Release Notes

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Release Notes | PharmaBharat Tools

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Adjudication Change Control Critical Data Data Management Plan(DMP)Data Review Plan Form Versioning Go-Live Readiness Protocol Amendment Impact Assessment Regression Testing Release Notes Requirements Traceability Version Control

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CDM Study Setup & PlanningRelease Notes

Release Notes

Study Setup & Planning

Definition

Summary of changes made in a build/version so teams understand what changed.

Example

Used in CDM operations to support consistent execution: Release Notes.

Common mistakes

Not documenting decisions and assumptions related to "Release Notes".

Inspector question

How do you apply "Release Notes" in practice and how is it evidenced?

cdmstudy-setup-and-planning

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Regression Testing Requirements Traceability

Release Notes

Study Setup & Planning

Definition

Summary of changes made in a build/version so teams understand what changed.

Example

Used in CDM operations to support consistent execution: Release Notes.

Common mistakes

Not documenting decisions and assumptions related to "Release Notes".

Inspector question

How do you apply "Release Notes" in practice and how is it evidenced?

cdmstudy-setup-and-planning