Consider what your research involves? Anything which includes a change or addition to standard clinical care practice and requires additional data collection becomes research and therefore requires the development of a protocol.

Develop your research question

A good clinical study comes down to setting a single and clear question, which is your primary objective, and then determining what you are going to measure in order to answer that question, your primary endpoint. If you keep this in mind in everything you do then you will run a good study. What is my question? Is what I am doing going to answer that question accurately?

In this first step towards developing a clinical research study, you must determine the research question or hypothesis to be tested [The Global Health Network Process Map - see 'Develop research question'].

The research question forms the foundation of any study and is vital to the effectiveness and validity of the research to be carried out. This short course is aimed at all those carrying out clinical research and explores the main factors which affect and influence the development of a valid research question.

Researchers need to consider carefully the questions they set and their appropriateness to the local community and the public health gaps in the region. This article covers important considerations when formulating a research question.

The PICOT format (Population, Intervention, Comparator, Outcome, Time) is a helpful approach for formulating research questions that explore the effect of therapy.  This directs researchers to consider the sample of subjects that a researcher wishes to recruit, the intervention to be provided to participants, what the chosen intervention will be compared with, what will be measured to examine the effectiveness of the intervention and the duration for data collection. [What is your research question? An introduction to the PICOT format for clinicians]

What input might be required?

The process of developing a protocol is should be a collaborative one. It might involve many partners for a large multi-centred study and so the number of contributors will vary with the size and complexity of the planned research. Regardless of whether it is a single centre study or an international collaboration, developing the protocol should always involve all the roles and teams who are going to be involved in implementing each step. Therefore, it is important to consider what input might be required from different team members [The Global Health Network Process Map - see 'Develop study protocol'].

It is likely you will need to include:

• The clinical team
• Statistician
• Pharmacist
• Study coordinators
• Data managers
• Laboratory staff
• Community engagement

Consider also consulting other specialists, if your study plans might require other expertise.