Clinical Research Support Team (CReST)

Services Provided

Provides a pool of experienced study coordinators and regulatory staff to assist with clinical research study 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 & Administration

  • Assistance with budget preparation and negotiation
  • Proposal routing and management
  • OnCore submission and sign offs
  • Sponsor invoicing
  • Hospital and CU Medicine Invoice payments

IRB & Regulatory

  • Submission to HSR portal, PRMS, External IRB review
  • Creation and submission of initial applications, amendments, and continuing reviews for CoMIRB, WIRB, CIRB and other IRBs
  • 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

  • Coordination of Site Qualification Visit
  • SIV scheduling and participation
  • Subject recruitment, prescreening and scheduling
  • Obtain Informed Consent (following process mandated by Sponsor/PI)
  • Data collection/abstraction
  • 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

Clinical Monitoring

  • Develop monitoring plan
  • Source data verification
  • Site initiation visits, interim monitoring visits, and close out visits
  • Multisite study site coordination and oversight

Pricing

The needs of a study will determine the amount of time needed by CReST team members and this will be discussed and agreed to with the investigator on a case-by-case basis.

 Study typeCost per hour (effective 7/1/2019 - 6/30/2020)

Startup and Administration

IRB and Regulatory

Clinical Coordination

 

Investigator-initiated$62
Industry-sponsored$85
Clinical MonitoringInvestigator-initiated$85
Industry-sponsored$115

 

  • Costs can increase on a yearly basis by 6% due to inflation. Studies spanning for more than one year, budget correctly for steady spending. Prices are subject to change July 1st of every year.
  • Micro-grants cannot be used to pay for CReST services
  • Payment for services will be through iLab to a university speed type