project manager internet server

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Project Manager Internet ServerProject Manager Internet Server

Introduction

User Interface

Designer Information

Technical Information

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IntroductionIntroduction

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PurposePurpose

• ProMISe is a genericgeneric tool to Design and Manage single/multi center clinical research projects (both registrations and prospective trials)

• Information is stored and retrieved using the Internet Explorer browser over a (secure) internet connection

• The Designer (study coordinator) manages the entire project (design as well as logistics)

• All projects can be dynamically changed and extended during their life cycle, incorporating new scientific developments are the need for more in-depth information

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• The number of studies (projects) is unlimited• Studies are implemented at the Dpt of Medical

Statistics of the Leiden University Medical Center (current version; the next version allows for design via Internet)

• Data are stored in a relational data base system in SQL-Server

• Tools are included to maintain the structure of the project, the data bases, log files and user access authorization tables

DesignDesign

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• Each center has access to its own data (in full detail) and to the combined data of all centers (descriptive statistics only)

• The entire project is placed on a WEB server and access is managed by the WEB part of ProMISe

• The internet connections are protected by the Server’s security mechanisms

PrivacyPrivacy

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• The user enters and retrieves data using the Internet Explorer (5.5/6) WEB browser only

• ProMISe contains a set of dynamic HTML forms, computed in real time and automatically reflecting the underlying structure of the project and any user preferences

• Only one software copy exists on a server and any updates take effect immediately in all projects and all centers

User interfaceUser interface

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• The same copy of the software is used for any number of data entry/retrieval projects

• No programming is involved in the design and maintenance of a project: data bases with structural information are continuously queried to generate the user interface dynamically

• Software improvements/additions created for one project become available to all users of all projects instantaneously!

EfficiencyEfficiency

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• Development of an entire Internet data management system is reduced to hours or days of (clinical) specifications instead of months or even years of programming labor

• All aspects of the electronic CRF’s can be modified during the study without jeopardizing the integrity of the data

• Additional (sub)studies or clinical trials can be integrated with very little effort

Cost-effectivenessCost-effectiveness

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• ProMISe can also be used as an information retrieval-only system for centers while data are being entered in the central study center

• The ProMISe system can co-exist with any other data management system

• The system uses an open architecture; runs on Windows NT/2000 Server + SQL-server + IIS Web Server

• Organisations can independently build their own websites which can display data interactively requested from a protected ProMISe project (for example statistical data for patient information sites)

IntegrationIntegration

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• Any clinical study that can be conducted using standard paper Case Report Forms (CRF’s), can also be realized within the ProMISe framework

• Since only standard SQL-Server tables are used, already existing data can be converted to ProMISe easily after creating the appropriate structure

• Users can download their own private MS-Access data bases or Excel files for local data analysis or connection to other local data base systems

ApplicationApplication

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• ProMISe is in production now for over 2 years in over 500 hospitals in Europe

• Some of the Current Projects:* Blood and Marrow Transplantation data in EuropeBlood and Marrow Transplantation data in Europe

• 195 hospitals entered >10.000 transplant over the past 2 years totalling now 150.000 transplants and 300.000 follow-up records

* Dutch Knee SocietyDutch Knee Society• 11 departments of Orthopaedics running a permanent registry on knee-related data

* Study registration in chronic leukemia in EuropeStudy registration in chronic leukemia in Europe• All currently going-on analyses in the CLWP available to all member-researchers

* Clinical trials in Bone Marrow TransplantationClinical trials in Bone Marrow Transplantation• Several multi-country trials in CLL and CML

* European registry on NeutropeniaEuropean registry on Neutropenia (under development)* Clinical trial in the Netherlands on leukocyte depletion* Clinical trial on transfusion triggers in orthopaedic surgery

* DEMO PROJECTS ON HIP, KNEE AND SHOULDER DEMO PROJECTS ON HIP, KNEE AND SHOULDER ARTHROPLASTY FOR THE NERASS GROUPARTHROPLASTY FOR THE NERASS GROUP

ApplicationsApplications

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• DEMO PROJECTS ON HIP, KNEE AND SHOULDER DEMO PROJECTS ON HIP, KNEE AND SHOULDER ARTHROPLASTY FOR THE NERASS GROUPARTHROPLASTY FOR THE NERASS GROUP

• The projects represent the core of a much larger clinical dictionary for the registration of hip, shoulder, knee, wrist and ankle prosthesis research data

• The purpose is to start with a pan-European, small yet fully extendable research data set where contributing members also have full statistical access to the complete data base

• A scientific committee should advise about the items actually collected by all participants

• Statistical multi or single center analyses will be part of such a European registration project

ApplicationsApplications

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Introduction

User Interface






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User InterfaceUser Interface

Examples drawn from 3 specific registry projects in orthopaedic surgery

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• the Home page of the study center should contain a link to the list of available projects

Starting pointStarting pointA link to all A link to all

projects projects supported supported

by your by your organizationorganization

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• When multiple projects are run by the same organization, a WEB page will have to list them for easy access by the users

• This is the last page created manually: all other WEB pages are generated in real time by the ProMISe software

List of projectsList of projects

Click on the linkClick on the linkof the projectof the project

you want to startyou want to start

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Start of a sessionStart of a session

• A typical page contains * a button to access the PRIVATE data

base for each center* a button to access the COMMON data

base (for information on all centers together)

* a button to TEST the hard and software for compatibility with ProMISe

Click here to Click here to obtain obtain

anonymous anonymous info on all info on all study datastudy data

Choose your Choose your own private own private data base data base from the from the

pick list ....pick list ....

... and press ... and press the button the button

to start your to start your session.session.

TEST your TEST your configuration configuration before using before using

ProMISe for the ProMISe for the 1st time!1st time!

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• National Views can be enabled by the study coordinator

• Authorized users will be able to retrieve data on ALL centers within one country

• ProMISe automatically creates in this way a National Registry for each participating country!

National Views (Registries)National Views (Registries)

Click here if Click here if you are you are

authorized to authorized to obtain obtain

information information on a national on a national

levellevel

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Main View on your SessionMain View on your Session

Tabulations:Tabulations:•data listingsdata listings•CRF printoutsCRF printouts•frequency frequency tablestables•missing datamissing data•survival survival analysisanalysis

Enter or Enter or modify the modify the

data stored in data stored in your Private your Private data basedata base

Determine Determine which items which items you actually you actually want to seewant to see

To To change change

to to another another center center

or to the or to the COMMOCOMMO

N fileN file

All other All other programprogram

ss

Close Close sessionsession

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A quick graphical overview A quick graphical overview

Initially you Initially you see the see the

frequency frequency distribution distribution

of an of an item .....item .....

... which you ... which you can change can change

into any into any other item other item from your from your data base data base

with the pick with the pick list ...list ...

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Another item ...Another item ...

... to see ... to see its its

frequency frequency distributiodistributio

n.n.

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ObtainingObtaining information: Tabulate information: Tabulate

• Tabulation * condensed overviews* columnar listings of data* status-like overviews* frequency tables and crosstabs* missing data reports* survival analyses

At At any any time time during a during a

session you session you can press one can press one

of the of the TABULATE TABULATE buttons to buttons to

obtain these obtain these kind of reports.kind of reports.

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• To obtain any report, you must ....* choose the items to appear in the report

* the type of layout you want

* press the RECALCULATE button

• ... or ...* choose from a list of reports prepared for

you by the Designer of your project

Specification of data listsSpecification of data listsTo the To the left you left you see a see a

column column with all with all

currently currently available available items...items...

... in ... in which which

you can you can simply simply select select one or one or more more

items to items to appear appear

in a in a report.report.

Choose Choose the TYPE the TYPE of data of data list you list you want to want to see ...see ...

... and ... and press the press the Calculate!Calculate!

buttonbutton

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• A condensed list is actually an overview of all Unique Identification Codes (called UIC’s) in your data base

• These UIC’s provide you with a link to the actual data

Condensed listsCondensed lists

60 patients 60 patients currently in currently in

the data the data basebase

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• each line in such a report represents one item from the data base

• all information on a single UIC is listed on the screen

• when follow-up forms are present, all of them are retrieved at once

A status-like printoutA status-like printoutYou can You can

change the change the layout in layout in

various waysvarious ways

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Changing layout of a status printChanging layout of a status print

Just Just experiment by experiment by choosing from choosing from the options at the options at the top of the the top of the

screen!screen!

Here values Here values and labels and labels

are merged are merged into 1 into 1

column to column to save spacesave space

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• each column now represents one item• each line corresponds to an individual observation

* a line may correspond to a UIC * a line may also correspond to one particular

follow-up record

Requesting a columnar data listRequesting a columnar data list

Mark all Mark all items you items you want to want to

appear in appear in the report as the report as a column ...a column ...

... choose ... choose the columnar the columnar structure ...structure ...

... and press ... and press the the

Calculate! Calculate! buttonbutton

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Columnar data listColumnar data list

Want to Want to know the know the

distribution distribution of Gender?of Gender?

Click Click here ..here ..

..

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Quick frequency table from listQuick frequency table from list

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Obtaining other kinds of tabulationsObtaining other kinds of tabulations

Choose any of the Choose any of the 5 tabulation types 5 tabulation types

and the screen and the screen will adapt itself to will adapt itself to

allow you to allow you to specify the specify the

contents of the contents of the reportreport

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• ProMISe supports both one-way and two-way tables

• One-way tables can be displayed graphically

Specification of frequency tablesSpecification of frequency tables

Choose Choose the items the items for which for which you want you want to count to count

the codesthe codes

Choose the Choose the type of tabletype of table

Tables and Tables and graphics?graphics?



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Frequency tables and graphicsFrequency tables and graphics

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Specification of a cross tabulationSpecification of a cross tabulation

... and ... and choose 1 choose 1 item from item from

the pick list; the pick list; then press then press

the the Calculate! Calculate!

button againbutton again

For a For a cross cross

tabulatiotabulation of 2 n of 2 items, items, first first

change change the the

structure structure ......

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Cross tabulation of two itemsCross tabulation of two items

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• More options are available, e.g.* applying logical restrictions* sorting of output

Advanced specification of queriesAdvanced specification of queriesTo select To select

UIC’s UIC’s choose a choose a

free free SLOT....SLOT....

... click on ... click on the item to the item to

be be consideredconsidered

......

... and ... and specify a specify a

restriction restriction for for

example: example: ‘equals 1’‘equals 1’

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• Use of summary statistics (means etc.) in the tables

• Automatically treat ‘dates’ as ‘time-elapsed-since...’

• Influence presentation of multiple response items

• Make the tables link-sensitive

Detailed specification of frequency tablesDetailed specification of frequency tables

Click on any Click on any category in a category in a

frequency frequency table (or cross table (or cross tabulation) to tabulation) to

instantly instantly obtain a list of obtain a list of

all patients all patients belonging to belonging to that category that category

(or (or combination combination

of categories)of categories)

Replace Replace Dates by Dates by

‘Time-‘Time-elapsed elapsed

since since another another

date’date’

Replace Replace counts by a counts by a summary of summary of a 3rd itema 3rd item

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• Currently 3 types are implemented:* missing data reports: a listing of all

UIC’s on which at least one of the items chosen by you, are missing

* survival analysis reports (K-M and COX)

* Log file reports

Obtaining special reportsObtaining special reports

Choose the correct Choose the correct layout layout

•WebpageWebpage•Filled paper coding Filled paper coding

formform•Excel spreadsheetExcel spreadsheet

•MS-Access data baseMS-Access data base



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Overview of missing itemsOverview of missing items

Each item still Each item still missing is missing is

clearly markedclearly marked

A UIC is listed A UIC is listed only only when at when at leastleast one one of of the items the items checked ischecked is

missingmissing

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Selecting ItemsSelecting Items

Your session was Your session was started with a started with a

‘default’ selection of ‘default’ selection of items, in this project items, in this project called ‘OPERATION’.called ‘OPERATION’.

Other selections may Other selections may be pre-programmed be pre-programmed

by your study by your study coordinator or you coordinator or you can define them can define them

yourselfyourself

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Pre-programmed ItemSelectionsPre-programmed ItemSelections

The The Designer Designer

determines determines with which with which selection selection

you always you always startstart

You can switch You can switch to any other to any other collection collection (just think of (just think of

another paper another paper coding form with coding form with

partially overlapping partially overlapping

information)information) at any time in at any time in any report or any report or during data during data

entryentry

IndexData Entry!Data Entry!

To start To start Data Data

Entry on Entry on your CRF, your CRF, press this press this

buttonbutton

Some Some buttons buttons change change

their their meaningmeaning

All UIC’s in All UIC’s in your data base your data base are loaded into are loaded into

a list from a list from which you can which you can

choosechoose

All Follow-Up All Follow-Up forms forms

belonging to belonging to the current UIC the current UIC

are also are also loadedloaded

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The current The current values values

(obtained form (obtained form the data base the data base on the server)on the server)

are are automatically automatically filled on the filled on the

CRFCRF

Data Entry: the CRFData Entry: the CRF

The CRF is The CRF is divided into divided into

blocks of related blocks of related information by information by the Designerthe Designer

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How to load another patient (UIC)How to load another patient (UIC)

Just pick a Just pick a UIC from UIC from the list ...the list ...

... And press ... And press the LOAD the LOAD BUTTONBUTTON

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Details of the CRFDetails of the CRF

Click for Click for a new a new

UICUIC(patient or (patient or transplant)transplant)

Coding Coding system system

and Helpand Help

DescriptiDescription of on of itemitem

CurrenCurrent valuet value

Label of Label of current current valuevalue

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Entering data on the CRFEntering data on the CRF

Click on Click on any item any item you want you want

to editto edit

Extensive help Extensive help available available

whenever usefulwhenever useful

IMPORTANIMPORTANTT

you should you should complete each complete each new value by new value by pressing the pressing the

‘Tab’ key‘Tab’ key

only in that only in that way will the way will the

cursor ‘jump’ cursor ‘jump’ to the next to the next

item item automaticallyautomatically

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Storing modificationsStoring modifications

IMPORTANTIMPORTANTthis counter display the this counter display the number of modifications number of modifications

notnot yet yet savedsaved in your data in your data basebase

in other words: the in other words: the number of values that number of values that differdiffer between your between your

screen (local) and the screen (local) and the data base (server)data base (server)

PressPress this button this button whenever you want to whenever you want to

SAVE your modifications SAVE your modifications to disk in your Private to disk in your Private

data basedata base

A list of modifications to A list of modifications to be executed appears.be executed appears.

Press ‘Confirm’ to Press ‘Confirm’ to execute...execute...

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Quick Frequency tableQuick Frequency table

Click here to Click here to obtain anobtain anup-to-date up-to-date overview of overview of

this item this item from your from your data basedata base

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• ProMISe maintains the address tables of all participating centers

• The tables are kept up-to-date by your project Designer

Other functions: Center ID’sOther functions: Center ID’s

ChooseChooseSHOW SHOW

ADDRESSESADDRESSES

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• You can choose between Registries and Centers (if applicable)

• You can choose between condensed and complete addresses

• You can count how many UIC’s each center contributes to the COMMON file

The CIC address tablesThe CIC address tables

Just move the Just move the mouse over the mouse over the link to see the link to see the

details details projected at the projected at the top of the pagetop of the page

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• Downloading has a 2-fold purpose!* It provides you with a BACKUP

of your private data base

* It enables you to analyze your data locally and possibly merge your data with a MS-Access database in your own center!

Other functions: downloadingOther functions: downloading

Choose Choose DownloaDownload from d from

the Main the Main MenuMenu

Then fill Then fill in this in this

form and form and press press

the DOIT the DOIT NOW NOW

buttonbutton

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• Downloading uses the functionality of your browser

• Always use the RIGHT mouse button for downloading

Download your own Download your own Private Data BasePrivate Data Base

Click with your right Click with your right mouse button on the mouse button on the

linklink

and then choose and then choose option ‘Save as...’option ‘Save as...’

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• The downloaded data base contains some utilities for your convenience* automatic conversion to .DBF files* automatic creation of SPSS-WIN source files to

convert your data, including all variable labels, value labels, missing values etc. to a SPSS system file

Local functionalityLocal functionality

Press to Press to convert all convert all

data data to .DBF to .DBF

filesfiles

Press to Press to write a write a

complete complete SPSS setup SPSS setup

for youfor you

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• Your MS-Access Private Data Base contains* your actual data

* all relevant information from the Dictionary for a correct interpretation of the values in your data base

StructureStructure of the Private tables of the Private tables

Patient-Patient-operation operation

tabletable

FolloFollow-Up w-Up

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• The current Dictionary (the meaning of all items and codes in your project) is always available to you* all items* all value labels* all quality tests and warnings* all jumps which determine what the ‘next’

item is when you press the Tab key in Data Entry

Other functions: the DictionaryOther functions: the Dictionary

Choose Choose DictionaryDictionary

on the Main on the Main MenuMenu

IndexAll All itemsitems, codes, quality control etc., codes, quality control etc.

ItemItemss

Click Click on on

‘Labe‘Label’ ...l’ ..... ..

screescreen n

movemoves to s to labellabel

ss

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Finishing your sessionFinishing your session

• Always finish your session correctly to bring the administration on the Server up-to-date!

Do Do NOT NOT close close your session by your session by

closing the closing the BrowserMaster BrowserMaster

Window ...Window ...

… … but but click on click on ‘‘EXITEXIT’ ..’ ..

..… … and then and then

either finish the either finish the session or session or

download a download a backup copy backup copy

first.first.

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Introduction

User Interface






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Designer InformationDesigner Information

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Complete project maintenance Complete project maintenance

• In the current version, the DESIGN of each project is maintained by the foundation IMSOR which is a cooperation between the Dpt of Medical Statistics and the Dpt of Orthopaedics of the LUMC

• In the next version it will be possible that others contribute to the Design of these projects also via Internet

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Introduction

User Interface






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Technical InformationTechnical Information

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Data base system: SQL-ServerData base system: SQL-Server

• Every project has its own data base• Access protection via WEB Server (secure,

encrypted connections)

• Access to individual data at center level

• Statistical access to data of all centers together

• Items can be protected against statistical evaluation

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SecuritySecurity

• Microsoft IIS secure server under Win2000 advanced server with Thawte Security Signature

• Server maintained by Dpt. of Med.Statistics, Leiden University Medical Center

• User access authorization at Server level (password and IP-address)

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Security (2)Security (2)

• Software level authorization by Project coordinator* level 1: user can obtain statistical information not

relating/identifying patient, physicians, centers or countries* level 2: user can list individual patient data but no

modification allowed* level 3: user may modify data* level 4: user may also download a copy of the private data

base

• Access to the COMMON file will not exceed level 1 under any circumstances

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Data Access by usersData Access by users

• All access via Internet (secure connections)

• IE 5.5 or higher required (others will not work)

• No local software needed

• Software minimizes data traffic over Internet at the expense of heavy use of the local PC in terms of processor load and memory requirements

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Data Access by users (2)Data Access by users (2)

• All centers must acquire authorization on official hospital paper with the central project coordinator

• Data Entry is disabled unless explicitely requested and allowed by study coordinator

• Although backups are made by the Server Administrator, centers are ultimately responsible for downloading their private .MDB file as a BACKUP at regular intervals

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ServerServer

• Currently Win2000, 4000 Mb memory, 4 CPU’s, 3*32 Gigabyte RAID-controller

• HTML generating ISAPI DLL by Heitml, Germany

• Interactive Graphics by Netcharts

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Technical requirementsTechnical requirements

• Users can interactively verify requirements at startup time

• Minimally equipped PC: * 233Mhz, 64Mb memory, IE5.5, 1024*768 resolution, true

color (16-bit), 56K modem connection

• “Work as if local & no delay” -equipped PC:* 600Mhz, 256Mb memory, IE5.5, 1024*768, true color,

permanent internet connection

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Introduction

User Interface






project manager internet server

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