Project Management Plan: A comprehensive document that outlines the strategy, processes, and guidelines for managing a project from initiation to completion. It serves as a roadmap for achieving project objectives, ensuring that the project is completed on time, within budget, and to the required quality standards.

Clinical Validation Plan/Clinical Performance Plan: Designed to confirm that a drug, device, or diagnostic test performs as intended in a real-world clinical setting. This plan is crucial for demonstrating the clinical utility and accuracy of the product.

Performance Evaluation Plan (PEP): Outlines the methodology for assessing the effectiveness and efficiency of a drug, medical device, or intervention within a clinical setting. This plan ensures that the product meets predefined performance criteria and regulatory standards

Risk Management Plan (RMP): Document used in clinical trials and pharmaceutical development to identify, assess, and mitigate risks associated with a drug or intervention. It outlines strategies to manage potential risks to ensure patient safety, maintain product quality, and meet regulatory requirements.

Patient safety narratives: Patient safety narratives are detailed and structured accounts of individual patient experiences related to adverse events or safety issues observed during clinical trials or in real-world settings