raghavendra_s
★    

2010-09-28 15:41
(5338 d 00:03 ago)

Posting: # 5942
Views: 2,786
 

 Who needs to sign the Protocol [GxP / QC / QA]

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Dear Madam/Sir,

In a bioequivalence study protocol, if the clinical part of the study is outsourced but the bioanalytical part is in-house (within the company); please let me know if bioanalytical investigator should sign protocol both as sponsor and bioanalytical investigator. Please also provide me relevant reference from GCP/GLP guideline.

Thanks in advance.

Kind regards,
 
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