U.S. patent application number 12/416747 was filed with the patent office on 2010-02-25 for automated identification of tasks that must be completed before a clinical trial database can be locked.
This patent application is currently assigned to NUMODA TECHNOLOGIES, INC.. Invention is credited to John W. Houriet, JR., Jianbo Peng.
Application Number | 20100049545 12/416747 |
Document ID | / |
Family ID | 41581391 |
Filed Date | 2010-02-25 |
United States Patent
Application |
20100049545 |
Kind Code |
A1 |
Houriet, JR.; John W. ; et
al. |
February 25, 2010 |
AUTOMATED IDENTIFICATION OF TASKS THAT MUST BE COMPLETED BEFORE A
CLINICAL TRIAL DATABASE CAN BE LOCKED
Abstract
Management of a database lock for a clinical trial study is
provided. A database is provided that includes clinical trial data
and the status of the data for a plurality of patients. Lock
criteria is defined for the study from a plurality of selectable
subsets of the clinical trial data. A processor automatically
generates a list of tasks that must occur to achieve the lock
defined by the lock criteria using the clinical trial data and the
status of the data.
Inventors: |
Houriet, JR.; John W.;
(Yardley, PA) ; Peng; Jianbo; (Drexel Hill,
PA) |
Correspondence
Address: |
PANITCH SCHWARZE BELISARIO & NADEL LLP
ONE COMMERCE SQUARE, 2005 MARKET STREET, SUITE 2200
PHILADELPHIA
PA
19103
US
|
Assignee: |
NUMODA TECHNOLOGIES, INC.
Philadelphia
PA
|
Family ID: |
41581391 |
Appl. No.: |
12/416747 |
Filed: |
April 1, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61091142 |
Aug 22, 2008 |
|
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Current U.S.
Class: |
705/3 |
Current CPC
Class: |
G06Q 10/103 20130101;
G16H 70/20 20180101; G16H 15/00 20180101; G06Q 30/018 20130101;
G16H 10/20 20180101 |
Class at
Publication: |
705/3 ;
707/104.1 |
International
Class: |
G06Q 50/00 20060101
G06Q050/00; G06F 17/30 20060101 G06F017/30; G06Q 10/00 20060101
G06Q010/00 |
Claims
1-4. (canceled)
5. The method of claim 20 further comprising selecting at least
criteria (i) in step (a) the criteria (i) further comprises
specific clinical patient data of interest.
6. The method of claim 20 wherein the summary data includes the
number of task items that must occur to achieve the database
lock.
7. The method of claim 20 wherein the summary data provides
information that allows for a determination of the number of
clinical sites that have patients with uncompleted task items.
8. The method of claim 20 wherein the summary data provides
information that allows for a determination of patients with
uncompleted task items.
9. The method of claim 20 wherein the summary data is organized by
types of uncompleted tasks.
10-13. (canceled)
14. The method of claim 21 further comprising selecting at least
criteria (i) in step (a) wherein the criteria (i) further comprises
specific clinical patient data of interest.
15. The method of claim 21 wherein the list of task items includes
locking a case report form.
16. The method of claim 21 wherein the list of task items includes
identifying missing or incomplete case report forms.
17. The method of claim 21 wherein the list of task items includes
identifying case report forms that have not been signed by
authorized medical personnel.
18. The method of claim 21 wherein the list of task items includes
identifying case report forms that include open queries.
19. (canceled)
20. An automated method of generating summary data regarding task
items that must occur to achieve a database lock for a clinical
trial study that is performed based on a previously defined
clinical trial protocol, the clinical trial study being managed
using (i) a processor, and (ii) a database in communication with
the processor, the database including clinical trial data and the
status of the data for a plurality of patients participating in the
clinical trial study, the method comprising: (a) electronically
selecting at least one of the following criteria for a database
lock: (i) one or more subsets of clinical trial data from a
plurality of subsets of clinical trial data, (ii) one or more time
frames or a time point in the study, (iii) one or more patient
types, and (iv) a predefined number of patients; (b) receiving in a
processor the electronically selected criteria; (c) defining in the
processor clinical database lock criteria for the study from the
electronically selected criteria; (d) inputting into the processor:
(I) the clinical database lock criteria for the study, and (ii) the
clinical trial data and the status of the data, as retrieved from
the database, for the plurality of patients participating in the
clinical trial study as defined by the clinical database lock
criteria; and (e) automatically and programmatically generating via
the processor summary data regarding task items that must occur to
achieve the database lock as defined by the clinical database lock
criteria for the study, wherein different summary data will be
generated for different clinical database lock criteria.
21. An automated method of generating a list of task items that
must occur to achieve a database lock for a clinical trial study
that is performed based on a previously defined clinical trial
protocol, the clinical trial study being managed using (i) a
processor, and (ii) a database in communication with the processor,
the database including clinical trial data and the status of the
data for a plurality of patients participating in the clinical
trial study, the method comprising: (a) electronically selecting at
least one of the following criteria for a database lock: (i) one or
more subsets of clinical trial data from a plurality of subsets of
clinical trial data, (ii) one or more time frames or a time point
in the study, (iii) one or more patient types, and (iv) a
predefined number of patients; (b) receiving in a processor the
electronically selected criteria; (c) defining in the processor
clinical database lock criteria for the study from the
electronically selected criteria; (d) inputting into the processor:
(i) the clinical database lock criteria for the study, and (ii) the
clinical trial data and the status of the data, as retrieved from
the database, for the plurality of patients participating in the
clinical trial study as defined by the clinical database lock
criteria; and (e) automatically and programmatically generating via
the processor a list of task items that must occur to achieve the
database lock as defined by the clinical database lock criteria for
the study, wherein a different list of task items will be generated
for different clinical database lock criteria.
22. An article of manufacture for generating a list of task items
that must occur to achieve a database lock for a clinical trial
study that is performed based on a previously defined clinical
trial protocol, the clinical trial study being managed using (i) a
processor, and (ii) a database in communication with the processor,
the database including clinical trial data and the status of the
data for a plurality of patients participating in the clinical
trial study, the article of manufacture comprising a
computer-readable medium encoded with computer-executable
instructions for performing a method comprising: (a) electronically
selecting at least one of the following criteria for a database
lock: (i) one or more subsets of clinical trial data from a
plurality of subsets of clinical trial data, (ii) one or more time
frames or a time point in the study, (iii) one or more patient
types, and (iv) a predefined number of patients; (b) receiving in a
processor the electronically selected criteria; (c) defining in the
processor clinical database lock criteria for the study from the
electronically selected criteria; (d) inputting into the processor:
(i) the clinical database lock criteria for the study, and (ii) the
clinical trial data and the status of the data, as retrieved from
the database, for the plurality of patients participating in the
clinical trial study as defined by the clinical database lock
criteria; and (e) automatically and programmatically generating via
the processor a list of task items that must occur to achieve the
database lock as defined by the clinical database lock criteria for
the study, wherein a different list of task items will be generated
for different clinical database lock criteria.
23. The method of claim 20 further comprising selecting a plurality
of the criteria in step (a).
24. The method of claim 20 further comprising selecting at least
criteria (i)-(iii) in step (a).
25. The method of claim 21 further comprising selecting a plurality
of the criteria in step (a).
26. The method of claim 21 further comprising selecting at least
criteria (i)-(iii) in step (a).
27. The article of manufacture of claim 22 further comprising
selecting a plurality of the criteria in step (a).
28. The article of manufacture of claim 22 further comprising
selecting at least criteria (i)-(iii) in step (a).
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 61/091,142 filed Aug. 22, 2008.
COPYRIGHT NOTICE AND AUTHORIZATION
[0002] Portions of the documentation in this patent document
contain material that 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 file or records, but
otherwise reserves all copyright rights whatsoever.
BACKGROUND OF THE INVENTION
[0003] Pharmaceutical, Biotechnology, Bio-Pharmaceutical, Medical
Device Companies and academic researchers conduct clinical studies
to evaluate the safety and efficacy of new products to help
determine suitability for the market. These groups or companies are
known as Clinical Trial Sponsors. An important part of the clinical
study is to collect a variety of clinical data on patients to test
the product in a controlled setting. These data are typically
presented by the Sponsor in a variety of formats including various
statistical analyses to the appropriate regulatory agencies, such
as the Food and Drug Administration for review and approval.
[0004] A clinical study team can be comprised of many individuals,
from many organizations, and from many countries. In addition to
the Sponsor, there is usually a group, or groups, tasked with
conducting the study on behalf of the Sponsor. These groups are
known as Clinical Research Organizations (CROs). In addition to the
Sponsor and CROs, the study employs Clinical Sites (Site) which are
managed by physicians, known as the Principal Investigator (PI).
Sites are typically located at doctors' offices, hospitals or
clinics, depending upon the therapeutic area of the study itself.
Each Site will recruit and enroll patients into the study until the
number of patients required for the appropriate statistical
analyses has been reached. The larger the study and the more
countries involved, the more staff will be required. The number of
Sites and CROs required to conduct the study may also be
larger.
[0005] The integrity of the data collected in the study is
paramount to the success of the study. The staff of the Sites, as
defined by the Sponsor, must carefully execute the clinical
protocol. All data must be properly recorded in compliance with
Good Clinical Practice (GCP) policy, as well as other local and
global regulations for study conduct. In order to ensure data
integrity and regulatory compliance, personnel are dispatched to
the Sites to review clinical data, protocol compliance, and
regulatory compliance. These personnel are known as Study Monitors
(Monitors) or Clinical Research Associates (CRA). Any monitor can
make several trips to their Site during the course of the study.
During each visit, the monitor checks various electronically
entered clinical data against their source sheets for accuracy. The
monitor can then either accept the Case Report Form (CRF) if there
have been no discovered discrepancies, or create a query where an
inconsistency occurs. The time that monitors spend at a site is
very limited. Thus, having a focused plan of action to review
outstanding data issues saves valuable time. Monitors often have no
way to know what data-related issues may exist, and must perform
quite a bit of discovery once they arrive at the site.
[0006] Locking a clinical database is essentially freezing all
entry or changes to data once the data has been reviewed and
accepted by the clinical team working on the study. This can be a
laborious and time-consuming process that can have many stages of
lock. Soft lock of a database typically includes a subset of the
overall database made up of the key efficacy and safety data
points. A hard lock typically includes all of the data points in
the database. An interim lock includes a subset of the database up
to a certain number of patients reaching a certain time point in
the study. There are many steps in the lock process that can delay
the process of collecting, cleaning and verifying the accuracy of
the data. These include data entry into the CRF, having the CRF
signed by the site personnel, having the CRF data reviewed by the
CRA for accuracy, the CRA locking the CRF, and coding the data into
standard dictionaries. The traditional process for these activities
takes a significant amount of time, since tracking the status of
each activity as it occurs is a major challenge.
[0007] The impact on patient heath is also compromised by product
approval delays. Such result in important treatments not yet being
available to patients who need them. The business impact on these
delays is also significant. The longer it takes to complete the
analysis of the study data, the longer it takes to get the product
to market. Each month of delay could cost the sponsor hundreds of
millions of dollars in revenue at the time the product is at peak
sales on the market.
[0008] Accordingly, there is an unmet need for methods and systems
that can speed up the database locking process. The present
invention fulfills such a need.
BRIEF SUMMARY OF THE INVENTION
[0009] One preferred embodiment provides an automated method of
managing a database lock for a clinical trial study. The clinical
trial study is managed using a database that includes clinical
trial data and the status of the data for a plurality of patients.
The method operates as follows: [0010] 1. A lock criteria is
defined for the study. [0011] 2. A processor is used to
automatically generate a list of tasks that must occur to achieve
the lock using the clinical trial data and the status of the
data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The foregoing summary, as well as the following detailed
description of preferred embodiments of the invention, will be
better understood when read in conjunction with the appended
drawings. For the purpose of illustrating the invention, there is
shown in the drawings embodiments which are presently preferred. It
should be understood, however, that the invention is not limited to
the precise arrangements and instrumentalities shown.
[0013] In the drawings:
[0014] FIG. 1-3 show objects used in one accordance with one
preferred embodiment of the present invention.
[0015] FIG. 4 shows a schematic diagram of a hardware configuration
in accordance with one preferred embodiment of the present
invention.
[0016] FIGS. 5-25 show user interface display screens in accordance
with one embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0017] Certain terminology is used herein for convenience only and
is not to be taken as a limitation on the present invention.
[0018] This patent application includes an Appendix having a file
named appendix.txt, created on Aug. 22, 2008, and having a size of
48,955 bytes. The Appendix is incorporated by reference into the
present patent application. One preferred embodiment of the present
invention is implemented via the source code in the Appendix. The
Appendix is subject to the "Copyright Notice and Authorization"
stated above.
[0019] The present invention is described in the context of a
web-based service. However, the scope of the present invention is
not limited to this particular implementation of the invention. The
present invention is described in the context of a plurality of
distributed computers, all of which are linked together by an
electronic network, such as a LAN or the Internet. The computers
may be any type of computing device that allows a user to interact
with a web site via a web browser. For example, the computers may
be personal computers (PC) that run a Microsoft Windows.RTM.
operating system. The computers may also be handheld, wireless
devices. I
I. Overview of Present Invention
[0020] The system described herein provides a means to define the
lock criteria for a database. In other words, one can define a
subset of data in the overall database or the overall database
itself as the target to be locked. The term "locked" means the data
is locked from further editing by the study team, and has been
determined to be "clean," meaning that the data has passed a series
of review steps that include source verification monitoring by the
CRA at the clinical sites, programmatic verification by clinical
data managers, and medical verification by physicians. In most
cases, the database must be formally locked before the study data
can be formally analyzed by biostatisticians, and approvals from
the above groups are required prior to lock. Once locked, the data
may be "unblinded" for analysis. Unblinding provides the study team
access to blinded treatment codes which identify the specific
treatments provided to each patient. For example, some patients are
taking placebo while other may be taking various doses of active
treatment. These treatments are kept blinded to prevent a bias in
treatment or subjective evaluations by the site doctors, study team
or patients themselves.
[0021] The lock criteria for a complete study in most cases will
include the entire database. There are many instances where a
database lock may include a subset of the data. These are known in
the industry as "interim locks" or "soft locks." Interim locks
typically are done prior to an interim analysis, and are also built
into the overall study design. The concept is to look at both the
efficacy and safety of a drug or device prior to the completion of
the study. An interim lock may be defined by many variables. These
include some number of patients that have completed some number of
study visits. For example, a study may be designed to treat 100
patients for six monthly treatment visits. An interim analysis may
be defined to look at data for the first 50 patients to complete
five months of treatment. Once these variables are put into the
system, specific reports may be generated regarding which patients
will be included in the lock, and which data for those patients are
to be included in the lock. Additional reports display all tasks
required to clean the data to achieve the lock.
[0022] Another type of lock definition is a soft lock. A soft lock
typically includes only the key primary efficacy and safety values
for all patients. The full database lock, or a hard lock, will
include all variables for all patients. There can be as many
definitions for lock criteria as there are designs for clinical
studies. Some can be very straightforward and some quite complex.
In some study designs, patients are offered the opportunity to
participate in an "open label extension." This allows patients who
may have been treated with a placebo, a comparator or lower doses
of an active compound or treatment to all take the preferred dose
of the active compound or treatment for a number of months or years
after the blinded study has been completed. This is increasingly
done to collect more safety data on patients up until the point
where the product is approved for market by a regulatory agency
such as the FDA. Accordingly, a hard lock could include all of the
blinded study data as well as any available open label data, up to
a specific point in time. This further complicates the task of the
study team in cleaning the data and focusing their efforts
exclusively on the data to be included in the lock. This can be
quite a daunting task, especially in large studies with a tight
deadline to lock the data.
[0023] A database lock can be accomplished more rapidly by
identifying the remaining tasks for a specific lock, and focusing
the attention of the monitors and data managers on those specific
tasks. Examples of such tasks are as follows: [0024] 1. Monitoring
and locking activities--monitors may lock a specific CRF after
review provided there are no queries pending. [0025] 2.
Identification of missing or incomplete CRFs. [0026] 3.
Identification of CRFs that remain unsigned by the physician.
[0027] 4. Identification of items such and medications and adverse
events that need to be coded to a standard dictionary. [0028] 5.
Summarize the status of reaching database lock [0029] 6. Provide
detailed task lists to the monitors for remaining tasks
[0030] Preferred embodiments of the present invention use a
computer-based electronic system for collecting, reviewing, and
querying clinical case report forms (CRFs.) In addition, the system
displays the management status of each CRF and summarizes the
required actions on a monitor-by-monitor, site-by-site, and
patient-by-patient basis for a successful database lock. In effect,
the system notifies each monitor of the exact tasks that remain at
a given site so they may focus their efforts on those specific
tasks. The study team managers may view summaries of the status for
each monitor to more effectively direct the work activities of the
monitors. The system uses programming objects to present report
screens to users via a web browser interface. System users are
provided role-based access to perform the monitoring tasks and
generate the reports. The data and reports are stored in a database
though a web-based interface using a series of processing objects.
Additional processing objects could be added to perform additional
functions. An administrative user can create the access identity
for other system users as follows:
TABLE-US-00001 User Type Type of Access Sponsor Views reports and
summary data for all sites Project Manager Views reports and
summary data for all sites Monitor Views reports and summary data
for their specific region(s) Views task lists for their sites
Administrator Manage user access Defines lock criteria
[0031] A prerequisite for using the system is to have the system
configured with correct case report forms (CRFs) to reflect the
requirements of the study protocol. Next is to deploy data
collection tools to the clinical sites for data entry. Sites will
then be able to record clinical data which will be aggregated into
the central clinical database.
[0032] Once the clinical database is ready to collect clinical
data, the process works as follows: [0033] 1. Database lock
criteria are defined and entered into the system by an
administrative user. The system generates a summary list of the
status of all clinical sites and tabulates metrics for each site
that are defined in a "site object," based on the lock criteria of
the study defined in a "study lock object." The system generates a
summary list of the status of each patient within a clinical site
and tabulates metrics for each patient that are defined in a
"patient object," based on the lock criteria of the study defined
in the study lock object. [0034] 2. Finally, the system creates a
task list for a given site based on open items for each patient as
compared to the lock criteria in the study lock object. The details
of the objects are described below.
[0035] Objects:
[0036] A "site object" has 9 properties, as follows (see FIG.
3):
TABLE-US-00002 # Enrolled total enrolled patients # Done number of
locked patients CRFs Complete number of complete CRFs CRFs Locked
number of locked CRFs CRFs Inc/Pending number of incomplete or
pending CRFs CRFs Queried number of CRFs with open queries Log
(Lock/Complete) number of locked and complete Log CRFs (Adverse
Events (AE), (Concomitant Meds (ConMeds), etc.) Visit Queries
number of open queries on visit date # Queries number of open
queries
[0037] A "patient object" has 8 properties (see FIG. 2):
TABLE-US-00003 Status patient status: locked or not; complete,
discontinued or pending CRFs Complete number of complete CRFs CRFs
Locked number of locked CRFs CRFs Inc/Pending number of incomplete
or pending CRFs CRFs Queried number of CRFs with open queries Visit
Queries number of open queries on visit date Log (Lock/Complete)
number of locked and complete Log CRFs (AE, ConMeds etc) # Queries
number of open queries
[0038] A "Study Lock object" has 3 properties (see FIG. 1):
TABLE-US-00004 CRFs List list of the CRFs to the used in the lock
Timeframe list of the time points to be used in the lock Status
list of the categories of patients to be used in the lock
[0039] Types of Reports:
[0040] 1. Lock Summary
[0041] A brief view of all Site objects based on chosen country and
site options. This report also give a total number of all selected
sites.
[0042] 2. Lock Site Detail
[0043] A brief view of all Patient objects of a given site. If user
wants to learn what tasks are left to make a patient locked, the
user can get more detailed information from a Remaining Task List
report.
[0044] 3. Remaining Task List
[0045] Listing of all tasks left for a given site to make
patient(s) become locked.
[0046] 4. Lock Patient Detail
[0047] Provides the subset of CRF data view. A user can view all
required CRFs here. Based on the requirement of the study, it will
display some special CRFs datasets, such as Adverse/Serious Events,
Concomitant Medications, and Therapies.
II. Detailed Disclosure
[0048] The initial system configuration is put together as shown in
FIG. 4. Item 1 depicts the central data center where the database
is stored and the system processes the reports. Clinical Data is
entered at the clinical site (item 2) and transmitted through the
internet (item 3) to the data center (item 1). A clinical monitor
can view the data, lock specific CRFs, create clinical queries, and
acknowledge responses to queries on a remote computer (item 4) or
at the clinical site (item 2.) The clinical project manager who
directs the activities of the monitors, may do so from the computer
at their office (item 5). The sponsor of the study may view the
overall progress of the data lock from a computer in their office
(item 4).
[0049] A system administrator or data manager will enter the
criteria for a lock into the system as shown in FIG. 5. The data
for the criteria is stored in an object depicted in FIG. 1. First,
the name of the lock criteria is defined (FIG. 5, item 1) and
saved. Next, the subset of CRF types to be included in the criteria
is selected from the available CRFs in the clinical database (FIG.
5, item 2). The time points, which are typically predetermined
schedule assessment points defined by the clinical protocol, are
then selected, or a specific date which include the selected visits
completed up to a certain date is selected (FIG. 5 item 3.)
Finally, the type of patients to include in the lock are selected
(FIG. 5, item 4). Available patient types may vary depending upon
the design of the study. Once the criteria have been selected, they
are saved (FIG. 5, item 5) in the object shown in FIG. 1. Two
examples of lock criteria are shown. The first example is called a
"soft lock" which is a subset of CRFs up to a certain visit. An
example of a summary report for a soft lock is shown in FIGS. 12a
and 12b. A second example is called a "hard lock." In this case,
the criteria include all CRFs up to a specific date as shown in
FIG. 20.
[0050] To view the summary report for the soft lock, a user logs
into the system (FIG. 6). The user then selects the monitoring tab
from the category list (FIG. 7, item 1). The user selects the Soft
Lock Summary (FIG. 8, item 1), the geographic regions of the sites
(FIGS. 9 and 10), and the range of clinical sites within that
geography (FIG. 11). Upon completion of the selections, the report
will appear (FIGS. 12a and 12b).
[0051] The summary report indicates the site number (FIG. 12a, item
1), the number of patients enrolled (FIG. 12a, item 2), and the
number of patients who are clean having no outstanding tasks to be
addressed (FIG. 12a, item 3). These patients are considered "done"
having no further work required. The number of CRFs collected for
that site is displayed (FIG. 12a, item 4) and the number of which
have been locked is displayed (FIG. 12a, item 5). The number of
CRFs requiring signature from a physician are displayed (FIG. 12a,
item 6). Also displayed is a summary of the number of CRFs having
open clinical queries (FIG. 12a, item 7), the number of queries
related to a visit date (FIG. 12a, item 8), and the total number of
outstanding clinical queries at the site (FIG. 12a, item 9).
[0052] A detail report for a given site can be created by selecting
the hyperlink as shown in 30 FIG. 12a, item 10. The site detail
report shown in FIG. 13 contains the patient number (item 1), the
patient status (item 2), CRFs completed and required (item 3), CRFs
locked (item 4), CRFs incomplete or pending signature (item 5), the
number of CRFs with clinical queries awaiting resolution (item 6),
the number of visit date queries which applies to all the CRFs in a
single visit (item 7), and the total number of queries for each
patient (item 8).
[0053] The task list for that site may be selected by clicking on
the link in FIG. 13, item 9. The task list itself is shown in FIG.
14. It outlines the specific tasks required to have each patient
clean and locked. The patient number is shown in item 1, and the
specific task items are shown in item 2, and if a task has a
clinical query pending, the details are shown in item 3.
[0054] The details of all of the CRFs needed for a specific patient
(FIG. 15a) may be viewed by selecting the patient number link (FIG.
13, item 11). FIG. 15a, item 1 shows the grid of CRFs (item 2) and
visits (item 3) specific to the lock criteria. FIG. 15b shows an
example for another patient.
[0055] The purpose of these tools is to focus the monitoring
activity done by the CRAs on the specific tasks required to meet
the lock criteria, and not on tasks that can wait. This maximizes
the efficiency of each monitoring visit at the clinical sites.
[0056] Another example of a type of lock is called a "hard lock."
In this example, the criteria are set to include all CRFs up to a
certain point in time. To view this report, the monitor elects the
hard lock summary report (FIG. 8, item 2). Next the geographic
region is selected (FIGS. 16 and 17) and the specific range of site
in that region (FIG. 18). The summary is then displayed in FIG. 19.
FIG. 19 item 1 shows the site number. In this example, the study
design has two studies combined together. The first is called
blinded study, and the second is called an open label study. The
blinded study section is shown in FIG. 19, item 2, and the open
label study section is shown in FIG. 19b, item 3. The lock criteria
were defined as all CRFs and all visits for the blinded study, and
all CRFs and all visits in the open label study up to a certain
date. The site number link (FIG. 19, item 4) will display the site
detail report (FIG. 20).
[0057] In this example, the site detail report is divided in two
showing the blinded study components (FIG. 20, item 1), and the
open label component (FIG. 20, item 2). The columns are identical
to that of the soft lock detail (FIG. 13). There are also separate
task lists for each of the two studies which may be selected by the
links (FIG. 20, items 4 and 5). The patient detail is selected by
the link on the patient number (item 3). FIGS. 21 and 22 depict
each of the task lists for the blinded and open label studies,
respectively.
[0058] FIGS. 23a-23d show the detail for each patient. As in the
soft lock, the CRF and visit grid is displayed. FIG. 23a shows the
blinded grid and 23b shows the open label grid. FIGS. 23c-23d lists
the coded adverse events recorded for the patient, as well as coded
concomitant medications. In this example, the lock criteria
required that each of these items be coded to a term in an industry
standard medical dictionary. Specific CRFs (FIG. 25) may be viewed
by selecting a link on the grid (FIG. 23a, item 1). A query history
(FIG. 24) can be displayed by selecting the query history link
(FIG. 25, item 1).
[0059] As discussed above, one preferred embodiment of the present
invention is implemented via the source code in the Appendix.
[0060] The present invention may be implemented with any
combination of hardware and software. If implemented as a
computer-implemented apparatus, the present invention is
implemented using means for performing all of the steps and
functions described above.
[0061] The present invention can be included in an article of
manufacture (e.g., one or more computer program products) having,
for instance, computer useable media. The media has embodied
therein, for instance, computer readable program code means for
providing and facilitating the mechanisms of the present invention.
The article of manufacture can be included as part of a computer
system or sold separately.
[0062] It will be appreciated by those skilled in the art that
changes could be made to the embodiments described above without
departing from the broad inventive concept thereof. It is
understood, therefore, that this invention is not limited to the
particular embodiments disclosed, but it is intended to cover
modifications within the spirit and scope of the present invention
as defined by the appended claims.
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