Development of a standard operating procedure for investigational product rights of administration in clinical trials.

Medication errors in clinical care and in clinical research are preventable situations requiring quality improvement approaches to mitigate negative safety trends. The "Rights of Medication Administration" framework has existed in hospital and clinic settings for decades to aid clinicians with ensuring medication administration safety for patients. These quality measures such as expanded rights of medication administration, bar coding, and "time outs" have been employed to improve clinical patient safety. In clinical trials, drug accountability standard operating procedures are established standards; however, policies for direct administration of the investigational medical product to the study participant in a trial are lacking. Current administration rights were examined through the lens of clinical research practices, regulations, and case studies leading to proposed revisions for local adaptation. The authors suggest a standard operating procedure for investigational product that includes a "time out" checklist to ensure improved quality study performance and safety for clinical trial participants. This new standard operating procedure considers evolved quality practices suggested in the new "Good Clinical Practice" guidelines, ICH E6 (R3). With safety and quality at the forefront, this newly proposed SOP has been developed for implementation at the local site. Future research is encouraged.