Standard Operating Procedures (SOPs) & Guidance

It's the researchers responsibility to ensure that they follow the SOPs. Guidance documents are available to assist.

  • Sponsorship

    CTS-SOP001

    Sponsorship

    CTS-GD101

    Pre- & Post-Award Process

  • Study Setup and Conduct

    CTS-GD001

    Template Protocol, Patient Information Sheet and Informed Consent

    CTS-SOP002

    Trial Master File

    CTS-GD002

    TMF Index

    CTS-GD003

    ISF Index

    CTS-SOP003

    Clinical Trial Authorisation

    CTS-SOP004

    Substantial and Non-Substantial Amendments

    CTS-SOP005

    Safety Reporting

    CTS-GD004

    Template AE Form

    CTS-GD005

    Template SAE Form

    CTS-SOP006

    Delegation of Responsibilities

    CTS-SOP007

    Risk Assessment

    CTS-GD006

    Template Risk Assessment

    CTS-SOP008

    Clinical Trial Committees

  • Data Management

    CTS-SOP009

    Data Management & Information Governance

  • Clinical Trials Unit

    CTS-SOP010

    Clinical Trial Unit

  • Monitoring

    CTS-SOP011

    Monitoring of trials

  • Archiving

    CTS-SOP012

    Archiving