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 (effective 7/1/2019 - 6/30/2020) | |
Startup and Administration IRB and Regulatory Clinical Coordination
| Investigator-initiated | $62 |
| Industry-sponsored | $85 | |
| Clinical Monitoring | Investigator-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