Common use of Adaptive Monitoring Clause in Contracts

Adaptive Monitoring. If the Study is designed to comply with Risk Based Monitoring (RBM) or Adaptive Monitoring (AM) principles, in addition to or alternatively in lieu of on-site monitoring activities, the significant portion of the Study may be monitored/managed remotely. In this circumstance, the Investigator and Institution undertake to facilitate the remote evaluation carried out by Sponsor/PRA personnel or representatives (e.g., clinical monitors, Data Management personnel, or statisticians) in a timely manner to ensure quality data collection and the safety of study subjects. RBM an AM monitoring activities might include and are not limited to: communication with the Study Site Team member, review of Site’s processes, procedures, records and corroboration. For clarity, remote evaluation refers to evaluation activities that are performed in a location other than where the study is being conducted. 4.

Adaptive Monitoring. If the Study is designed to comply with Risk Based Monitoring (RBM) or Adaptive Monitoring (AM) principles, in addition to or alternatively in lieu of on-site monitoring activities, the significant portion of the Study may be monitored/managed remotely. In this circumstance, the Investigator and Institution undertake to facilitate the remote evaluation carried out by Sponsor/PRA personnel or representatives (e.g., clinical monitors, Data Management personnel, or statisticians) in a timely manner to ensure quality data collection and the safety of study subjects. RBM an and AM monitoring activities might include and are not limited to: communication with the Study Site Team member, review of Site’s processes, procedures, records and corroboration. For clarity, remote evaluation refers to evaluation activities that are performed in a location other than where the study is being conducted. 4.

Adaptive Monitoring. If the Study is designed to comply with Risk Based Monitoring (RBM) or Adaptive Monitoring (AM) principles, in addition to or alternatively in lieu of on-site monitoring activities, the significant portion of the Study may be monitored/managed remotely. In this circumstance, the Investigator and Institution undertake to facilitate the remote evaluation carried out by Sponsor/PRA personnel or representatives (e.g., clinical monitors, Data Management personnel, or statisticians) in a timely manner to ensure quality data collection and the safety of study subjects. RBM an AM monitoring activities might include and are not limited to: communication with the Study Site Team member, review of Site’s processes, procedures, records and corroboration. For clarity, remote evaluation refers to evaluation activities that are performed in a location other than where the study is being conducted. 4.

Adaptive Monitoring. If the Study is designed to comply with Risk Based Monitoring (RBM) or Adaptive Monitoring (AM) principles, in addition to or alternatively in lieu of on-site monitoring activities, the significant portion of the Study may be monitored/managed remotely. In this circumstance, the Investigator and Institution undertake to facilitate the remote evaluation carried out by Sponsor/PRA personnel or representatives (e.g., clinical monitors, Data Management personnel, or statisticians) in a timely manner to ensure quality data collection and the safety of study subjects. RBM an AM monitoring activities might include and are not limited to: communication with the Study Site Team member, review of Site’s processes, procedures, records and corroboration. For clarity, remote evaluation refers to evaluation activities that are performed in a location other than where the study is being conducted. 4Such Adaptive Monitoring shall be performed in a professional manner and subject and in accordance to all applicable laws, including privacy laws and regulations. 5.