SOLICITATION NOTICE
R -- Professional Service - To de-identify clinical trials data
- Notice Date
- 8/14/2009
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- NOI-1166218
- Archive Date
- 9/12/2009
- Point of Contact
- Liem T Nguyen, Phone: 3014358780
- E-Mail Address
-
ln18x@nih.gov
(ln18x@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Health (NIH), National Institute on Drug Abuse (NIDA) Office of Acquisitions, Station Support Simplified Acquisitions Branch on behalf of the National Institute of Mental Health (NIMH) intends to negotiate, on a sole source basis, under authority of FAR 13.106-1(b)(1), with Duke University, Office of Sponsored Programs, 2200 West main Street, Durham, North Carolina 27705, for professional service in de-identifying Clinical Trials Data. The North American Industry Classification System Code is 541990 and the business size standard is $7.0M. One of the responsibilities of the Clinical Trials Operations and Biostatistics (CTOB) Unit in the Division of Services and Intervention Research, NIMH, is to ensure that data from clinical trials funded by research contracts and cooperative agreements that are made available to the public have been completely de-identified to protect the privacy of all participants and documented. The appropriately cleaned databases and documentation are usually provided by the data centers responsible for the trials. However, there are several trials that were conducted prior to current policies and standards for preparing limited public access databases and therefore the responsibility for preparing those databases for public access has fallen substantially to the CTOB Unit. The Child / Adolescent Multimodal Treatment Study (CAMS) is a multi-site NIMH funded cooperative agreement testing various approaches to the treatment of childhood anxiety disorders. This is a clinical trial, with a large, complex database. Dr. Compton at Duke University was part of the original CAMS team during the study and has been managing the Data Center for the CAMS project since its inception. Dr. Compton has the requisite database experience in general, and importantly, familiarity with the CAMS database. As part of the original CAMS team, Dr. Compton's role on the project included overseeing programming and data management activities. Given his prior experience with the data structure and his expertise in SAS, Dr. Compton will be able to oversee the development of efficient macro programming to expedite the preparation of the database. Most importantly, Dr. Compton has extensive experience working with sensitive databases and fully understands the need for and concepts of the de-identification process. The Purpose of this proposed acquisition is to completely de-identify the CAMS database, create "cleaned" PC SAS datasets, and create user-friendly data documentation to be made available for public use. This is a complex process and requires an intimate familiarity with the dataset and associated variables. Dr. Compton's experience in building system for data editing, manipulation, and analysis in support of sensitive research and evaluation projects paired with his prior experience with the CAMS protocol and data structure makes him uniquely qualified to complete the required tasks. The contractor shall provide two deliverables at the end of the purchase order period: 1) A complete set of PC SAS transportable data files, de-identified according to HIPAA rules and other conventions specified by CTOB, 2) A complete set of documentation for users of these data, specifically data dictionaries and a detailed User's Guide. The final product will be a CDROM containing well-organized directories of data files, documentation files, and instructional files. The document, to be provided by CTOB, "Documenting and Preparing Limited Access Datasets from NIMH Supported Clinical Trials Guidelines for Clinical Trials Data Centers and Data Managers" should be used when preparing the data files and associated documentation for delivery to the NIMH. The contractor will consult with NIMH staff on an as-needed basis through email and telephone conferencing during the performance period. PEORIOD OF PERFORMANCE The period of performance will be for 9 months commencing on or about September 1, 2009. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, interested party believes it can meet the above requirement may submit a statement of capabilities to Liem T Nguyen, ln18x@nih.gov on or before 2:00 PM ET August 28, 2009. All information furnished must be in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered in and have valid certifications in the Central Contractor Registration (CCR), www.ccr.gov and the Online Representations and Certifications Application (ORCA) www.orca.bpn.gov. Please reference announcement number NOI-1166218 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/NOI-1166218/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01912681-W 20090816/090815002827-208aeff5d6409e69295153d493ae13af (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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