OM t of c.iii - Vision Research Coordinating Center - Washington ...

2/22/96 Chapter 15 Coordinating Center page 15-8
(1) Forms are be self-contained, when possible. Their completion should not
require reference to separate instruction manuals or tables of codes for completion. The
instructions necessary for the completion of a form are routinely printed on the forms.
(2) Individual items are self-explanatory. Compactness of the forms is sacrificed
to achieve clarity when necessary.
(3) Forms include only that information which is available at a given point in
time. Information which is collected at a later date is incorporated into another form.
(4) Each person responsible for data collection and/or data entry will be
identified along with relevant dates of processing. This increases our ability to manage
the data collection/data entry aspects of the study and to identify staffing or quality
control problems.
15.8 Records Flow Within the Coordinating Center
Within one working day of receipt, the Project Assistant manually checks
agreement between the form type, the patient identification number, and visit date with
the Transmittal Log. When the transmittal log and the data received do not agree,
disagreements are resolved when possible. Unresolved disagreements are flagged with
an edit code when the data clerk enters Transmittal Log information. Additional
manual checks conducted by the data clerk include checking for the correct number of
pages, the patient identification number, and the date on the form. The Project Manager
performs a manual scan of forms before they are bundled by form type for key data
entry. The Project Assistant then bundles forms by type, stamps a unique batch number
on each page of the forms and stamps the batch number on the corresponding
transmittal log. Forms with serious problems are not sent to data entry pending
resolution of the problem.
Frequently, problems of protocol adherence are noted at this stage, and
remedial actions are initiated. The Coordinating Center response to problems with
protocol adherence range from discussions with the Clinic to a discussion with the
Study Chairman and the Executive Committee about possible changes to the protocol.
Another action to be considered is scheduling a site visit to the Clinic.
Key to disk entry of data is performed off-site by a subcontractor. Data are
picked up by courier daily. Data are keyed to disk by two different key operators, with
the second operator performing verification. The turnaround time for data to be
received on disk from time of pick-up by courier is three working days.
The data entry contractor completes a problem report for each batch of forms
processed. In this manner, the Coordinating Center is able to distinguish data errors