As well thought-out protocol can ensure that your research ques­tions are addressed, and that the aims of your study are met. The questions below can provide a path to a well- constructed research protocol.

What is my research problem? The idea for a research protocol starts with a research problem, hypothesis or question. It is essential to demonstrate that the problem you have identified is significant enough to warrant investi­gation. It is prudent to review the lit­erature to see if the research problem has been previously studied. Are there gaps in the literature? Is there any evidence to support or contradict your hypothesis? Does your study need to be done?

What is the purpose of the study? A review of the literature will enable you to refine your research questions into specific research hypotheses and articulate the purpose of your study.

What is the nature of the study? Once the purpose is defined, decide on your overall approach to answer­ing your research questions. Planning to count frequencies of events (e.g., preferences for vanilla vs. chocolate) would lead to a quantitative type study design, whereas if you are trying to obtain a deeper understanding of a phenomenon, a qualitative interview with open ended questions would be more appropriate (e.g. Why do people like vanilla more than chocolate?).

Who will be the research population? Can you access the appropriate study participants who can answer your research questions? Are you investi­gating college students’ or 5th graders’ ice cream preferences?

Do your specific study procedures capture the necessary data that will answer your research questions? For example: Asking specific ques­tions about the ice cream’s texture, sweetness and color can lead to why people prefer one flavor over another.

A structured outline can be useful in guiding the development of a pro­tocol. Electronic protocol develop­ment tools are available, providing investigators with structured guidance for writing protocols that are complete and ready for IRB submission.

Written by Guest Writer Michael Belotto, MPH, CCRC, CCRA. Belotto is the director of the BRANY Institute for Research Education. He also serves as a research compliance expert responsible for auditing sites to ensure investigator and staff compliance with ethical and clinical guidelines and FDA regulations, and he serves on the BRANY IRB. He was a paramedic in the New York City Emergency Medical Service for 10 years and has seven years of experience in hospital administration. www.protocolbuilderpro.com

This article was reprinted from Volume 22, Issue 07, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>