Where to start

The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. The recommendations are outlined in a 33-item checklist and figure and important details for each checklist item can be found in the Explanation & Elaboration paper.

The SPIRIT 2013 Explanation and Elaboration paper provides a description and examples of what should be included for each SPIRIT checklist item.

'This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the [SPIRIT] checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.'

The SPIRIT 2013 Explanation and Elaboration paper

Toolkits and Guidance

There are several websites available where you can explore information and templates to get a fuller picture of what you might need to include in your protocol. See our External Resources page for a searchable list or try the links below.

Writing skills

Even with the assistance of a great template writing a research protocol can be a challenging and difficult task. The links below offer guidance and support on writing and publication skills to assist you.

The development process is a cycle of review and modification by contributors and reviewers so input may be required several times before the protocol is finalised.

AuthorAID is a free pioneering global network that provides support for researchers in low and middle income countries.

Collaborative writing and version control

If you have multiple contributors working on your protocol it may be useful to learn more about collaborative writing. Collaborative writing has many benefits, but it requires coordination planning and communication to be successful. Consult the resources below for further guidance on writing collaboratively and version control.

Click here for an example guideline on document version control from the Spirit Statement.

Click here for an overview of a collaborative writing process.