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RCHT Research and Development Strategy 2024-2028 including service vision, strategic objectives, service priorities and implementation plan.

This standard operating procedure (SOP) details how R and D procedural documents, including SOPs, work instructions (WI) and associated documents relating to the trust-wide systems should be generated, updated and approved.Keywords~: Standard Operating Procedures (SOP).Work Instructions (WI).Good Clinical Practice (GCP).Research and Development (R and D).

This Standard Operating Procedure (SOP) describes the procedures for carrying out risk-based monitoring activities of clinical trials and studies sponsored by the Royal Cornwall Hospitals NHS Trust (RCHT). It describes the process of preparing, conducting and reporting monitoring activities.Keywords:Standard Operational Procedure (SOP). Research and Development (R and D). Good Clinical Practice (GCP). Quality Management System (QMS). Quality Assurance (QA.)Quality Checks (QC). Non-compliance.

The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for internal auditing of research hosted or sponsored by the Royal Cornwall Hospitals NHS Trust (RCHT). It describes the procedures of preparing, conducting and reporting internal audit activities.Keywords: Standard Operating Procedures (SOP). Good Clinical Practice (GCP). Research and Development (R and D).

This SOP describes the processes of reporting and managing non compliances and serious breaches upon identification. This includes guidance on the procedure for reporting to the appropriate regulatory bodies, Research Ethics Committee and other stakeholders.Keywords: Standard Operational Procedure (SOP). Research and Development (R and D). Good Clinical Practice (GCP).Quality Management System (QMS). Quality Assurance (QA).Quality Checks (QC). Non-compliance.

Defines the roles and responsibilities for research staff, providing clear guidance on the conduct of Research Studies and Clinical Trials, aligned to the UK Policy Framework for Health and Social Care Research - Health Research Authority.Keywords: Standard Operating Procedures (SOP).Good Clinical Practice (GCP).Research and Development (R and D).

Defines the training requirements for research staff, providing clear guidance on the conduct of Research Studies and Clinical Trials, aligned to the HRA Framework for Health and Social Care Research.Keywords: Standard Operating Procedures (SOP). Good Clinical Practice (GCP). Research and Development (R and D).Keywords: Standard Operating Procedures (SOP).Good Clinical Practice (GCP).Research and Development (R and D).

This SOP outlines the requirements and the processes for collecting income for research activity in accordance with the contractual arrangements for hosted research. Keywords:

The SOP describes the essential study documentation and procedures for preparing and maintaining the Investigator Site File (ISF) as evidence that the data generated is complete, accurate, verifiable, and traceable.Keywords:Standard Operational Procedure (SOP).Good Clinical Practice (GCP).Research and Development (R and D).

The SOP describes the procedures for the management and protection of data (both paper and electronic) for clinical trials and studies conducted for the Royal Cornwall Hospitals NHS Trust (RCHT).Keywords: Standard Operational Procedure (SOP).Research and Development (R and D).Good Clinical Practice (GCP).

This document describes the processes for uploading and viewing source data and relevant documentation for research studies and clinical trials, using the eNotes system at the Royal Cornwall Hospitals NHS Trust (RCHT).Keywords: Standard Operating Procedures (SOP).Good Clinical Practice (GCP).Research and Development (R and D).

This SOP also outlines the participant informed consent process, including the required documentation and procedures for completing and filing the essential study documentation.

The SOP describes the procedures for the delegation of duties when setting up and delivering all research studies being conducted at RCHT. Keywords: Standard Operational Procedure (SOP).Research and Development (R and D).Good Clinical Practice (GCP).

This SOP provides guidance for preparing and maintaining essential documents in the Trial Master File (TMF) for studies sponsored by RCHT.

This SOP describes the procedures for recording, managing and reporting Adverse Events which occur during a clinical trial or research study. Keywords: Standard Operating Procedures (SOP). Good Clinical Practice (GCP). Research and Development (R and D).

This SOP describes the procedure for the closure of trials and studies hosted by the Royal Cornwall Hospitals NHS Trust (RCHT).Keywords: Standard Operational Procedure (SOP).Research and Development (R and D).Good Clinical Practice (GCP).

This SOP describes the required documentation and procedures for the filing and archiving of essential documentation for research studies and clinical trials. Keywords: Standard Operating Procedures (SOP).Good Clinical Practice (GCP).Research and Development (R and D).