The cSDRG and ADRG apply to a
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single study. Sponsors have used these templates when creating a
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reviewer's guide for integrated Study Data and
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reviewer's guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies.
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There is an opportunity to create a template for integrated Study Data and integrated
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Analyses Data. The project team will determine if this can be accomplished in one
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reviewer's guide or if there should be two separate
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reviewer's guide. Deliverables include a template, completion guidelines
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and example documents
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Project Leads:
Kiran Kundarapu - kiran.kundarapu@merck.com
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