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Access for External Monitors to Advarra eRegulatory at Michigan Medicine
Access to Academic Research Applications for Vendors and Contractors
Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
IRB Standard Operating Procedures
AHRQ: Mandatory Use of Data Safety and Monitoring Plans
Payment to Research Participants
Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist

Biologic(s)

  • A biological product subject to licensure under the Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Examples include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology.
  • Any therapeutic serum, toxin, antitoxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.