SOW PCA-NIDA-09054.pdf
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- Solicitation number
- NOI-PCA-NIDA-09054
About this file
This is a Statement of Work (SOW) for services issued by the National Institutes of Health, National Institute on Drug Abuse for pharmacogenomic analysis of biospecimens from the STAR-B randomized clinical trial evaluating semaglutide for alcohol use disorder treatment.
The contractor shall provide comprehensive genomic laboratory and bioinformatics services including biospecimen receipt and processing, DNA extraction and quality control assessment, genome-wide genotyping and/or sequencing, standard bioinformatics processing, and delivery of raw and processed genomic data files with associated documentation. The STAR-B study, coordinated with the STAR-T study at Oklahoma State University, aims to identify genetic factors associated with treatment response, adverse events, alcohol-related outcomes, and clinical phenotypes using harmonized protocols and pooled analyses. The period of performance is 12 months from award. Deliverables include sample receipt and inventory reports, DNA quality assessment reports, laboratory processing reports, raw data files (FASTQ, IDAT, CEL, or equivalent), processed genotype/variant call files, variant annotation files, comprehensive quality-control reports, bioinformatics methods documentation, and a final project summary report. Acceptability of deliverables depends on government verification that quality-control metrics are met, data files are complete and accessible, and documentation is sufficient to reproduce analytical procedures. No travel is approved, contractor will not receive system access with communication via email, phone, and MS Teams. All data remains NIH property and must not be distributed outside NIDA IRP clinical teams. The contractor must maintain all participant information per applicable federal requirements and institutional policies, with samples and data de-identified prior to transfer.
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Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
Title of Project:
Statement of Need and Purpose:
Background Information and Objective:
Period of Performance:
General Requirements:
National Institutes of Health National Institute on Drug Abuse
STATEMENT OF WORK (SERVICES)
(SOW)
GENERAL INFORMATION
Pharmacogenomic Analysis of Participants Enrolled in the STAR-B Randomized Clinical Trial of Semaglutide for Alcohol Use Disorder
The Contractor shall provide comprehensive genomic laboratory and bioinformatics services for pharmacogenomic analysis of biospecimens collected from STAR-B participants.
The STAR-B study is a randomized, placebo-controlled clinical trial evaluating semaglutide for the treatment of Alcohol Use Disorder (AUD). The study includes collection of biospecimens for pharmacogenomic analyses intended to identify genetic factors associated with treatment response, adverse events, alcohol-related outcomes, and relevant clinical phenotypes.
STAR-B was designed in coordination with the STAR-T study conducted at Oklahoma State University. The studies utilize harmonized protocols, outcome measures, and statistical analysis plans that include pooled and comparative analyses across studies.
12 months from time of award
SCOPE OF WORK
The Contractor shall:
1. Receive and process biospecimens supplied by the Government.
2. Perform DNA extraction (if required).
3. Conduct quality control assessment of DNA quantity and integrity.
4. Perform genome-wide genotyping and/or sequencing as specified by the Government.
5. Generate raw and processed genomic data files.
Specific Requirements:
Travel:
Information System Security Plan:
Data Rights:
6. Conduct standard bioinformatic processing and quality-control procedures.
7. Deliver data and associated documentation to the Government.
8. Maintain chain-of-custody and sample-tracking documentation throughout the project.
GOVERNMENT RESPONSIBILITIES
Deliverables shall be considered acceptable upon Government review and confirmation that:
• Required quality-control metrics have been met;
• Data files are complete and accessible;
• Documentation is sufficient to reproduce analytical procedures;
• Deliverables satisfy all requirements specified in this Statement of Work.
DELIVERY OR DELIVERABLES
The Contractor shall provide the following:
1. Sample receipt and inventory report.
2. DNA quality assessment report.
3. Laboratory processing report.
4. Raw data files (e.g., FASTQ, IDAT, CEL, or equivalent).
5. Processed genotype/variant call files.
6. Variant annotation files.
7. Comprehensive quality-control report.
8. Bioinformatics methods documentation.
9. Final project summary report.
OTHER CONSIDERATIONS
No travel is provided or approved.
The contractor will not be provided any system access. The primary means of communication will be email, phone, and MS Teams.
All data provided to the contractor will remain solely the property of NIH. It is not to be distrubted outside of the NIDA IRP clinical teams.
Section 508—Electronic and Information Technology Standards:
Confidentiality of Information:
N/a
The Contractor shall maintain all participant information in accordance with applicable federal requirements, institutional policies, and data-security standards. Samples and data shall be de-identified prior to transfer.
| National Institutes of Health |
| National Institute on Drug Abuse |
| STATEMENT OF WORK (SERVICES) (SOW) |
| GENERAL INFORMATION |
| Pharmacogenomic Analysis of Participants Enrolled in the STAR-B Randomized Clinical Trial of Semaglutide for Alcohol Use Disorder |
| SCOPE OF WORK |
| DELIVERY OR DELIVERABLES |
| OTHER CONSIDERATIONS |
File details come from the government source that posted it. Updated .