Protocol amendments

This section contains the following:

Introduction
Things to consider
Additional resources

Introduction

Good research governance requires that research is carried out according to an approved protocol. In addition to obtaining initial approval for the protocol and study commencement, any amendments to the protocol should also be recorded.

Amendments which are considered as "substantial" must be approved by the relevant regulatory authorities. These are amendments to the protocol which may affect the trial conduct significantly (Checklist of substantial amendments). Many of the regulatory authorities now have appropriate forms for applying for amendment approval (see additional resources). Once approval has been obtained all participating sites should be informed. The protocol containing a new version number and date with the amendments and approvals should then be sent to participating sites.

Non-substantial amendments (see checklist of non-substantial amendments) are regarded as changes to the protocol or trial procedures which have no significant implications for subjects or the conduct, management or scientific value of the study. In the UK these should be reported to the project sponsor, the ethics committee, funders and research and development. It is advisable to check for country specific guidance.

If the amendment is the result of an adverse event or a safety concern it should be implemented immediately. Notification and approval to the relevant authorities must not delay changes to safety systems.

Things to consider

When applying for approval for a protocol amendment -

Describe the amendment, or proposed change you wish to make to the study.
Explain why you propose the amendment and what study changes this will entail. For example, changes to the methodology or participant recruitment.
Describe the changes this will require in the documentation.
Describe the changes this will require in trial procedures.
Consider whether the change will require re-consent of any current subjects.

Additional resources

Checklist of substantial amendments

Examples of amendments to the protocol or trial procedures which require the sponsor/principal investigator, to notify the relevant regulatory authorities. The checklist is from the UK's National Research Ethics website.

Checklist of non-substantial amendments

Examples of amendments to the portocol or trial procedures which have no significant implications for subjects or the conduct, managment or scientific value of the study. The checklist is from the UNK's national Research Ethics website.

The UK National Research Ethics Website

The UK National Research Ethics Website which gives details of regulations for protocol amendments in both medicinal and non-medicinal studies.

Clinical Trials Tool Kit

On this site you will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations implement the EU Clinical Trials Directive in the UK. Even if your research falls outside the Regulations, you could still find the Route Maps useful. Much of the advice they contain is relevant to clinical trials and research more generally.

International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice , 1996.

The Guideline is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.