Core A: Clinical

NIH RePORTER · NIH · U19 · $347,140 · view on reporter.nih.gov ↗

Abstract

CORE A: Clinical SUMMARY/ABSTRACT This Core project will perform the central task of patient screening and enrollment, training of personnel, IRB application preparation, monitoring of clinical study components, sample collection, and collection of demographic data in concert with the Data Management and Analysis Core C through the following Aims: Aim 1: Study initiation, screening and subject enrollment. This goal will be realized through the experience and clinical trials expertise of the clinical leads at each site and will include reaching targets in patient enrollment and following subjects as they progress through the study, ensuring study visits and CMV PCR testing dates are not missed, and ensuring that objectives of Good Clinical Practice and regulatory compliance are met. Aim 2: Specimen collection. Designated study samples including blood, urine and biopsy samples will be collected according to the established study design and standard clinical practices. The Data Management and Analysis Core C will support this Aim by providing software support for automatic patient tracking. Aim 3: Clinical Outcome Collection. Clinical data will be gathered from direct patient contact and review of the electronic medical record, utilizing the REDCap online data collection tool in collaboration with the Data Management And Analysis Core C. Data collected will include CMV PCR testing results, CMV disease, rejection and treatment for rejection, other episodes of infection and quantitative measurements of allograft function. Aim 4: Safety and monitoring. A Data and Safety Monitoring Board will be convened to capture and report any adverse events associated with the 24 month kidney biopsy at UCSF, which will be performed for study purposes. Audits will be performed to ensure that study procedures have been followed and key research samples, tests and clinical data are collected. Progress of the patient enrollment, unanticipated problems, protocol deviations and adverse events will be summarized and reported. Accomplishing of the Aims in this core will provide clinical specimens and clinical data that are essential to the successful execution of Projects 1-3. The unique transplant volume, diversity, and track record of clinical excellence and clinical trial leadership at UCLA and UCSF, working in concert with other key Cores, will ensure the success of the proposed research.

Key facts

NIH application ID
10225358
Project number
5U19AI128913-05
Recipient
UNIVERSITY OF CALIFORNIA LOS ANGELES
Principal Investigator
Suphamai Bunnapradist
Activity code
U19
Funding institute
NIH
Fiscal year
2021
Award amount
$347,140
Award type
5
Project period
2017-08-01 → 2024-07-31