Writing a WMO research protocol

  • WMO

Writing a protocol

The research protocol sets out the trial’s objective, the study population, the safety risks, the methodology used, the outcome measurements and the planned statistical analyses.

A solid research protocol contains, depending on the nature of the trial, several mandatory sections. The Central Committee for Research involving Human Subjects (CCMO) has drawn up templates for research protocol for medicinal product and medical device with accompanying explanatory notes, for research subject to the WMO.

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 CMC monitors can advise you on specific aspects of the protocol 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. 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 at the Methodology Helpdesk can advise you about such things as functional research design, choosing the right patient population or the selection of outcome measurements.

The statisticians at the Statistics Helpdesk can give you support in calculating the required sample size, choosing the best randomisation technique, writing the statistical paragraph or drawing up a Statistical Analysis Plan (SAP).

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.