Trial site staff (e.g., investigators and research coordinators) must be trained in the use of the investigational product, the patient informed consent process, the proper collection of trial data, and data reporting requirements. Without effective site training, trial data may be missed, collected improperly, or reported incorrectly. Proper use of the investigational product is imperative to minimize patient safety risks. Training also helps sites conduct the trial in accordance with applicable regulations and ethical guidelines.
Ultimately, if trial data are untrustworthy for any reason, or are dismissed by regulators due to compliance concerns, the entire endeavor becomes a waste of time and resources. We focus on comprehensive site training with continuous performance monitoring to ensure study sites are providing the highest quality data. Intermittent retraining is performed as needed to ensure site performance throughout the duration of the trial. To ensure data integrity, clinical research associates and monitors verify the submitted trial data and verify the trial sites are conducting the trial in accordance with the trial protocol and all applicable regulations and ethical standards (e.g., Good Clinical Practice; ICH GCP).