• bg


An individual (not a corporation) who both initiates (plans and designs) and conducts a research project in an health-care institution (which can be the sponsor institution), and under whose immediate coordination the drug in study is administered or dispensed. The term does not include any person other than an individual. 21 CFR 312.3 (Code of Federal Regulation 21FDA) and ICH E-6 (GCPs) 1.54.

The sponsor-investigator is responsible not only for the planning, design, conduction, monitoring and management of data, preparation of reports but also for the overseeing all regulatory and ethical matters. Commitment and accountability is crucial in every aspect of a sponsor-investigator’s work. Sponsoring a clinical trial entails numerous regulatory responsibilities.


Guidance pack

Listing of external resources for trialists such as Study Registries and European Guidelines. 

STUDY REGISTRIES US National Institutes of Health (ClinicalTrials.gov)
The European Union Clinical Trials Register (EU Clinical Trials Register)
International Clinical Trials Registry Platform (ICTRP)
The World Medical Association Helsinki Declaration (WMA)
International Committee for Harmonisation (ICH Guidelines) and Guidelines for Good Clinical Practice (E6)
Eudralex - Volume 10 Clinical Trials guidelines (Eudralex)
Clinical Study Protocol (SPIRIT Statement)
Consolidated Standards of Reporting Trials (CONSORT Statement)
Reporting of Observational Studies (STROBE Statement)
RECORD guidelines for reporting studies conducted using observational routinely-collected health data (RECORD Statement)
Core Outcome Measures in Effectiveness Trials (COMET)

For more detailed information please consult the  Clinical Trial Toolkit: an interactive route map that will guide you through the main steps needed for the design and implementation of a clinical research project.