protocol development and amendments - Accord - University of ...

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR007v2.0
Effective Date: 14/SEP/2011
1. INTRODUCTION
The nature and conduct of a study will be described in a clear and detailed protocol.
Protocols will be written in accordance with the principles of Good Clinical Practice
(GCP) and will describe the objective(s), design, methodology, statistical
considerations and organisation of a study. Protocols must be carefully designed to
safeguard the health and safety of the participants, as well as answer specific
research questions.
All protocols must be submitted for approval from the applicable Research Ethics
Committee (REC), approval from the licensing authority (if required) and NHS R&D
management approval for the participating NHS sites. Any substantial amendments
made to the protocol must also be submitted for the required approvals.
Amendments cannot be enacted until the required approvals have been granted.
2. PURPOSE
To describe the procedure for writing a research protocol in accordance with ICH-
GCP E6 Guidelines and applicable regulatory requirements. This SOP describes
general principles of protocol development and amendments and provides a
template, primarily for Clinical Trials of Investigational Medicinal Products (CTIMPs).
3. SCOPE
This SOP applies to clinical researchers designing and participating in studies
sponsored by NHS Lothian and/or the University of Edinburgh (UoE). This SOP does
not apply to the design of clinical investigation plans/protocols for clinical
investigations of medical devices. This is described in the International Organisation
for Standardisation (ISO) standard 14155.
4. REFERENCES
Medicines for Human Use (Clinical Trials) Act 2004, Statutory Instrument 2004/1031
as amended
ICH-GCP E6 Guidelines
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects
European Commission CT-1 communication (2010/C 82/01) – Detailed guidance on
the request to the competent authorities of a clinical trial on a medical product for
human use, the notification of substantial amendments and the declaration of the end
of the trial.
5. PROCEDURE
5.1 Protocol Contents
All protocols must be version controlled with the version number and date on the title
page. The protocol, and amendments, will be signed by the Chief Investigator (CI) to
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
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