Home

How to use the Online Randomization System

image

Contents

1. TENALEA User Manual Ritazarem Trial Version 1 G TEN Trans European Network for Clinical Trials Services Table of Contents Tapie OF COM eN Soen E E E T E 2 HEE OQUCUION seein e E E E E E E 3 POPC WON O a E E A A E 3 Chapter 1 TENALEA Data Management ServicCe sscsccsccsccccscccceccsceccscencs 4 1 1 Accessing the TENALEA Data Management on the web ALL cssccccecsssescecceses 4 Fun ber TA GUD aore E 7 Chapter 2 Selecting forms and Data entry ALL ccccsccescesccsccscessceccees 8 2 1 Selecting study forms and randomising a patient Investigator RN RM 8 2 2 Randomisation Investigator RN PHARM RM 0 s cccscccsccecccsscesscecccescesssescsecs 11 2 3 Permissions to Forms Reports and Notifications ALL ccccccccesssscccescsccccescecs 13 Chapter 3 Patient amp Overall Study Management ALL csscsscsscees 13 3 1 FORM OV CIVIC sirasscs mene sencte ae rsesa two s TT TET NE ATOE 14 3e SOGG aE E E E E EE E E E 15 33 Reports ALL vaccrenscavecccecsvencaescccnsscasenceeprenasncsronceaesdcenancsrenesneseesasneseesesdescscasseces 17 Chapter 4 Site Management RM TC ccssccssscssscsscssscssccssscesssessseceees 20 41 SIRS GCLIVGQTION RM aoa ta cee ctecetcecenas cee etesesaccerteseceneckdeaeee uses cesaesacsensaceecteceiectenescece 20 4 2 Site deactivation RM TC ccecceccosscecccsccsccescccccccceccesccscceccescesccsccecceccessescseccesse 21 4 3 Si
2. access permissions see Picture 2 0 2 Instances have occurred on the first log in where this menu does not appear Hitting the browser refresh button after logging out and in resolves this bug RITAZAREM11 view Patient Management Site Management Picture 2 0 2 Left navigation menu of the TENALEA Data Management module The list contains all management areas of the study for which the user has access permissions 2 1 Selecting study forms and Enrolling a patient INV RN RM A study can be selected by clicking the study name in the left navigation menu After clicking the Patient Management a list of all investigators for which the user is granted permission to enter data is displayed as shown in Picture 2 1 3 RITAZAREM 11 view Patient Management 4 Lewin NO1 RITAZAREM11 View Patient Management Merkel A01 Patient Management Lewin N01 EJ Add patient Site Management Merkel 4014 EJ Patient 401 001 view Picture 2 1 3 Selecting a study within the TENALEA Date Management module left displays the three management menus A Middle The Patient management menu lists all names of investigators B for which the user has permission to enter data Right after selecting an investigator the list of previously registered patients is shown C Selecting a patient shows the study forms D A new patient can be registered by clicking Add patient E This will display the Registration form Selec
3. University of Pennsylvania Target Randomisation Date 4 months after enrollment 22 10 2012 Picture 2 1 4 Evolution Registration form Ritazarem TENALEA End User Manual V1 Page 9of 21 Chapter 2 As the form is completed the following fields will be calculated e Body Surface area DuBois Formula e Induction dose e Enrollment Date e Target Date for Randomisation Enrollment Date 4months The screen displayed on submitting the form provides the Subject Number and the information entered and calculated An email confirmation of this is sent to the appropriate roles Form names can appear in the left menu bar in two different fonts each indicating a different form status Table 2 1 5 lists the different form statuses and the fonts that are associated with them Table 2 1 5 Fonts i e italics or no italics appearing in the navigation menu of the TENALEA Data Management service indicating a specific form status Font Description of forms status 1 Empty forms These are forms which are either empty unsaved not validated or not submitted 2 Completed forms Forms that could have been completed or not but already have been either saved validated or submitted and can be edited if necessary Using the left menu to select and open a form the form opens in Edit mode data can be entered or selected and altered View form When pressing the view button next to study name the form opens in a new browser window or tab This
4. configured to assign each user a particular role Each role is given permission to interact with the system in a variety of ways that can be broken down broadly into three categories of permission e Ability to submit forms e Rights to read previously submitted forms e Receipt of email notifications The table below summaries the seven different roles created against the different forms in the system in terms of the permissions given Category Patient Management Patient Management Site Management Site Management Site Management Chapter 3 ALL Task Enrollment Randomisation Site Activation Site De Activation Site Re Activation Read Only access via website ERn ERn RN RN RN J0 ESISIAU SINN ERn ERn udieasay RN RN RN RN RN Adewueud Jaseuel ERN ERN ERN ERN ERN uoljesimopuey JOJEUIPIOO RN ERN ERN ERN Jed JOWUOIA Edit permission can fill in the form and edit it within site patients Notification get an email with the details each time a Task is completed by any user at the site Notification as above but limited to those tasks completed by the user themselves Patient amp Overall Study Management The Data Management Module contains links to pages and overviews that support the data management process Besides the link for Logging off from TENALEA Data Management module a link to a Help section a Dashboard pa
5. the Data Management Module showing the Summary Forms overview and Queries overview The drop down list box Order is visible The status of the forms is shown as a coloured box Table 3 1 2 explains the colour codes and form status as they appear in the forms overview These colour codes mainly apply to the electronic Case Report Forms not applicable to all studies The status of standard ALEA Randomisation forms appearing in the Forms overview should always be submitted The last column right of the Status column in the Forms overview contains the links View Form and View audit trail see Picture 3 1 4 a View form View audit trail kaa View form View audit trail View form View audit trail a View form View audit trail Picture 3 1 4 Last column of the Forms overview including View form and View audit trail links The View form option allows the form to be viewed again With this option a form can be viewed without having the intention to edit it Multiple forms can be opened at the same time as they will be displayed in a new window The View audit trail option provides an overview of all validation errors within an electronic Case Report Form 3 2 Search The Search option allows the user to locate specific patients or investigators clinicians within the Data Management module The Search option is accessed by clicking the link in the panel bar at the top of the screen see Picture 3 2 1 Logo
6. ating that the password has been changed or created Close the window and go back to the correct Production web address highlighted in yellow see Table 1 1 on page 2 As Username use your e mail address Next enter the previously established password and press the Login button Further Help In the event of requiring further assistance to log in then contact the Randomisation Manager simon bond addenbrookes nhs uk Ritazarem TENALEA End User Manual V1 Page 7 of 21 Chapter 2 Chapter 2 Selecting forms and Data entry ALL After logging on see Chapter 1 the Data Management module is displayed see Picture 2 0 1 ALEA Data Management cetu 3 0 70627 196 Microsoft Internet Explorer provided by Addenbrookes NHS Trust File Edit View Favorites Tools Help e dh e LEA Data Management cctu w3 0 202 195 rfar 13 F ae Hey afr errr Py TENALEA Trans European Network ALEA Data Management for Clinical Trials Services BLOCKDEMO View Welcome to the ALEA Data Management module The navigation pane at the left side of the screen shows the studies to which you have internet Hi0 Picture 2 0 1 TENALEA Data Management module On the left the navigation pane with study names for which the user has access permissions In this example the study name BLOCKDEMO is displayed The left part of the Data Management module contains a list of all studies for which a user has
7. d from clicking on view at the top level of the menus 4 2 Site deactivation RM TC If a site needs to be deactivated during the course of the study whereby randomisation is to be stopped at that site then the Site Deactivation Menu is to be used i Trans European Network for Clincal Tial Services Study RITAZAREM11 Form Site Deactivation BLOCKDEMO view Site identification Evolution view Are you sure you want to de activate this site for all users RITAZAREM11 view Patient Management Site Management Site Activation Site Deactivation w Site Reactivation 4 3 Site Reactivation RM TC If as site has been deactivated but subsequently needs to be open to randomisation again then the Site Reactivation form must be used The Site Activation form cannot be used in these circumstances Trans European Network for dintal Ties services Study RITAZAREM11 Form Site Reactivation BLOCKDEMO view Site identification sd Evolution view Do you want to reactive for all accounts within the site RITAZAREM11 view Patient Management Site Management Site Activation Site Deactivation Site Reactivation Ritazarem TENALEA End User Manual V1 Page 21 of 21
8. earch options Decommissioning and arching Study decommissioning archiving and snapshottin Study data export Export patient data Export patient data in flat CSV format Export AML meta data Export to MS Access Study meta data import Import patient study data Batch data processing Batch data processing Account permissions all studies Accrual month Alea parameters Audit Trail all studies Blind box overview Completed Forms overview Data entry sessions Institute drug su osition Hotification log Password change requests Persons involved Shipments overview Stratification totals Studies overview Picture 3 3 1 Overview of options including the Reporting options This overview is accessible through clicking the view link behind the study name Ritazarem TENALEA End User Manual V1 Page 18 of 21 Chapter 4 Ritazarem TENALEA End User Manual V1 Page 19 of 21 Chapter 4 Site Management RM TC Three operations are available regarding site management e Site Activation e Site Deactivation e Site Reactivation with self explanatory meanings A patient cannot be randomised within a site until the site has been activated Any site will be assigned a short code which is required to perform any of the three operations above Sites will be added to the study on an ongoing basis The current list of site codes at the time of writing is given below If a new site or investigator needs t
9. erview Form names are links allowing for direct access to the form The Status column can contain several icons The first icon is a coloured box which indicates the form status The colour codes of these boxes are explained in Table 3 1 2 Table 3 1 2 Form status colour codes as shown in the Forms overview Status Description W Sava Form has been saved but not submitted Submitted The form has been completed and is submitted Verified Central Data Management has verified and approved all the answers by relating them to the source documents Missing Data One or more fields on the form were specified as mandatory i e fields which cannot be left blank but the form has been submitted leaving at least one of these fields empty Submitted with override The form has been submitted while a warning message informed the user about an incorrect value to one or more of the questions on the form Submitted query pending Form has been submitted and there is a pending query from Central Data Management associated with this form The Forms overview of the Data Management module can be sorted in several ways Picture 3 1 3 shows the available options for arranging the order in which the forms are displayed date study user form status and by Patient ID Ritazarem TENALEA End User Manual V1 Page 14 of 21 Chapter 4 DATA MANAGEMENT MODULE Logged in as edonk tenalea net on Logged in since 01 1 Picture 3 1 3 Detail of
10. ff Home Help Dashboard Forms Queries Search f Picture 3 2 1 Detail of the TENALEA Data Management top navigation pane including the Search link Ritazarem TENALEA End User Manual V1 Page 15 of 21 Chapter 4 If the user has access to more than one study a selection can be made by using the drop down list Search by study After selecting a study a drop down list containing all registered patients becomes available see Picture 3 2 2 Search Search by study Search studies clinicians and subj PS View E AD1 001 Merkel 401 002 Merkel AUT 005 Merkel Picture 3 2 2 Search option window showing part of the list containing all registered patient numbers and the clinicians investigators to whom these patients belong In the drop down list all patients are sorted by patient number and the clinicians investigators to whom the patients belong If a patient is selected a display of which forms are completed or available for completion is show picture 3 2 3 The individual forms can be accessed by clicking on the coloured square boxes DATA MANAGEMENT MODULE Logged in as simon bondi eddenbrookes nhs uk On Logged in since 22 06 2012 09 5 Logoff Home Change password RITAZAREMI1 RITAZAREM11 Patient ID 401 002 Registration date 22 06 2012 11 50 Study site University of Pennsylvania Investigator Merkel Status SEND QUERY VIEW OTHER FORMS Enroll
11. ge Forms overview Query overview and a Search option page are available on the top bar of the Data Management module see picture 3 0 1 Ritazarem TENALEA End User Manual V1 Page 13 of 21 Chapter 4 DATA MANAGEMENT MODULE Logged in on Logged in since 01 12 2010 10 43 Logoff Home Help Dashboard Forms Queries Search Picture 3 0 1 Data Management top panel bar including links to data management pages and overviews 3 1 Form overview Forms in the Form overview are listed in rows see Picture 3 1 1 Each row represents a previously Completed form and the columns show subsequently the Date date of submitting the form Study name of study Event only applicable for eCRF studies Form name of form Subject Patient Trial ID Investigator name of investigator responsible for the patient including a site ID User name of user submitting the form Status form status and view options Form overview Date Study Event Form Patient Investigator User Status 22 06 2012 12 10 RITAZAREM11 BASELINE Randomisation AQ1 002 Merkel AD1 Bond isl O View form Send query 22 06 2012 12 09 RITAZAREM11 BASELINE Enrollment A01 002 Merkel A01 Bond jy View form Send query 22 06 201212 09 RITAZAREM11 BASELINE Randomisation A01 003 Merkel A01 Bond yj View form Send query 22 06 201212 06 RITAZAREM11 BASELINE Enrollment A01 003 Merkel A01 Bond jy Yiew form Send query Picture 3 1 1 Form ov
12. is to allow viewing multiple forms while keeping the Data Management module the central page Submitting Submitting a form will transfer its data to Central Data Management If needed these forms can still be modified afterwards provided a reason for the modification is specified A message such as the one shown below in Picture 2 1 6 indicates a form has been submitted successfully Ritazarem TENALEA End User Manual V1 Page 10 of 21 Chapter 2 Form Enrollment has been submitted The subject has been enrolled and assigned the study ID A01 003 Questions Answers Date of Birth 04 08 1982 Weight kg Height Units Height feet Body Surface Area m2 reg ANCA Type anti MPO Confirm the infexclusion criteria are all met and have been recorded yes Enrollment Date 22 06 2012 Induction Dose mg 814 mg Picture 2 1 6 Confirmation of a successful randomisation including the allocated patient kit 2 2 Randomisation INV RN PHARM RM Four months after enrollment to within 14 days randomisation can take place The relevant form on is found by navigating through the Ritazarem gt Investigator gt Subject Id gt Randomisation RITAZAREM11 view Patient Management Lewin H01 Merkel 401 EJ Add patient EJ Patient 401 001 view Ea Patient 401 002 view Ea Patient 401 003 View ES Enrolment B Randomisation The extra information to be collected at randomisation is e Prednisone Dose mus
13. ment Site Reactivation Study Subject functions Change the clinician of this subject to Lewin M0 Change Change the subjectkey ofthis subject to ha bi BBS 8 e cmore ili Change Remove this patient trom this study Remove Wanage CT scans MRI scans and CT Plans for this subject _ Manage PACS object Manage ALEA PACS Gateway Manage PACS gateway Picture 3 2 3 Search option window showing a selected patient forms and the name of the clinician to which the patient belongs Ritazarem TENALEA End User Manual V1 Page 16 of 21 Chapter 4 3 3 Reports ALL Study reports can be accessed by clicking the View link in the navigation pane just next to the study name Evolution An overview of options is displayed as shown in Picture 3 3 1 Ritazarem TENALEA End User Manual V1 Page 17 of 21 Chapter 4 Study RITAZASREM11 Study definition version 0 123 of 22 06 2012 12 08 12 Select an option or hyperlink Your role in this study Privileged datacenter Delete test data Delete stu atients Remove shipments and reset study site and account status Remove concealment list and blocks Study site and account status Study site activation de activation and reactivation and user account management study status and study definition publish approval Study data import import study data from production site Notifications View notification queue Resend notification select s
14. n be created see Picture 1 1 6 Important make sure you click the link within 30 minutes after receiving the Password change request email For security reasons a time frame of 30 minutes after submitting a password change request has been set for allowing users to change their password Ritazarem TENALEA End User Manual V1 Page 6 of 21 Chapter 1 Change password for ALEA J a Le a mirarem is L Js Usermame 2ancbergen a nki Password expiration The password you set now will expire in 365 days When you log in after your password has expired you are prompted to renew your password after logging in You can change your password at any time by selecting forgotten password in the TENALEA login screen Password length The password you set should have a minimum lenath of 8 characters Confirm sie Jo Enter your new password in both textboxes Close window Change password Rules Regulations and Disclaimers Gtenalea net Picture 1 1 6 Change password for TEN ALEA page Enter a password with a minimum length of 8 characters and which contains at least one digit e g 1 2 3 Enter the password again in the Confirm new password field and press the button Change password The next window signifies the password was changed successfully see Picture 1 1 7 Change password for ALEA Your password has been changed Close window Gtenalea net Picture 1 1 7 Confirmation window st
15. o be added to the system then the Randomisation Manager simon bond addenbrookes nhs uk will need to be contacted 4 1 Site activation RM Before patients can be registered and randomised by a study site the site needs to be activated This task is carried out by completing a Site activation form The Site activation form can be accessed by selecting Evolution and clicking the Study site management menu Selecting Site activation displays the Site activation form as shown in Picture 4 1 1 ie oe Trans European Network for Clinical Trials Services Study RITAZAREM1 1 Form Site Activation BLOCKDEMO view Site identification Evolution view Are you sure you want to activate this site ra GF RITAZAREM11 View af Patient Management Do you want to activate all accounts for the site you are activating Site Management Site Activation i Site Deactivation Site Reactivation Picture 4 1 1 Site activation form Ritazarem TENALEA End User Manual V1 Page 20 of 21 After completing and submitting the form the site is activated If the answer to the third question Do you want to activate all accounts for the site you are activating is yes then all users registered within that site will be able to access the randomisation and resupply forms if the answer is no then individual investigators will need to be activated by the Set study site and account status page accesse
16. personal password Ritazarem TENALEA End User Manual V1 Page 5 of 21 Chapter 1 Enter the e mail address which was used to create the TENALEA account and press the button Send request The message shown in Picture 1 1 5 is displayed TENALEA Trans European Network for Clinical Trials Services Picture 1 1 5 Password request screen with a text message notifying an e mail has been sent to the specified e mail address An e mail is sent to the submitted e mail address This email contains the following text Subject User credentials for the use of tenalea net services Password change request You have requested to receive your user account details by email to mail address j zandbergen nkinl You are registered at tenalea net as user j zandbergen nki nlj This account can be used to access the test environment This environment is used by central datamanagers to test the functionality of eCRF or randomisatio To change your password please click this link or cut and paste the address into your Internet browser h production nLonconnect net nkiavl aleadataentrv C hangePassword aspx PwdC hangeRequestID ec34bS8be f46f 48e7 a2 b5 952616917cf3 After setting your password you can login to ALEA data management at by clicking here For any further instructions please contact support at support tenalea net Click the link in the Password change request e mail This will redirect you to a page on which a password ca
17. t an investigator clinician by clicking the name If no patients have been registered for the Ritazarem TENALEA End User Manual V1 Page 8 of 21 Chapter 2 investigator clinician yet there will be no entry under the selected clinician Click Add subject to display the first form This may be just a registration or a combined registration randomisation form form Completing and submitting the Enrollment form see Picture 2 1 4 registers the following details on the system e Patient Initials up to 3 letters e Patient DoB in dd mm yyyy e Current Date Is recorded automatically e Site is recorded automatically e Choice of Weight Units kg Ib o Weight in Kg o Or Weight in Lb e Choice of Height units cms feet amp inches o Height in cm o or Height feet amp Height inches e Selected prednisone or prednisolone induction regimen 1A or 1B e ANCA type anti PR3 anti MPO e Relapse Type Severe Non Severe e Omnibus confirmation that the general in exclusion criteria are met A TENALEA Trans European Network for Clinical Trials Services BLOCKDEMO view Patient Initials Evolution view rd Ca RITAZAREM11 view F z Patient Management Weight Units _ m K Lamia Mt Sa Merkel A01 Eq Add patient Weight pounds E 0 lb EJ Patient 401 001 View Site Management Height cm L Height inches _ _ i inches Prednisone or Prednisolone Induction Regime Severity of Relapse Site
18. t be lt 10mg to be eligible e BVAS WG score must be lt 1 e Confirmation that the patient meets the criteria for randomisation Ritazarem TENALEA End User Manual V1 Page 11 of 21 Chapter 2 Study RITAZAREM11 Form Randomisation Patient Date of Birth 04 08 1982 Patient Initials sdf ANCA Type anti MPO Severity of Relapse Severe Prednisone Induction Regime 14 Prednisone Dose mg ooo e mg BVAS WG Score Target Randomisation Date 4 months after enrollment 22 Oy 2012 Days after or before the Target Randomisation Date 122 Confirm that patient details are correct and you want to randomise Upon completion of the form the following screen is displayed showing what treatment the subject has been assigned to An email confirmation is sent Form Randomisation has been submitted The Subject has been assigned Azathioprine Questions Patient Date of Birth Patient Initials ANCA Type Severity of Relapse Prednisone Induction Regime Prednisone Dose mg BYAS WG Score Target Randomisation Date 4 months after enrollment Days after or before the Target Randomisation Date Confirm that patient details are correct and you want to randomise Randomisation Randomisation Ritazarem TENALEA End User Manual V1 Answers 04 08 1945 asd anti PR3 Severe 14 5 0 22 06 2012 0 yes Azathioprine Page 12 of 21 Chapter 2 2 3 Permissions to Forms Reports and Notifications ALL The system is
19. te Reactivation RMI TC ccecceccosscecccsccsccescecccsccsscesccsccsccescescesccescescescesccsscecce 21 Ritazarem TENALEA End User Manual V1 Page 2 of 21 General Introduction Foreword This User Manual describes the features of the TENALEA Data Management service used for the Evolution trial It describes how to access the system and the procedures for patient registration randomisation and drug supply management This manual is a general user manual Depending on the role you have in the trial sections may or may not be relevant to you To find the sections which apply to your role please identify your role code from the table below The title of each paragraph will indicate the roles for which the information provided is relevant Role description Investigator RN Research nurse OOOO O Ritazarem TENALEA End User Manual V1 Page 3 of 21 Chapter 1 Chapter 1 TENALEA Data Management Service 1 1 Accessing the TENALEA Data Management on the web ALL This section explains how a new user of the TENALEA Data Management service can gain access to the data entry environments Test Acceptance and Production Open an internet browser and type one of the web addresses described below in the address bar see Picture 1 1 1 S ALEA Data Management cctu v3 0 2082 198 Microsoft Internet Explorer provided by Adden Sele go 6 https acc tenalea net cctu OM default aspx ki ry P File Edit Vie
20. tu w3 0 2082 4 fy b m i z Page h ic Tools Login to Data Management we Pp Pr A TENALEA leenenell yy rans European Network oe for Clinical Trials Services Password I forgot my password I never logged in before Tae Internet 100 Picture 1 1 3 Login window of TENALEA Data Management module During regular use the users email address will be entered into the Username box But on first use click the link I forgot my password I never logged in before see Picture 1 1 3 above The screen shown in Picture 1 1 4 is displayed Request change password for tenalea net F nih aia TENALEA EE rans European Network for Clinical Trials Services Send request Picture 1 1 4 Password request window Note that TENALEA accounts are created on the basis of personal e mail accounts Personal in this context refers to the fact that passwords are kept private and are not known to the TENALEA service provider It does not mean home e mail accounts are used In case a Local Data Manager is responsible for maintaining the local data management at multiple institutes it is best to choose an office and or job related e mail account to create one account that allows access to all patients across the different institutes User accounts are provided by TENALEA Certified Support Centres or Trial Coordination Centres All users will receive an email containing instructions for setting a
21. w Favorites Tools Help we ote Eae Data Management cctu v3 0 2082 198 ct ied deh gt E Page E Toos e amp P Internet 100 Picture 1 1 1 Address bar of an internet browser in which the TENALEA web address should be specified Throughout the study design process the forms and the entire study definition i e clinicians and investigators user permissions are published to different environments Each environment has its specific purpose in the development process The different environments are shaped after the DTAP model which stands for Development Testing Acceptance and Production The Development environment is used by TENALEA study designers the remaining three are used by different users of the service Table 1 1 2 shows the web address of these latter 2 data entry environments Table 1 1 2 Web addresses of the TENALEA data entry environments aimed at testing by users Name of data entry environment Web address URL Production LIVE STUDY SITE https prod tenalea net cctu DM default aspx Acceptance TEST SITE https acc tenalea net cctu dm Ritazarem TENALEA End User Manual V1 Page 4of 21 Chapter 1 Next a login screen is displayed on the computer screen like the one shown in Picture 1 1 3 ALEA Data Management cctu v3 0 2082 198 Microsoft Internet Explorer provide Lio QO Erroaren BE E esa eE File Edit View Favorites Tools Help Ww dar Enen Data Management cc

Download Pdf Manuals

image

Related Search

Related Contents

WatchGuard XTM 830-F & 2-Y Security  HD6159, HD6158  Patriot Memory PSF16G266CF flash memory  AIN ROMAIN!  BDP5180/12 Philips Blu  130 Series Manual  Manuale - Hanna Instruments  RC-8616N仕様書 V1-2 (微弱電波モデル16操作標準型)  USER MANUAL  Sony VGC-RC320P Welcome Mat  

Copyright © All rights reserved.
Failed to retrieve file