The Department of Pediatrics continues to be a leader in the management of our clinical research program, providing information and training to the surrounding clinical research community and piloting new programs. By continuing to centralize our clinical research program within the department, we seek to maintain greater regulatory compliance, maximize the use of organizational resources, and permit expansion of clinical research into smaller, unsupported divisions and centers. New faculty can get their studies initiated faster, with existing knowledgeable personnel to complete the budgeting and regulatory necessities of a study. We are also able to fund new programs and attempt new and innovative ways to consolidate the most time-consuming aspects to getting a trial off the ground.
P-CRSL Clinical Research Support Services
Funded by the Department of Pediatrics and UPMC Children’s Hospital of Pittsburgh, the Clinical Research Support Services (CRSS) program facilitates the start-up, implementation, coordination, internal data monitoring, and completion of investigator initiated, grant funded, multi-center cooperative group, and industry-sponsored trials by providing research management, regulatory, and research coordinator support within all departments across CHP.
This program began in 2017 and has been a growing success. CRSS supports 8 pediatric divisions with greater than 65 open studies. Our intention is to fully develop this into a recognized University Core facility, and begin billing for services under a recognized business model.
The services provided including the following:
- Clinical Research Management: A Clinical Research Manager (CRM) is responsible for day-to-day operations of the program, including oversight of research staff, ongoing clinical trials, and activities associated with activation of new clinical trials. CRM communicates with sponsors, assists pre-award administrator with budget development, ensures timely submission of all regulatory documents through metric tracking, and develops recruitment plan with investigator and research team.
- Regulatory support: A regulatory coordinator is responsible for document preparation for submission to all governing bodies, in accordance with all applicable regulatory bodies. Completed documents are submitted to UPMC (OSPARS) or the Pitt Office of Research (OOR) as appropriate. Communication continues until approval. Documentation/reporting of adverse reactions (serious and non-serious) to all appropriate regulatory committees, (e.g., IRB, FDA, NIH, OBA, NCI, UPMC DSMC, etc.).
- Clinical Research Coordinators (CRCs): Experienced clinical research nurse and non-nurse coordinators are responsible for protocol execution to include recruitment of research subjects, scheduling and conduct of research visits, ensuring protocol requirements are met, assisting with specimen collection, processing, and shipping as needed, developing study-specific source documents (data collection forms), and continued and timely communication with the clinical team.
- Quality Assurance Review: The Department of Pediatrics supports a team of experienced regulatory and research coordinators who are available by request to ensure studies conducted at CHP are protocol and regulatory compliant. The program will identify areas where action is necessary and support the study team in both resolution and prevention of compliance issues.
Mobile Research Services (MRS)
In FY2015, the department initiated the MRS program as an attempt to address the most frequent reason for patient refusal to participate in a research study: the need to travel to a congested campus (Oakland and Lawrenceville) to comply with protocol-mandated visits. We utilize existing experienced clinical research staff, who are pre-exposed to protocol-specific training, to conduct the visits in a location convenient for the participant; the concept of this program is that patients are more likely to consent and maintain compliance for a research study if the visit can take place in their community or in their home. This program has achieved great success and is now being expanded into other areas within CHP.
The Pediatric Clinical and Translational Research Center (PCTRC) is a unique multidisciplinary setting that provides physicians the opportunity to investigate childhood diseases in a controlled clinical environment in both an inpatient and outpatient basis.