Slide 1: 20R3 Customer Webinar: Randomization
20R3 Customer Webinar Randomization November 12, 2020 Veeva
Slide 2: CDMS Product Team
CDMS Product Team Sharon Lin Principal Product Manager, Vault CDMS Copyright © Veeva Systems 2020 Quentin Paresys Product Manager, Vault CDMS
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Slide 4: Randomization
V Randomization
Slide 5: Randomization provides a way to randomly allocate study treatment
Randomization provides a way to randomly allocate study treatment, thereby ensuring unbiased data for statistical analysis within and across patient groups. MARKET CHALLENGE Medical Device companies have simple randomization needs and do not want to pay for a sophisticated IRT with robust features.
Slide 6: Simple way to randomize; easy access to data; support of blinded data
Simple way to randomize Once all defined criteria have been met, subjects can be randomized in one click. The action of randomizing is driven off of a specific permission that is assigned to the standard CRC role. Easy access to randomization data Once a subject has been randomized, the unblinded ra
Slide 7: Enabling randomization; strata variable considerations; support in the SDS
Enabling randomization Once enable in a Vault, Randomization can be turned on at the study level in Studio. Strata variable considerations If an item is used as a strata variable, some actions will be restricted in Studio, e.g. moving/deleting the item. For codelist items, values can only be added i
Slide 8: Randomization type, randomization ID, collecting kit or device ID
Randomization Type We support multiple randomization types: Simple, Block, Mixed Blocks, Stratified, Stratification with Blocks, Unequal (unbalanced) Randomization ID The randomization ID can be created in different ways: uploaded with the randomization list, matching the subject ID or system genera
Slide 9: Enablement
Enablement Randomization is not enabled automatically, — Must be turned on at the Vault level — Call Support to enable it at the Vault level Once enabled at the Vault level, Randomization needs to be enabled in Studio Copyright © Veeva Systems 2020 1@ Support
Slide 10: Randomization Demo
Randomization Demo
Slide 11: Questions
2 Questions
Slide 12: For a dedicated demo of any these features
For a dedicated demo of any these features, please contact your Account Executive OR Customer Success Manager
Slide 13: Thank you
V Thank you