The Clinical Perspective - Biomedical Informatics in Translational Research - page 20

subject's name will be stored, and who, besides the principal investigator, will have
access to this information.
To this end, a database containing the patient's demographic information that is
needed by clinic staff, as well as the patient's unique, research-specific ID number
must be maintained in a secure way. Access to it should be password protected and
available to essential staff only. Documents containing both the patient's name and
unique research ID number should be used and viewed only by essential staff in the
clinic. Paper files requiring storage that link the participant's name with his or her
research-specific ID number should be locked and viewed only by essential staff.
Such files should be shredded when disposal becomes necessary. All data that will be
entered into the biomedical informatics platforms, and analyzed for research pur-
poses must contain the research-specific ID number of the patient, and must not con-
tain other patient identifiers such as names or medical record numbers, assuming
this level of deidentification has been promised to the patient within the informed
consent. Thus, the researchers conducting research analysis will see only a research
ID for the patient, but those clinical research staff who need the information will
have access to both the patient's name and research ID number.
Biospecimens and questionnaires require a tracking barcode or unique identifier
of their own. That identifier links to the research subject's specific ID number and
also links to the date these data are collected. This becomes essential when multiple
surveys, images, and biospecimens from one research subject are collected through-
out the lifetime of the project. One participant may have five yearly mammograms
on file in the biomedical informatics repository. Each mammogram needs to be iden-
tified as belonging to that unique patient (research-specific ID number), and each
needs to be identified as a unique data element of its own, associated with the date it
was obtained (e.g., a unique barcode ID number that maps back to the research-spe-
cific ID number and the date the mammogram was obtained).
2.6.3 Quality Assurance
The clinical team will need to communicate closely with the data management staff
that receive and review the questionnaires, biospecimens, and other clinical data
such as mammograms and ultrasound images. It is vital to have open communica-
tion channels for resolving discrepancies, as well as electronic data tracking tools for
making changes to data collected. Neither medical charting, nor the processes of
retrieving medical and social histories from patients are 100% reliable.
The process of obtaining as accurate and complete a data record as possible
from a patient can require much back and forth between data collectors and data
reviewers, depending on the volume of patients participating in the research study,
the volume of data collected, and the precision with which data is collected. For
example, a research nurse may record that a mammogram was completed on a
patient the same day she completed a research questionnaire, but forgets to include
the actual mammogram result on the questionnaire. The research staff conducting
the quality review of the questionnaire identifies the missing value and must commu-
nicate with the research nurse to obtain it.
At the CBCP, the Windber Research Institute developed a user-friendly online
data tracking tool that streamlines the process of identifying, communicating, and