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raghavendra_s ★ 2010-01-27 11:25 (5998 d 23:56 ago) Posting: # 4650 Views: 2,899 |
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Hi Friends, Is there any guidance available on the requirements for completeing / correcting sample collection and sample collection tube labels when errors have occurred (errors determined at the processing lab in either tube label or accompanying documentation). As well as what is expected at both the sponsor level and CRO/Site level. Thanks in Advance, Kind regards, |
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raghavendra_s ★ 2010-02-18 07:22 (5977 d 03:59 ago) @ raghavendra_s Posting: # 4784 Views: 2,205 |
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Dear Sir, I am looking for any guidance that might exist on the requirements on the sites parts in completeing / correcting sample collection and sample collection tube labels when errors have occurred (errors determined at the processing lab in either tube label or accompanying documentation). As well as what is expected at both the sponsor level and site level. Kind regards, Edit: Linked to previous post. [Helmut] |
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Dr_Dan ★★ Germany, 2010-03-12 12:47 (5954 d 22:35 ago) @ raghavendra_s Posting: # 4906 Views: 2,100 |
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Dear raghavendra Note for Guidance on Good Clinical Practice, CPMP/ICH/95, ICH Topic E6 I would categorize the deviations you mentioned according to EMEA as critical: Conditions, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. A major deviation would be: Conditions, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. Major observations are serious deficiencies and are direct violations of GCP principles The sponsor will be obliged to repeat the study on cost of the CRO. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz