If staff members are performing standard of care tasks, such as vitals they need protocol specific training if the task is part of a protocol specific procedure. There could be protocol specific requirements. For example, clinics and hospitals have a standard of care practice for performing vital signs. Protocols also have a specific requirement at times when performing vital signs, such as the subject may need to be seated for 10 minutes, utilizing a non-dominant arm, capturing the vital signs in duplicate with two minutes of separation are not Standard of Care. Depending on the protocol and the study requirements, USDM Life Sciences auditors expect protocol specific training to be listed on the delegation laws and study specific training documentation to be available.
USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.