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University of Wisconsin Comprehensive Cancer Center (UWCCC) Data & Safety Monitoring Plan Policy & Procedures
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Document Date: 2012-04-16 13:47:09


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File Size: 522,82 KB

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Company

AEs / Phase I/Disease Group / UWCCC Regional Partners / Disease Oriented Working Group / /

Event

Person Communication and Meetings / /

Facility

University of Wisconsin Comprehensive Cancer Center / Cancer Center / PROCEDURES FOR DATA AND SAFETY MONITORING University of Wisconsin Comprehensive Cancer Center / /

IndustryTerm

clinical trial services / internal audit / given protocol / research / cooperative / external monitoring device / /

MedicalCondition

Cancer / disease / /

Movie

Conflict of Interest / /

Organization

D. Data and Safety Monitoring Committee / Clinical Research Committee / UWCCC DSMC / Monitoring Committee / FDA / B. Mission / UWCCC CRO / Clinical Research Compliance Office / External Data and Safety Monitoring Board / Wisconsin Oncology Network / Program Managers Committee / Safety Monitoring Committee / University of Wisconsin / PROCEDURES FOR DATA AND SAFETY MONITORING University of Wisconsin Comprehensive Cancer Center / /

Person

Grant Trials / /

Position

investigator / protocol Study Chair / Safety Monitoring Coordinator / clinical research coordinator / NCI Program Director / Compliance Monitoring Specialist / research nurse / Outreach Coordinator / Program Manager / Manager Review Implementation NCI Approval w/mods Revision / Director / study coordinator / Monitoring Specialist / Director / Industry Sponsor Medical Monitor / Cooperative Group Study Chair / Chair / as well as others requiring documentation / physician / Leader Review Program Manager / Chair / sub-investigator / Study Chair / lead auditor / /

Product

Protocol Review / /

ProvinceOrState

Wisconsin / /

PublishedMedium

the UWCCC Protocol Review / the Protocol Review / The SAE review / /

Technology

database management system / given protocol / /

SocialTag