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Defining Roles and Responsibilities in Clinical Trial Documentation with the RACI Model
In a clinical trial, ambiguity regarding roles and responsibilities can lead to significant delays and compliance risks. A structured framework like the RACI model is essential for managing clinical trial documentation. It ensures every task, from the initial drafting of a protocol to the final approval of a clinical study report (CSR), has a clearly
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A Guide to Document Review and Approval Workflows in Clinical Trials
Structured document review and approval workflows in clinical trials are the operational framework for creating, verifying, and finalizing essential regulatory documents. These are not merely administrative procedures; they are core processes designed to ensure data integrity, maintain regulatory compliance, and establish a verifiable audit trail for every document, from initial draft to final archival. The
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Mastering Version Control Best Practices for Clinical Trial Documents
In clinical research, version control is a foundational component of data integrity, patient safety, and regulatory compliance. Effective version control establishes a single source of truth for every critical document, from the clinical trial protocol to the Informed Consent Form. Every change must be tracked, justified, and auditable to meet regulatory expectations and ensure the
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A Guide to Change Control in Clinical Trial Documentation
Change control is the formal, structured process for proposing, assessing, approving, implementing, and verifying modifications to critical documents in a clinical trial. This is a systematic approach to ensure every modification—from a minor clarification to a major protocol amendment—is managed to maintain patient safety, data integrity, and regulatory compliance. Why Change Control Is a Pillar
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Protocol Deviations vs. Protocol Amendments: Documentation Implications
The distinction between a protocol deviation and a protocol amendment is defined by timing and intent. A protocol deviation is an unplanned departure from the approved study protocol, documented retrospectively. In contrast, a protocol amendment is a prospective, deliberate change to the protocol, formally documented and approved before implementation. While the concepts are distinct, their