INTRODUCTION: Investigator-initiated trials (IITs) bridge the gap between applied clinical research and everyday clinical practice. However, they require the skilled multidisciplinary teams from different backgrounds but all with clinical trial training to ensure trials are designed, conducted and reported according to best practice and regulatory standards. The availability of trainings to fulfil these needs is limited. The CONSCIOUS II project facilitated to expand the supply of such programmes. The objective is to describe the curriculum designed for PhD students and early-career researchers, and evaluate participants' perceptions and feedback after completion of the training. METHODS: The curriculum was developed according to key principles that underpin building of competencies relevant to quality IITs and transdisciplinary skills. A multidisciplinary team created the curriculum, elaborated a comprehensive set of study materials, including the training platform. This team also conducted an international, collaborative pilot course. The effectiveness of the educational materials for the target audience was assessed through questionnaires administered after the pilot course. Additionally, all learning materials, including the video recordings of the pilot course, were externally evaluated. RESULTS: A 12-chapter thoroughly revised curriculum was developed for asynchronous preparation and served as a pre-class reading for a 3-month pilot course. The chapters, along with supplementary materials, and recordings of the pilot course are freely accessible on the CONSCIOUS II training platform. This platform facilitates the dissemination and implementation in the existing curricula. The feedback from both the pilot course participants and the stakeholders was uniformly positive across all survey aspects. CONCLUSION: This remote programme which combines asynchronous and synchronous components with international and interprofessional collaboration effectively addresses the gap in developing core competencies for the 21st -century clinical researchers. The implementation of this curriculum has the potential to improve the quality of IITs.

Centre of Excellence CREATIC at Masaryk University Brno Czech Republic

Clinical Coordinators Team in the NOVA Clinical Research Unit NOVA Medical School Universidade NOVA de Lisboa Lisbon Portugal

Départment de Médecine Interne at Hopital Lariboisiere Université Paris Cité Paris France

Department of Pharmacology Faculty of Medicine Masaryk University Brno Czech Republic

European Clinical Research Infrastructure Network Paris France

HRB Clinical Research Facility and School of Public Health University College Cork Cork Ireland

iNOVA4Health NOVA Medical School at Universidade NOVA de Lisboa Portuguese Clinical Research Infrastructure Network Lisbon Portugal

iNOVA4Health NOVA Medical School Universidade NOVA de Lisboa Lisbon Portugal

NOVA Information Management School Lisbon Portugal

Pharmaceutical Development and Clinical Research Competence Center University of Szeged Szeged Hungary

St Anne's University Hospital Brno Brno Czech Republic

Szentágothei Research Centre University of Pécs Pécs Hungary

Université Paris Cité UFR EILA Paris France

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