Whether monitoring activities are on site or remote, learn how to prepare, schedule, and manage the monitoring visit for sponsor monitors, auditors or regulatory inspectors.

• Faculty: Candice Vance
• ID: Pr-041900

Sponsor Monitoring quiz

• Faculty: Candice Vance
• ID: Qu-041975

Learn about the approved process at MedStar Health for requesting limited access to the network and electronic health record (EHR) for external sponsors, monitors, and regulatory inspectors to conduct monitoring of clinical studies.

• Faculty: Candice Vance
• ID: Pr-041901

Requesting Restricted Access to the MedStar Health Network for Research Monitoring quiz

• Faculty: Candice Vance
• ID: Qu-041976

Focuses on understanding the purpose of reconstructing study events, how to meet Good Clinical Practice guidelines and agency regulations, and protecting subject rights and safety.

• Faculty: Candice Vance
• ID: Pr-041902

Source Documentation quiz

• Faculty: Candice Vance
• ID: Qu-041977

Guides you through the complete event reporting cycle and critical timelines and reported according to the more stringent requirements between the study protocol and institutional policies.

• Faculty: Candice Vance
• ID: Pr-041903

Adverse Event Management quiz

• Faculty: Candice Vance
• ID: Qu-041978

Emphasizes the importance of data integrity, accountability, and security when transitioning from traditional handwritten signatures to an electronic process to ensure signatures are considered trustworthy, reliable, and equivalent to paper records with handwritten signatures.

• Faculty: Candice Vance
• ID: Pr-041904

Use of Electronic Signatures for Essential Documents in Clinical Research quiz

• Faculty: Candice Vance
• ID: Qu-041979