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TRIO-019 ID-net User Manual v1

1. GMT 1 7j Download kit allocation Fegine Crespin a 25 04 54 7j Download End of _ 23 Jul 2009 00 42 52 Treatment Fegine Crespin GMT 1 Oisease progression Te Download Sate acute FC Callahan 23 Jul 2009 01 27 59 Demonstrating the Gode Break function for the S50 GMT 1 User Manual Product Kits Assigned hy Pare 100467 FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 100774 Regine Crespin 22 Jul 2009 23 04 54 6MT 1 Site Information MeO Blowebeae nnn A ID Net Investigator Procedures Manual Version 1 0 Page 51 60 19 August 2009 Novartis CIRG BOLERO 1 13 Medication Management The supply of study drug is managed by D net Site level users Investigators Study Coordinators and Pharmacists only have the capability of confirming receipt of supply shipments and reporting medication kits as damaged The initial shipment 6 kits will be sent to the site when the first subject is registered in ID net and re supply will be automatic 13 1 Confirm Receipt of Medication If a medication shipment is In Transit to your site the quantity of kits in the shipment is displayed on your ID net home page These kits must be confirmed as received in ID net before they are available for allocation to subjects Confirmation should be performed immediately because not confirming receipt of medication may prevent the randomization of new subjects at your site or the shipment of re supply kits This site has six kits In Transit that
2. For issues arising during North American business hours you may call the U S based Help Desk at 1 866 767 4334 This number is available 24 7 This contact information is also available by clicking the Contact IDDI link in the Navigator pane 16 Site Staffing Changes All requests for new user access must be approved by the sponsor so please forward all requests for new user accounts to your monitor It is important that all information in ID net regarding site personnel be current at all times All changes in site personnel or in the names or contact information of study participants must also be approved by the sponsor Therefore please direct all such requests to your monitor ID Net Investigator Procedures Manual Version 1 0 Page 60 60 19 August 2009
3. if the previous allocation date is 30 June the first day the next allocation may be requested for the subject is 22 July If you attempt to perform the medication allocation transaction before the 21 day interval is complete you will receive a message informing you of this You will see this message if the interval between allocation requests is less than 21 days Error The previous treatment allocation was requested on 14 Aug 2009 00 35 45 The interval between 2 administrations should be no less than 1 days lt lt Back Note that all dates in ID net are calculated on the basis of Central European Time GMT 1 Therefore if you think the 21 day interval has passed but you do not have the allocation option check your login time and date in ID net If it is close to midnight the option may appear once the ID net server time changes to the next day You can refresh the time and date by pressing the F5 key on your keyboard The IDDI Help Desk can also be contacted if you are still experiencing errors ID Net Investigator Procedures Manual Version 1 0 Page 35 60 19 August 2009 Novartis CIRG BOLERO 1 Your login date and time is displayed in the ID net Title Bar User Regine Crespi L oc g g m of It may be almost 08 00 on Thursday in eastern Australia but it is still Wednesday for the ID net server Sao Paulo Sa London Brussels Wednesday 06 57 PM 15 wednesday 10 57 PM wednesday 11 57 PM Ban
4. re Save and Continue submission ID Net Investigator Procedures Manual Version 1 0 Page 25 60 19 August 2009 Novartis CIRG BOLERO 1 8 2 Screen Failure Data Review When you click the Save and Continue button on the Screen Failure form you will be presented with the Data Review screen Here you may review the information entered for your subject If any of the information is incorrect click the Back button to return to the Screen Failure form If all information is correct click the Continue button to complete the screen failure transaction The Screen Failure Data Review screen Email idditcox net subject Screen Failure Patient Data Review Question Subject ID 0004 00010 Subject DOB 10 October 1955 Site number OIL Screen failure reason Eligibility issue 8 Please review your data before continuing Ifyou wish to modify any of your answers please click on the Back button lf you are satisted with your answers please click on Continue lt lt Back Conkinue gt gt International Drug Development Institute 2009 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 26 60 19 August 2009 Novartis CIRG BOLERO 1 8 3 Screen Failure Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the Screen Failure Result screen On this screen you will see various information related to th
5. Kits screen Bolerot Validation pp Subiect Registration Confirm Receipt of kits J E Subject Management info Hy Subject 00000004 Ey Subject 000400002 wy Subject 0004 00003 Hy Subject 0004 00004 Medication Kit Number Status Center Expire Date 100379 In Transit 31 14 2009 x 100507 In Transit 31 14 2009 s Flay Subject 000400005 wy Subject 000400006 Hyg Subject 000400007 Hy Subject 0004 00008 Hy Subject oo00 00009 100556 In Transit 31 12 2009 m 100707 In Transit 31 14 2009 m 100756 In Transit 31 12 2009 Hy Subject 000400010 100640 In Transit 317142009 L Contirm R ipt of Kits Eoo Signature a Total medication kitisi LJ If you are certain you have received all the kits in the list you may use the Select All button to select them all at once When you click the Confirm Receipt of Kits button the selected kits are moved from In Transit to On Site status and are available for allocation to subjects A Result screen appears confirming the success of the transaction Clicking the Back button on this screen returns you to the Confirm Receipt of Kits screen A confirmation document in PDF format is sent to all designated users as an email attachment Signing the Confirm Receipt of Kits form 100540 In Transit 0004 31142009 Signature eee E of cts Select il ID Net Investigator Procedures Manual Version 1 0 Page 53 60 19 August 2009 No
6. Result screen for your records by clicking the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing In addition for code breaks no PDF will be available for downloading The following actions are available for the subject after a code break e Code Break e Medication Allocation for subjects not reported as end of treatment The Subject Code Break Result screen Code break subject Codebreak Successtul This patient s treatment was successfully revealed Subject ID Subject DOB 0004 00007 OY Jun 1905 Code break date and Code break by time 24 Jul 2009 01 27 59 ChAT 4 FC Callahan 50 Site name Test Center Four The subject was randomized to Arm Il Placebo To review your subject s data please click here Print this page International Drug Development Institute O07 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 50 60 19 August 2009 Novartis CIRG BOLERO 1 12 4 Subject Details The reason for code break is listed in the subject s Subject Details screen but not the subject s treatment No confirmation document is available for download for code breaks subject Details Subject Identification E Subject number 0004 00007 E Subject DOB 09 Jun 1905 Description By Date Registration Regine Crespin eTe 2202 43 7j Download n FC Callahan 19 Jun 20095 23 39 12 Randomization CO
7. Site Identification 1 Subject ID FR 0004 00007 2 Subject DOB p coo Disease Progression j Death Other Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONC WO LONGER POSSIBLE TO CHANGE YOUR ENTRI Save and Continue 3 Site number 4 End of Treatment reason Enter your password to digitally sign your ie submission Page 43 60 Novartis CIRG BOLERO 1 11 2 End of Treatment Data Review When you click the Save and Continue button on the End of Treatment form you will be presented with the Data Review screen Here you may review the information entered for your subject If any of the information is incorrect click the Back button to return to the End of Treatment form e Please be certain you want to perform this transaction A subject reported as End of Treatment is withdrawn from the study in ID net If all information is correct click the Continue button to complete the allocation transaction The End of Treatment Data Review screen Subject End of Treatment Email idditicox net Patient Data Review Question Subject ID 0004 0000 Subject DOB 09 June 1905 Site number HU End of Treatment reason Disease Progression 8 Please review your data before continuing lf you wish to modify any of your answers please click on the Back button lf you are satistied with your answers please click on Continue lt lt Back Conkinue gt gt International Dru
8. Site Name Test Center Four To review your subject s data please click here Print this page International Drug Development Institute 2007 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 45 60 19 August 2009 Novartis CIRG BOLERO 1 11 4 Subject Details The details of the end of randomized treatment are presented on the subject s Subject Details screen You may also view print or download the end of treatment confirmation document in PDF format by clicking the associated Download link Subject Details after subject is reported as End of Treatment Note that only Code Break is available for the subject Bolero Validation Study a i User Regine Crespin rvesttgatorl e Pr 7009 00 12 05 GhiT E E e Subject Details ae Bolerod validation l sel pp Subiect Registration Fy Subject Management tinto H Subject 0004 0000 4 Fly Subject 00044 00002 H Subject 0004 00005 Ay Sublect 00044 00004 H Subject 0004 00005 i ig et CUCUCLL CUCUCUCLE Subject Details The following information is held an your subject in the central randomization database If any information is incorrect please contact your monitor or the helpdesk as soon as possible Please note that it may no longer be possible to change this data ubject Identification E Subject number 0004 00007 E Subject DOB 09 Jun 1905 Pfovccsucsaruccsusevssssussesanesseecssreerscssrs
9. Version 1 0 Page 24 60 19 August 2009 Novartis CIRG BOLERO 1 The Screen Failure form with all fields completed Bolero Validation pp Subiect Registration 5 Subject Management tinto Hy Subject 0004 00004 Ely Subject 0004 00002 Hy Subject 00000003 Hy Subject 0004 00004 Hy Subject 0004 00005 Flay Subject 0009 00006 Hy Subject ooo0 00007 yy Subject 0004 00008 Hy Subject 00000005 rae E H pp Enfim Receipt of Kits Bolero1 Validation Study ran Subject Screen Failure Subject Screen Failure INSTRUCTIONS This form will enable you to report your subject as a screen failure in the BOLERO TRIO 019 stud subjects reported as screen failures Please fill out all of the applicable fields and then enter your pa receive a confirmation onscreen in addition ta an e mail confirmation You should keep this confirma TIPS i If you place your mouse pointer over the TIP icons you will recelve additional information to aid you Patient and Site Identification 1 Subject ID FR 0004 00010 2 Subject DOB H to le cet e 1955 yy yy 3 Site number p coo Consent withdrawal Lost to FUP 4 Screen failure reason aN Eligibility issue Other Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONC LONGER POSSIBLE TO CHANGE YOUR ENTRI Enter your password to digitally sign your i
10. document may be printed or saved to your hard drive The Subject Details screen Bolero Validation Study TIST LE ged on 14077200 5a Conn ervices Subject Details serie a te D net Navigator Subject Details The following information is held on your subject in the central randomization database If any information is incorrect please contact your monitor or the helpdesk as soon as possible Please note that it may no longer be possible to change this data Subject Identification E Subject number 0004 00001 E Subject DOB 29 Feb 1960 ubject Status Description By ate Comment Download Registration Regine Crespin 04 Jun 2009 00 29 06 GMT 1 TE Download FA Randomization FC Callahan CO 04 Jun 2009 00 45 43 GMT 1 Th Download Code Break FC Callahan sponsor 04 Jun 2009 00 58 34 GMT 1 Validation testing character acceptance End of Treatment Regine Crespin 04 Jun 2009 01 06 45 GMT 1 Disease progression TE Download pp Site Activation roduct Kits Contact IDDI Assignedby Date 100445 FC Callahan CO 04 Jun 2009 00 45 45 GMT 1 E Site Number o004 lt gt E Site Name Test Center Four ID Net Investigator Procedures Manual Version 1 0 Page 14 60 19 August 2009 Novartis CIRG BOLERO 1 5 TIPS Most screens in ID net that allow the entry of data by the user include pop up tips to aid in the accurate entry of the infor
11. the OK button to confirm the activation DENMARK Two City 15 29 04 Active Deactivate X Deactivate Ore vou sure you want to Activate center jeact ate xr r 03 Test Centres l Deactivate Activate DENMARK Inactive Activate The activation screen updates to indicate the activation was successful The Activate link changes to Deactivate for activated sites To deactivate a site follow this same procedure only clicking the Deactivate link Site 03 has been activated J DENMARK Copenhagen Inactive Activate x 14 08 2009 ee 03 DENMARK 00 17 34 Active Deactivate J4 DENMARK Inactive Activate ID Net Investigator Procedures Manual Version 1 0 Page 18 60 19 August 2009 Novartis CIRG BOLERO 1 7 Registration A subject must be registered in D net in order to participate in the study Subjects must sign informed consent prior to being registered e All individuals who sign informed consent should be registered in the study To register a subject you will need the Subject s date of birth Subjects must be 18 years of age or older 7 1 Registering a New Subject To register a new subject click the Subject Registration link in the tree view This opens the Registration data capture screen Enter the subject s date of birth in the appropriate fields and sign the form using your ID net password Your site number will be pre filled on the form if this number is not correct do not continue with
12. 00400004 Feng Subject 000400005 Ew Subject 000400006 Ey Subject 000400007 Ey Subject 000400008 Ey Subject 000400009 H g Subject 000400010 ID Net Investigator Procedures Manual Version 1 0 Page 16 60 19 August 2009 Novartis CIRG BOLERO 1 Scroll through the list to find the site you wish to activate sites are listed in numerical order When you find the site click the Activate link in the far right column Action A pop up window will appear asking if you wish to activate the site Click the Activate link to activate Site 03 Site Activation site Sumber 0001 O02 jugs guga O01 Fl Name Country Mwest gator Mvest aqator Mwest gators Mir Arnaud Invest DENMARK DENMARK DENMARK DENMARK DENMARK a LL DENMARK TEN RARE Jerome Invest aator Sa City One City Tweety Three City Testberg DK 8000 Arhus C Ottanies Louvain la Neuve ID Net Investigator Procedures Manual Version 1 0 19 August 2009 Activation date 2M O3 2009 13 2902 2 03 2009 13 29 04 25 03 2009 16 44 41 25 03 2009 164443 14 05 2009 16 36 36 OsfOb 2009 TPO 4p Current activation status Active Actly Active Actiy Active Action Deactivate Deactivate Deactivate Deactivate Deactivate A tinte PEEEECECETEEELELELETEEELELLIS Activate vale Deactivate Page 17 60 Novartis CIRG BOLERO 1 Click
13. 9 By E ubject 0004000410 elgg Subject OOO4 00014 B Contact IDEI Bolero1 Validation Study m R A 2 Weer FC Callahan 50 En Logged on 23 707 16 S Email f c callahanibc edu Code break subject Code break subject INSTRUCTIONS Subject code break enables you to reveal the treatment arm allocated to a subject for emergency safety unmasking requirements only PLEASE CONTACT CIRG BEFORE UNBLINDING THE PATIENT Please fill in the form below enter your password to sign your data and submit to the server The subject s treatmerr revealed onscreen and an email will be sent confirming the subject s treatment allocation TIPS H lf you place your mouse pointer over the TIP icons you will receive additional information to aid you in filling out the Subject and Site Identification 1 Subject ID BB 0004 00007 2 Subject DOB osv un 1905 yyyy 3 Site Number p ioo Subject Code break information 4 Subject code break reason J Cemonstrating the Code Break function for the User Mar Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONCE SUBMITTE NO LONGER POSSIBLE TO CHANGE YOUR ENTRIES Enter your password to digitally sign your El vesees submission ID Net Investigator Procedures Manual Version 1 0 Page 48 60 19 August 2009 Novartis CIRG BOLERO 1 12 2 Code Break Data Review When you click the Save and Continue button on the Code Break form you will be present
14. Allocation form you will be presented with the Data Review screen Here you may review the information entered for your subject If any of the information is incorrect click the Back button to return to the Medication Allocation form e Please review this information carefully Once a kit is allocated it may not be possible to correct any errors If all information is correct click the Continue button to complete the allocation transaction The Medication Allocation Data Review screen Email idditcox net Medication allocation Patient Data Review Question Subject ID 0004 0000 Subject DOB 09 June 1905 Dose 10 mgiday Site number 0004 2 Please review your data before continuing If you wish to modify any of your answers please click on the Back button lf vou are satisfied with vour answers please click an Continue lt lt Back Continue gt gt International Drug Development Institute 2009 Boston Brussels Faris ID Net Investigator Procedures Manual Version 1 0 Page 39 60 19 August 2009 Novartis CIRG BOLERO 1 10 4 Medication Allocation Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the Medication Allocation Result screen On this screen you will see information related to the allocation including the medication kit allocated to the subject the date and time of the allocation the individual w
15. Download roduct Kits FC Callahan CO 19 Jun 2009 23 39 12 MT 1 Regine Crespin 22 Jul 2009 23 04 54 MT ite Information E Site Mumber ID Net Investigator Procedures Manual Version 1 0 Page 41 60 19 August 2009 Novartis CIRG BOLERO 1 11 Subject End of Treatment everolimus A subject who leaves everolimus treatment should be reported as End of Treatment in ID net Once a subject is reported as End of Treatment no further medication allocations are possible The option for Code Break will remain available IMPORTANT The End of Treatment in ID net is different than the End of Treatment in the CRF In ID net this refers to the end of everolimus treatment 11 1 Completing the End of Treatment Form To report the end of randomized everolimus treatment for a subject open the options for the subject in the tree view by clicking the symbol next to the Subject ID and then click the End of Treatment link This opens the end of treatment data capture screen Complete the form entering the requested information in each section All questions must be answered to complete the randomization e Subject ID pre filled e Subject DOB Enter the date of birth recorded at the time of registration End of Treatment Reason Choose one of the three options o Disease Progression o Death o Other e Site Number This is pre filled If the site number is incorrect cancel the End of Treatment transaction and contact the
16. GMT 1 Reporting Kit 100774 as damaged 100707 in Transit 0004 31 12 2009 100756 In Transit 0004 317122009 100774 Re Allocation 0004 34122009 0004 00007 O 100822 Re Allocation 0004 34122009 0004 00003 100840 in Transit 0004 31 12 2009 Signature esses OO o Report Damaged Kits Select All Total medication kits 25 ID Net Investigator Procedures Manual Version 1 0 Page 56 60 19 August 2009 Novartis CIRG BOLERO 1 The Report Damaged Kits Result screen Report Damaged Kits Email iddi cox net EE You have successfully reported the damaged kits you will receive a confirmation soon lt lt Back Kit 100774 is no longer associated with the subject ubject Identification E Subject number 0004 00007 E Subject DOB 09 Jun 1905 ubject Status Comment 08 Jun 2009 22 52 33 GMT 1 19 Jun 2009 23 39 12 GMT 1 Registration Regine Crespin Randomization FC Callahan CO Kit allocation Regine Crespin 22 Jul 2009 25 04 54 GMT 1 End of Treatment Regine Crespin 23 Jul 2009 00 42 52 GMT 1 Disease progression Code Break FC Callahan 50 23 Jul 2009 01 27 59 GMT 1 Demonstrating the Code Dreak func roduct Kits 100467 FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 ite Information E Site Mumber 004 Site Mame Test Center Four ID Net Investigator Procedures Manual Version 1 0 Page 57 60 19 August 2009 Novartis CIRG BOLERO 1 14 Reports The Reports section of ID net is avai
17. IDDI Help Desk Once all information is entered sign the form with your ID net password and click the Save and Continue button Signing the End of Treatment form Enter your password to digitally sign your H submission ID Net Investigator Procedures Manual Version 1 0 Page 42 60 19 August 2009 Novartis CIRG BOLERO 1 The End of Treatment form with all fields completed Boleroad validation pp Sublect Registration AY Subject Management into ID Net Investigator Procedures Manual Version 1 0 Hy Subject o004 00004 Hy Subject ooo4 o0002 Hy Subiect ooo4 o00003 Hy Subject ooo4 o0004 Hy Subject oo004 00005 Hy Subiect 0004 00006 Ay Subject ooo4 o0007 3 pp End of treatment Fey Subiect ooo4 o0009 H Subiect ooo4 tooo40 Hwy Subject o004 00044 pp Contin Receipt of Kits pp Report Damaged Kits Contact IDDI 19 August 2009 pp iedication Allocation Bolero Validation Study A S User R e rE Logged Email i Subject End of Treatment Subject End of Treatment INSTRUCTIONS This form will enable you to report the end of treatment of your subject in the BOLERO study Please fill out all of the applicable fields and then enter your password to submit the request Yol onscreen in addition ta an e mail confirmation You should keep this confirmation with the subjec TIPS i If you place your mouse pointer aver the TIP icons you will receive additional information to aid Patient and
18. Novartis CIRG BOLERO 1 International Drug Development Institute ID NET USER MANUAL 19 August 2009 Version 1 0 NOVARTIS CIRG STUDY TRIO CIRG 019 CRADO01 J2301 BOLERO 1 A Randomized Phase III Double Blind Placebo Controlled Multicenter Trial of Everolimus in Combination with Trastuzumab and Paclitaxel as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer IDDI 30 Avenue Provinciale 1340 Louvain la Neuve Belgium Tel 32 10 61 44 44 Fax 32 10 61 88 88 ID Net Investigator Procedures Manual Version 1 0 Page 1 60 19 August 2009 Novartis CIRG 1 El Table of Contents Introduction User Profiles 1 1 1 Investigator 1 1 2 Study Coordinator 1 1 3 Pharmacist 1 1 4 Sponsor CIRG amp Novartis 1 1 5 CIRG Officer 1 1 6 Monitor 1 1 7 Safety Officer 1 1 8 Drug Distributor supplier 1 2 1 3 2 1 2 2 3 1 3 2 NH Ul A 7 1 7 2 7 3 7 4 8 1 8 2 8 3 8 4 9 1 9 2 9 3 9 4 9 5 10 10 1 10 2 10 3 Study Design Web Browser Requirements ID net Logging onto ID net Passwords ID net Home Page Navigator Pane Navigator Options Subject Details TIPS Site Activation Sponsor and CIRG Officer Registration Registering a New Subject Registration Data Review Registration Result Screen Subject Details Screen Failure Completing the Screen Failure Form Screen Failure Data Review Screen Failure Result S
19. Subject 000400007 vee pp Codebre ak Subject O E Eiere 2 7 yy Subiect 000400009 Description By ate Comment l Download Heyy Subject 0004 00010 Registration Regine Crespin 08 Jun 2009 22 52 33 GMT 1 TE Cownload Hy Subject 0004 00041 S Randomization FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 Te Download a pp Contin Receipt of Kits Kit allocation Regine Crespin 22 Jul 2009 23 04 54 GMT 1 Te Download End of Treatment Regine Crespin 23 Jul 2009 00 42 52 GMT 1 Disease progression TE Download Product Kits l pp Report Damaned Kits Ba E Contact IDDI Assigned by Date 100467 FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 ID Net Investigator Procedures Manual Version 1 0 Page 46 60 19 August 2009 Novartis CIRG BOLERO 1 12 Subject Code Break In rare cases were a subject s treatment needs to be revealed for reasons of safety the Code Break function may be used This function is available to users with Investigator or Safety Officer accounts in ID net Only the person performing the code break will receive the result Please remember that this information will unblind you to the data Code break is available for all randomized subjects including those who have been reported as end of treatment e INVESTIGATORS SHOULD CONTACT NOVARTIS or CIRG BEFORE PERFORMING A CODE BREAK 12 1 Completing the Code Break Form To perform a code break for a subject open the options for the su
20. aging subject registration randomization and treatment for data collection and for managing medication supplies Users access D net via the Internet using Microsoft Internet Explorer other Web browsers are not supported The address URL for the secure ID net Web site is https idnet iddi com This is the URL for ID net er y 7 https Hidnet iddi com x e 4 X A User ID and password are required to log onto ID net These will be provided to you by your monitor at an appropriate time User IDs and passwords must not be shared Additional site users can be added at any time if needed You will also need a Study Code to log onto ID net The Study Code for this study is bolerol ID Net Investigator Procedures Manual Version 1 0 Page 7 60 19 August 2009 Novartis CIRG BOLERO 1 The ID net Logon screen Welcome to the International Drug Development Institute 119 net T Please Enter your User ID User Password and Stuery Code User ID rcrespin User Password seseeses study Code boleral lf you have forgotten your User ID or Password please contact Centralized Data Services by e mail or call one of the following numbers U S Europe 1 866 S05 IDD1 32 16 270 969 Log onto ID net by entering your User ID password case sensitive and the Study Code into the appropriate fields on the Logon screen and clicking the button The first time you log onto ID net and every 90 days thereafter you will b
21. al Version 1 0 Page 23 60 19 August 2009 Novartis CIRG BOLERO 1 8 Screen Failure If a registered subject is determined to be ineligible prior to being randomized in the study you should report the subject as a screen failure in ID net e Please note Once a subject is randomized the Screen Failure option is no longer available 8 1 Completing the Screen Failure Form To record a subject as a screen failure open the options for the subject in the tree view by clicking the symbol next to the Subject ID and then click the Subject Screen Failure link This opens the Screen Failure data capture screen Complete the form entering the requested information in each section e Subject ID pre filled e Subject DOB Enter the date of birth recorded at the time of registration e Site Number This is pre filled If the site number is incorrect cancel the screen failure and contact your monitor or the IDDI Help Desk e Screen Failure Reason Choose one of the four available reasons for screen failure o Consent Withdrawal o Lost to FUP o Eligibility Issue o Other You must choose a reason for screen failure to complete the transaction Sign the form with your ID net password and click the Save and Continue button This will take you to the Screen Failure Data Review screen Signing the Screen Failure form Enter your password to digitally sign your H submission ID Net Investigator Procedures Manual
22. at the site E Recruitment closure date 01 Aug 2011 Site information site Number 900 site name IDDI E EE 30 avenue Provinciale Pping 1340 Ottignies Louvain la Neuve ID Net Investigator Procedures Manual Version 1 0 Page 10 60 19 August 2009 Novartis CIRG 3 1 Navigator Pane BOLERO 1 The Navigator pane tree view is where you access subject information and the various actions available to you The items in this pane are hyperlinks which you click to access information or a function Investigator Navigator Pane tree view Bolerod Walidatian ofp pp Subject Registration a was Ubject Management info fl gf Sublect o00 0000 1 H y Sublect OO04 00002 Hy Subject o00 00003 E ubise O004 00004 Bly Subject oo04 00005 yy Subject 0004 00006 z To ooo4oo007 Eada ppitin Allocation Eain opp Codebreak Subject _ pp End of tre atment H g Subleet o00 00008 H Subject o004 00009 H oy Sublect o004 00010 Ppp Contin Receipt of Kits opp pp Report Damaged Kits EE Contact IDDI Transactions related to subjects are accessed by clicking on the symbol in the small box next to the subject s Subject ID Only those transactions available for your specific profile will be visible If the subject options are already displayed the symbol in the box is the sign clicking on this will collapse the options tree for that subject ID Net Investigator Procedures Manual 19 Aug
23. ay also view print or download the registration confirmation document in PDF format by clicking the associated Download link Subject Details after Registration Bolero1 Validation Study Pd Eo User Regine Crespin rwesttigaior e 2 Logged on 150772008 00 41 19 GIT 1 Email idditcox net Subject Details Subject Details The following information is held on your subject in the central randomization database If any Information is incorrect please contact your monitor or the helpdesk as soon as possible Please note that t may no longer be possible to change this data E Subject number 0004 0001 1 Subject DOB 20 Apr 1950 Description By Date Registration Regine Crespin 15 Jul 2009 00 30 57 GMT 1 T Download E Site Murmber a004 E Site Mame Test Center Four IMPORTANT Upon registration of the patient in ID net the 5 RANDOMIZATION FORMS pages must be completed and sent to CIRG for randomization of the subject in the study For Australia Canada USA and LatAm countries For all other countries Fax 1 780 702 0189 Fax 33 1 58 10 09 10 Or send them by email to rando019 cirg org CIRG will contact you in case a clarification is required or in case the subject is determined to be ineligible If the subject is determined to be eligible she will be promptly randomized by CIRG and you will automatically receive a confirmation document in PDF format as an email attachment ID Net Investigator Procedures Manu
24. bject in the tree view by clicking the symbol next to the Subject ID and then click the Code Break Subject link This opens the code break data capture screen Safety Officers should select the subject s site from the drop down list to locate the subject s record Complete the form entering the requested information in each section All questions must be answered to complete the code break transaction e Subject ID pre filled e Subject DOB Enter the date of birth recorded at the time of registration e Site Number This is pre filled If the site number is incorrect cancel the code break transaction and contact the IDDI Help Desk e Subject Code Break Reason Enter the reason for the code break in the text box This field accepts up to 100 alpha numeric characters Once all information is entered sign the form with your ID net password and click the Save and Continue button Signing the Subject Code Break form Enter your password to digitally sign your He submission ID Net Investigator Procedures Manual Version 1 0 Page 47 60 19 August 2009 Novartis CIRG BOLERO 1 The Code Break form with all fields completed Safety Officer profile n i er ee io ee Oe Lt La ae Bolero Validation By Subject Management tinto i Hy Subject 0004 00004 Elgg Subject 0004 00002 Hy Subject oo040000 3 Egg Subject o004400004 Hy Subject oo0400005 oe it OUI OCU ay Subject OO0 00007 Hyr ubject OOO4 0000
25. cked at least one check box ID Net Investigator Procedures Manual Version 1 0 Page 54 60 19 August 2009 Novartis CIRG BOLERO 1 Signing the Report Damaged Kits form 100540 in Transit 0004 317122009 meee E E ff clear Total medication kit s 25 Although it is an option we recommend that you do not use the Select All button due to the risk of reporting kits as damaged that are not in fact damaged especially kits already allocated to subjects The Report Damaged Kits screen Bolero Validation Study User Regine Crespin r vestiga a me ogged on 22072009 18 52 3 a 2 Logged on 23 07 2009 18 52 23 SAT 1 Email a E Report Damaged Kits Bolerot Yalidation ad pp Subject Registration 4 Subject blanagement tinto Report Damaged Kits H Subject 000400002 Fy Subject 000400003 Hwy Subject 0004 00004 i 100201 On site 0004 31 12 2009 Hg Subject 0004 00005 Fly Subject 0004 00006 Hay Subject 000400007 Ely Subject 000400008 Hwy Subject 000400009 Bly Subject 0004 00010 Hwy Subject 0004 00044 oer Conti R ipt ot kits pene E BA 100308 On Site oon 31 12 2009 Ee es o o i 100352 On Site 0004 31 12 2009 O Once you are certain the correct kits have been selected sign the form with your ID net password and click the Report Damaged Kits button to complete the transaction You will be presented with a Result screen
26. creen Subject Details Randomization CIRG Officer Requirements for Randomization Completing the Randomization Form Randomization Data Review Randomization Result Screen Subject Details Medication Allocation Interval Between Allocations Completing the Medication Allocation Form Medication Allocation Data Review ID Net Investigator Procedures Manual Version 1 0 19 August 2009 BOLERO 1 11 13 19 21 22 23 24 26 2 28 29 29 32 33 34 35 37 39 Page 2 60 uMmunMnnH amp A DA 10 14 15 16 19 24 29 35 Novartis CIRG 10 4 10 5 11 11 1 11 2 11 3 11 4 12 12 1 12 2 12 3 12 4 13 13 1 13 2 14 15 16 Medication Allocation Result Screen Subject Details Subject End of Treatment everolimus Completing the End of Treatment Form End of Treatment Data Review End of Treatment Result Screen Subject Details Subject Code Break Completing the Code Break Form Code Break Data Review Code Break Result Screen Subject Details Medication Management Confirm Receipt of Medication Report Damaged Kits Reports Help Desk Site Staffing Changes ID Net Investigator Procedures Manual Version 1 0 19 August 2009 BOLERO 1 40 41 42 44 45 46 47 49 50 51 52 54 Page 3 60 42 47 52 58 60 60 Novartis CIRG 1 Introduction BOLERO 1 This document describes the features and use of ID net the IDDI IWRS system for the BOLERO 1 st
27. d Allocation by Time 22 Jul 2009 23 04 54 E GMT 1 d P Site Name Treatment kit number 100774 has been allocated to this subject To review your subject s data please click here Print this Page International Drug Development Institute 003 Boston Brussels Paris Page 40 60 Novartis CIRG BOLERO 1 10 5 Subject Details The details of the allocation are presented on the subject s Subject Details screen You may also view print or download the allocation confirmation document in PDF format by clicking the associated Download link The medication kit allocated to the subject is listed in the Product Kits section of the page Subject Details after Medication Allocation Bolerot Validation study User Regine Crespin gr vestigator A E Logged on 22 07 2009 23 01 05 F re E but T SP 1 Subject Details i NE Subject Details The following information is held on your subject in the central randomization database If any Information is Incorrect please contact your monitor or the helpdesk as soon as possible Please note that t may no longer be possible to change this data Subject Identification E Subject number 0004 00007 E Subject DOB 09 Jun 1905 ubject Status Description By FD Registration Regine Crespin Oe Jun 2009 22 52 33 GMT 1 T Download Randomization FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 T Download Kit allocation Regine Crespin 22 Jul 2009 25 04 54 ahl 1 T
28. e required to change your password You may also change your password at any time from the Logon screen by entering your logon information and clicking the button ID Net Investigator Procedures Manual Version 1 0 Page 8 60 19 August 2009 Novartis CIRG BOLERO 1 The Change Password dialogue 119 net Change Password Your password has expired Please change tt study Code boleral User ID rcrespin Old User Password Mew User Password Confirm Mew User Fassword If you have forgotten your User ID or Password please contact Centralized Data Services by e mail or call one of the following numbers E U S A Europe 1 566 505 IDBI 32 16 270 969 2 2 Passwords Important Passwords are case sensitive PASSWORD is different from password Repeated attempts to log onto D net with an incorrect password will result in your account being locked If you forget your password please contact the Help Desk to have it reset There are no specific requirements for creating passwords however we recommend you choose a password containing at least eight characters for security reasons ID Net Investigator Procedures Manual Version 1 0 Page 9 60 19 August 2009 Novartis CIRG BOLERO 1 3 ID net Home Page Logging onto D net brings you to your Home Page From here you can access every ID net function available to you The Home Page screen consists of three parts e Title Bar Displayed here i
29. e screen failure including the date and time of the screen failure the individual who performed the screen failure and other relevant information Note that all dates and times in ID net are the local time in Belgium where the IDDI servers are located You may print the Result screen for your records by clicking the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing All designated users will receive a confirmation document in PDF format as an email attachment e No further actions are available for subjects reported as screen failure The Screen Failure Result screen Bolero Validation study User Regine Crespin Dir ves Ae EP ogged on 1607 r200 23 a 2 io on 1670772009 23 Email idditicox net Subject Screen Failure Screen failure Successtul Subject ID Subject DOB 0004 00010 10 Oct 1955 Screen Failure Date and Screen Failed By Time 16 Jul 2009 23 52 02 E GMIT d P Site Name Test Center Four To review your subject s data please click here Print this page ID Net Investigator Procedures Manual Version 1 0 Page 27 60 19 August 2009 Novartis CIRG BOLERO 1 8 4 Subject Details The details of the screen failure are presented on the subject s Subject Details screen You may also view print or download the screen failure confirmation document in PDF format by clicking the associated Download link Subject Details
30. ed with the Data Review screen Here you may review the information entered for your subject If any of the information is incorrect click the Back button to return to the Code Break form If all information is correct click the Continue button to complete the code break transaction The Code Break Data Review screen ode break subject Patient Data Review Question Subject ID 0004 00007 Subject DOB 09 June 1905 Site Number HU Subject code break reason Demonstrating the Code Break function for the User Manual EH Please review your data before continuing lf you wish to modify any of your answers please click on the Back button lf you are satisted with your answers please click on Continue lt lt Back Conkinue International Drug Development Institute 2009 Boston Brussels Faris ID Net Investigator Procedures Manual Version 1 0 Page 49 60 19 August 2009 Novartis CIRG BOLERO 1 12 3 Code Break Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the Code Break Result screen On this screen you will see information related to the transaction including the subject s treatment the date and time of the transaction the individual who performed the code break and other relevant information Note that all dates and times in ID net are the local time in Belgium where the IDDI servers are located You may print the
31. et all the inclusion exclusion criteria as outlined in the protocol Yes No o If the answer to this question is No the subject will not be randomized Please record the subject as a screen failure Section 5 above ID Net Investigator Procedures Manual Version 1 0 Page 29 60 19 August 2009 Novartis CIRG BOLERO 1 The subject cannot be randomized if the answer to the Eligibility Confirmation question is No Error subject is considered as not eligible and should be reported as screening failure lt lt Back Sign the form with your ID net password and click the Save and Continue button This will take you to the Randomization Data Review screen Signing the Randomization form Enter your password to digitally sign your ee submission ID Net Investigator Procedures Manual Version 1 0 Page 30 60 19 August 2009 Novartis CIRG BOLERO 1 The Randomization form with all fields completed in _net Navioator Boleroad Walidatian Subject Management tinto Ew Subject 0004 00004 Hy Subject 00040000Z Ey Subject OO04 00003 Hy Subject 0004 00004 Fay Subject 000400005 Ew Subject 0004 00006 Hy Subject 000400007 Hy Subject 00400008 Hy Subject 000400000 ay Subject o00 00011 0004 Test Center Four gt Bolero1 Validation Study 2B E EN Subject Randomization INSTRUCTIONS This form will enable you to rand
32. following Screen Failure Note that no further actions are available for this subject Bolero walidation pp Subiect Registration H i i ga Subject hianagement Cinta Hy Sublet oo0 00004 H Subject oo0 00002 Hy Subiect o00 00003 y Subiect 0004 00004 2 Hy Subject ooo4 o0005 2 Hyr Subiect 0004 00006 Brg Subiect 0004 00007 2 Hyr Subject ooo o0008 ID Net Investigator Procedures Manual Version 1 0 oe r CTL LUM Ely Sublect o004 00010 z i joja 19 August 2009 Bolero1 Validation Study L gs Zu bj ect Details User Regine Crespin Wr ve stigator M2009 23 29 04 6M Email idditicox net Subject Details The following information is held on your subject in the central randomization database If any information is Incorrect please contact your monitor or the helpdesk as soon as possible Please note that it may no longer be possible ta change this data Subject Identification Subject number 0004 00010 E Subject DOB 10 Oct 1955 Description By e a Comment Download Fegistration F Craig Callahan IDDM 10 Jun 2009 21 33 15 GMT 1 Te Download 16 Jul 2009 25 52 02 GMT 1 Eligibility issue E Download E site Number 004 E Site Name Test Center Four E Site Shipping Address 1234 Test Center Drive screen Failure Regine Crespin Page 28 60 Novartis CIRG BOLERO 1 9 Randomization CIRG Officer Registered subjects who meet all eligibility criteria may be randomized Onl
33. g Development Institute 2009 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 44 60 19 August 2009 Novartis CIRG BOLERO 1 11 3 End of Treatment Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the End of Treatment Result screen On this screen you will see information related to the transaction including the date and time of the transaction the individual who reported the end of treatment and other relevant information Note that all dates and times in ID net are the local time in Belgium where the IDDI servers are located You may print the Result screen for your records by clicking the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing All designated users will receive a confirmation document in PDF format as an email attachment The following actions are available for the subject after being reported as end of treatment e Code Break The Subject End of Treatment Result screen Bolero Validation Study E E E E E deen a User Regine Crespin ir vestigator A Logged on 2307 2009 00 12 05 Shit F i iz gg Email idditcox net Subject End of Treatment End of treatment successfull Subject ID Subject DOB 0004 0000 09 Jun 1905 End of Treatment Date End of treatment and lime reported by 23 Jul 2009 00 42 52 m GMT 1 3 P
34. gister the subject in the BOLERO TRIO 019 study You should register all subjects who have signed the informed consent form Once you have registered the subject you will receive a unique subject ID which should be used whenever referencing your subject in this study Please fill out all of the applicable fields and then enter your password to submit the registration request You will receive a confirmation onscreen of your subject registration in addition to an e mail confirmation You should keep this confirmation with the subject s records TIPS H you place your mouse pointer over the TIP icons you will receiwe additional information to aid you in filling out the form Subject and Site Identification 1 Subject DOB FB 20 v apr 1950 tyyyy 2 Site Number p ooo Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONCE SUBMITTED IT IS NWO LONGER POSSIBLE TO CHANGE YOUR ENTRIES Enter your password to digitally sign i lssecee your Dmi ah Save and Continue Signing the Registration form Enter your password to digitally sign your 7 submission ID Net Investigator Procedures Manual Version 1 0 Page 20 60 19 August 2009 Novartis CIRG BOLERO 1 7 2 Registration Data Review When you click the Save and Continue button on the Registration form you will be presented with the Data Review screen Here you may review the information entered for your subject If the date of birth is incorrec
35. gkok Hong Kong Melbourne Thursday 04 57 4M Thursday 05 57 AM Thursday 07 57 AM ID Net Investigator Procedures Manual Version 1 0 Page 36 60 19 August 2009 Novartis CIRG BOLERO 1 10 2 Completing the Medication Allocation Form To allocate a medication kit for a subject open the options for the subject in the tree view by clicking the symbol next to the Subject ID and then click the Medication Allocation link This opens the allocation data capture screen Complete the form entering the requested information in each section All questions must be answered to complete the medication allocation e Subject ID pre filled e Subject DOB Enter the date of birth e Dose Choose one of the three dose options o 10 mg day o 5 mg day o 5mg 2 days o NOTE Once a dose lower than the initial dose is selected it is not possible to return to a higher dose at any subsequent visit e Site Number This is pre filled If the site number is incorrect cancel the allocation transaction and contact the IDDI Help Desk Once all information is entered sign the form with your ID net password and click the Save and Continue button Signing the Medication Allocation form Enter your password to digitally sign your 7 submission ID Net Investigator Procedures Manual Version 1 0 Page 37 60 19 August 2009 Novartis CIRG BOLERO 1 The Medication Allocation form with all fields completed Boleroad Wa
36. ho performed the allocation and other relevant information Note that all dates and times in ID net are the local time in Belgium where the IDDI servers are located You may print the Result screen for your records by clicking the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing All designated users will receive a confirmation document in PDF format as an email attachment The following actions are available for the subject after medication allocation e Medication Allocation e Code Break e End of Treatment Medication Allocation Result screen Bolero Validation Study User Regine Crespin vestigation A ogged on 227072009 23 01 05 ti e Logged on 22 07 2009 23 01 05 GhiT 1 Email e Patient Realocation Bolerad validation pp tiest Registration EY Subject Management tintoj H Subject 000400004 Medication Allocation Successful yy Subject ooo4 o0002 H Subiect ood 00003 Ey Subject ooo4 00004 Hy Subject 0004 00005 Hy Subject 0004 00006 Eby Subject ooo4 00007 pend of treatment Hy Subject 000400008 Bly Subject 000400009 Bly Subject 000400010 H Subject o004 00011 pp Eentinn Receipt of Kits pps ont Damaged Kits E Contact IDDI ID Net Investigator Procedures Manual Version 1 0 19 August 2009 pp filedication Allocation pp Codebreak Subject Subject ID Subject DOB 0004 0000 09 Jun 1905 Allocation Date an
37. indicating that the transaction was successful Clicking the Back button on this screen returns you to the Report Damaged Kits screen If the kit reported as damaged has already been allocated to a subject but not used it is removed from the subject s record and no longer appears on the subject s Subject Details screen If the kit was In Transit it no longer appears in the list of kits on the Confirm Receipt of Kits screen ID Net Investigator Procedures Manual Version 1 0 Page 55 60 19 August 2009 oy Sots dobinda Medication Kit Number Center Expire Date PATIENT CRF 100179 Allocated OUD 31 12 2009 0004 0001 1 100245 Allocated OUD 31 12 2009 0004 00004 100264 Re Allocation 0004 31 12 2009 0004 00004 100267 Re Allocation 0004 31 12 2009 0004 00004 100286 Re Allocation 0004 31 12 2009 0004 00004 Novartis CIRG BOLERO 1 Kit 100774 has been allocated to Subject 0004 00007 Subject Identification E Subject number 0004 00007 E Subject OOB 09 Jun 1905 Fegistration Regine Crespin Ue Jun 2009 22 52 33 GMT 1 Randomization FC Callahan CO 19 Jun 2009 23 39 12 GMT 1 Kit allocation Regine Crespin 22 Jul 2009 23 04 54 GMT 1 End of Treatment Regine Crespin 23 Jul 2009 00 42 52 GMT 1 Disease progression Code Break FC Callahan SO 23 Jul 2009 01 27 59 GMT 1 Oernonstrating the Code Break fum roduct Kits 100467 FC Callahan CO 19 Jun 2009 43 39 12 GMT 1 100774 Regine Crespin 22 Jul 2009 23 04 54
38. ing the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing All designated users will receive a confirmation document in PDF format as an email attachment The following actions are available for the subject after randomization e Medication Allocation e Code Break e End of Treatment The Randomization Result screen Bolero Validation Study 7 a fi p User FC Callahan CO ARG Legged on 177072009 00 17 Email callahtemcox net Subject Randomization Randomization Successtul Subject ID Subject DOB 0004 0001 1 20 Apr 1950 Randomization Date and Randomized by Time 17 Jul 2009 00 52 47 GhtT 4 FC Callahan CO Site Name Test Center Four Treatment kit number 100179 has been allocated to the subject To view your subject s data please click here Prink this Page International Crug Development Institute 008 Boston Brussels Faris ID Net Investigator Procedures Manual Version 1 0 Page 33 60 19 August 2009 Novartis CIRG BOLERO 1 9 5 Subject Details The details of the randomization are presented on the subject s Subject Details screen You may also view print or download the randomization confirmation document in PDF format by clicking the associated Download link The medication kit allocated to the subject at randomization is listed in the Product Kits section of the page Subject Details after randomizat
39. ion Bolero Validation Study 7 ee A e B User FC Callahan COJ RG Offices Logged on 170772009 00 17 01 GM Email callahfeteoox net Subject Details Subject Details The following information is held on your subject in the central randomization database If any Information is Incorrect please contact your monitor or the helpdesk as soon as possible Please note that it may no longer be possible to change this data E Subject number 0004 0001 1 E Subject DOB 20 Apr 1950 Description By Date Registration Regine Crespin 15 Jul 2009 00 30 57 GMT 1 Te Download Randomization FC Callahan CO 17 Jul 2009 00 52 47 GMT 1 Te Download Product Kits Kit Number Assigned by Date 100179 FC Callahan CO 17 Jul 2009 00 52 47 GMT 1 Site Information Site Number ID Net Investigator Procedures Manual Version 1 0 Page 34 60 19 August 2009 Novartis CIRG BOLERO 1 10 Medication Allocation At each cycle for a subject a medication kit is allocated to the subject in ID net using the Medication Allocation feature In order to prevent partial unblinding at least one kit for each treatment arm must be On Site at your site to complete the allocation 10 1 Interval Between Allocations A minimum of 21 days is required between medication allocations This interval is calculated with the previous allocation date being Day O and the next date at which an allocation may be requested as Day 22 For example
40. ists of the four digit site number a dash and a five digit number sequential at the site level You may print the Result screen for your records by clicking the Print This Page button Please note that once you leave this screen it is no longer available for viewing or printing All designated users will receive a confirmation document in PDF format as an email attachment The Registration Result screen Bolero Validation Study a 2 F Fr Subject Registration 1 Email iddi ec net Boleroal Validation ppp Hublect Reaistration Registration Successful oT an Subject ID 0004 00011 E Sublect o00 00001 Hy Subject 000400002 Site Number Subject DOB Bly Subject 000400003 D004 50 Apr 1950 gg Subject 000400004 2 eo P Registration Date and qg Subject 000400005 Hwy Buble Time yy Subject 0004 00006 15 Jul 2009 00 30 57 Ebay Subject 000400007 GMT 1 Regine Crespin Eebyy Subject 000400008 Site Name Oo to Tn Test Center Four Registered by 5 Subject 00040004 4 i i 1 To review your subject s data please click here pp aves Screen failure Print this Page International Drug Development Institute 2009 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 22 60 19 August 2009 Novartis CIRG BOLERO 1 7 4 Subject Details The details of the registration are presented on the subject s Subject Details screen You m
41. lable to Sponsors CIRG Officers Monitors and Drug Distributors In this section a variety of online reports are available depending on the user s profile These reports are accessed by clicking the Online Reports icon in the title bar of your Home Page Some reports may be opened and saved as Excel worksheets UIC IC tha nnlinan ranr tl 1 ONINE repo GRRE UD E a LB GLOBAL RANDOMIZATION REPORT Online Reports E Subject Status Repor GLOBAL RANDOMIZATION REPORT Excel version of report RITE On site i 8 a ene Site Site Investigator Subject Subject Sas Sa ere y Number Mame Mame ID DOE Shipments In Transit Site List T Ji er Center 0001 01 Jan 2 userlist DENMARK 0001 One Mvestiqatort qnoos 1970 Pending Shipment T jj g T a DENMARK ooo VEn Myestigatory COUT E Subject Code Break Line OOO 1990 Recruitment per site Center 0001 a7 07 Apr E E ee eae DENMARK 00g One Mvestigator nocos 1958 ID Net Investigato
42. lidation pp Sublect Registration ey Subject Management tinto Ey Subject 0004 00004 Hy Subject oo04 0002 Hy Subject 0004 00003 Hy Subject 0004 00004 Ey Subject 0004 00005 elgg Subject 0004 00006 pend of treatment Hy Subiect 00400008 Hy Subject 0004 00009 Hy Subject 000400040 Hy Subject 000400014 pp Confirm Receipt of Kits h ot Damaged Kits ID Net Investigator Procedures Manual Version 1 0 19 August 2009 Bolero1 Validation Study E rE ga Medication allocation Medication allocation INSTRUCTIONS This form will enable you to allocate a new treatment kit to the subject in the BOLERO1 study Please fill out all of the applicable fields and then enter your password to submit the request You w addition to an e mail confirmation You should keep this confirmation with the subject s records TIPS H you place your mouse pointer over the TIP icons you will receive additional information to aid yi Subject and Site identification 1 Subject ID FR 0004 00007 2 subject DOB 10 magfday my OE mg day O5 mg days 4 Site number p ooo Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONCES POSSIBLE TO CHANGE YOUR ENTRIES Enter your password to digitally sign your submission Save and Continue Page 38 60 Novartis CIRG BOLERO 1 10 3 Medication Allocation Data Review When you click the Save and Continue button on the Medication
43. mation To view the tip for a data field hover the mouse pointer over the associated Mil icon Hold the pointer of your mouse over a TIP icon to see the pop up tip TIPS H iti you place your mouse pointer over the TIP icons you will recelve additional information to ald you in filling out the form Subject and Site Identification 1 Subject DOB EnEn yyy Please enter the subject s date of birth using the ddirinim yyy Format Incomplete dates are not accepted RTP TE Lug The subject s date of birth will be used For identification Purposes 2 Site Number PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITTING ONCE SUBMITTED IT IS NO LONGER POSSIBLE TO CHANGE YOUR ENTRIES Enter your password to digitally sign your submission Save and Continue ID Net Investigator Procedures Manual Version 1 0 Page 15 60 19 August 2009 Novartis CIRG BOLERO 1 6 Site Activation Sponsor and CIRG Officer Before a site can register subjects or receive medication supply shipments the site must first be activated in ID net This feature is reserved for users with the CIRG Officer profile To activate a site log into ID net and click the Site Activation link in the tree view This opens the activation screen Click the Site Activation link to access the activation screen SP Boleros Validation Seen Subject Management into Hy Subject o00400004 Hy Subject 000400002 Hy Subject 000400003 Hy Subject 0
44. need to be confirmed as received Trastuzumab and Paclitaxel as First Line Therapy in Women with HERZ Positive Breast Cancer Current Statistics E Total number of randomized subjects Site Study aye E Number of subjects with code break 5 Site E Total number of registered subjects TE pending randomization Site Study E Number of subjects with screen failures 14 Study E Number of subjects on Study Treatment JA Study E Date of the last subject randomized at the site 17072009 in center 0004 sig 2011 Number of kits to confirm z A Please confirm the kits to be able to randomize a new subject Note To view the details of subjects included at your site click on Subject man the screen ID Net Investigator Procedures Manual Version 1 0 Page 52 60 19 August 2009 Novartis CIRG BOLERO 1 To confirm receipt of medication click on the Confirm Receipt of Kits link in the tree view This opens the Confirm Receipt of Kits screen Here you will see a list of all kits In Transit to your site Check the box next to each kit you have received sign the form with your ID net password and click the Confirm Receipt of Kits button Please note that the button does not become active until you have checked at least one check box e Be sure to select only those kits you have actually received otherwise ID net may allocate to a subject a kit you do not have On Site The Confirm Receipt of
45. omize the subject in the BOLERO1 TRIO 019 study F applicable fields and then enter your password to submit the request You will receive a In addition to an e mail confirmation You should keep this confirmation with the subject TIPS H you place your mouse pointer over the TIP icons you will receive additional informat out the form Subject and Site Identification 1 Subject ID 0004 00011 2 Subject DOB FA 20 vw apr v 1950 yyy 3 Site Number p 0004 Yes 4 Visceral Metastases i No 5 Prior adjuvant or neo adjuvant treatment with n Yes trastuzumab No Eligibility Confirmation 6 Does subject meet all the inclusion exclusian n Yes criteria as outlined in the protocol O No Signature and Submission PLEASE DOUBLE CHECK YOUR DATA BEFORE SUBMITT SUBMITTED IT IS NO LONGER POSSIBLE TO CHANGE YO Enter your password to digitally sign He your submission ID Net Investigator Procedures Manual Version 1 0 Page 31 60 19 August 2009 Novartis CIRG BOLERO 1 9 3 Randomization Data Review When you click the Save and Continue button on the Randomization form you will be presented with the Data Review screen Here you may review the information entered for your subject If any of the information is incorrect click the Back button to return to the Randomization form e Please review this information carefully Once the subject is randomized it may n
46. ot be possible to correct any errors If all information is correct click the Continue button to complete the randomization The Randomization Data Review screen Patient Data Review Question Subject ID 0004 00011 20 April 1950 Site Number OO Visceral Metastases Mo Subject DOB Prior adjuvant or neo adjuvant treatment with trastuzumab Yes Does subject meet all the inclusion exclusion criteria as outlined in the Yes protocol 8 Please review your data before continuing Ifyou wish to modify any of your answers please click on the Back button lf you are satistied with your answers please click an Continue lt lt Back Continue gt International Drug Development Institute 2009 Boston Brussels Paris ID Net Investigator Procedures Manual Version 1 0 Page 32 60 19 August 2009 Novartis CIRG BOLERO 1 9 4 Randomization Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the Randomization Result screen On this screen you will see information related to the randomization including the medication kit allocated to the subject the date and time of the randomization the individual who performed the randomization and other relevant information Note that all dates and times in ID net are the local time in Belgium where the IDDI servers are located You may print the Result screen for your records by click
47. r Procedures Manual Version 1 0 Page 58 60 19 August 2009 Novartis CIRG BOLERO 1 It may be necessary to change certain Internet Explorer security settings regarding ActiveX controls in order to open the reports as Excel files Your site s IT specialist can show you how to do this Internet Options ta x General security Settings Trusted Sites Zone Settings Disable Enable LJ Download signed Actives controls Disable Enable a Download unsigned Actives controls Disable Enable a Initialize and script Actives controls not marked as safe For si Disable Enable Prompt a Run Actives controls and plug ins fi Sdminicte star sanmecseod IIl Takes effect after you restart Internet Explorer To return to your home page and access Subject Management info click the Open Navigator icon Bolero1 S ray axe GLOBAL RANDOMIZATION REPORT ID Net Investigator Procedures Manual Version 1 0 Page 59 60 19 August 2009 Novartis CIRG BOLERO 1 15 Help Desk For routine support queries or requests please send an email message to the IDDI Help Desk at helpdesk iddi com For urgent issues IDDI provides 24 7 telephone support e Europe 32 16 270 969 The operator will ask the caller his name the study protocol number the sponsor the site number the phone number the fax number and description of the problem
48. ration View subject information by clicking on the Subject ID View a table of all subjects in the study Subject Management info Confirm Receipt of Kits Report Damaged Kits IDDI contact information Pharmacists e Confirm Receipt of Kits Report Damaged Kits View subject information by clicking on the Subject ID View a table of all subjects in the study Subject Management info IDDI contact information Monitors Safety Officers e View subject information Subject Details e View a table of all subjects in the study Subject Management info e Access the online reports click the Online Reports icon e IDDI contact information CIRG Officers Sponsors e View subject information Subject Details View a table of all subjects in the study Subject Management info Access the online reports click the Online Reports icon Site Activation IDDI contact information Drug Distributors e Confirm dispatch of orders e Confirm receipt of kits at the depot e Access the online reports click the Online Reports icon e IDDI contact information ID Net Investigator Procedures Manual Version 1 0 Page 13 60 19 August 2009 Novartis CIRG BOLERO 1 4 Subject Details Clicking directly on a Subject ID will display the Subject Details screen for that subject Clicking a Download link on the right side of the window will open the associated confirmation document for that transaction in PDF format The
49. rsion 1 0 19 August 2009 BOLERO 1 Page 5 60 Novartis CIRG BOLERO 1 1 2 Study Design This is a randomized phase III double blind placebo controlled multicenter study of Everolimus in combination with Trastuzumab and Paclitaxel as first line therapy for women with HER2 positive locally advanced or metastatic breast cancer The study will include 717 subjects at 250 study sites worldwide The stratification criteria are e Visceral lung liver peritoneal or pleural Metastasis Yes vs No e Prior adjuvant or neo adjuvant treatment with trastuzumab Yes vs No To register a subject in the study you will need the following information e Subject s date of birth dd mmm yyyy e Your ID net login and password 1 3 Web Browser Requirements ID net requires Microsoft Internet Explorer IE ver 5 5 or higher running on Windows 98 or newer For best performance use IE 6 or IE 7 on Windows XP or newer We do not recommend using Internet Explorer 8 at this time Firefox Netscape Opera Safari and other Web browsers are not supported and will not work properly with ID net Mac OS Linux Solaris and other UNIX and UNIX derived operating systems are not supported ID Net Investigator Procedures Manual Version 1 0 Page 6 60 19 August 2009 Novartis CIRG BOLERO 1 2 ID net 2 1 Logging onto ID net ID net is a Web based software application connected to a centralized database It is used for man
50. s the study name your name and email address the time and date you logged on and the Exit to Portal button Click this icon to log off ID net a e Main Window Displayed here is information about the study and your site This is also where the Registration and other data capture screens and information screens will appear as you perform tasks in ID net e Navigator Pane tree view Here you find links for the various actions you can perform subject information and IDDI contact information r gw Bolero ead pp Subiect Registration Sy Subject Management info The Investigator Home Page Tit Bolero Study User Regine Crespin rvestigator F a Logged on 10 07 2009 G Email craig callahant iddi com Investigator Home Your password has been changed BOLERO1 TRIO019 Study information A Randomized Phase Ill Double Blind Placebo Controlled Multicenter Trial of Everolimus in Combination with Trastuzurmab and Paclitaxel as First Line Therapy in Women with HERS Positive Locally Advanced or Metastatic Breast Cancer Current Statistics E Total number of randomized subjects a70 Site Study E Number of subjects with code break Site O E Total number of registered subjects q o pending randomization Site Study E Number of subjects with screen failures 0 Study E Number of subjects on Study Treatment 0 Study E Date of the last subject randomized
51. t or you have previously registered the subject click the Back button to return to the Registration form If the DOB is correct click the Continue button to complete the registration Registration Data Review screen Bolero Validation Study User Regine Crespin rwestigaiton A oogged on 15707 00a 00 18 02 i j Logged on 15 07 2009 00 18 04 hiT 4 Email idditicox net Subject Registration Patient Data Review Question Subject DOB 20 April 1950 Site Number 0004 Please review your data before continuing If you wish to modify any of your answers please click on the Back button lf you are satistied with your answers please click on Continue lt lt Back Continue gt International Drug Development Institute 2009 Boston Brussels Faris ID Net Investigator Procedures Manual Version 1 0 Page 21 60 19 August 2009 Novartis CIRG BOLERO 1 7 3 Registration Result Screen When you click the Continue button on the Data Review screen the transaction is completed and you are presented with the Registration Result screen On this screen you will see the subject s Subject ID the date and time of the registration and other relevant information Note that all dates and times in D net are the local time in Belgium where the IDDI servers are located Your new subject will now also appear in the list of subjects in the tree view e The Subject ID is in the format XXXX XXXXX and cons
52. the registration and contact your monitor or the IDDI Help Desk e If the date of birth for your subject is the same as the date of birth of another subject already registered at your site you will receive a notification message in order to confirm you have entered the information correctly You may continue with the registration if you are registering a new subject and the date of birth is correct or you may cancel the registration if the subject has already been registered You will see this message if the DOB of your new subject is the same as the DOB of a subject already registered at your site Warning Please note that a patient with the same date of bith already exists in the site lt lt Back Continue ID Net Investigator Procedures Manual Version 1 0 Page 19 60 19 August 2009 Novartis CIRG BOLERO 1 The Registration form with all fields completed Elerai Validation o Subject Registration Fy _ Wanagement infoj Hy Subject 000400001 Ey Subject OO04 00002 Ey Subject 000400003 Hy Subject 000400004 Hy Subject 000400005 Ely Subject 000400006 Hy Subject 000400007 wy Subject 0004 00008 ly Subject 000400009 H Subiect o004 00010 ae pp Confirm Receipt of Kits Bolero Validation Study e User Regine Crespin ir a Logged on i ne WW Pec n z Email iddi subject Registration Subject Registration INSTRUCTIONS This form will enable you to re
53. udy The features included are those available for the following user profiles user types Investigator Study Coordinator Pharmacist Monitor Sponsor CIRG Officer Safety Officer and Drug Distributor 1 1 User Profiles The ID net transactions available for each user profile are as follows 1 1 1 1 1 2 1 1 3 Investigator Subject Registration Subject Screen Failure Medication Allocation End of Randomized Treatment Code Break Confirm Receipt of Medication Report Damaged Medication View Subject information Study Coordinator Subject Registration Subject Screen Failure Medication Allocation End of Randomized Treatment Confirm Receipt of Medication Report Damaged Medication View Subject information Pharmacist Medication Allocation End of Randomized Treatment View Subject information ID Net Investigator Procedures Manual Version 1 0 19 August 2009 Page 4 60 Novartis CIRG 1 1 4 1 1 5 1 1 6 Sponsor CIRG amp Novartis View Subject information Site Activation Access online reports CIRG Officer Subject Randomization Subject Screen Failure Site Activation Access online reports Monitor View Subject information Access online reports Safety Officer View Subject information Code Break Access online reports Drug Distributor supplier Confirm dispatch of orders Confirm receipt of kits by the depot Access online reports ID Net Investigator Procedures Manual Ve
54. ust 2009 Version 1 0 Page 11 60 Novartis CIRG BOLERO 1 The subjects registered at the site are automatically displayed for site level users Monitors Sponsors CIRG Officers and Safety Officers need to choose a site from a drop down list to see the subjects at that site and access the available transactions for those subjects CIRG Officer Navigator pane Choose a site from the drop down list to see the subjects at that site Bolero Validation Study 2B CIEC Officer Home D net Navigator 0O04 Test Center Four PLEASE SELECT A CENTER Trastuzumab and Paclitaxel as First Line Therapy in VYorr El wy Subject 0040000 Metastatic Breast Cancer Hy Subject 0004 00003 Hy Subject o0o400004 Fy Subjest 0004 00008 Current Statistics Ely Subiect 000400006 E Total number of expected subjects 717 i pp Randomize Patient E Recruitment closure date 01 Aug 2011 TO pp Sublect Screen failure El ag ainda E Total number of randomized subjects 44 Hy Subject 0004 00008 fey Subject 000400008 ee ee vy E J otal number of registered subjects ae 5 H Sublest ottoon pending randomization l pp site Activation fa Contact IDEI E Number of subjects with screen 13 fathures ID Net Investigator Procedures Manual Version 1 0 Page 12 60 19 August 2009 Novartis CIRG BOLERO 1 3 2 Navigator Options Investigators and Study Coordinators e Subject Regist
55. vartis CIRG BOLERO 1 The Confirm Receipt of Kits Result screen Bolero Validation Study Per E NE B E User Regine Crespin Wr vestigator i Logged on 23 07 2008 01 48 09 F ChiT 1 Ernail idditicox net Cantirm Receipt of Kits 2 You have successfully confirmed the receipt of kits you will receive a confirmation soon lt lt Back 13 2 Report Damaged Kits If a medication is found to be damaged you should report it damaged in ID net using the Report Damaged Kits function Any kit that is In Transit On Site or that has been allocated to a subject may be reported as damaged e In cases where the damaged kit has already been allocated but not used by the subject the kit will be disassociated from the subject in ID net The site will need to call the IDDI Help Desk for a replacement kit Since this requires a manual update to the database ID net will not show the change until the next business day in Belgium e Kits already used must not be reported as damaged To report a kit as damaged click on the Report Damaged Kits link in the tree view This opens the Report Damaged Kits screen Here you will see a list of all kits that have been shipped to your site excluding blocked damaged and expired kits Check the box next to each kit you need to report as damaged sign the form with your ID net password and click the Report Damaged Kits button Please note that the button does not become active until you have che
56. y users with the CIRG Officer profile may randomize subjects 9 1 Requirements for Randomization In order to randomize a subject the CIRG Officer will need to know whether the subject has visceral metastases and if the subject has had prior adjuvant treatment with trastuzumab CIRG will also have to confirm that all inclusion exclusion criteria have been met In addition the site will need to have On Site at least one blinded medication kit for each treatment arm RADOO1 and Placebo e Randomization will not be possible if the site does not have sufficient study drug on site and confirmed in the ID Net system 9 2 Completing the Randomization Form To randomize a subject select the subject s site from the drop down list Open the options for the subject in the tree view by clicking the symbol next to the Subject ID and then click the Randomize Subject link This opens the Randomization data capture screen Complete the form entering the requested information in each section All questions must be answered to complete the randomization e Subject ID pre filled e Subject DOB Enter the date of birth recorded at the time of registration e Site Number This is pre filled If the site number is incorrect cancel the randomization and contact the IDDI Help Desk e Stratification Criteria o Visceral Metastases Yes No o Prior adjuvant treatment with trastuzumab Yes No e Eligibility Confirmation o Does the subject me

TRIO-019 ID-net User Manual v1

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