Vocabulary

["MNJ (Maria Nymann Jensen)" <mnj@novonordisk.com>]

Line 116, RM 106 Source Data Verification

Should be included.

Definition: To document source data and  associated verification activity

 

Comment: In our organisation we use SDV agreement form and we have a tool to plan and document for Risk Based Monitoring.

This section should be in the OASIS model

 

 

_____________________________________

Maria Nymann Jensen
Competency Development Professional
Trial Management Anchor

Novo Nordisk A/S
Vandtårnsvej 114
DK-2860 Søborg
Denmark
+45 4444 8888 (phone)
+45 30793864 (mobile)
mnj@novonordisk.com

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