Research Roadmap

Writing a protocol

The research protocol sets out the research project's rationale and objective(s), the study population, the safety risks, the proposed methods, the outcome measurements, the planned statistical analyses, the reporting, the organization and ethical considerations.

A solid research protocol contains, depending on the nature of the research project, several mandatory sections. The Central Committee for Research involving Human Subjects (in Dutch: CCMO) has drawn up protocol templates for research subject to the WMO. With accompanying explanatory notes. Please note that separate templates apply for clinical trials with medicinal products (CTR) clinical investigations with medical devices (MDR), performance studies using in-vitro diagnostics (IVDR) and other WMO medical research.

Additional, international standards exist for different types of research protocols e.g. the EQUATOR Network has developed reporting guidelines for different types of research designs. These reporting guidelines can also be helpful in the design phase. 

Ensure that the protocol only sets out the essential, relevant and strictly applicable aspects of the investigation. If you deviate from the described protocol (protocol deviations) when performing the research, you will have to list and explain these deviations.

If specific personal data is collected for your study (e.g. ethnicity/race), make sure this is mentioned and clearly motivated in the approved protocol and subject Information Letter and Consent Form. The collection of this data is only approved by the MREC in exceptional cases.

Specific support

A number of departments offer support in composing the various parts of the research protocol.

Methodologists and CMC have elaborated the text of the chapter 'Safety Report' of the CCMO model research protocol (version September 2018) and have developed an example chapter 'Safety report'  for medicinal research.

The CRA's (clinical research associates) of the CMC departmentcan advise you on specific aspects of the protocol, such as safety reporting, administrative procedures and monitoring. They also give practical advice about how to include certain formulations in the protocol that help you prevent protocol deviations, for more information see this page. You can contact them at:  cmc_diensten@amsterdamumc.nl.

The pharmacists at the Medicines Research Centre can give you support in collecting and drawing up the necessary documentation for trials of research products. If the research product is a medical device, you can ask the people at adviesmedischehulpmiddelen@amsterdamumc.nl for advice concerning the necessary documentation.

The staff of the Department of Epidemiology & Data Science can advise you about methodological issues like functional research design, choosing the right patient population, the selection of outcome measurements, as well as more statistical issues like esthablishing the required sample size, choosing the best randomisation technique, writing the statistical paragraph or drawing up a Statistical Analysis Plan (SAP). You can ask for consultation on their Service Portal EDS-Consult 

We would also like to draw your attention to the Biostatistics Wiki  which has answers to frequently asked questions about using statistics in medical research and can help you find the right metrics and calculations for your analysis.

You are advised to give some thought to how the research results will ultimately be reported at an early stage. Reporting guidelines have been drawn up for this purpose for a large number of research designs by the EQUATOR Network.