IE20070670U1 - A data management system and method - Google Patents
A data management system and methodInfo
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- IE20070670U1 IE20070670U1 IE2007/0670A IE20070670A IE20070670U1 IE 20070670 U1 IE20070670 U1 IE 20070670U1 IE 2007/0670 A IE2007/0670 A IE 2007/0670A IE 20070670 A IE20070670 A IE 20070670A IE 20070670 U1 IE20070670 U1 IE 20070670U1
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- 238000003860 storage Methods 0.000 claims abstract description 13
- 238000004140 cleaning Methods 0.000 claims description 5
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- 238000004519 manufacturing process Methods 0.000 description 4
- 238000010586 diagram Methods 0.000 description 3
- 230000001360 synchronised Effects 0.000 description 3
- 230000000875 corresponding Effects 0.000 description 2
- 238000003908 quality control method Methods 0.000 description 2
- 238000010200 validation analysis Methods 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 1
- 201000000522 chronic kidney disease Diseases 0.000 description 1
- 238000004590 computer program Methods 0.000 description 1
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Abstract
ABSTRACT A clinical trial data management system (1) receives clinical trial data in Case Record Forms (CRFs), which are scanned by a document management system (3) to provide an indexed image file. Client workstations and the document management system (3) communicate via a local area network (LAN) 4 with clinical data management application sewers (5) in turn linked with database servers (7) which manage a clinical data database (8) in a storage area network (SAN). There is a separate path for work flow data, namely from the document management system and workstations (3) via LANs (4, 6, 9) to a cluster of work flow engine application and database servers 10. The work flow servers (10) perform work flow processing and manage work flow databases (1 1) in a second SAN. The work servers (10) execute a snapshot process comprising copying a portion of each of the clinical response data and of the work flow data from their respective databases (8,ll) to a temporary file in which said data is merged, and automatically generate reports exclusively from the temporary file without accesses to the clinical data or work flow databases (8,ll). The data is copied according to dynamically-set criteria, including metric requirements, and the data is copied from the full databases (8.11) irrespective of data age. The snapshot
Description
The invention relates to management of data for clinical trials.
Prior Art Discussion
Our prior British patent GB2273 799 describes a method for receiving and storing data
to ensure data integrity. The method is performed by a document simulator, a database
controller and workstations. There is access control at the workstations, verification of
format of data received at different workstations, and resolution operations between
data in memory maps.
US668422l (Oracle) describes a system and method for accessing and updating a
thesaurus of clinical terms.
US2003/0208378 (Silicon Valley Int. Prop. Group) describes an Internet-based
clinical trial management centre.
US2005/0038673 (Stookey) describes a system for automated management of a
clinical trial, in which there is primary and secondary clinical trial data.
EPl 452983 (Cmed Group) describes a database system for clinical trial management,
databases having nodes corresponding to a natural hierarchy of the data.
The present invention is directed towards providing an improved data management
system, particularly where the data originates in a wide variety of geographical
locations and the data is received in different formats.
SUMMARY OF THE INVENTION
According to the invention, there is provided a clinical trial data management system
as set out in claim 1.
In one embodiment, the clinical data management application servers and the work
flow servers operate in synchronism to generate a simultaneous display of an image of
a case record form, a display of associated work flow data, and a display for entry of
clinical response data both automatically by the clinical data management application
servers and manually by an operator.
In one embodiment, said clinical data management application servers recognise
completion of the data entry window as an event for simultaneous updates to the
clinical data database and to the work flow database.
In one embodiment, said clinical data management application servers and said work
flow servers iteratively perform data entry and cleaning with query management
operations, in which the query management operations comprise generating a query
form for an investigator and monitoring responses from the investigator.
In one embodiment, the system comprise means for automatically performing a
snapshot process comprising copying a portion of each of the clinical response data
and of the work flow data from their respective databases to a temporary file in which
said data is merged, and for automatically generating reports exclusively from the
temporary file without accesses to the clinical data or work flow databases.
In one embodiment, the data is copied according to dynamically-set criteria, including
metric requirements, and the data is copied from the full databases irrespective of data
age.
In one embodiment, the snapshot process is executed only be applications on the work
flow servers.
In one embodiment, the system operates a portal site for data access by client
workstations of the system, and writes report data generated form the temporary file to
the portal site.
In one embodiment, the system automatically renames an output file with report data
when the data is written to the portal site.
In one embodiment, said clinical data management servers comprise means for
interfacing with an online data inputting system to receive clinical response data in
electronic form, and for merging said data received in this manner with data generated
by the document management system from hard copy forms whereby the work flow
processes are executed independently of origin of the clinical response data.
In one embodiment, the clinical data management application servers execute a
thesaurus application to search a database of terms for a matching term, to output a
matching term if one is found; and to assign a code to a matching term according to a
correspondence table; wherein the thesaurus application initially searches a standard
term reference list, and may subsequently search a project-specific reference list.
In one embodiment, the thesaurus application automatically generates a plurality of
text strings for a term, and iteratively uses each text string to attempt to locate a
matching term.
In one embodiment, the thesaurus application searches in a hierarchical structure of
router nodes leading to leaf nodes having associated candidate tenns.
In one embodiment, the thesaurus application automatically generates a list of terms
having partial or full matches and a user provides feedback including selections from
the list, and the thesaurus application automatically performs self-leaming in response
to said feedback.
In one embodiment, the work flow servers comprise means for automatically routing
data to a selected workflow process according to conditions.
In one embodiment, a condition is data document type.
In one embodiment, a condition is a data processing flag.
In one embodiment, the clinical data management servers comprise means for
automatically performing a quality control check on selected data.
In one embodiment, a particular document page triggers a quality control check.
In another aspect, the invention provides a computer program product comprising
software code for performing the operations of any system as defined above when
executing on digital data processors of said servers.
DETAILED DESCRIPTION OF THE INVENTION
Brief Description of the Drawings
The invention will be more clearly understood from the following description of some
embodiments thereof, given by way of example only with reference to the
accompanying drawings in which:-
Fig. 1 is a block diagram of the main components of a clinical trial data
management system of the invention;
Figs. 2 and 3 are flow diagrams showing system operation particularly the
major data flows; and
Figs. 4 to 9 are flow diagrams illustrating aspects of the system operation in
more detail.
Description of the Embodiments
Referring to Fig. l a clinical trial data management system 1 receives clinical trial
data in various formats including via the Internet 2 and in hard copy. The primary
fonnat is a document called a Case Record Form (CRF), which is scanned by a
document management system 3 to provide an indexed image file. The other
mechanism for delivery of a CRF is in original electronic form via the Internet 2 with
encryption for data security.
Client workstations and the document management system are generally indicated by
the numeral 3, and they communicate via a local area network (LAN) 4 with clinical
data management application servers 5 in a clustered arrangement for redundancy.
The application servers 5 are programmed to process received clinical data. The
clinical data is transmitted to a cluster of database servers 7 which manage a clinical
data database 8 in a storage area network (SAN). The SAN is made up of a fibre
fabric attached through brocade switches to a Network Appliance Filer storage. There
is a separate path for work flow data, namely from the document management system
and workstations 3 via LANs 4, 6, and 9 to a cluster of work flow engine application
and database servers 10. The servers 10 perform work flow processing and manage
work flow databases 11 in a second SAN. Fig. 1 shows case record forms (CRFS)
being logically delivered directly to the servers 10, however, the physical route to the
servers 10 is via the above path from the document management system and clients 3.
In addition, the database servers 7 are programmed for automatic replication of the
clinical data across to a replication server 12, which manages storage of this data in
mirrored clinical databases 13 in a third SAN on a LAN 14.
Referring to Fig. 2, in the overall data management method there are the following
steps performed by the system 1:
, pre-scanning electronic log receipt of documents by the document
management system 3;
, document management aspects of work flow processing, again by the
document management system 3;
, data entry and cleaning by the servers 5, for clinical response data received
from both documents and online in step 24;
, an automatic, self-leaming thesaurus application executing on the servers 5
feeding into the data entry and cleaning step 23;
, query management executed by the servers 5 with bi-directional
request/response interaction between the steps 23 and 24;
, query (“DCF”) form generation and transmission to an investigator by the
servers 5, as part of query management generally,
, clinical and work flow data storage in the databases 8 and 11 described with
reference to Fig. l;
, data analysis by the servers 5 and 10 to generate reports.
Referring to Fig. 3 as a part of the combination of overall steps 23 and 24 the
application servers 5 generate a display screen with the following windows:
, image ofthe CRF;
, work flow data drawn from the WP databases ll and associated with the
displayed image 41; and
, clinical data inputted in a process as described in our prior patent specification
no. GB2273799.
Population of the clinical data in the window 43 triggers an update to the clinical data
database 8 and a corresponding update to the WF database 11 to reflect the step of
completing input of the clinical response data record for the CRF.
All of the data is resident on the clinical and WP databases 8 and 11. The tables within
these databases can grow very large. Two of the main tables are a RESPONSES table
in the clinical database 8, and an ITEM_HlSTORY table in the WF database 11. The
RESPONSES table has a total of about 64 million records, and the ITEM_HlSTORY
table has a total of about 43 million records in one example. Because of the large
number of records, running reports directly from these tables could possible affect
data integrity and system performance for capturing clinical response data.
A portion of the active data from both databases 8 and 11 is copied to a temporary
“snapshot” file at regular intervals in a process called a “snapshot” process. In each
snapshot process a full refresh of all of the snapshot temporary files is run. This is
done by SQL scripts, which run on the WF servers10, even though data is copied from
both databases 8 and 11. These copy information from the full range of entries in the
database 8 and 1] tables according to dynamically-set criteria, and insert all copied
data into the snapshot files. The snapshots are activated and scheduled by dbms_job
functions in the database servers 10. A full refresh of all snapshot files occur in each
snapshot run based on the individual criteria for each snapshot. Because the snapshot
processes are run from the work flow servers 10 the processing does not need to
involve the clinical data management servers 5 and hence do not affect their
operations.
In any one snapshot process there may be multiple runs, each copying data according
to a different set of criteria.
To allow sponsors view metric reports, a process in the servers 10 analyses data in the
snapshot files and generates and uploads reports to a portal server. The data is
extracted from the snapshot files only. Once scheduled reports have run, a SQL job
then runs on a server 10 to check which reports have run, and outputs this information
into a reports table. A rename job will then check this table, and match up an output
filc (the output file is named as Ol234.0UT) for example. The job will check the
output file against the parameters used during the scheduled report generation job run.
So, when scheduling, one is required to enter data such as study name and patient. It
will then rename the job to something meaningful based on these parameters eg.
(missing _pages_repoit_study_l2345.xls). These reports are then uploaded to the
portal server by a server 10.
Because active subsets of both databases 8 and 11 are automatically written
(duplicated) to the temporary snapshot files, the number of accesses to the live
databases 8 and 11 is greatly reduced, thus minimising risk to data integrity. Another
important advantage is that the reports are generated from a combination of clinical
response data and work flow data, even though these two data categories are
separately stored on different storage area networks. Thus, the snapshot processes not
only divorce report generation from the live data but they also effectively merge the
data according to the dynamically-set criteria.
The table called ITEM_HISTORY in the WP database 11 has a full history of all
items that go through the WF servers 10. As this table grows, it can affect
performance, and also delay snapshots. The system 1 implements a dynamic archiving
process for this table, which, on a study-by-study basis, archives data from the
ITEM_HISTORY table into an ARCHIVE_HlSTORY table. This archiving process
operates exclusively from the database 11, and so does not affect the clinical data
itself, on the database 8.
When a clinical trial study is completed, the WP data for study is made ‘unavailable’
in the database 11. A script is run by the servers 10 which validates that the entered
study information exists, checks the number of rows in the table, and then commences
a process to archive the data. The data is then moved to the ARCHlVE_HISTORY
table. Once it has been moved, it checks that the number of rows moved matches the
number of rows that originally existed. Once the move is complete it then deletes data
from the ITEM_HISTORY table for that study. It then outputs a log of rows which are
completed/moved/deleted.
In circumstances where required, an alternate process is available, which moves data
back into the ITEM_HISTORY table from the ARCHIVE_HISTORY table for data
which has already been archived.
Returning again to the start of the method illustrated in Fig. 2:
The CRF documents have registry marks at comers for registration for optical
character recognition (OCR) of the data, or scanning to provide an image without
OCR. Where the latter, the data is inputted in a system as described in GB2273799.
The documents, are bar-coded for tracking.
The data entry and validation functions of the servers 5 perform data validation
operations according to allowed fields and terms. A thesaurus application on the
servers 5 automatically verifies validated terms, and once a thesaurus term has been
selected the system derives automatically a hierarchy associated with the selected
term. The thesaurus system automatically executes the following process:
(a) Receives a term.
(b) Determines a permutation of the term.
(c) Checks it against a database of valid terms and outputs a match.
(d) Repeats (b) and (c).
If there is more than one match then the output prompt is generated for the operator to
choose a correct match to be used. This is then used by the thesaurus application to
automatically learn by updating its nodes.
The output of the query management stage 26 is a code for each term in the received
data. Thus in overview, the full method receives terms (text strings) in certain contexts
(forms) and reliably outputs a set of codes representing the information in the terms.
The database 8 stores the original terms together with the codes and the thesaurus
match, for traceability purposes.
Prescanning Process (Document Management System 3):
Documents are received and tracked in an electronic log system, detailing date
of receipt/courier airway bill/study/site/patient details.
Pages are cross-checked with transmittal and signed. If pages are missing or
have incorrect information, a transmittal discrepancy is sent electronically to
site, detailing discrepancy. This is in conjunction with “Transmittal
Processing”, Fig 9.
Pages are separated into patient folders for smart batch and scanning
preparation
Pages are counted and marked.
Fig. 4 illustrates a work flow of the system 1 as follows.
Scanned documents enter the workflow at a Start task.
The document management system 3:
Verifies Investigator, Site and patient enrollment information before
scanning a document. Special attention is noted concerning the entry
and maintenance of investigator and site information, in that, this
information will be needed to create query DCF forms.
(ii)
(iii)
Scans the images using the appropriate smart batch information
for each document type. Example: C;VAL;;122.
' Document Types
Q — DCF
C — CRF
E — EXDCF
T — Transmittal
L — LABS
O - OPD
I Protocol — 4 Digit Work manager code representing the
protocol number
I Patient number — as defined in that table of contents.
Verifies the correct number of images have been scanned; the
CRF Work Manager Spicer viewer application provides a count
of the images that have been scanned.
Reviews each image for readability and rescans as necessary.
The batch of scanned images is cleaned.
Despeckle — remove stray speck marks
Deskew — straighten the page
Portrait/Landscape Recognition — automatically determine the
orientation of the image
Degree Rotation — flip the page into an upright orientation
if it is upside-down
Fax Header Remover — remove the fax header from the image.
Pages are sent to the release basket in CRF-INDEX and quality
checked and verified for correct batch name, page count & page
quality.
d) Pages that can be auto-indexed are sent to auto-index; all others are
sent to manual index.
e) The pages available for auto-index are processed by Auto-Index to
capture the remaining index fields.
f) The index information is verified against valid data for the protocol.
The valid data is stored.
g) If the index information is valid, the images are placed into the
production workflow for the protocol. Any image that does not have
valid index information or is identified as a duplicate page is sent to
manual index.
h) The index operator reviews the pages at manual index, enters the
appropriate index information and sends for index verification.
Document Type Routing
After the documents have been captured, indexed, and moved to the appropriate
production protocol workflow by the document management system 3, the primary
workflow processes are carried out by the servers 10. Fig. 5 depicts the top level
workflow process routing each document type to its appropriate processing option.
Documents are received by the servers 3 from the document capture process into the
production protocol workflow as an indexed page. As soon as a page is received into
the production workflow it is routed by the servers 10 according to the work flow
rules defined for that protocol and it is available for viewing by authorized users
through retrieval functionality.
The document is routed to the appropriate work flow process based on the document
type / processed flag:
a) CRFs, Labs, or other procedure documents with a Processed Flag
(TOC Interval) of ‘1’, ‘2’, or ‘3’ are routed to a CRF Processing
sub-workflow.
b) DCFS and EXDCFS are routed to the DCF Processing sub-workflow.
routed to the Transmittal Processing
c) Transmittal Forms are
sub-workflow.
(1) Documents with a Processed Flag (TOC Interval) of ‘4‘ are routed
directly for storage.
Each study has one or more pages that triggers a quality check:
a) If the page is a trigger page, then it is sent to a Quality Review task.
b) If the page is not a trigger page, then processing is complete.
A Quality Reviewer views the pages and uses Retrieve to review additional pages for
the subject to perform the Quality Review.
The workflow process is complete. The images are still available for review through
the retrieval functionality.
CRF / LAB / Other Procedure Documents Process
Fig. 6 illustrates how CRF, laboratory reports, and other procedure documents that
require data entry and/or review are processed through CRF Work Manager executing
on the servers 10. This section is broken down into several subsections, each building
on the previous process workflow(s) as new conditions are met.
Fig. 6 depicts the workflow process for all pages to be processed that have been
received for the first time.
All pages that are to be data processed (CRFS, laboratory reports, and other procedure
documents) are routed to the CRF Processing sub-workflow.
Pages received for the first time (ie, Version = 0), continue down the typical path.
Route based on the Processed Flag:
If the Processed F lag (TOC Interval) is ‘2’, then send the page to DB
Processing and follow the work flow rules for synchronized data entry
(SSDE) as appropriate.
If the Processed Flag (TOC Interval) is ‘ 1 ’, then send for parallel
processing to both DE Processing and medical/safety review.
If the Processed Flag (T OC Interval) is ‘3’, then send the page to
medical/safety review only.
If the Processed Flag (TOC Interval) is invalid, then send the page to
Processed Flag update task.
Route Documents for Both DE Processing and Medical Safety review.
Perform medical/safety review. A deadline alert notifies the supervisor if the page has
not been reviewed in a specified number of hours or days.
After data entry processing and medical/safety review, join the process paths back
together.
The CRF Process is complete.
If the page has been previously received (Version > 0), then it is routed to a
Duplicate Review task to determine what to do with the page. There are several
reasons a duplicate page may be received;
The page was indexed correctly, the previous pages were indexed
incorrectly and data was entered into the system. The incorrect
information entered to the system will need to be corrected and or
deleted. After corrections the properly indexed pages can then be
routed to the appropriate DE task. The original incorrect pages will
need to be corrected in the workflow and re-indexed to the correct
patient and routed to the appropriate DE task.
The page contains updated information and will be routed to the data
update step within the Data Entry workflow.
CRF Complete Route - The page is an exact duplicate of a previous
page, annotate the duplicate and send for storage.
Index Issue without correction - The pages were indexed incorrectly
and will require a manual correction to the indexing information and
routed to the appropriate workflow task taking into account Medical
Safety review.
Find and re-index the previous page as necessary; delete the previous system data,
reroute each page as needed.
If Processed F lag (T OC Interval) is not 1,2,3,4 documents will be routed to this task.
The purpose is to capture errors when setting up the table of contents. If the page was
not assigned an interval number (Processed Flag) the pages will appear in this step
and will be corrected by updating the table of contents in CRF maintenance.
User task to route DE2 (second data entry) pages to a CDC review task. The goal is to
allow review of pages for either system-generated queries, manual queries, or queries
generated externally (such as data error listings). Pages would only be released from
this task once all checks (listings included) had been canied out and all queries (where
practical) have been sent.
Data Entry Processing
Fig. 7 depicts the data entry process, having the following steps:
All pages requiring data entry are routed to a DE Processing sub-workflow.
Pages received for the first time (i.e., Version = 0), continue to first key entry.
The data entry operator perfonns first data entry through synchronized split screen
data entry (SSDE) as shown in Fig. 3 and controlled by the servers 5, creating data
entry comments as necessary. The first data entry operator verifies the image against
reference data to quality check the index information.
Pages that have index issues or other issues precluding data entry are routed to
a DE Issue task for resolution. The data entry operator must complete the
Release Comment field with a description of the data entry issue. The DE
supervisor or designee reviews the pages that have data entry issues and
performs the steps for resolution. The Study Lead will be responsible for any
items that cannot be resolved by the DE supervisor. Once the issue is resolved,
the page is routed back for data entry.
Pages that are successfully data entered are routed down the typical data entry
path.
Verify the status reflects first key entry is complete:
If Pass 1 Complete, then send on to Data Entry 2.
Otherwise, send back to Data Entry I .
The data entry operator performs second data entry through synchronized split screen
data entry (SSDE), creating data entry comments as necessary.
Pages that contain issues precluding data entry are routed to the DE Issue task
for resolution. The data entry operator must complete the Release Comment
field with a description of the data entry issue. The data entry supervisor or
designee reviews the pages that have data entry issues and performs the steps
for resolution. The Study Lead will be responsible for any items that cannot be
resolved by the DE supervisor. Once the issue is resolved, the page is routed
back for data entry.
Pages that are successfully data entered are routed down the typical data entry
path.
Verify the status reflects second key entry is complete:
If Pass 2 Complete, then send on.
Otherwise, send back to Data Entry 2.
Route required when a page is marked blank in OC.
The Data Entry Process is complete.
Data Update Process
Pages that have been previously received (i.e., Version > O) are sent for update in the
system. Update the appropriate data in the system.
Verify the updated data in the system.
The Data Update Process is complete.
DCF Processin Fi . 8
Discrepancies that cannot be resolved in-house are sent in step 27 to the investigator
for resolution. Occasionally, discrepancies may also be sent directly in from a site.
When these DCF forms are received back from the investigator, they are reviewed and
the clinical data is updated as appropriate.
Fig. 8 depicts the DCF process, as follows:
All DCFS and EXDCFS are routed to the DCF Processing sub-workflow.
Determine if the page is signed, unsigned, or version > 0: The signed decision task
will check the indexing (signed flag). The process for determining the presence of the
signature will be setup in the OCR template for DCF forms.
Unsigned pages and version > 0 are sent to the Signature Resolution task.
Signed, version = 0 pages are sent to the DCF Update task.
Review the page to determine if it is unsigned or signed with a version > 0.
If the page is unsigned, then coordinate with the site to receive a signed DCF
or EXDCF page. Leave the unsigned page at this task until the signed version
is received.
If the page is signed with a version > 0, then annotate the previous unsigned
page as obsolete and send for storage; route the signed page to the DCF
Update task.
Update the system as specified by the DCF. Annotate the CRF with a line annotation
crossing out the incorrect information and a text annotation noting the correct value.
Follow procedures based on study guidelines.
Verify the update(s).
The DCF Process is complete.
Transmittal Processina (Fig. 9)
Fig. 9 depicts a process to track transmittal form issues, as follows:
All transmittal forms will be routed to a Transmittal Processing sub—workflow.
Transmittal forms that have errors are sent for issue resolution.
If there are conflicts between the documents reported on the transmittal form
and those actually received, then send for resolution.
If the transmittal form accurately reflects the pages received, then the
Transmittal Process is oomplete.
The default path for transmittal documents is to transmittal complete. This
allows for scanning transmittal documents for information purposes only.
The study lead will review transmittal issues and generate discrepancies as
appropriate.
The Transmittal Process is complete.
It will be appreciated that the invention provides for very effective management of all
data associated with clinical trials, achieving excellent data integrity, management of
huge data volumes, and excellent versatility for report generation.
The invention is not limited to the embodiments described but may be varied in
construction and detail.
Claims (1)
- A clinical trial data management system (1) comprising: a document management system and operator workstations (3), programmed to control the steps of receiving and indexing clinical trial response data in electronic form via the Internet (2) and in hard copy form with scanning and indexing case record forms of clinical response data,; a cluster of clinical data management application servers (5) linked by a network (6) to the document management system and the client workstations (3), the clinical data management application servers (5) being programmed to: generate clinical trial response data from scanned and electronic case record forms, and storing said clinical trial response data in a clinical data database (8) of a storage area network; a cluster of work flow servers (10) linked in a network (9) with a second storage area network and with said clinical data management application servers (5), said work flow servers (10) maintaining a work flow database (1 1) in a second storage area network; means in the clinical data management application servers (5) for automatically updating the work flow servers (10) with updates as clinical response data in written to the clinical data database (8), the work flow servers (10) in response writing item history data to the work flow database (1 l) in synchronism with the clinical response data updates to the clinical data database (8); database servers (7, 10) for both of the storage area networks, at least some of said servers comprising means for automatically replicating the clinical data 070670 database (8) and the work flow database (11) to mirrored databases (13) at separate sites; and means in said work flow and database servers (10) for automatically archiving the work flow data independently of the clinical trial response data database (8). A clinical trial data management system as claimed in claim 1, wherein the clinical data management application servers (5) and the work flow servers (10) operate in synchronism to generate a simultaneous display (41) of an image of a case record form, a display (42) of associated work flow data, and a display (43) for entry of clinical response data both automatically by the clinical data management application servers (5) and manually by an operator; wherein said clinical data management application servers (5) recognise completion of the data entry window (43) as an event for simultaneous updates to the clinical data database (8) and to the work flow database (11); and wherein said clinical data management application servers (5) and said work flow servers (10) iteratively perform data entry and cleaning (23) with query management operations (26), in which the query management operations comprise generating (27) a query form for an investigator and monitoring responses from the investigator. A clinical trial data management system as claimed in any preceding claim, wherein the system comprise means for automatically performing a snapshot process comprising copying a portion of each of the clinical response data and of the work flow data fiom their respective databases (8, 11) to a temporary file in which said data is merged, and for automatically generating reports exclusively from the temporary file without accesses to the clinical data or work flow databases (8, 11); wherein the data is copied according to dynamically-set criteria, including metric requirements, and the data is copied from the full databases (8, 11) irrespective of data age; and wherein the snapshot process is executed only be applications on the work flow servers A clinical trial data management system as claimed in claim 3, wherein the system operates a portal site for data access by client workstations (3) of the system (1), and writes report data generated form the temporary file to the portal site; wherein the system automatically renames an output file with report data when the data is written to the portal site; wherein said clinical data management servers (5) comprise means for interfacing with an online data inputting system to receive clinical response data in electronic form, and for merging said data received in this manner with data generated by the document management system (3) from hard copy forms whereby the work flow processes are executed independently of origin of the clinical response data; and wherein the clinical data management application servers execute a thesaurus application to search a database of terms for a matching term, to output a matching term if one is found; and to assign a code to a matching term according to a correspondence table; wherein the thesaurus application initially searches a standard term reference list, and may subsequently search a project- specific reference list. A clinical trial data management system as claimed in claim 4, wherein the thesaurus application automatically generates a plurality of text strings for a term, and iteratively uses each text string to attempt to locate a matching term; wherein the thesaurus application searches in a hierarchical structure of router nodes leading to leaf nodes having associated candidate terms; wherein the thesaurus application automatically generates a list of terms having partial or full matches and a user provides feedback including selections from the list, and the thesaurus application automatically performs self-leaming in response to said feedback; and wherein the work flow servers (10) comprise means for automatically routing data to a selected workflow process according to conditions.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IEIRELAND19/09/20062006/0691 |
Publications (2)
Publication Number | Publication Date |
---|---|
IE20070670U1 true IE20070670U1 (en) | 2008-05-14 |
IES84904Y1 IES84904Y1 (en) | 2008-06-11 |
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