Revised - ATTACHMENT 8-Sample Task Order 02APR2020.pdf
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- CLINICAL CENTRAL LABORATORY SERVICES Federal contract opportunity
- Solicitation number
- 7529
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RFP Clinical Central Laboratory Services ATTACHMENT 2 Sample Task Order 1OCT2019 Page 1 of 2
RFP-NIAID-DMID-75N93020R00004
ATTACHMENT 8: SAMPLE TASK ORDER
CLINICAL CENTRAL LABORATORY SERVICES
RFP-NIAID-DMID-75N93020R00004
NOTE: The following Sample Task Order indicated in this Attachment is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of a Statement of Work for clinical studies and clinical trials of similar scope and size to be issued under contracts awarded in response to this solicitation. Although this Sample Task Order will NOT be executed nor will awards be made for the sample work, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order will be accomplished with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.
SAMPLE TASK ORDER STATEMENT OF WORK
I. SCOPE
DMID may conduct clinical trials in domestic and international locations. The Contractor shall perform clinical laboratory screening and safety testing to support multi-center trials.
II. TECHNICAL REQUIREMENTS
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work.
In addition to the tasks and functions defined in the parent IDIQ Statement of Work, which are general Technical Requirements for all Task Orders, the Contractor shall perform the following:
RFP Clinical Central Laboratory Services ATTACHMENT 2 Sample Task Order 1OCT2019 Page 2 of 2
RFP-NIAID-DMID-75N93020R00004
Request for Central Lab Services for VTEU Studies
Protocol Number: TBD
Estimated Study Start Date: 8 weeks from TO award
Number of Months Lab Services Required: 12
Total # Sites: 4 Seattle, WA Houston, TX Baltimore, MD Iowa City, IA
Total # Subjects to be Screened: 260
Total # Subjects to be Enrolled: 200
# Blood Draws/ Enrolled Subject: 2
Total Number of Samples for Enrolled Subjects: (200 x 2) x 1.1 = 440
Assume an additional 10% of samples to include unscheduled visits and repeat labs required for adverse event (AE) follow-up.
Sample Pick-up: Monday - Friday
Frequency of Data Transfer:
Data will be transferred from the Central Laboratory data base to the Statistical Data and Coordinating Center electronically, at 12:00 PM and 5:00 PM, Monday – Saturday. Cumulative data transmissions shall be sent to the SDCC via a cumulative comma delimited data file transferred via placement on their file transfer protocol (FTP) for automated pick-up.
Reporting of Test Results:
Only results for tests listed below should be included in the data transfer.
Visit # Tests to Be Run
Screening HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody
V1 See below
V3 See below
Hematology: hemoglobin, hematocrit, platelets w/ differential, total WBC, and absolute eosinophil, neutrophil, and lymphocyte cell counts
Chemistry: ALT, AST, total bilirubin, creatinine, glucose, BUN
Urinalysis: occult blood, protein
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