Data processing: presentation processing of document – operator i – Presentation processing of document – Layout
Reexamination Certificate
1998-06-05
2004-11-16
Feild, Joseph (Department: 2176)
Data processing: presentation processing of document, operator i
Presentation processing of document
Layout
C715S252000, C715S252000, C705S002000, C600S300000
Reexamination Certificate
active
06820235
ABSTRACT:
COPYRIGHT NOTICE
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
BACKGROUND OF THE INVENTION
Once a pharmaceutical, medical device manufacture or bio-technology company has developed a treatment, device or drug therapy, approval from a regulatory authority, such as the FDA in the US, must be obtained before it can be made available through prescription. The submission to the regulatory authority consists of a large volume of information, including clinical information which focuses on the safety and efficacy of the therapy. Much of that information is collected by conducting clinical trials.
A pharmaceutical, medical device manufacture or bio-technology company sponsors a series of clinical trials. Either an internal clinical group manages these trials or they are out-sourced to a clinical research organization (CRO). The clinical group or CRO contracts with investigation sites that in turn recruit patients for the study and collect the clinical data.
The clinical trials are performed in a series of phases, known as Phase I, Phase II, Phase III, and Phase IV. Each phase varies in duration, the number of patients involved and purpose. Failure at any stage of Phases I, II or III of the clinical trial process effectively ends the therapy's chances for final approval.
Before entering Phase I, the sponsor needs to obtain regulatory approval. Phase I trials typically last six months and involve tens of volunteer subjects usually all of whom are located at a single investigative site. Phase I trials test the safety of the therapy. Once Phase I rials are complete and the therapy has been shown to be safe, the sponsor requests permission from the regulatory authority to proceed with further clinical tests.
Phase II trials typically last six to twelve months, involve tens to hundreds of patients and are conducted to test the effectiveness of the treatment, device or drug. A sponsor may conduct many Phase II trials, attempting to find as many uses of the therapy as possible. If the therapy appears to be effective, the sponsor requests permission from the regulatory authority to proceed with large scale trials.
For each likely use of the therapy, the sponsor conducts at least two Phase III trials. Phase III trials typically last 24 to 36 months and involve thousands of patients. Phase III trials are blinded trials, that is, a portion of the patients receive the therapy and the remaining patients receive a placebo or active control, and the identities of patients taking the trial therapy are not known to anyone until the trial is complete. Phase III trails are conducted to test the safety and effectiveness of a therapy in a large population. The Phase III trial is the first opportunity to observe infrequent adverse effects in the general population; each and every one is carefully recorded. Since the effectiveness of the therapy is tested in a blinded environment, the results are not known until after the study is complete.
Phase IV trials occur after approval and are generally held to obtain approval to change a characteristic such as the delivery system, e.g., from liquid to tablets, or to change the status, e.g., from a prescription drug to an over-the-counter drug. Failure at any stage of a Phase IV trial effectively ends the therapy's chances of obtaining approval for such a change.
Every clinical trial has a protocol which specifies the exact timing and nature of the measurements and interventions to be performed on each patient. The protocol's time-line lists a series of events, or visits, where the data are collected from the study patient. The time-line of a typical study starts with the screening and enrollment of a patient and typically ends with the last patient visit.
FIG. 1
illustrates the preparation and processing of paperwork in a typical clinical trial. There are a number of points in the process where the data are audited and reviewed. A patient
401
visits the investigative site
413
. For each visit, the protocol instructs the investigator to collect certain information
403
about the patient
401
. After the information
403
is collected, it is recorded on a Case Record Form (CRF)
405
. Periodically, a Clinical Research Associate (CRA)
417
visits the investigative site
413
and compares the data in the original medical record
403
with the information on the CRF
405
. This process
406
is known as source document validation, or SDV.
Once the CRF has been source document verified, CRF
405
is delivered to the organization
407
running the trial (either a CRO or an internal clinical group at he sponsor) as indicated by arrow
408
. When the CRF
405
arrives at the sponsor/CRO
407
, its data is entered into a clinical database
409
twice to ensure that no errors are introduced, as indicated by arrows
410
A and
410
B.
A medical monitor
415
and clinical data manager (CDM)
419
at the sponsor/CRO
407
examine the CRF
405
to look for inconsistencies. If any of the data are incomplete or appear incorrect, the CRF is sent back to the investigative site
413
with a query
411
for correction, a process known as cleaning. If someone at the investigative site
413
makes a change as a result of a query
411
, the data is again source document verified by the CRA
417
, and is sent back to the sponsor/CRO
407
for data entry, as identified by arrow
412
. When all of the data cleaning is complete, the clinical database
409
is locked and data analysis begins.
As can be seen, a large volume of data is collected during each clinical trial, and the collection and management of clinical data is a large problem that requires many people performing a number of different and unique roles. These roles fall into three groups: the investigative site roles, the clinical data review roles, and other central sponsor roles.
SUMMARY OF THE INVENTION
Implementing such a system or method on the Web has the obvious advantage of ease—many people are now familiar with Web technology and even those with computerphobia are becoming comfortable accessing the Web. In addition, because browsers are so inexpensive, while the personal computers on which they run can typically be had for under $1,000, there are no major expenses involved for other than the development of the clinical trial database. No special software needs to be distributed.
On the other hand, one disadvantage is that access over the Web can be considerably slower than a direct connection to a host server. Another is that certain things that can be done easily in a closed environment with custom software, such as curved boundaries between frames, are not so readily done on the Web. The present invention is aimed at overcoming these and other disadvantages.
Therefore, a method of implementing a graphical user interface (GUI) control element within a client browser, comprising creating several bitmaps which can be constructed to present the GUI control element in a variety of different states. A Standard Generalized Markup Language (SGML)-derived language such as HTML or XML is used to specify placement of the bitmaps within a document. Upon receipt of the document, a browser displays a desired GUI control.
Preferably, placement of he bitmaps is specified by placing indicators such as URLs corresponding to the bit maps in certain locations, preferably table entries, within the document, such that the browser will correctly display the control element. Preferably, these bit maps are used by many similar GUI Controls.
Furthermore, a bitmap may be partitioned into multiple sections, where each section is associated with a different indicator.
In particular, in a preferred embodiment, one type of control element is a button control which comprises left, right, top and bottom pieces. A label
Bleicher Paul A.
Dale Richard M.
Klofft Jeffrey P.
Stamos Nicholas
Bashore William L
Feild Joseph
Hamilton Brook Smith & Reynolds P.C.
Phase Forward Inc.
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