Downloads

Please note that the CTRG pages are currently under development.
If you have any questions please contact elaine.chick@admin.ox.ac.uk

This section contains templates, forms and reference documents. The templates can be adapted for use in any department conducting clinical research where there are no such templates in place. They have been written to comply with relevant regulations and guidelines. Their content should be reviewed in conjunction with guidelines/procedures which are unique within the department and the text should be altered accordingly.

The text highlighted in yellow within the documents is advisory and should be deleted when the documents are finalised. If there is a footnote with details of the original author and the copyright logo of the University of Oxford, please retain them.

***NEW***University Core SOPs

University Core SOPs are to be used by default for all clinical trials sponsored by the University, and clinical research where appropriate.  Where units require more detail than appears in a relevant University Core SOP, unit SOPs or Work Instructions may be developed, provided they are compliant with University Core SOPs.  Please contact CTRG for assistance with this.

The University Core SOPs are effective from 1 August 2013.

The SOPs appearing on the CTRG website are the only official versions, and copies either printed or downloaded are valid only on the day they are printed or downloaded.

New Core SOPs are being developed to cover additional functions.  Please refer to the website for updates.

***New*** University Core SOPs
 University Core SOP 1: Generation issue and control of SOPs (2,755kb)
 University Core SOP 2: Protocol development (1,811kb)
 University Core SOP 3: Safety reporting for CTIMPs (3,213kb)
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Initial Concept to Submission

Ethics, Authorisation and R&D Applications
 SOP Template for Ethics Committee Applications V3.1 (51kb)
 Instructions for downloading the IRAS (Integrated Research Application System) ethics application form (628kb)
 SOP Template for Preparation of a Clinical Trial Authorisation (51kb)
SOP Template for Application for Trust Management (R&D) Approval (49kb)
Protocol Development
SOP Template for Study Protocol Development and Review (52kb) 
Clinical Research Study Protocol Template (42kb)
SOP Template for Document Control (56kb)
Clinical Trial Protocol Template (56kb)
Research Databank Protocol Template (103kb)
Research Tissue Bank Protocol Template (106kb)
 Independent Peer Review
Independent peer review template (110kb)
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Submission to Trial/Research Study Start

    SOP writing
     SOP Template for Generation, Issue and Control of SOPs (54kb)
     SOP Template (49kb)
    Case Report Forms
    SOP Template for Design and Development of Case Report Forms (51kb)
    Example Case Report Form (363kb)
    SOP Template for Case Report Form Completion (52kb)
    SOP Database Design (2,843kb)
    Training and Delegation
    SOP: Template for Qualification, Experience and Training of Clinical Research Personnel (51kb)
     Log of Delegation of Responsibilities and Signatures (35kb)
    Training Form (20kb)

    Trial/Research Studies Master Files
    SOP Template for Trial Master Files (122kb)
    Trial Master File Index (86kb)
    Subject Enrolment Identification and Code list (55kb)
    Research Master File Index (59kb)


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    Trial/Research Study Conduct

     Informed Consent
     SOP Template for Informed Consent (58kb)
    Safety Reporting
    SOP Template for Safety Reporting (96kb)
    Serious Adverse Events Reporting Form (103kb)
    Serious Adverse Events Reporting Form Completion Guidelines (61kb)
    Safety Reporting Requirements in Clinical Trials (48kb)
    CTRG are currently developing a Development Safety Update Report (DSUR) template document. Please contact elaine.chick@admin.ox.ac.uk to obtain a copy of the current version.
    Serious Breaches
    SOP Template for Serious Breach of Good Clinical Practice (64kb)
    Protocol Amendments
     SOP Template for Preparation and Approval of Protocol Amendments (59kb)
    Research Participant Complaint Procedure
    SOP Template for Research Participants Serious Complaints Procedure (65kb)

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    Trial/Research Study End

    Archiving
     SOP Template for Archiving of Essential Documents (55kb)
    Final Report
    Final Report Template (42kb)

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    Contacts

    • Contact the CTRG team if you require help in setting up a Clinical Trial or Clinical Research Study, or have any queries about the University's approach to Clinical Trials