# Core B: Clinical Research

> **NIH NIH P50** · BAYLOR COLLEGE OF MEDICINE · 2022 · $143,287

## Abstract

PROJECT SUMMARY
This core provides all projects with centralized clinical trial support and the infrastructure of personnel and
services essential to safely and effectively support such research to meet Good Clinical Practice (GCP)
standards. Core services will be provided in Regulatory Affairs, Study Co-ordination, Quality Assurance (QA)
and Control (QC) and Data Safety Monitoring (DSM) leveraging the clinical research infrastructure of the Dan
L Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine. The Regulatory Affairs
component collaborates with investigators to develop and submit all required regulatory documents, including
initial and revised submissions to the IRB, IBC, and FDA and the subsequent annual reports and adverse
event notifications as required. This core has extensive experience with IND submissions, successfully
submitting over 100 studies of complex biological agents on over 50 INDs: the completed studies have
enrolled over 1200 patients. The Study Co-ordination group arranges meetings of investigators, attending
physicians, research nurses and data managers; provides training on the standard operating procedures
(SOPs) for each protocol; and offers research coordinator support to ensure that clinical studies are conducted
safely, accurately and efficiently to GCP standards using the OnCore clinical trials management system. The
QC program will ensure that the standard operating procedures for protocol development, conduct of clinical
trials, data collection and management of clinical trials are followed. The QA program will audit each study
after the first patient is enrolled; subsequent audits are held in a randomized way to ensure that studies follow
Good Clinical Practices. Data Safety monitoring is provided through the DLDCCC Data Review Committee or
external DSMB operating under an NCI-approved data safety monitoring plan, which is responsible for
reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies.
Finally, the core provides comprehensive and centralized biostatistical support to projects including study
design, data analysis and data management for preclinical and clinical studies. Centralized biostatistical
support facilitates efficient use of these services and promotes collaboration between biostatisticians and
investigators in the design, conduct, analysis and interpretation of results for all projects. This ensures the
conduct of high-quality projects that incorporate appropriate and state-of-the-art statistical methods from their
design to their analysis.

## Key facts

- **NIH application ID:** 10495080
- **Project number:** 2P50CA126752-16
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** HELEN E HESLOP
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $143,287
- **Award type:** 2
- **Project period:** 2007-09-11 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10495080

## Citation

> US National Institutes of Health, RePORTER application 10495080, Core B: Clinical Research (2P50CA126752-16). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10495080. Licensed CC0.

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