Harry van Loen

Research expertise

Harry van Loen is a scientific expert at the ITM’s Clinical Trials Unit (CTU) and working since 2005 as a clinical data manager.

He has been involved in clinical data management support for studies in Belgium and in Low and Middle Income Countries (LMICs) on various diseases (COVID-19, HIV, Malaria, Tuberculosis, Ebola, Febrile Illness, Sleeping sickness, Buruli ulcer, Leishmaniasis and other neglected tropical diseases (NTDs). In addition specific study groups or topics have been targeted: children, pregnancy, co-infections e.g. TB-HIV, HIV-Leishmanaisis, syndromic approach, medications, diagnostics, vaccinations, emergency research response).

As a coordinating data manager he has been responsible for following activities, resulting in following outputs: 

General Activities:

• Coordination and setup of data management (DM) for clinical trials and observational studies
• Preparation of DM documentation
• Designing systems and tools for data management
• Supervising DM processes (planning, data collection, data entry, data review and querying, data management, database lock, reporting, archiving, data sharing)
• Compliancy to ethical, quality, regulatory and funder requirements
• Training and building capacity on data management

 General Outputs:

• Documentation: Standard Operating Procedures (SOPs), Case Report Forms (CRFs), Data Management Plan, Data Validation Plan,
• Good Clinical Practice (GCP) and Food & Drug Administration 21 CFR part 11 compliant validated databases and electronic CRFs
• Standardized data sets
• DM training packs
• Co-authoring publications

Services expertise

As member of the ITM's Data Access Committee Harry is involved in the discussion and approval of external applications for ITM's research data and to support ITM staff on data sharing.