Research Support Units

Project Management & Monitoring

General Services

Project Managers provide support and management of multi and single center research projects from start-up through termination. Project Managers are responsible for the major aspects of protocol implementation and data collection across all clinical sites.

  • Provide support and management of multicenter clinical projects from start-up through termination
  • Preparation and negotiation of budgets and contracts
  • Design of Case Report Forms (CRFs) (through the Data Management Unit)
  • Preparation of multi-site informed consent template(s)
  • Management of regulatory document submission
  • Maintenance of the operational study file
  • Coordination of investigator/study coordinator meetings
  • Editing and distribution of study newsletter

Clinical Site Management
Project managers organize and oversee day to day coordination of research sites involved in the research project.

  • Site initiation
  • Investigator and clinical site qualifications
  • Protocol specific site training/certification
  • Monitor site performance
  • Quality improvement
  • Development of manual of operations

Clinical Study Monitoring
Clinical Study Monitors oversee the progress of a clinical trial at each participating clinical site. The Monitor will ensure adherence to study protocol and the quality and integrity of data collection.

  • Adverse Event (AE)/Serious Adverse Event (SAE) reporting
  • Development of participant recruitment materials
  • Development of protocol manual of operations
  • Study site initiation
  • On-site clinical monitoring (routine site visits)
  • Quality assurance
  • Data query resolution
  • Study close-out visits
  • Investigational material accountability
  • Assisting investigators to reformat a protocol for the IRB
  • Coordinate multiple IRB submissions for multi-site or multi-sponsor protocols

Clinical Registry
Registry research is an important endeavor that faces unique regulatory requirements. At the Michigan Institute of Clinical and Health Research (MICHR), our dedicated and integrated staff can provided assistance at the various intervals, from inception to culmination, of your registry project. For more information, see Clinical Registry Research.

To access services, please contact PMM Manager Kevin Weatherwax, kweath@umich.edu.