Standard Operating Procedures (SOPs) - Oxford Brookes University

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SOPs are an essential element in the OxInAHR Quality Management System, a written documentation of processes that require a standard of quality and consistency, supporting entire clinical and other health research at the Institute. They enable an effective research environment towards further development, continuous improvement and excellence in research. SOPs are also used for research training purposes, audit trail and demonstrating transparency of research.

This page contains the OxInAHR SOPs suite as well as policies and guidance, applicable to all OxInAHR researchers in relation to their research projects.
The OxInAHR has developed its review and adoption procedures (flowchart - Internal access only) to ensure all SOPs are fully consistent with both the University and the national regulations, policies and guidance as relevant to health and clinical research.

OxInAHR Policies and Guidance

All SOPs accessible on this webpage are controlled documents. The master documents are posted on this website and any print-off or download of the documents will be classed as uncontrolled. Researchers and their teams may print off these documents for training and reference purposes but are responsible for regularly checking the this website for more recent versions

There is a 10 working day period from the date a SOP is posted on this webpage for any further comment or objection. After this period lapses, all OxInAHR researchers are required to follow these SOP, as applicable to their studies.

The SOPs are currently accessible to Oxford Brookes University members only.

For comments, objections or further information, please contact the OxInAHR Research Governance and Commercial Research Manager

OxInAHR-SOP-01 (SOP on SOPs)

Process for Writing Standard Operating Procedures (SOP on SOPs)

This document defines the procedures for writing, managing and reviewing SOPs that describe the standard activities used in research at the Oxford Institute of Applied Health Research (OxInAHR) consistent with the duties of research Sponsor, principles of the UK Policy Framework for Health and Social Care Research and ICH Good Clinical Practice.

Date SOP posted: 30. October 2023

OxInAHR-SOP-02 (Protocol)

Process for Writing Study Protocols for OxInAHR Health Research

This Standard Operating Procedure defines requirements for the format and content of study Protocols for OxInAHR health research (clinical and social research included).

Date SOP posted: 30. October 2023

OxInAHR-SOP-03 (IP)

Intellectual Property

Before any disclosure of results, researchers need to be sure that they have determined that the Intellectual Property (IP) Rights of the University are secured and that the rights of research sponsors, others with legitimate interests in their work and the researchers' own interests are protected. This SOP outlines the steps to be taken to ensure the IP matters are satisfactorily addressed.

Date SOP posted: 30. October 2023

OxInAHR-SOP-04 (Indemnity and Insurance)

Indemnity and Insurance

This Standard Operating Procedure describes the procedures used by the OxInAHR within Oxford Brookes University (OBU) for the purpose of assessing and providing indemnity and insurance for clinical/health research, including that involving the NHS.

Date SOP posted: 30. October 2023

OxInAHR-SOP-05 (Finance)

Financial Management

This Standard Operating Procedure (SOP) defines the process for identifying and documenting research project funding prior to the start of a study requiring University Sponsorship as defined by the UK Policy Framework for Health and Social Care Research (version 3, 2017) and the Medicines for Human Use (Clinical Trials) regulations 2004 (and subsequent updates).

Date SOP posted: 30. October 2023

OxInAHR-SOP-07 (Research Passport)

Research Passport Procedures

This Standard Operative Procedure describes the process for completing the forms necessary for a Research Passport in order to undertake research related activity in the NHS. This SOP is relevant for OxInAHR staff and students wishing to undertake research in the NHS as Oxford Brookes University (OBU) employees, visiting researchers or students.

Date SOP posted: 30. October 2023

OxInAHR-SOP-11 (Delegation of Duties)

Delegations of Study Duties

This Standard Operating Procedure ensures that all study tasks are appropriately delegated, with all common roles and appropriate allocation of day-to-day responsibilities for research team members detailed and recorded.

Date SOP posted: 30. October 2023

OxInAHR-SOP-12 (Biological Samples)

Handling Biological Samples

The aim of this Standard Operating Procedure (SOP) is to define the process for sample management in all OxInAHR research sponsored by Oxford Brookes University (OBU), and applies to all studies sponsored by OBU where samples are taken from human participants including archived and existing collections.

Date SOP posted: 30. October 2023

OxInAHR-SOP-13 (Training Record)

Training Record

This Standard Operating Procedure describes the OxInAHR processes to ensure that those involved in clinical research are demonstrably qualified by education, training and experience to perform their respective study roles and responsibilities. Nothing in this SOP shall be inconsistent with the relevant OBU Regulations.

Date SOP posted: 30. October 2023

OxInAHR-SOP-14 (Study registration)

Research Study Public Database Registration

This Standard Operating Procedure describes steps to be taken to register a research study on a publicly accessible database, as per research regulatory requirements and as matter of good clinical research practice.

Date SOP posted: 30. October 2023

OxInAHR-SOP-15 (Protocol Deviations)

Protocol Deviations and Good Clinical Practice Breaches

This Standard Operating Procedure outlines relevant steps to ensure the University as well as all relevant UK health and clinical research regulators defined specific course of actions regarding clinical and health research compliance with the research protocols and principles of health research.

Date SOP posted: 30. October 2023