Protocol: DUAG-7001 WebEZ System User Guide
Contents
1. 04 What is patient s date of birth Mar 2009 Es 05 Has the patient signed the study consent Form Please select a response Please select a response 06 If you answered no to the previous question please enter a reason All the drop down questions will be pre populated with default responses These default responses must be reviewed and corrected before the patient data is saved Use the drop down arrows to change the responses for the patient amp gender screening date and eligibility status 29 Apr 2009 Page 9 of 47 LL L A532aS AL KAAC i Protocol DUAG 7001 i Dites WebEZ System User Guide es aru Services You will be asked to e sign for the patient data Your e signature is your User ID and password Click on FSigno 5 eSignature Web Page Dialog E S gnature onfirm Patient Screening Data Wi zai O DD xc nHileess 8 Reason https f IcEs webez com webeztest pages eSignature aspx AC D Internet Electronic signatures are considered the same as a hard copy signature and should be regarded as such Do not share your e signature User ID and password Each person at your site who needs to use the WebEZ system must do so using his her own WebEZ account 29 Apr 2009 Page 10 of 47 ALMAAC Protocol DUAG 7001 CHAM WebEZ System User Guide Services By answering No to Question 5 the below pop up window will appear Click Save to continue saving the data2. f Protocol DUAG 7001 WebEZ System User Guide Iimmical c EDruli A new window will open with the Patient Event Report Ej https cts webez com webeztest pages REPORT ASPX RPTID 38SELECT fPMFNFVHjF9 2bDqcBTx5962ba4SEFWI Microsoft Internet Explorer E B File Edi GoTo Favorites Help m Printed 11 Mar 2009 11 10 AM EST Patient Event Report Process Screening Protocol DUAG D2 Site 9999 Demo Site Process Date EST 25 Feb 2009 11 56 am Process Performed By Site User Site User Patient Information Patient 9999 005 Final Message Thank you for screening your patient into Protocol DUAG 7001 No Question Response What is the patient s gender Male What are the patient s initials D S What is the screening date 25 Feb 2009 What is patient s date of birth 30 Jan 1981 Has the patient signed the study consent form Yes If you answered no to the previous question please enter a reason B Unknown Zone Please print this report and save with your source study documents 29 Apr 2009 Page 14 of 47 c Protocol DUAG 7001 WebEZ System User Guide Once the patient has completed the screening process if you need to modify the demographic information e g Date of birth was entered incorrectly select the patient and click on the MModify Data button Make the changes to the answer and click save Enter your e signature to save the data https cts webez com WebE Micro
3. T Protocol DUAG 7001 WebEZ System User Guide Use the Drop Down list to choose the report you wish to view Click on Run Selected Report https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Patient Management Ordering Reports Message Board Contact Information Study Documents Log OFF Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Select Report Site Patient Discontinuation Report v Site Patient Discontinuation Report Site Patient Enrollment Report Site Patient History Report Site Patient Randomization Report Site Patient Screening Report Run Selected Report The Site Patient Randomization Report gives a summary of all patients at your site including the patient number date of birth gender kit assignment and date of randomization The Site Patient Screening Report provides a summary of all patients screened at your site including patient demographic data and the screening result Pass or Fail The site Patient Discontinuation Report provides a summary of all patients discontinued at your site including the reason for discontinuation The Site Patient History Report shows the screening randomization resupply and discontinuation data combined for all randomized patients The Enrollment Report will not have any data for your patient The report will open but will be blank The reports will open in a new
4. EZYesNo Web Page Dialog https fcbs webez comfwebeztest pages EZ YesMo aspxiMes Internet 29 Apr 2009 Page 11 of 47 MZ 2 Protocol DUAG 7001 WebEZ System User Guide LAT TIL c Services Once the data is saved the Results screen will appear with the patient screening number i WebEz Web Page Dialog Results l j Patient Screening number ist 9999 006 Thank you for screening your patient into Protocol DUAG 7001 https cts webez com webeztest pages EZCanfirm as D Internet Close the Results window to return to the Screened Patient Listing 29 Apr 2009 Page 12 of 47 a Clinical Services Protocol DUAG 7001 WebEZ System User Guide To view the data for an existing patient click on the word fiViewO next to the patient details E https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help TD WebEZ Liser Mame DUAG LY Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Screening Screened Patient Listing Screening Number Initials DOB Gender Date Screened 9999 001 9999 002 9999 003 9999 004 9999 005 9999 0016 29 Jun 1963 05 Aug 1902 06 Mar 1951 30 Jul 1943 30 Jan 1981 e8 Mov 1958 Male Male Male Female Male Male 04 Feb 2009 05 Feb 2009 05 Feb 2009 05 Feb 2009 25 Feb 2009 11 Mar 2009 Screen New Pauent utodity Data Find Patient By Number EES ac Find 29 Apr 2009 Page 13 of 47 TL
5. T x rd Welcame to the WebEZ Account Assistance Page If your account is locked or you have forgotten your password please provide the information below and hit the Submit button If you do not have an account and require access to WebEZ please contact Almac Chrcal Services at the following numbers Us T1 818 4783 8850 UE 44 283836 2436 Microsoft Internet Explorer Password has been reset Enter your WebEZ UserID Enter your email address Submit Cancel If your account is locked and you do not wish to reset your password OR your account is no longer active please contact your Almac Cliucal Services Project Manager http qa webez webez pages Accaunt amp ssistance aspx re 4 Local intranet gt E javascript daPostBack EzLoginl lbl amp ccount amp ssistance EH il tes le J Local intranet Click FOKOto return to the log in screen You will receive the following e mail containing your new temporary password that you can use to log into the system You will be prompted to change your password the first time you log in Your WebEZ password has been reset The new password is listed below Password 4Io01x3P8 This 1S a courtesy e mail sent to you by the Almac Clinical Services WebEZ system Please do not respond to this email If you have questions please contact your Almac Clinical Services Project Manager Contact information can be found under the Contacts menu item in
6. WebEZ Thank you 29 Apr 2009 Page 47 of 47
7. and email address and click the FSubmitO button E Account Assistance Web Page Dialog Welcome to the WehbEZ Account Assistance Page If your account is locked or you have forgotten your password please provide the information below and hit the Submit button If you do not have an account and require access to WebEZ please contact Almac Chmcal Services at the following numbers Us T1 818 4 79 8850 UE 44 283856 2436 Beer WemrUem Enter your email address Email addresses must be entered in all lower case letters Cancel If your account is locked and you do not wish to reset your password OR your account is no longer active please contact your Almac Clinical Services Project Manager If further account assistance or technical assistance is required please contact the WebE Helpline at 1 800 923 3209 Additional country specific helpline telephone numbers are provided on the WebEZ International Quick Keterence pocket card Thank you Athos ficks webez com webez pages AccauntAssiskance aspx Internet User IDs and E mail addresses must be entered in all lower case letters 29 Apr 2009 Page 46 of 47 m Protocol DUAG 7001 WebEZ System User Guide The following window will appear to confirm that your password has been reset and your account has been unlocked E W ebEZ Microsoft Internet Explorer i te x File Edit View Favorite A Account Assistance Web Page Dialog i
8. b rA d Home Patient Management Ordering Reports Message Board Contact Information CIN a a be e Study Documents Log OF Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Patient Management 2 Internet 29 Apr 2009 Page 7 of 47 u Protocol DUAG 7001 ALIVE WebEZ System User Guide Clinical Services To enter a new patient click on Screen New Patient A WebEZ Microsoft Internet Explorer File Edit view Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Screening Screened Patient Listing Screening Number Initials DOB Gender Date Screened 9999 001 29 Jun 1963 04 Feb 2009 9999 002 05 Aug 1902 05 Feb 2009 9999 003 06 Mar 1951 05 Feb 2009 9999 004 30 Jul 1943 05 Feb 2009 9999 005 30 Jan 1981 25 Feb 2009 ENEE T 29 Apr 2009 Page 8 of 47 omm 3 Protocol DUAG 7001 WebEZ System User Guide ATTIC Services Answer the questions about your patient A WebEZ Microsoft Internet Explorer File Edit Yiew Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Screening Steps qj e Enter Answers b Save Screening Question Response 01 What is the patient s gender Male v 02 What are the patient s initials 03 What is the screening date Mar ww 2009 Es
9. com webeztest pages EZConfirm asp 4 Internet Close the Results window to return to the Active Patient listing 29 Apr 2009 Page 30 of 47 u ud Protocol DUAG 7001 WebEZ System User Guide THE Services Click on fiViewOto the left of the patient number za WebEZ Microsoft Internet Explorer File Edit wiew Favorites Tools Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Re supply Active Patients with Randomization Events Randomization Number Initials DOB Gender Date Randomized 05 Aug 1902 05 Feb 2009 9999 004 30 Jul 1943 Female 05 Feb 2009 9999 005 30 Jan 1981 Male 04 Mar 2009 9999 006 28 Mov 1959 Male 11 Mar 2009 Find Patient By Number Po rS Find 29 Apr 2009 Page 31 of 47 AC Protocol DUAG 7001 m WebEZ System User Guide A new window will open with the Patient Resupply History Report Ej https cts webez com webeztest pages REPORT ASPX RPTID 50 amp 5P True amp SELECT RkQ4Kzolm2GbBaF bWjOEn Microsoft Inter e IB File Edit GoTo Favorites Help ay Geeks Printed 12 Mar 2009 Patient Resupply History Report 7 13 AM EST Protocol DUAG 7TD2 Site 9999 Demo Site Patient 3999 002 Initials K L DOB 05 Aug 1902 Gender Male Visit Name Date Resupplied In Visit Date Numbered Medication WebEZ Entered Assigned Randomization 05 Feb 2009 MA Down Titration 12 Mar 2009 12 Mar 2009 This report details both the kit number assigned at R
10. number The patient 1s assigned one kit at Randomization which contains 1 up titration wallet card to cover week 1 and 12 fixed wallet cards for weeks 2 25 E WebEz Web Page Dialog Results f l Li The Patient Randomization Number is 9999 006 The medication Ng 10847 Thank you for randomizing your patient into Protocol DUAG O01 https icts webez comiwebeztest pages EZConfirm ast d Internet 29 Apr 2009 Page 22 of 47 a ALMIAC Protocol DUAG 7001 A a WebEZ System User Guide Clinical Services To view the data for an existing patient click on the word MNViewOnext to the patient number https cts webez com WebEZ Microsoft Internet Explorer File Edit Yiew Favorites Tools Help Q wevez User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Randomization Randomized Patient Listing Randomization Number Initials Gender Date Randomized 9999 001 29 Jun 1963 Male 04 Feb 2009 9999 002 05 Aug 1902 Male 05 Feb 2009 9999 003 06 Mar 1951 Male 05 Feb 2009 9999 004 30 Jul 1943 Female 05 Feb 2009 9999 005 30 Jan 1981 Male 04 Mar 2009 9999 006 28 Nov 1959 Male 11 Mar 2009 Find Patient By Number MEE PO Find 29 Apr 2009 Page 23 of 47 HE ALMAC iInical Protocol DUAG 7001 WebEZ System User Guide A new window will open with the Patient Event Report Z https cts webez com webeztest pages REPORT ASPX RPTID 3 amp SELECT fPMFNFVHjF 62bDqcBTx5262ba4SEFWI Mic
11. patientG visit is correct and enter the kit number dispensed to the patient at inclusion E WebEZ Patient Resupply Web Page Dialog QUIT TT RSNASTT O2 E Previous Patient Visits for Patient ID Wisil ation Patient ID Randomization To Resupply Select a visit from the Once selected you ll need to enter the list of available visits below visit date and patient s last allocated Kit number in the space provided Visit wewm MEER EE oe Name 1 Down Titr a ti an E 10958 amp Click Resupply button to complete resupply https fcts webez comfwebeztestipagesjPatientVisits aspx Ep Internet 29 Apr 2009 Page 28 of 47 aia LMAC Protocol DUAG 7001 A m ien WebEZ System User Guide oT TIC eH Services E eSignature Web Page Dialog f 2 Signature onfirm Patient Re supply Wis uu OLLAG De x cmendijesees 8 Reason Completed maintenance medication https IeEs webez com webezbest pages eSignature aspx AC Internet 29 Apr 2009 Page 29 of 47 M n n LMAC Protocol DUAG 7001 an WebEZ System User Guide Clinical Services A Results window will pop up detailing the new Patient assignment E WebEz Web Page Dialog Results Patient Initials K L Date of Birth 05 Aug 1902 Patient Number 9999 002 Current Date 12 Mar 2009 Visit Down Titration Entered Visit Date 12 Mar 7009 ccesstully obtained down ur patient https ticks webez
12. EZ System User Guide To obtain the down titration medication for patients click on the Patient Re Supply button WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help W e b Z Home Reports Message Board Contact Information Study Documents A Log Off Help n a S Patient Management Enrolirn arit User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Peetje Doe HET RESIPDY 29 Apr 2009 Page 26 of 47 u AL MAAC Protocol DUAG 7001 A eiiie m WebEZ System User Guide nica Services Select the patient you want to re supply by clicking on the patientG initials Click on Patient Re Supply WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Re supply Active Patients with Randomization Events Randomization Number Initials DOB Gender Date Randomized 05 Aug 1902 05 Feb 2009 9999 004 30 Jul 1943 05 Feb 2009 9999 005 30 Jan 1981 04 Mar 2009 9999 006 28 Nov 1959 11 Mar 2009 Find Patient By Number mm PO Find 29 Apr 2009 Page 27 of 47 amt ALMAC Protocol DUAG 7001 Clinical WebEZ System User Guide Services Follow the 3 steps highlighted below to assign down titration medication single wallet card to your patient Verify that the Patient ID is correct and that the date of the
13. System User Guide AN Ca Services Verify the patientG initials date of birth and gender from screening https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Randomization Steps dije Enter Answers d Save Randomization Question Response O1 What is the patient s gender Male 02 What are the patient s initials D F 03 What is patient s date of birth 28 m Nov 1959 v EE 04 Did the patient meet all inclusion and exclusion criteria Please select a response ie ALMAC Clinical c ervices Screening Number 9999 006 Screening Date 11 Mar 2009 a B internet Once you have answered all questions for your patient click on MSaveO 29 Apr 2009 Page 20 of 47 aia LMAC Protocol DUAG 7001 A m ien WebEZ System User Guide oT TIC eH Services You will be asked to e sign for the patient data 5 eSignature Web Page Dialog E Signature anfirm Patient Randomization Data Wis uu OLLAG De cm nHijeses 8 Reason https IcEs webez com mwebezbest pages eSignature aspx AC D Internet 29 Apr 2009 Page 21 of 47 a f Protocol DUAG 7001 WebEZ System User Guide LATTICE L VELIS 3ervices Once the patient data is saved the Results screen will appear with the patientG randomization number and medication
14. User Name DUAG D2 Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Randomization Randomized Patient Listing Randomization Number Initials Gender Date Randomized 9999 001 29 Jun 1963 04 Feb 2009 9999 002 05 Aug 1902 05 Feb 2009 9999 003 06 Mar 1951 05 Feb 2009 9999 004 30 Jul 1943 05 Feb 2009 9999 005 30 Jan 1981 04 Mar 2009 Find Patient By Number ees eS Find 29 Apr 2009 Page 17 of 47 ee Clinical Services Protocol DUAG 7001 WebEZ System User Guide You must select a screened patient to Randomize Click OK on the reminder message A EZSelectPatient Web Page Dialog Screening Screened Patient Listing Screening Number Initials DOB Gender Date Screened Vie 9999 006 eo Now 1959 11 Mar 2009 1 FeQuIres f Select Patient Find Patient By ies o ws TT TS https ficts webez com webeztest pages EfSelectPatient aspx 4CTION R r Internet 29 Apr 2009 Page 18 of 47 a ALMAC Protocol DUAG 7001 dis eiiie m WebEZ System User Guide nica Services Select a patient by clicking on the initials and highlighting the record Then click on Select Patient A EZSelectPatient Web Page Dialog Screening Screened Patient Listing Screening Number Initials DOB Gender Date Screened 28 Mov 1959 y 11 Mar 2009 Select Fave Tce d Find m com webeztest pages EzsSeleckPatient aspx 4CTION R 7 Internet 29 Apr 2009 Page 19 of 47 h z Z un b MAAC Protocol DUAG 7001 A Clio n WebEZ
15. andomization and the down titration kit number Print the Patient Resupply History Report and retain with your source document records 29 Apr 2009 Page 32 of 47 ass IU Clinical Services Click on FCloseOto exit Resupply S WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7001 WebEZ System User Guide Protocol DUAG 7D2 Frederiksborg Hosp Re supply Active Patients with Randomization Events Randomization Number Initials 9999 002 9999 004 9999 005 9999 006 Gender 05 Aug 1902 30 Jul 1943 30 Jan 1981 28 Nov 1959 Date Randomized 05 Feb 2009 05 Feb 2009 04 Mar 2009 11 Mar 2009 Find Patient By Number MEM PS Find 29 Apr 2009 Page 33 of 47 a Protocol DUAG 7001 WebEZ System User Guide In the event that a patient withdraws early from the study first assign Down titration medication to the patient Refer to p 26 32 for assignment of Down titration medication and then in Patient Management click on fDiscontinuation A https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Ordering Message Board Contact Information Study Documents Lig OF Help User Name DA JAG D2 Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Patient Management Discontinuation should only be used to indicate a patient that will no
16. lways 9999 2i https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Q webEz Select a Protocol and Site and click Continue Status Customer Contact Active Frederiksborg Hosp Project Manager 9999 Demo Site onec oo Everyone uses the same Demo system In the live system sites will only have access to the data for their site Client users will have access to data for all sites 29 Apr 2009 Page 5 of 47 a A Protocol DUAG 7001 E WebEZ System User Guide This will take you to the home page for the study At the top of the home page you will see various action buttons Click on the fPatient ManagementO button d https cts webez com WebE7 Microsoft Internet Explorer SEE Tools Help File Edit View Favorites Patient Management Ordering Reports Message Board Contact Information Study Documents Log Off Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp WebEZ Home Site User Site User WebE Role Site User Welcome Client Frederiksborg Hosp Statistics Total Patients Screened 5 Total Patients Enrolled Total Patients Randomized 5 29 Apr 2009 Page 6 of 47 Protocol DUAG 7001 ALMAC WebEZ System User Guide Click on fScreeningOto enter or view screening data for your patient F https cts webez com WebEZ Microsoft Internet Explorer File Edit view Favorites Tools Help Q We
17. nt s initials are Ko On what date did the patient discontinue ap What was the reason For discontinuation Randomization Number 9999 00 Randomization Date 05 Feb 7009 29 Apr 2009 Page 36 of 47 mm t Protocol DUAG 7001 ALMACG WebEZ System User Guide Clinical Services Click on FSaveO A https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help CD WebEZ Protocol DUAG D User Name DUAG D Frederiksborg Hosp Site 9999 Demo Site Steps dj ws Enter Answers e Save Question Response The patient s gender is Male 05 Aug 1902 The patient s date af birth is Kc The patient s initials are Patient withdrew consent On what date did the patient discontinue What was the reason For discontinuation Randomization Number 9999 00 Randomization Date 05 Feb 7009 Once a patient is discontinued it will not be possible to obtain down titration medication for that patient If a patient is discontinued in error please contact the WebEZ Helpline 806 000 03 to report the error 29 Apr 2009 Page 37 of 47 T cO M9 Protocol DUAG 7001 WebEZ System User Guide LAT Ved Services After entering your e signature the Results window will appear confirming the patient has been discontinued from the trial Please print the Results window and maintain with y
18. our source document records E WebEz Web Page Dialog Patient Number 9999 002 You have successfully discontinued your patient from Protocol DUAG 7O01 ake https cts webez com webeztest pages Ez Confirm asp D Internet Click on ACloseOto return to the active patient listing 29 Apr 2009 Page 38 of 47 i AL MAAC Protocol DUAG 7001 eiiie m WebEZ System User Guide nica Services Click on ACloseOto exit Discontinuation E https cts webez com WebE Microsoft Internet Explorer File Edit View Favorites Tools Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Discontinuation Active Patient Listing Randomization Number Initials DOB Gender Date Randomized 30 Jul 1943 Female 05 Feb 2009 9999 005 30 Jan 1981 04 Mar 2009 9999 006 2o Noy 1959 11 Mar 2009 ALMAL Clin ical Services Find Patient By Number EE go 29 Apr 2009 Page 39 of 47 Protocol DUAG 7001 ALMA WebEZ System User Guide To run summary reports for your site click on the MReportsO button d https cts webez com WebEZ Microsoft Internet Explorer File Edit view Favorites Tools Help We b Z Home Patient Management Ordering Message Board Contact Infor mation Study Documents Log Off i Help mame Patient Management rrelimsrt User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp 29 Apr 2009 Page 40 of 47 i
19. rosoft Internet Explorer File Edit GoTo Favorites Help 11 Mar 2009 Patient Event Report 11 47 AM EST Process Randomization Protocol DUAG 7D2 Site 9999 Demo Site Process Date EST 11 Mar 2009 11 36 am Process Performed By Site User Site User Patient Informatian Numbered Medicatiog 10847 Patient Final Message Thank you for randomizing your patient into Protocol DUAG 7001 No Question Response What is the patient s gender Male What are the patient s initials D F What is patient s date of birtn 28 Nov 1959 Did the patient meet all inclusion and exclusion criteria Yes l B Unknown Zone Please print this report and save with your source study documents 29 Apr 2009 Page 24 of 47 u Protocol DUAG 7001 WebEZ System User Guide unici Services Click the ACloseO button to exit Randomization https cts webez com WebEZ Microsoft Internet Explorer File Edi View Favorites Tools Help Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Randomization Randomized Patient Listing Randomization Number Initials Gender Date Randomized 9999 001 29 Jun 1963 Male 04 Feb 2009 9999 002 05 Aug 1902 Male 05 Feb 2009 9999 003 06 Mar 1951 Male 05 Feb 2009 9999 004 30 Jul 1943 Female 05 Feb 2009 9999 005 30 Jan 1981 Male 04 Mar 2009 28 Nov 1959 11 Mar 2009 Trac iis O tn o o OOt 29 Apr 2009 Page 25 of 47 Protocol DUAG 7001 ALMAC Web
20. soft Internet Explorer File Edit View Favorites Tools Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Screening Screened Patient Listing Screening Number Initials DOB Gender Date Screened 9999 001 29 Jun 1963 04 Feb 2009 9999 002 05 Aug 1902 05 Feb 2009 9999 003 06 Mar 1951 05 Feb 2009 9999 004 30 Jul 1943 05 Feb 2009 30 Jan 1981 25 Feb 2009 9999 006 20 Nov 1959 11 Mar 2009 Aog DS Find Patient By Number PS Find TT L Internet Please note the response to Question 3 AWhat is the screening date 0 should not be modified This date should always be the date that consent was obtained Click on the close button to exit screening 29 Apr 2009 Page 15 of 47 LMAC Protocol DUAG 7001 A Eia WebEZ System User Guide https cts webez com WebEZ Microsoft Internet Explorer File Edi View Favorites Tools Help We b Z a m Patient Management Ordering i Reports Message Board Contact Information Study Documents Log Off Help User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Patient Management enrollment Jnblingirig j 0B internet 29 Apr 2009 Page 16 of 47 u Protocol DUAG 7001 WebEZ System User Guide linicz Services To randomize a new patient click on PRandomize NewO Ji https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help Q webEz
21. t complete the trial not for patients that have completed the trial 29 Apr 2009 Page 34 of 47 u ALMAC Protocol DUAG 7001 A eiiie m WebEZ System User Guide nica Services Click on the initials of the patient you want to discontinue Only randomized patients will be listed Click on PDiscontinued https cts webez com WebEZ Microsoft Internet Explorer PEE Eie Edit View Favorites Tools Help ay Q webEz User Name DUAG D2 Site 9999 Demo Site Protocol DUAG 7D2 Frederiksborg Hosp Discontinuation Active Patient Listing Randomization Number Initials Gender Date Randomized 05 Aug 1902 05 Feb 2009 9999 004 30 Jul 1943 05 Feb 2009 9999 005 30 Jan 1981 04 Mar 2009 9999 006 28 Nov 1959 11 Mar 2009 Find Patient By Number a PS Find 29 Apr 2009 Page 35 of 47 EE L MAC Protocol DUAG 7001 ii Clio m WebEZ System User Guide ICa Services Enter the date the patient withdrew from the trial This may differ from the date of the final follow up contact or final visit assessment Enter the reason the patient will not complete the trial https cts webez com WebEZ Microsoft Internet Explorer Sele File Edit wiew Favorites Tools Help L4 WebEZ User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp Steps qj wb Enter Answers ws Save Question Response The patient s gender is Male J The patient s date of birth is os Aug 1902 The patie
22. use of the system i 12 Jun 2005 09 11 25 PM Example Project Example of Project Specific Messages i 12 Jun 2005 09 11 25 PM 29 Apr 2009 Page 43 of 47 FU IEEE ALMAC To exit WebEZ click on the FLogoff0 button WebEZ Microsoft Internet Explorer Fil Edit View Favorites Tools Help Patient Manage ment Ordering Study Documents User Name DUAG D Site 9999 Demo Site Protocol DUAG 7001 WebEZ System User Guide Reports Message Board Contact Infor mation Log CH Help Protocol DUAG D2 Frederiksborg Hosp WebEZ Home Welcome Site User Site User WebE Role Site User Client Frederiksborg Hosp Statistics Total Patients Screened 6 Total Patients Enrolled Total Patients Randomized 6 Helpful Hints You must disable your pop up blocker for the WebEZ and WebEZ Demo sites If you enter your password incorrectly 3 times your account will be locked For technical support 24 hours a day 7 days a week please call 806 000 03 29 Apr 2009 Page 44 of 47 p A4c M Protocol DUAG 7001 ALMAG WebEZ System User Guide If your account is locked or you have lost your password click on NAccount assistance needed 0 E https cts webez com WebEZ Microsoft Internet Explorer File Edi View Favorites Tools Help 29 Apr 2009 Page 45 of 47 p 88 83 m Protocol DUAG 7001 WebEZ System User Guide Enter your User ID
23. wi Protocol DUAG 7001 ALMAC WebEZ System User Guide DUAG 7 AJA Danish University Antidepressant Group Se LE Protocol DUAG 7001 WebEZ System User Guide 29 Apr 2009 Page 1 of 47 P n m n ALMAC Protocol DUAG 7001 WebEZ System User Guide The live website for viewing patient and site data for the study 1s https webez almacgroup com webez pages webez aspx To use the Demo system for practice and training connect to the following website https webez almacgroup com webeztest pages webez aspx Note the Demo system is a replica of the live system The process is the same All pop up blockers must be disabled for the WebEZ and WebEZ Demo sites You will see the following screen E https cts webez com WebEZ Microsoft Internet Explorer File Edit View Favorites Tools Help DUAG D2 wot sword CAT Ww j Enter the User ID DUAG 7001 and Password demo Click on OK to log in Note that both the User ID and password are case sensitive 29 Apr 2009 Page 2 of 47 _ LaLaLaA A A EE Protocol DUAG 7001 WebEZ System User Guide Na Services After your first login to the live system you will be prompted to change your password WebE Microsoft Internet Explorer O Back 3 E ix z A ye Search Top Favorites J pa FA WebEZ Password Change Required o DIESEN vee EIINENIEENN Confirm New Password Please check the bo
24. window as Adobe Acrobat pdf files The reports can be printed or saved for reference 29 Apr 2009 Page 41 of 47 Protocol DUAG 7001 WebEZ System User Guide File Edit View Favorites Tools Help Patient Management Ordering Message Board Contact Information Study Documents Log Off Help User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hosp WebEZ Home Site User Site User WebE Role Site User Welcome Client Frederiksborg Hosp Statistics Total Patients Screened 6 Total Patients Enrolled Total Patients Randomized 6 Message Board The Message Board alert on the Home Page will notify you of new messages that have been posted 29 Apr 2009 Page 42 of 47 _ ALMIAC Protocol DUAG 7001 A Clio n WebEZ System User Guide AN Ca Services Click on the PForumOe g General Discussion you want to explore A new window will open with related topics and specific messages that you can view 2a WebEZ Microsoft Internet Explorer PIB File Edit view Favorites Tools Help A Study Documents n Ww e b E 7 i Home Patient Management Ordering d Reports 1 l Message Board User Name DUAG D Site 9999 Demo Site Protocol DUAG D2 Frederiksborg Hos qn General Discussion General Discussion about WebRand WwebEZ Protocols Sites etc Any issues that do nat Fall into the other categories l I eom FAQ Frequently Asked Questions regarding
25. x to indicate your agreement to the A KAA regarding the use of WebEZ I Clinical xl IEEE Cte Your user ID and password for the live system will be sent via e mail An example of this email will look like Welcome to the Almac Clinical Services WebEZ system To access WebEZ please use the following Userid and Password If you have any questions please contact your Almac Clinical Services Project Manager Userid SampleClient Password oW8p3Nf3 Your user ID will consist of lower case letters from your first and last name followed by numbers typically 001 or 002 Your initial password will be a temporary one that you will be prompted to change the first time you log in Passwords must be at least 8 characters long Click on MOKOafter entering your new password information and indicating your agreement to the fiTerms and ConditionsO of WebEZ use 29 Apr 2009 Page 3 of 47 ALMAC Protocol DUAG 7001 Clinical WebEZ System User Guide Services A message will appear to confirm that your password was changed Click FOKOon the message Select a Protocol and Site and click Continue Status Customer Contact t PEE m ALMAL Clinical Services 29 Apr 2009 Page 4 of 47 B LN tnan AA A Em Protocol DUAG 7001 WebEZ System User Guide ATTIC E Services Select the site number from the drop down list at the bottom of the screen and click MContinueO In the Demo system the site number is a
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