# Clinical Trial Operations Core

> **NIH NIH P50** · DUKE UNIVERSITY · 2020 · $252,623

## Abstract

ABSTRACT – Clinical Trial Operations Core (Core 2)
The Clinical Trial Operations Core provides critical research support to promote seamless and efficient
development, recruitment and conduct of the clinical trials in the Duke Brain SPORE's three projects and
clinical studies proposed by Developmental and Career Enhancement awardees. Bringing strong expertise in
neuro-oncology and clinical trial operations to the SPORE, the Core ensures the safe and efficient conduct of
clinical studies (Aim 1) and recruitment, consent and enrollment of a diverse group of subjects for biospecimen
collection and clinical studies (Aim 2). Through these Aims, the Core provides critical oversight of the full range
of clinical trial activities, including study design, protocol preparation, research staff training, patient
recruitment, patient evaluation during treatment and follow-up, assessment and treatment of complications,
and evaluation of patient outcomes. To ensure rigorus trial conduct, the Core mainatins a full portfolio of
standard operating procedures (SOPs). In addition, the Core is fully integrated with other Duke Brain SPORE
components to ensure seamless research coordination. For example, in partnership with the Administrative
Core, this Clinical Trial Operations Core provides regulatory specialists to meet the requirements of the federal
government, Duke University Health System (DUHS), and Duke Cancer Institute (DCI) and avoid conflict of
interest (COI). This Core also collaborates with the Biostatistics and Bioinformatics Core (Core 1) in the
development of the protocol electronic case report forms (eCRFs), study database, data management, quality
assurance, and summarization of clinical data for presentation at international meetings and manuscript
publications. Finally, the Clinial Trial Operations Core supplies electronic data acquisition and documentation
services for the Biostatistics and Bioinformatics Core (Core 1) and facilitates tissue biobanking with the
Biospecimen and Immune Monitoring Core (Core 3). By enchancing interdisciplinary communictation and
collaboration in this way, the Core supports the the SPORE's commitment to both translate laboratory findings
to the clinic and collect clinical material to be studied in the laboratory.

## Key facts

- **NIH application ID:** 9996525
- **Project number:** 5P50CA190991-07
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Annick Desjardins
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $252,623
- **Award type:** 5
- **Project period:** 2014-09-24 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996525

## Citation

> US National Institutes of Health, RePORTER application 9996525, Clinical Trial Operations Core (5P50CA190991-07). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9996525. Licensed CC0.

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