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 type Cost per hour
Clinical Coordination Investigator-initiated $62
Industry-sponsored $85
Clinical Monitoring Investigator-initiated $85
Industry-sponsored $115

 

  • Costs will increase on a yearly basis by 6% due to inflation. Studies spanning for more than one year, budget correctly
  • Micro-grants cannot be used to pay for service

The CCTSI can help you set up and administer your Data and Safety Monitoring Board (DSMB).

All clinical research projects submitted for IRB approval must have an appropriate plan for data and safety monitoring. In some cases, this will require periodic review of data pertaining to participant safety and study integrity by an independent review committee.  

Having a DSMB in place will ensure subject safety and data integrity, and it will speed up your IRB approval.

DSMBs are made up of multidisciplinary members knowledgeable in the conduct of research, including backgrounds in biostatistics, clinical trial methodology, bioethics and relevant medical and scientific specialties. These committees play a unique role in ensuring the safety of human subjects enrolled in trials. While many sponsoring agencies will provide such oversight committees, some projects will require, but do not have in place, an independent data and safety monitoring board.  

Under the expert leadership of Dr. Barbara Hammack, one of the editors of the recently published DSMB Training Manual, the CCTSI will assist with the establishment and administration of the DSMB for your study. This resource alleviates the associated administrative burden and need to recruit individual board members.

Services provided:

  • Determine the composition of your DSMB and identify individuals with appropriate expertise to serve on your board
  • Assist with the development of DSMB charter
  • Distribute review materials to board members
  • Provide administrative oversight of the board
  • Provide meeting notes and summary for chair approval
  • Schedule meetings and keep you and your entire team on track 
  • Provide compensation to board members
  • Costs are handled on a case-by-case basis

Pricing

Costs are handled on a case-by-case basis and are determined by the complexity of the study and the funding source.

Set upInternalExternal
$2500$5000
Cost per meeting
Medium complexity$1500$1800
High complexity$1700$2300