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4 Cards in this Set
- Front
- Back
- 3rd side (hint)
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What is the purpose of the CLS? |
The CLS is the Central Lab scop of work for that protocol It details what the central labe will be doing for that study Directions for the database build Details everything the Central Lab is responsible for during the study The "Playbook" |
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What departmens use the CLS? |
All functional departments - Finance, GSS, DM, Sample Management, PM, PDM, Lab |
7 Depts. |
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If the CLS is modified post-signature, what is the impact? |
Pushes back timelines Fees to client CNF is required which has fees plus 20 business days to execute |
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Pre-study launch, when is an updated version of the CLS required to be signed by the client prior to the database build? |
The changes that require a client to resign the CLS before the PDM can build the database includ: - Adding or removing visits - Addint or removing testing - Changes to rules - Changes to blinding
Note that a signed version of the CLS is needed before DM verification can take place
Note: Some sponsors must sign off on ALL changes (i.e. Takeda) |
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