SOLICITATION NOTICE
B -- Coordinating Center for Continuation of Follow-up of DES-exposed Cohorts
- Notice Date
- 8/5/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CP-51019-66
- Response Due
- 9/26/2005
- Archive Date
- 10/11/2005
- Description
- COORDINATING CENTER FOR CONTINUATION OF FOLLOW-UP OF DES-EXPOSED COHORTS. The Office of the Director (OD), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute is seeking a contractor to coordinate the continued follow-up of several established cohorts of women and men who were exposed to diethylstilbestrol (DES) in utero. The purpose of the study is to measure the incidence and mortality of cancer, especially cancers of the breast and reproductive system, in exposed and unexposed subjects. Disease outcomes will be ascertained by means of questionnaires, medical record review, and tissue samples as appropriate. The final cohorts include 9,477 mothers, 7,439 daughters and 4,101 sons. Baseline questionnaires were mailed to cohort members and pathology reports confirmed reported cancers and preneoplastic lesions in 1994, 1997 and 2001. Overall, the work will include but not be limited to, developing study materials and manuals, acting as a liaison with NCI and their contractors, and preparing and processing questionnaire, outcome validation and NDI and death certificate data. In addition, the work will include monitoring, documenting and reporting on the study?s progress. Specific tasks will include 1) establishing contact with each of the five field centers selected by NCI: establishing contact and coordinating activities as needed with NCI?s computer programming support services contractor; assisting in arranging communications or meetings, as needed, between the NCI Project Officer and field center staff; attending and reporting on such meetings, providing background materials as needed and take action on recommendations in consultation with the NCI Project Officer; and responding to queries from and meeting in-person at least quarterly with the NCI Project Officer. 2) Developing Study Materials and Manuals in collaboration with the field centers and NCI Project Officer: developing mail questionnaires to be sent to daughters and sons, and to other selected subpopulations as needed, developing and updating procedure manuals for the study, and establishing standardized procedures for each of the sub-studies; developing and updating abstract forms as needed, to record the results of clinical exams and abstraction information from medical records and pathology reports; assisting field centers in developing cover letters, newsletters, and other materials to be sent to cohort members to enhance participation rates and assisting centers in dealing with problems that arise in validating medical outcomes reported on the questionnaire; maintaining and updating the study web site (http://www.desfollowupstudy.org/); organizing logistical aspects of pathology slide review for diagnoses of high grade cervical intraepithelial neoplasia by receiving slides from field centers, and developing a tracking system for sending and receiving the slides to and from the designated central pathologist; organizing logistical aspects of autoimmune disease abstract review by receiving abstracts from field centers, and developing a tracking system for sending and receiving the abstract forms to and from the designated rheumatologist. 3) Data Preparation and Processing: receiving mail questionnaires and abstract forms from field centers for data entry; coordinating and conducting National Death Index searches to determine vital status, and assisting in reconciliation of vital status using available sources; coding specific diseases reported on questionnaires, pathology reports and death certificates using standard ICD coding procedures; scanning mailed questionnaires, and entering data from questionnaires and abstract forms as needed; editing and correcting computer files as needed; maintaining a master study file with vital status and response to the follow-up questionnaires; transmitting computerized data files containing edited, corrected data to the NCI Project Officer at the completion of each wave of follow-up, or as appropriate. 4) Monitoring, Information Management, Reporting and Documentation: utilizing a computerized information system to monitor the progress of data collection; initiating regular monthly telephone calls to the field centers to monitor progress and address problems during the data collection phase of the study, and receiving monthly reports from the field centers and providing them to the NCI Project Officer for review. On a quarterly basis, create a combined report from all the field centers to monitor the overall progress of the study. 5) Documenting all of the individual steps in the study and maintaining orderly files of all relevant materials, so that any aspect of the study can be reviewed and evaluated by NCI staff at any time during the course of the study and sub-studies, and coding decisions for questionnaires and medical records. The Government envisions the level of effort to be in the area of 17,500 hours over the 5 year period of performance. Award is anticipated by April 2006. This is a recompete of contrac N02-CP-11000 with Westat, Inc. It is anticipated that the RFP will be available on/about September 1, 2005 with responses due within 30 calendar days after the actual date of issuance of the solicitation. The RFP may be accessed via the NCI Research Contract Branch (RCB) website:http://rcb.cancer.gov/rcb-internet/ under Current Requests For Proposals. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE INTERNET SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. All responsible sources may submit a proposal which shall be considered by the NCI. No collect calls will be accepted.
- Record
- SN00863283-W 20050807/050805211918 (fbodaily.com)
- Source
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