to present original content and restrict plagiarism to the max.

I believe all are in agreement with this.

Feel free to post your comments.

Thanks and regards,
pnreddy


Offline kufun

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Re: Good Clinical Data Management Practices
« Reply #3 on: Fri, 19 Sep 2008 »
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Dear I Like CDM/pnreddy,

Since GCDMP is a chargeable document, I can completely understand the situation.

I'd apologize for my rash request to CRF.

But as to copyright, the post http://clinicalresearchforum.com/index.php?topic=2811.0 confused me. Are those books not chargeable and free for all?

Thanks and regards

Offline ilikecdm

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Re: Good Clinical Data Management Practices
« Reply #4 on: Fri, 19 Sep 2008 »
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Dear reddy,

You need to answer Kufun's query. I don't have answer!!

I Like CDM  :)

Offline pnreddy

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Re: Good Clinical Data Management Practices
« Reply #5 on: Fri, 19 Sep 2008 »
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Dear Kufun,

I hope you did not find my comment offensive. I was trying to emphasize how our approach should be for making CRF a unique place.

Regarding your query, Those books are all for free for download but we do not upload them(most of the times) on our server. We use a third party server and upload them which will help us not to breach copyright violation act.

Did it clarify your question??

Regards,
pnreddy

Offline dryathish.qa

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Re: Good Clinical Data Management Practices
« Reply #6 on: Fri, 19 Sep 2008 »
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Dear pnreddy,

What kufun questioned is correct.

I agree with you with the books in the rapidshare which is not CRFs responsibility. But please check all files attached  directly in the CRF which are copyrighted, it is better to remove and upload it to third sever and give the link.

I am suggesting it to you because I dont want my CRF to face any issues of copyrighits.

Regards,
Dr.Yathish.S
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Offline kufun

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Re: Good Clinical Data Management Practices
« Reply #7 on: Fri, 19 Sep 2008 »
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Dear Kufun,

I hope you did not find my comment offensive. I was trying to emphasize how our approach should be for making CRF a unique place.

Regarding your query, Those books are all for free for download but we do not upload them(most of the times) on our server. We use a third party server and upload them which will help us not to breach copyright violation act.

Did it clarify your question??

Regards,
pnreddy


Roger that! Cool Reddy~@_@

Offline venkatesancra

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Re: Good Clinical Data Management Practices
« Reply #8 on: Sun, 28 Nov 2010 »
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nice

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