P R O G R A M P R O F I L E
Clinical Trials Resources Group guides researchers
EVEN THE MOST EXPERIENCED researcher can find the myriad of regulations and requirements that govern clinical trials confusing. All clinical trials go through three major stages of activity (pre-study, study conduct and post-study), and each phase has distinct requirements, depending upon the nature of the project. Fortunately, UC Davis clinical researchers have access to a CTSC resource to assist them. The Clinical Trials Resource Group (CTRG) helps clinical research teams navigate the labyrinth of regulations and requirements encountered in planning and conducting clinical trials.
Kate Marusina, manager of the Regulatory Knowledge and Support Program, including the CTRG team, assists with each phase of the study process. For example, team members can help with the documentation required to gain regulatory approval of human-subject protocols and compliance with Institutional Review Board (IRB), FDA and Medicare regulations through the duration of a study. Marusina and her staff accommodate a variety of requests from investigational teams in every phase of the project. The group can develop consent forms, prepare IRB submissions, file IND, IDE and other regulatory documentation, monitor clinical trials, and determine which charges are payable by insurance or study funds.
“Recently we assisted a MIND Institute researcher in completion of the entire IRB submission packet for a study involving children with genetic disorders. We prepared the parental consent form for this study,” Marusina said. “Since the study enrolled patients of various ages, we also composed the forms required for minors to participate, such as an assent form for ages 12 to 17 and a letter of information for ages 8 to 11. We also helped prepare a telephone screening script to describe eligibility requirements for parents of potential subjects. Because screening is part of the informed-consent process, the document had to include specific information required by the IRB,” Marusina explained. With assistance from the CTRG, the project was approved in a timely fashion so the study could proceed on schedule.
Monitoring study activity is another service that the CTRG offers to help investigators comply with applicable regulatory requirements.
“Once a study protocol is approved by the IRB, we can create regulatory binders and offer guidance on required documentation, including study personnel responsibility logs, training logs and study-product accountability documentation,” Marusina said. “A monitoring plan is typically protocol-specific to reflect the variables of the study, such as number of subjects, study visits and study-related procedures, and reflects the overall complexity of the trial. We also go to the study site to review study documents for completeness and accuracy.”
In addition, the Clinical Trials Resource Group hosts a robust education program that includes training for clinical research budgeting and billing, the informed-consent process, coverage analysis, navigating the clinical trials process, and other relevant topics. The CTRG team includes certified clinical research professionals Denise Owensby and Virina De Jesus, who oversee clinical trial monitoring services and help investigators prepare IRB paperwork; Suzan Bruce, a certified professional coder who specializes in coverage analysis and billing; and Debie Schilling, an analyst who performs data extraction and analysis.
|Clinical Trials Resource Group services
• IRB, FDA and Medicare regulations
• IRB application forms, ICFs, annual reports, AEs and Deviations
• Filing of INDs and IDEs
• Coverage analysis (determining what is payable by insurance, and what is payable by the study account)
• Study monitoring
• Preparing for regulatory audits (FDA or industry sponsors)
• Coordination of study subject visits
• Preparing case report forms
Visit http://www.ucdmc.ucdavis.edu/clinicaltrials/forinvestigators/forinvestigators.html for more information about the Clinical Trials Resource Group.