Center for Clinical Research and Trials in Surgery
The UMass Center for Clinical Trials and Research in Surgery (CCRT) is designed to serve the needs of faculty and industry by providing the infrastructure necessary for the efficient conduct of clinical research and studies at UMMHC sites. The CCRT supports any type of research activity that is deemed suitable including in-house prospective studies, national trials and industry sponsored studies. Any faculty within the UMass Department of Surgery or other departments may access the expertise of the CCRT by arrangement. Services include:
- Study design and biostatistical analysis
- Review of study feasibility
- Liaison to industry including the completion of all required study start up and close out documentation.
- Support including study initiation, regulatory document assistance, preparation of first draft of IRB submission and assistance with IND applications
- Completion of yearly reporting obligations and study renewals
- Clinical support for inpatient and outpatient clinical studies provided by experienced nurses with expertise in phlebotomy, IV Therapy and EKG testing. Clinical staff will undertake training and appropriate credentialing to meet the needs of your specific research project. Staff have completed a Good Clinical Practice Program, Biohazard Shipping Certification, CPR, Telemetry monitoring and ACLS.
- Biostatistician Services provided by You Fu Li MD, MPH, as well as additional biostatistics and computer programming resources by arrangement
Human Subjects Educational Training Program
Researchers are required to successfully complete the online Collaborative IRB Training Initiative (CITI) Program before beginning projects that involve human subjects research.
IRB applications and/or amendments will be reviewed and processed after this program is completed.
When you register for the CITI program on line, you will be asked to select a course. Select the Biomedical Investigator Course Learner Group 1. Do not select the Social & Behavioral Investigator Course. For more information, click here.
Please feel free to contact the Clinical Research Nurse: Shauneen Valliere RN, MSN (phone: 508-856-1767) or the Center’s Director Shimul Shah M.D. (office: 508-334-2023) regarding any projects in which we may be able to offer assistance.