# Clinical & Biostats Core

> **NIH NIH P50** · BAYLOR COLLEGE OF MEDICINE · 2021 · $157,518

## Abstract

PROJECT SUMMARY 
This core provides all projects with centralized clinical trial support and provides 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, FDA and 
NIH/ORDA and the subsequent annual reports and adverse event notifications as required. This core has 
extensive experience with IND submissions, successfully submitting 66 studies of complex biological agents 
on 32 INDs: the 30 completed studies have enrolled over 600 patients. The Study Co-ordination group 
arranges meetings of investigators, attending physicians, research nurses and data managers; provides 
training on the SOPs for each protocol; and offers research nurse 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 DLDCC Data 
Review Committee 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:** 10247733
- **Project number:** 5P50CA126752-15
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** HELEN E HESLOP
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $157,518
- **Award type:** 5
- **Project period:** 2007-04-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247733

## Citation

> US National Institutes of Health, RePORTER application 10247733, Clinical & Biostats Core (5P50CA126752-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247733. Licensed CC0.

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