Document bundles

Planning document bundle

A coordinated set of 10 planning working templates with completion guidance. Each document needs study-specific adaptation and review.

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NCR working documentsInternationalEnglishPlanningWorking template · review required

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Planning document bundle A coordinated set of 10 planning working templates with completion guidance. Each document needs study-specific adaptation and review. Included documents are listed below. Purchase and licence terms remain subject to operator confirmation.

Included templates

Protocol development template
Protocol synopsis
Country and site feasibility assessment
Study risk assessment
Study management plan
Quality management plan
Monitoring plan
Data management plan
Statistical analysis plan outline
Investigator brochure content checklist