Clinical Research Process & Fees
Once the Principal Investigator (PI) has performed a preliminary review of the sponsor protocol for clinical and technical feasibility and has decided to proceed with the study, the PI or designee:
- Contacts the Investigational Drug Service for an estimate of support service (if the research involves the use of investigational drug or research is being conducted under an IND) (see below for further information);
- Contacts the Clinical Research Center/Clinical Trial Unit (CRC) (if CRC resources will be needed) and consult with the CRC manager (see below for further information);
- Submit the project to the OCR Translational Research Accelerator (TRAcs) Portal. For clinical trial agreements the following documents may be required:
- Clinical Trial/Study Agreement
- Study Protocol
- Sponsor Budget
- Investigational Drug Service and/or Clinical Research Center pricing as soon as it is obtained, if applicable
- Contact information for CRO (if applicable) and direct contact to sponsor
Investigational Drug Service (IDS) at UMass Chan Medical School is located on the sixth floor in the Ambulatory Care Center. IDS has a dedicated staff of pharmacists and a technician to assist investigators with the execution of clinical research. They assure that drug studies are conducted in a safe, effective and efficient manner. IDS assures compliance with all federal, state and JCAHO regulations concerning investigational drugs. For more information about IDS and their services please see Investigational Drug Service Information.
Clinical Research Center (CRC) at UMass Chan Medical School is located on the first floor of the Ambulatory Care Center. The CRC has a team of experienced nurses willing and able to assist investigators with conducting high quality clinical research. The CRC is able to offer nursing, research and regulatory support all in one location. For more information about the CRC and their services please see Clinical Research Center Information.