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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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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,
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Last Edited On: 2009-09-01 21:47:23 By GCP HelpDesk for the Reason
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