Writing a WMO research protocol
- WMO
Content
The research protocol outlines the key components of a study, including its rationale and objective(s), study population, the nature and extent of the burden and risks for participants, proposed methods, study parameters and endpoints, the planned statistical analyses, safety reporting, and ethical considerations and administrative aspects.
The Central Committee for Research involving Human Subjects (CCMO) provides protocol templates for different types of research, including:
- Clinical trials involving medicinal products
- Clinical investigations involving medical devices
- Performance studies using in-vitro diagnostics
- Other research subject to the WMO
Additionally, international standards exist for different types of research protocols. For example the SPIRIT statement is a widely endorsed guideline for clinical trial protocols, and the EQUATOR Network has developed reporting guidelines for different types of research designs. It is advised to consider how the research findings will ultimately be reported during the design phase.
The research protocol should focus on the essential, relevant and strictly applicable aspects of the study.
Note: If your study involves the collection of specific personal data (e.g. ethnicity/race), make sure this is mentioned and motivated in the research protocol and the Subject Information Letter and Informed Consent Form. The collection of such data is only approved by the Medical Research Ethics Committee (MREC) in exceptional cases.
Specific support
Several departments offer support in composing the various parts of the research protocol.
The Clinical Research Associates (CRA's) of the Clinical Monitoring Center (CMC) can advise on specific aspects of the research protocol, such as safety reporting, administrative procedures and monitoring. They also offer practical advice on phrasing in the research protocol to prevent protocol deviations. You can contact them via cmc_diensten@amsterdamumc.nl.
The Department of Epidemiology & Data Science can offer support with methodological issues, including functional research design, defining the right study population, selecting outcome measures, as well as more statistical issues like calculating the required sample size,
choosing the best randomisation method, and writing the statistical paragraph
or a full Statistical Analysis Plan (SAP). You can request a consultation via the EDS-Consult Service Portal.
For statistical questions, the Biostatistics Wiki is also a helpful source. It provides answers to frequently asked questions and can help identify the right metrics and calculations for your analyses.
If ionizing radiation is used in the study, the expected radiation dose for each study participant must be determined in advance and documented in the research protocol. For standard dose estimates or a specific radiation dose calculation request, consult the information on the MREC website.
Support for clinical trials involving medicinal products, clinical investigations involving medicial devices or performance studies using in-vitro diagnostics can be found on the dedicated pages.