What type of study is this?
The Articulate Pro study is classified as an "Evaluation of Clinical Care". For more information, see the table below:
Type of Study
This is Not a research study
The software is ready to use and no further developments to the software will be made as a result of the study.
The software is market authorised.
The Study Sponsor, The University of Oxford through its Clinical Trials and Research Governance Team
Has confirmed that this is not a research study
|NO Consent is required|
This is Not a clinical trial
|The project design does not fit the criteria for a clinical trial|
The Study Sponsor, The University of Oxford through its Clinical Trials and Research Governance TeamHas confirmed that this is not a clinical trial
NO Research Ethics Committee approval required
NO Consent is required
This is Evaluation of Clinical Care (Service Evaluation)
Under the control and responsibility of the clinicial team
Forms part of the usual patient care pathway
De-identified data used
Patient specific data behind secure NHS Firewall
The Study Sponsor, The University of Oxford Clinical Trials and Research Governance Study Classification Committee
Has reviewed the project and confirmed that this is Service Evaluation
NO Project Specific Consent is required
Opt out options available under existing OUHFT "Consent to Examination or Treatment Policy "
and via PALS (Patient Advisory and Liaison Service)
For further information please see:
OUHFT "Consent to Examination or Treatment Policy V 6 .2 January 2020
Other regulatory requirements for data either apply or not as below:
Set Aside 251 RE THE USE OF PATIENT DATA
Section 251 of the National Health Service Act 2006 and the Health Service (Control of Patient Information) Regulations 2002 allows the Secretary of State for Health to make regulations to set aside the common law duty of confidence for defined medical purposes. This would allow the use of patient data for medical purposes. BUT THIS DOES NOT APPLY TO THE STUDY AS WE ARE USING DE-IDENTIFIED PATIENT DATA.
National Data Opt Out (NHS)
DOES NOT APPLY to this project as the National Data Opt Out scheme only applies to data usage and processing in circumstances other than direct / individual care.
Data Protection Act 2018 / GDPR
In this project the LEGAL BASIS for processing data is:
Article 6 - 1e: Necessary for performance of a task carried out in public interest or in exercise of official authority
Article 9 (Special category data) - 2(h) Necessary for provision of health and/or social care, including preventative or occupational medicine.
Common Law Duty of Confidentiality
In this project scanned images are going to be added to the PathLAKE data lake. Patients whose data has been analysed using the Paige Prostate tool will need to have agreed to their data being used for research on the NHS "Consent to Procedure form" (Agreement to Investigation or Treatment form) that they signed before undergoing a biopsy. We will check each consent form.