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Study Management Consultation

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What is this service?

Study management consultation services empower study teams to efficiently plan, initiate, and manage their research study using standard tools and best practices. A consultant can provide guidance on protocol development, IRB submission, adherence, and study progress through completion. Working with a consultant, the team will discover efficient and practical solutions that align with the specific needs of the project and generate high quality results. Consultant services are available, but not limited to, the following areas:

  • Management of multicenter clinical projects from protocol implementation through study completion

  • Preparation and negotiation of budgets and contracts

  • Preparation of multi-site informed consent template(s)

  • Management of regulatory document submission

  • Maintenance of the operational study file

  • Coordination of meetings (i.e. investigator, team, DSMB, study coordinator, etc.)

  • Editing and distribution documents (i.e. newsletters, reports, safety plans, etc.)

  • Subject recruitment/enrollment

  • Issues regarding compliance

  • SAE/AE

  • MedDRA and WHODRUG coding processes

Who can use this service?

These services are available to all study teams.

When should I contact MICHR about this service?

We encourage study teams to contact us early in the development of the project.

How much does this service cost?

There is no fee for this service. The cost pricing/recharge rates for this and other MICHR services are available here.

 

Study Management Mentoring