An investigational site is the location where study-related activities are actually conducted. This is typically a clinic, hospital, doctor’s office, or other medical facility where study participants are managed by the principal investigator and their team.
At an investigational site, all essential interactions with the patient take place: recruitment, obtaining informed consent, administration of study medication, conducting examinations, and data collection. The quality of work performed at individual investigational sites is crucial for the success of the entire study. A central task for a CRO is the selection, initiation, training, monitoring, and support of these investigational sites to ensure high quality and protocol adherence across all locations.