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