Service Page: Management and Prevention of Protocol Deviations
Management and Prevention of Protocol Deviations
Developing a well-prepared Major Protocol Deviations Guidance document by the responsible Medical Monitor, early in the study setup phase enables the appropriate training of all site monitors. Vigilance during the early parts of the trial by collecting and analyzing feedback on the identified deviations from the site monitors, and recommended steps to prevent them, should be in place. A strong operational management approach including regular review of the regulatory binder, consent documents, and source documents minimizes the occurrence of these study deviations. Regular review of the reported deviations by the Medical Monitor should ensure prompt actions when required to guard patient’s safety and, in the same time, establish any applicable corrective and preventive actions to maintain the scientific integrity of the study.