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Colorado Clinical and Translational Sciences Institute

University of Colorado Denver
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Clinical Research Support Team (CReST)

Services Provided:



 
Provides a pool of experienced research staff to assist with clinical start-up, implementation, and closeout. This resource alleviates the administrative burden associated with training and managing research staff and allows investigators to pay only for the amount of effort required.

 

 Startup 
  • Assistance with budget preparation and negotiation
  • Office of Grants and Contracts interaction
  • OnCore management 

 

​​IRB & Regulatory

  • Creation and submission of initial applications, amendments, and continuing reviews for CoMIRB, WIRB, CIRB
  • Informed Consent form and subject recruitment materials development
  • Preparation and submission of regulatory documents (e.g. 1572, IND, IDE, Financial Disclosure Forms, CVs, etc.)
  • Creation and maintenance of Regulatory Binders
  • Preparing and maintaining clinicaltrials.gov submissions
  • Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)

 

Clinical Coordination
  • Subject recruitment, prescreening and scheduling
  • Obtain Informed Consent (following process mandated by Sponsor/PI)
  • Data collection
  • CRF completion/Data entry into local or external databases
  • Financial tracking and invoicing
  • Complete study visits and perform/assist with required procedures
  • AE and SAE reporting
  • Act as liaison for all subject-related communications with PI/study team
  • Schedule and implement monitoring visits
  • Prepare for and support for audits/reviews​​

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