Project Details
Description
Subrecipient's Scope of Work
The subaward will be necessary in order to achieve the goal of childhood follow-up of patients from the original study. Without the subaward at this center, attainment of the study sample size could be
compromised.
Responsibilities of the Subrecipient include:
• Obtaining and maintaining IRS approval and training for study personnel
• Obtaining sufficient study areas for study personnel to conduct participant visits and perform study procedures, including storage of study supplies.
• Participate in study related meetings, conference calls, and subcommittees as indicated by the Clinical or Data Coordinating Centers
• Contact and consent patients from the original CHAP trial. Each center will have the flexibility to use an approach that is most efficient and suitable for their system, while adhering to the study protocol.
• Obtain written informed consent at a study visit. After verbal consent (on phone) is obtained, the parents/guardians with the child of interest will present for a study site visit.
Agreement to provide outcome measures as defined in the protocol:
• To obtain a tube of blood will then be drawn from the child, it will be processed and frozen prior to shipment to the biorepository at the clinical coordinating center.
• Trained research staff will conduct research data abstraction from patient medical records and conduct patient interviews as required by the protocol. Research staff will undergo centralized specific training to ascertain study outcomes.
• Data collected will be entered into the data management system. No personal identifiers will be entered into the data system.
Compensate patients for participating
• Site PIs/Investigators will participate in centralized blinded review of pertinent primary outcomes to confirm the primary outcomes.
• Meet the yearly follow-up goals as determined by at least an 80% follow up rate of the recruitment from the primary CHAP trial at their given site over a 5-year period.
Status | Active |
---|---|
Effective start/end date | 9/20/23 → 5/31/25 |
Funding
- University of Alabama - Birmingham ( Award #5R01HD11299402): $24,878.00
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