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MERC+GSI – DRAFT Test Plan
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SiCURE system installed and operating at GSI by August 17, 2009
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Two SiCURE calibration run completed by August 28, 2009
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GSI evaluation of the SiCURE system initiated by August 31, 2009
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GSI evaluation of the SiCURE system complete by October 9, 2009
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Draft report on the performance of the SiCURE system for review by the Advisory
Board/Committee and Siemens by December 31 2009
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Final report submitted and released to public by March 2010
8. Data Recording, Processing, and Storage
This section describes methods employed during data recording, processing, and storage
to minimize errors and assure high quality analyses.
MERC -
Documentation and Records:
A variety of data will be acquired and recorded electronically and manually by MERC
partners (CBL/UMCES, SERC, UM and WREC) during this evaluation. Operational
information and results will generally be documented in field/laboratory record books and on the
data sheet/chain-of-custody forms (see below). Copies of these raw data will be transferred to
the MERC office, which will store it permanently along with the rest of the study data.
Data Review:
All data are to be recorded directly in the field/laboratory record book as soon as they are
available. Records are to be written in water-proof ink and written legibly. Any corrections will
be initialed by the person performing the correction, will be crossed out with a line (not
blackened or white-out), and will be dated according to the date that the correction was made.
These data will include electronic data, entries in field/laboratory record books, operating data
from the MERC test facility, and equipment calibration records. Records will be spot-checked
within two weeks of the measurement to ensure that the data are recorded correctly. The checker
shall not be the individual who originally entered the data. Data entries shall be checked in
general for obvious errors and a minimum of 10 percent of all records shall be checked in detail.
Errors detected in this manner shall be corrected immediately. The person performing the
review will add his/her initials and the date to a hard copy of the record being reviewed. The
MERC staff member will place this hard copy in the files for this evaluation. In addition, data
generated by each MERC staff will be provided to the MERC Program Coordinator and
reviewed before they are used to calculate, evaluate, or report results.
GSI -
Data Recording:
Specific forms (i.e., by size class of organism, by scale of testing, etc.) are used to record
sample collection and analysis data. All relevant GSI Senior Personnel are responsible for
ensuring that the forms are correctly filled out at the time of sample collection and analysis. They
are also responsible for maintaining the forms on file, creating electronic copies, and posting to
the GSI Sharepoint website for storage. QAQC spot-checks of these forms and the processes
used to complete and maintain them are undertaken periodically by GSI QAQC officers and