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Dholani Perera |
The Utah CTSI had the privilege of talking to Dholani Perera, the clinical research compliance manager for Clinical Research Support Office (CRSO). We thank her for taking the time to answer our questions about her work with CRSO.
What is your name and title, and what part of the CTSI do you work for?
My name is Dholani Perera and I'm a Clinical Research Compliance Manager for the Clinical Research Support Office.
What services or resources does your core provide?
Our team provides monitoring and quality assurance services for clinical research studies conducted at the University of Utah. Our primary focus is currently on reviewing Investigator-initiated trials (or IITs).
What are your responsibilities within CRSO?
- For investigator-initiated trials that hold an IND (which is an Investigational New Drug) or IDE (which is an Investigational Device Exemption) our team conducts a pre-IRB audit to ensure that all required documentation is in place before the study begins. We then conduct routine monitoring after the first participant has been enrolled through the end of the study.
- We also provide FDA audit support- our team will conduct pre-reviews (when possible), and also provide assistance to study teams throughout the audit process.
- We can also assist with non-FDA audits such as sponsor GCP audits and audits by other regulatory agencies such as the European Medical Agency (EMA).
- In addition, we can assist study teams with review and development of protocols, protocol risk assessments, monitoring plans, and case report forms, and provide staff training.
What is one of the most interesting research projects CRSO has supported?
I would say implementation of eReg which is essentially an electronic regulatory binder that all study teams can utilize. This will alleviate the need for paper binders many teams are accustomed to and provide a standardized and more efficient method to maintain and store regulatory essential documents for studies.
What is your proudest accomplishment as part of the CTSI team?
Helping initiate the Data and Safety Consultation Committee (DSCC) that is able to intervene in the conduct of studies as necessary to ensure the safety of research participants, and verify protocol and data compliance.
What is one of your favorite things about working for CRSO and the CTSI?
I would have to say the people that I work with on a daily basis. I think we have a great team and we always try to support each other and lend a hand whenever we can. How should people reach out for support from CRSO? You can visit the CRSO website and you can find contact information for different groups at this site. If you would like to contact the QA team, please email us at crsoqa@hsc.utah.edu.
Tell us how the CTSI can support your research.