# Patient Safety Monitoring in International Laboratories (SMILE)

> **NIH NIH N01** · JOHNS HOPKINS UNIVERSITY · 2024 · $3,230,524

## Abstract

NIAID places the highest priority on ensuring the safety and optimal management of individuals who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing. NIAID aims to achieve comparability between U.S. (licensed labs) and non-U.S. generated study results. The purpose of this contract for Patient Safety Monitoring in International Laboratories (SMILE) is to enhance the ability of current and future mostly non-U.S. laboratories participating in NIAID Division of AIDS (DAIDS)-supported clinical trials to perform tests in accordance with good clinical laboratory practice standards and produce reliable test results. The contract will provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring compliance with good clinical laboratory practice standards, (2) monitoring the quality and reliability of protocol-specified laboratory test results, (3) providing labs with various means of assistance, guidance and training to improve the quality of laboratory operations, and (4) hosting and maintaining the existing electronic data management system.

## Key facts

- **NIH application ID:** 11032795
- **Project number:** 75N93020C00001-P00009-9999-1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** LORI SOKOLL
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $3,230,524
- **Award type:** —
- **Project period:** 2023-11-15 → 2024-11-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11032795

## Citation

> US National Institutes of Health, RePORTER application 11032795, Patient Safety Monitoring in International Laboratories (SMILE) (75N93020C00001-P00009-9999-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11032795. Licensed CC0.

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