Clinical Research

Study coordinators provide support for activities related to identifying and recruiting patients for studies and entering them into studies. Study coordinators also ensure that each patient is managed according to the protocol and take responsibility for timely, accurate collection and reporting of adverse event data.

• Verify eligibility criteria
• Obtain informed consent and enroll subject
• Collect and maintain study data
• Manage study participants

Specialists provide support  for regulatory management of a clinical research study.

• Coordinate and process regulatory documents and regulatory file management
• Submit regulatory documents and report unanticipated events to AWRI committees as necessary and appropriate external agencies
• Coordinate monitoring visits and audits

The Clinical Research Office ensures high-quality standards for data collection and management of clinical trials by utilizing peer reviews of study documents. 

• Review patient data for accuracy
• Ensure adherence to protocol 
• Review regulatory files for completion and accuracy

Comprehensive protocol review and facilitation of applicable study feasibility reviews:  

• Institutional, Clinical and Scientific feasibility
• Safety, Ethical and Regulatory feasibility
• Operational, Financial and Legal feasibility

The Ascension Wisconsin (AW) statewide Investigational Drug Lead Pharmacist coordinates and supervises the activities of the staff engaged with Investigational Drug Management at participating sites. 

• Initiate and monitor investigational drug studies to ensure compliance with institutional, federal and state regulatory guidelines