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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Interpretation of " Relevant Correspondence " in ICH GCP 8... 2009-09-01 21:47:23 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Interpretation of " Relevant Correspondence " in ICH GCP 8.3.11

Dear all,

The GCP Records Managers Association has published a guidance document to help those involved in clinical trials to understand and interpret the requirement to retain "relevant correspondence" The Guidance Document is available at the following link:

http://gcp-rma.org/Documents/2009-06-30%20GCP-RMA%20Relevant%20Communication%20Policy%20v1.1.pdf

Regards,
IP Logged
Last Edited On: 2009-09-01 21:47:23 By GCP HelpDesk for the Reason
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 Subject :US-FDA IRB Registration Rule.. 2009-07-17 20:27:36 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : US-FDA IRB Registration Rule

Dear All,

The FDA IRB Registration Rule is effective Tuesday, July 14, 2009.  All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009.  IRBs that review FDA-regulated studies and that are not already in the OHRP IRB registration system must submit an initial registration.  If your IRB is already registered in the OHRP system, the registration information must be updated to include all of the information required by the FDA IRB Registration Rule.  Please see the guidance referenced below for more information.

This registration will be accomplished through a modified version of the database used by the Office for Human Research Protections (OHRP).  (Please note:  the database for electronic submission of IRB registrations will not be available until July 14, 2009.)

A guidance document on the FDA IRB Registration Rule is available  through a link from http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm.

 
Regards,
IP Logged
Last Edited On: 2009-07-17 20:27:36 By GCP HelpDesk for the Reason
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 Subject :Rules and Regulations.. 2009-07-10 19:12:16 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Forum : General Category
Topic : Rules and Regulations

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IP Logged
Last Edited On: 2009-07-10 19:12:16 By GCP HelpDesk for the Reason
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