IVRS User Manual
Contents
1. Bracket Genentech OAM4971g Study IXRS Site User Instruction Manual For Site Users Only Version 3 0 28 August 2012 Bracket Genentech OAM4971g Site User Instruction Manual TABLE OF CONTENTS 1 Overview Interactive Voice Response System and Interactive Web Response System IXRS 3 2 IVRS Telephone Numbers and User Types esee nennen nnne nnn n nnn nnne nnn 4 3 System Identifiers c MERIT T 4 4 IXRS Login Your UserID and PIN Username and Password cccccececececececeeeeeeeeeeeeeeeeeeeeeeeeeeees 5 4 1 Frequently asked UserID and PIN Username and Password Questions eere 5 42 IVRS Study Worksheets esie ecxsesee rerba C eF area yay Ye ka ist ay YR Ye ska CV Rma A ek Ya ka rr a ERU E NE aa 5 4 3 EU ER 6 4 4 VRS First TIma amp LSOr crois eno e teu noo reru an de RE ERR S eani ye ERES S ENERER ens AAEE Ee RENS EFRESSERETERSYRRRRRR 6 vH CIIM 7 5 IVRS Call D tails pr hy 8 S1 IVR Main Mensaner n M 8 5 2 IVRS Tissue Pre Screening reco ecrire sincerscstesevensivecherstisdiuastvedrerstesetaeeisnetesstessacaveteerett 9 X XEMI EDI 9 5 4 IVRS Screen Failure 5 iieri d ere eiie eec eden xad e xa iea aae es exea sub ccdsstasdenestacdeeye berense 10 9 5 KIVRS Re SGreerillig 15 soe eoece i s ee e toti innt asra aaa eo Ene2. 19 Enter and confirm Subject s tumor assessment 1 Measurable 2 Non measureable a For Status tissue screened proceed to next step b For all others skip to step 21 20 Enter and confirm the Subject s histology type 1 Squamous 2 Non Squamous 3 Unknown a For Squamous or Unknown skip to step 22 b For Non Squamous proceed to next step 21 Enter the Subject s Non Squamous histology type 1 Adnocarcinoma 2 Bronchioloalveolar Carcinoma 3 Undifferentiated 4 Unknown 22 Subject Screen Failure is successfully recorded 23 To return to the main menu press 1 To end the call press 9 TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 10 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual Upon completion of the call a Screen Failure notification will be faxed and or emailed to your Site This notification will serve as a record of the Screen Failure call Upon receipt please place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 11 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 5 IVRS Re Screening To Re Screen a Subject in the IVRS 1 Obtain a new Re Screen worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 4 To Re Screen a Subjec
3. 3 Previous 11 Enter and confirm the Line Number of Eligibility Criterion Not Met followed by the pound or hash key The Line Number of Eligibility Criterion Not Met can be found on your IVRS worksheet XX a For additional Line number of Eligibility Criterion Not Met repeat step 11 NOTE For subjects screened on initial protocol dated 11Jun2011 range 01 29 will be used NOTE For subjects screened on protocol amendment dated 23May2012 range 30 59 will be used 12 Enter and confirm any other reason not related to the eligibility criterion for this screen failure 1 Lost to Follow Up 2 Subject Decision to Withdraw 3 Physician Decision to Withdraw 4 Adverse Event 5 Progression of Disease 6 Other 7 Not Applicable 13 Enter and confirm Subject s previous NSCLC treatment XX The list of NSCLC treatment options can be found on your IVRS worksheet a For additional Previous NSCLC treatments repeat step 13 14 Enter and confirm Subject s ECOG performance score 02Zero 1 One 2 Two 3 Three 4 Four 15 Enter and confirm Subject s disease staging at screening 12 Three B 2 Four 16 Enter and confirm Subject s disease state 1 Locally Recurrent 2 Metastatic 3 Both 17 Enter and confirm the Subject s Met IHC Clinical Score 02Zero 1 One 2 Two Plus 3 Three Plus 4 Test Not Evaluable 5 Test Not Performed 18 Enter and confirm the Subject s EGFR activating mutation value 0 Zero 1 Yes 2 Test Not Evaluable 3 Test Not Performed
4. Bracket Genentech OAM4971g Site User Instruction Manual 12 Bracket Technical Support You can contact Bracket Technical Support via telephone or email The maximum response time for telephone requests is 20 minutes You can also email your non urgent issues or questions to Bracket Technical Support at support bracketglobal com The maximum response time to email requests is one business day Bracket Technical Support phone numbers and email address are specified on your IVRS Coversheet Bracket Technical Support email address All countries support bracketglobal com When contacting Bracket Technical Support please be prepared to provide the following Name Genentech OAM4971g Phone Number Site Number Subject Number TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 34 of 34 Version 3 0 Confidential
5. Contact your Study Manager You can also contact Bracket Technical Support to receive your IVRS UserID and PIN and IWRS Username and password The next time you log on you will be prompted to change your PIN password to a new four digit PIN number password Also check your email spam folder in the event your email system filtered out the email from Bracket I received the IXRS message You have exceeded the allowable number of attempts to access the system What does that mean The IXRS will play show this message if you attempted to access the system 5 times within a thirty minute window using the incorrect PIN password You will not be able to access the IXRS again for thirty minutes after this event occurs At the end of 30 minutes please attempt to access the system again Can I use my co worker s UserID Username and PIN Password You should never use someone else s UserID and PIN Username and password as these are equivalent to your written electronic signature Please contact your Study Manager to request your own UserID and PIN Username and password What do I do if the PIN Password sent in the Bracket email no longer works Remember the first time you log into the IVRS IWRS you are required to reset your PIN password The new reset PIN password will work for all subsequent IVRS IWRS logins You can contact Bracket Technical Support to have your PIN password reset and provided to you The next time you login you will be prompted
6. Screening Date from the drop down menus and click next to continue 10 Select the following from the drop down menus and click next to continue a Date Subject or Legal Guardian Signed Informed Consent b Number of Prior Lines of Therapy c Histology 11 A confirmation page will be displayed with the Subject s data Change any data entered by clicking modify to return to the previous screen or click save to complete screening visit 12 A success page will display the Subject s data as well as provide the six digit Screening Number Patient Management Screenin TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 21 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 4 IWRS Screen Failure To record a Screen Failure in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Screen Failure from the menu bar 5 Select the Screening Number from the drop down menu and click next to continue e If Subject Status Screened proceed to the next step e If Subject Status Re Screened Tissue Pre Screened or Screen Failed Re Screen skip to step 7 6 Select if the will the Subject Re screen from the drop down menu and click next to continue e If No proceed to next step e If Yes skip to step 10 7 Select the following f
7. Subject 02Zero 1 One 9 The IVRS will assign a six digit Screening Number 10 Confirm the six digit Screening Number XXXXXX 11 To return to the main menu press 1 To end the call press 9 Upon completion of the call a Tissue Pre Screening notification will be faxed and or emailed to your Site This notification will serve as a record of the Tissue Re Screening call Upon receipt please place the notification with the Subject s source documents 5 3 IVRS Screening To Screen a Subject in the IVRS 1 Obtain a new Screening worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 2 To Screen a Subject 5 Enter if the visit occurred today 1 Yes O No a If No enter the visit date DD MM YYYY 6 For a new Subject press 1 Proceed to next step For a tissue pre screened Subject press 2 Skip to step 9 7 Enter and confirm the Subject s Date of Birth MM YYYY 8 Enter and confirm the Subject s weight in kilograms followed by the pound or hash key Use the star key as a decimal point XXX X 9 Enter the date of Subject or legal guardian signed informed consent DD MM YYYY 10 Enter and confirm Subject s number of prior lines of therapy 12One 22 Two 11 Enter and confirm Subject s histology value 12 Squamous 2 Non Squamous 12 The IVRS will assign a six digit Screening Number 13 Confirm the six digit Screening Number XXXXXX 14 T
8. Subject s status is randomized Erlotinib only skip to 9 8 Enter and confirm if the Subject wishes to discontinue Metmab or Placebo Study drug 1 Yes 0 No 9 Enter and confirm if the Subject wishes to changes their Erlotinib dose a For No change skip to step 10 b For Dose change enter the Erlotinib dose the Subject will be changing to and confirm 10 The IVRS will state the Subjects current Infusion Schedule Please record this information on the worksheet XX a Ifthe Subject is on a 21 day cycle with 2 or more dose reductions prior to completion of Cycle 4 proceed to next step b If the Subject is on a 28 day cycle or on a 21 day cycle with 2 dose reductions before cycle 4 or on a 21 day cycle after cycle 4 skip to step 12 11 Enter and confirm if the Subject requires changing their infusion schedule to 28 day duration 02No 1 Yes a IfSubject s Erlotinib 2 Omg skip to step 13 12 The IVRS will instruct you to dispense Erlotinib from a particular Lot Number s Record the number of Kit s and assigned Lot Number s on the worksheet and re enter the Lot Number s in the IVRS to confirm 13 The IVRS will instruct you to dispense MetMab from a particular Lot Number s Record the number of Kit s and assigned Lot Number s on the worksheet and re enter the Lot Number s in the IVRS to confirm a If Subject is randomized to Placebo proceed to next step b If Subject is randomized to MetMab skip to step 15 14
9. Subject s data Change any data entered by clicking modify to return to the previous screen or click save to complete screening visit 8 A success page will display the Subject s data as well as provide the six digit Screening Number 000000 Patient Management Tissue Pre Screening Please select the information for the subject that you are tissue pre screening and then click next to continue erisk indicates a required field Tissue Pre Screening Site ID 200000 Date of Birth month issue Pre Screening Date TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 20 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 3 IWRS Screening To record a Screening in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Screening from the menu bar 5 Select new or pre screened Subject from the drop down menu and click next to continue a Fortissue pre screened Subject skip to step 7 b For new Subject proceed to next step 6 Select the following from the drop down menus and click next to continue e Date of Birth e Weight kg e Screening Date a Skip to step 9 7 Select the Screening Number from the drop down menu and click next to continue 8 Select the Weight of the Subject in Kilograms 9 Select the
10. The IVRS will assign a Placebo Assignment Number Please record it on the worksheet and dispense Placebo this Subject XXXXXX a This call is successfully recorded 15 The IVRS will assign a MetMab Assignment Number Please record it on the worksheet 16 Subject Medication Assignment Visit is successfully recorded 17 To return to the main menu press 1 To end the call press 9 Upon completion of the call a Medication Assignment notification will be faxed and or emailed to your site This notification will serve as a record of the Medication Assignment call Upon receipt place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 14 of 34 Version 3 0 Confidential 5 9 Bracket Genentech OAM4971g Site User Instruction Manual IVRS Unscheduled Medication Assignment Site Pharmacist Only To record a Unscheduled Medication Assignment in the IVRS 8 Obtain a new Unscheduled Medication Assignment worksheet from your site file Dial the IVRS telephone number noted on the Coversheet Enter your UserID and PIN Site Pharmacist Select Option 2 To record a Unscheduled Medication Assignment Enter and confirm the five digit Subject Number XXXXX Confirm the Subject s Date of Birth MM YYYY The IVRS will state the Subjec t scurrent Erlotinib Dose Enter if the Subject wishes to change their Erlotinib Dose 0 No 1 Yes a Ifcontinuing on same d
11. To record an Acknowledgement of Receipt in the IVRS 1 Obtain a new Acknowledgement of Receipt worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select 1 for the Inventory Management Module 5 Select Option 1 To Record an Acknowledgement of Receipt 6 Enter and confirm the consignment number 7 Enter and confirm if date of actual arrival and unpacking at your Site was today 12 Yes 0ZNo e For no please enter date of actual arrival and unpacking at your site DD MM YYYY 8 Enter and confirm the time of actual arrival and unpacking at your Site Please use 24 hour time and the two digit minutes TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 16 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 9 Enter and confirm if any medication was damaged or missing 1 Yes O No e If Yes proceed to next step e If No please re enter your UserID and PIN This call is successfully recorded 10 Press 1 to confirm that this consignment contains only open label medication 11 Select and confirm the material description of the missing or damaged medication 12 Select and confirm the manufacturing lot batch number of the missing or damaged medication 13 Select and confirm the barcode of the missing or damaged medication 14 The IVRS will indicate the quantity of medication packages in this cons
12. completion of the third site activation approval steps in any order SRP Approval Site Contract Approval CTM Approval close screening or open or close Enrollment Confirmation Screening Transaction Transaction Screen Failure Confirmation Sent following the recording of a Screen Failure transaction Re Screening Confirmation Sent following the recording of a Re Screening transaction Blinded Randomization Confirmation Sent following the recording of a Randomization transaction Confirmation transaction Visit transaction Treatment Confirmation Treatment transaction by an authorized Unblinder Unblinded Lost or Damaged Kit Sent following the recording of a Lost or Damaged Kit Frequently asked Notification questions e How doIget an email or fax notification resent Please contact Bracket Technical Support to have the email or fax notification resent to you If you need a notification resent after the data was updated via a Change Form please ask your Study Manager to request a notification re generation from Bracket TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 32 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 11 Data Change Forms If the wrong information was entered in the IXRS please use the Data Change Form DCF to document errors and request data modifications Data Change Forms must be completed on site and emailed or faxed to Bracket Sponsor
13. e Replacement Kit Required 14 Select and confirm the following from the drop down menu Change any data entered by clicking modify to return to the previous screen or click next to continue e Lot Number e Kit Status 15 A confirmation page will display the Kit status and the Subject s data if applicable Change any data entered by clicking modify to return to the previous screen or click save to complete the Lost or Damaged Kit 16 A success page will confirm the study drug was successfully recorded as Lost or Damaged and if applicable provide the replacement study drug information Patient Management Lost or Damaged Kit Please select if the kit to be marked lost or damaged is assigned to a subject and then click next to continu Note An asterisk indicates a required field ssignment Lost or Damaged Kit SiteID 100000 gt Lost or Damaged Kit Kit Assigned to Subject select one TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 28 of 34 Version 3 0 Confidential 6 11 Bracket Genentech OAM4971g Site User Instruction Manual IWRS Acknowledgement of Receipt NOTE Lot Number and Batch Number may be interchangeable To record an Acknowledgement of Receipt in the IWRS 8 9 9 Log into the web system using the Web login address Enter your UserName and Password Choose Inventory Management Module from the study list You will be automatically directed
14. eio Eo REX es Oea eia EETA ri Ere eo bres der SG 12 5 6 IVRS Randomlization iore cto crane exo Dese enean esee Poncium aaa ERRRE a aa FERE YR D dEEr a aea K Y RRa lace n En FRE 13 S EMEN LIE HE PICTero a STATI ujo gt X 13 5 8 IVRS Medication Assignment Visit Site Pharmacist Only esee 14 5 9 IVRS Unscheduled Medication Assignment Site Pharmacist Only eese 15 5 10 IVRS Lost or Damaged Kit Site Pharmacist Only eesseeeeeeeeeeeeen nnnm nnns 16 5 11 IVRS Acknowledgement of Receipt ee eee enn 16 5 12 IVRS Quarantine Medication cr enne nnn nn nn nnne nr nn nn nnne nnn nn nnns 18 6 IWRS Overview Logih x c uoxuka Cute rape Rx e Re Cuna hua anaa ERES FARE URRERRRE iaa kaaa ainiaan 19 6 1 IWRS S ISERNIA 0S CSCQ GCRn 19 6 2 IWRS Tissue PresScreenlrg s iecore rre men eter hax rena a x kDa rapa da E XRR Radar AER ERRARE 20 COMMA MEUM 21 o MEM EST ccet c 22 6 5 IWRSHRE SChESMIMG sees m 23 6 6 IWRS RandomizatiOh 5 cisci eorr aerei ret uer eode exe Enna NELA ana Saa EEAS EAEAN Sai 24 6 7 IWRS Discontinuation from All Study Treatment sseeseseeeeeeneeeennn nnne enne nnn nnn nnns 25 6 8 IWRS Medication Assignment Site Pharmacist Only eene 26 6 9 IWRS Unscheduled Medication Assignment Site Pharmacist Only eese 27 6 10 IWRS L
15. from All Study Treatment Enter and confirm the Subject Number XXXXX Confirm Subject Date of Birth MM YYYY Enter and confirm if this Visit occurred today If No enter the Visit date DD MM YYYY Confirm that you want to discontinue this Subject form all study treatment by pressing 1 10 To return to the main menu press 1 To end the call press 9 Upon completion of the call a Discontinuation from AII Study Treatment notification will be faxed and or emailed to your site This notification will serve as a record of the Discontinuation from All Study Treatment call Upon receipt place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 13 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 8 IVRS Medication Assignment Visit Site Pharmacist Only To record a Medication Assignment Visit in the IVRS 1 Obtain a new Medication Assignment Visit worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 1 To record a Medication Assignment 5 Enter and confirm the five digit Subject Number XXXXX 6 Confirm the Subject s Date of Birth MM YYYY 7 The IVRS will now state the Cycle and Day that is being recorded Please record this information on the worksheet a IfSubject s status is randomized proceed to next b If
16. of Receipt notification will be emailed to your Site This notification will serve as a record of the Acknowledgement of Receipt call Upon receipt please place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 17 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 12 IVRS Quarantine Medication NOTE Lot Number and Batch Number may be interchangeable To record Medication as Quarantined in the IVRS 1 Obtain a new Quarantine Medication worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select 1 for the Inventory Management Module 5 Select Option 2 To Record Medication as Quarantined 6 Select and confirm the material description of the medication to quarantine 7 Select and confirm the manufacturing lot batch number of the medication to quarantine 8 Select and confirm the barcode of the medication to quarantine 9 The IVRS will indicate the quantity of available medication packages that match the selected manufacturing lot batch number and barcode at your Site 10 Enter and confirm the quantity of medication packages to record as quarantined 11 Please re enter your UserID and PIN 12 To return to the main menu press 1 To end the call press 9 Upon completion of the call a Quarantine Medication notification will be emailed
17. to your Site This notification will serve as a record of the Quarantine Medication call Upon receipt please place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 18 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 IWRS Overview Login You will be sent your Web Username and Password along with your UserID and PIN notification The notification will also contain the URL link to access the IWRS login home page If you do not receive your Username and password via email please contact your Study Manager or Bracket Technical Support You can sign in to the Genentech OAM4971g Study website by using one of the links below and using the Client Sign In box after selecting your language You will only be allowed to view and enter data for your site Primary https client unitedbiosource com sign in Secondary http www unitedbiosource com login aspx Note Internet Explorer is the only supported web browser The first time you access the study web site you will be prompted to update your password to one that will be easy for you to remember The password must be at least 8 characters in length and contain at least 1 capital letter and 1 number or symbol 6 1 IWRS First Time User Please record your IWRS User Name here e Web Username e Password Confidential Do NOT write your Password here Your
18. IWRS login codes are equivalent to your written signature Please do NOT share your login information To log on to the Genentech OAM4971g IWR System 1 Login to the study website 2 Enter your IWRS Username and Password The first time you interact with the IWRS you will be directed to change your assigned temporary Password 3 Enter and confirm your new Password 4 Always use your new Password for subsequent interactions with the IWRS 5 You will then be directed to the Genentech OAM4971g IWRS Main Menu Page After successfully entering your Username and Password the IWRS will present the Genentech OAM4971g Main Menu TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 19 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 2 IWRS Tissue Pre Screening To record a Tissue Pre Screening in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Tissue Pre Screening from the menu bar 5 Select the following from the drop down menus and click next to continue e Date of Birth e Tissue Screening Date 6 Select the following from the drop down menus and click next to continue e Date Subject or Legal Guardian Signed Informed Consent for Tissue Collection e Number of Prior Lines of Therapy 7 A confirmation page will be displayed with the
19. PPD approval will be required Bracket will process ONLY completed and approved signed Data Change Forms Note Bracket will not accept e signatures on these forms Below is a summary of the Data Change Form Submission Process o E Data wees Updated Enter Data Review and Process into Form Approve Data Change Please be as clear as possible when entering information into the Data Change Forms If you have any questions please contact the Bracket Technical Support helpdesk for assistance Please mark the Data Change Form processing orders as follows e Standard e Urgent Additional rush fees may apply NOTE It is recommended that you follow up by calling Bracket Technical Support after submitting DCFs that need to be processed urgently Frequently asked IVRS data change questions e How do I find out if my Data Change Form has been processed You will not be notified that a Data Change Form has been processed To find out if a Data Change Form has been processed please ask your Study Manager to verify the data change on the study website e What do I do if I never received the system worksheets or Data Change Forms Contact your Study Manager or download the worksheets or Data Change Forms via the study website under the Help menu You may also contact Bracket Technical Support to have them emailed to you TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 33 of 34 Version 3 0 Confidential
20. b page Click Re Screening from the menu bar Select the Screening Number from the drop down menu and click next to continue Select the following from the drop down menus Change any data entered by clicking modify to return to the previous screen or click next to continue e Weight e Date Subject or Legal Guardian Signed Informed Consent e Number of Prior Lines of Therapy e Re Screening Date A confirmation page will be displayed with the Subject s data and study data information Change any data entered by clicking modify to return to the previous screen or click save to complete Re Screening A success page will display the Subject s data and confirm the Re Screening transaction TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 23 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 6 IWRS Randomization To record a Randomization in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Randomization from the menu bar 5 Select the Screening Number from the drop down menu and click next to continue 6 Select the following from the drop down menus and click next to continue e Met IHC Clinical Score e EGFR Activation Mutation 7 Select if the Subject s Number of Prior Lines of Therapy and Histology Corre
21. ct from the drop down menu and click next to continue 8 A confirmation page will be displayed with the Subject s data Change any data entered by clicking modify to return to the previous screen or click save to complete the Randomization 9 A success page will display the Subject s data and study data information as well as provide the Subject Number assigned to the Subject XXXXXX Site ID 200000 Screening Number select one TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 24 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 7 IWRS Discontinuation from All Study Treatment To record a Discontinuation from All Study Treatment in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Discontinuation from All Study Treatment from the menu bar 5 Select the Subject Number from the drop down menu and click next to continue 6 Select the Discontinuation from All Study Treatment Date from the drop down menus Change any data entered by clicking modify to return to the previous screen or click next to continue 7 Aconfirmation page will be displayed with the Subject s data and study data information Change any data entered by clicking modify to return to the previous screen or click save to complete the Discon
22. d which Lot Number s to dispense the Kits Patient Management Unscheduled Medication Assignment Visit Please select the subject number and then click next to continue Note An asterisk indicates a required field Unscheduled Medication Assignment Visit Site ID 600001 Subject Number selectone w TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 27 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 10 IWRS Lost or Damaged Kit Site Pharmacist Only To record a Lost or Damaged Kit in the IWRS 1 Log into the web system using the Web login address 2 Enter your Username and Password 3 You will be automatically directed to the Main Menu web page 4 Click Lost or Damaged Kit from the menu bar 5 Select the Kit Assigned to Subject from the drop down menu and click next to continue a If No proceed to next step b If Yes skip to step 9 6 Select the Lot Number from the drop down menu and Change any data entered by clicking modify to return to the previous screen or click next to continue 7 Select the following from the drop down menus and click next to continue e Quantity of Kit s Lost or Damaged e Kit Status a Skip to step 14 13 Select the following from the drop down menu Change any data entered by clicking modify to return to the previous screen or click next to continue e Subject Number
23. edication Assignment Visit Discontinuation from All Study Treatment Lost or Damaged Kit Acknowledgement of Receipt via Inventory Management Module Quarantined Medication via Inventory Management Module The IXRS for the Genentech OAM4971g study also includes a training system for the IVRS IWRS The training system provides users the opportunity to practice each of the above transactions without saving any data Users will be provided IVRS worksheets for each transaction type which should be completed before calling into the IVRS The IVRS Coversheet will contain all the telephone numbers or web address information needed to access the IXRS from each site TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 3 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 2 IVRS Telephone Numbers and User Types Bracket provides toll free numbers for accessing the IVRS Country specific information for calling the IVRS is included on the Coversheet that you received with your IVRS worksheets The following numbers are provided e Primary IVRS Telephone Number e Secondary IVRS Telephone Number e Bracket 24 Hour Technical Support Telephone Number The IXRS provides for three types of users 1 Site User User at a site who is authorized to access Tissue Pre Screening Screening Screen Failure Re Screening Randomization and Discontinuation from All Study Treatment branches 2 Site P
24. eet Enter your UserID and PIN Select Option 5 To Randomize a Subject Enter and confirm the six digit Screening Number XXXXXX Confirm the Subject s Date of Birth MM YYYY Enter and confirm Subject s Met IHC Clinical Score 2 2 Two Plus 3 Three Plus Enter and confirm the Subject s EGFR Activity Mutation Value O No 1 Yes Confirm the Subject s Number of prior line of therapy 1 Yes O No 10 Confirm the Subject s histology value 1 Yes 0 No 11 To confirm you randomized this Subject re enter your PIN now DO Not write your PIN on the worksheet 12 Subject Randomization is successfully recorded 13 To return to the main menu press 1 To end the call press 9 NOTE If the Subject s number of prior lines of therapy or histology value is incorrect please contact your monitor to have this value updated prior to randomizing the subject Upon completion of the call a Randomization notification will be faxed and or emailed to your site This notification will serve as a record of the Randomization Visit call Upon receipt place the notification with the Subject s source documents 5 7 IVRS Discontinuation from All Study Treatment To record a Discontinuation from All Study Treatment in IVRS Obtain a new Discontinuation from All Study Treatment worksheet from your site file Dial the IVRS telephone number noted on the Coversheet Enter your UserID and PIN Select Option 6 To Record a Discontinuation
25. harmacist user at a site who is authorized to access Medication Assignment Visit and Lost or Damaged Kit branches 3 Training User User is authorized to make practice calls transactions into IXRS No data will be saved during these calls transactions 3 System Identifiers When working within the IVRS users will be required to enter the following types of information commonly referred to as System Identifiers Identifiers used by the Genentech OAM4971g IVRS are as follows e Caller UserID XXXXXX Six Digit Number e Caller PIN XXXX Four Digit Number e Screening Number XXXXXX Six Digit Number e Subject Number XXXXX Five Digit Number TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 4 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 4 IXRS Login Your UserID and PIN Username and Password A unique six digit UserID Web Username and a four digit personal identification number PIN password will be sent to the user via email if an email address is available If an email address is not available the UserID Username and PIN password will be made available from the Study Manager If you do not receive your UserID Username and PIN password via email please contact your Study Manager or Bracket Technical Support 4 1 4 2 Frequently asked UserID and PIN Username and Password Questions What do I do if I never received or I lost my UserID Username and PIN Password
26. ignment that matches the selected manufacturing lot batch number and barcode 15 Enter and confirm the medication status 1 Missing Only 2 Damaged Only 3 Some Missing and Some Damaged e If medication is missing or damaged proceed to next step e If some is missing and some is damaged skip to Step 20 16 Enter and confirm the quantity status of the missing or damaged medication 1 All Medication Packages 2 Quantity of Medication Packages e If All skip to Step 20 e If Quantity proceed to next step 17 Enter and confirm the quantity of missing or damaged medication 18 The IVRS will indicate that the medication has been marked as missing or damaged e Skip to Step 24 19 Enter and confirm the quantity of missing medication 20 The IVRS will indicate that the medication has been marked as missing 21 Enter and confirm the quantity of damaged medication 22 The IVRS will indicate that the medication has been marked as damaged 23 Enter if there is any other damaged or missing medication 1 Yes 0 No e If Yes repeat Steps 12 through 24 24 Please re enter your UserID and PIN This call is successfully recorded 25 To return to the main menu press 1 To end the call press 9 Any medication not damaged or missing in this consignment has been approved for use Any medication not damaged or missing in this consignment is now Quarantined and must not be used Please inform your monitor Upon completion of the call an Acknowledgement
27. n a Subject press 2 3 To Screen Fail a Subject press 3 4 To Re Screen a Subject press 4 5 To Randomize a Subject press 5 6 To Record a Discontinuation from all Study Treatment press 6 For Pharmacist Users 1 To Record a Medication Assignment Visit press 1 2 To Record an Unscheduled Medication Assignment press 2 3 To Record a Lost or Damaged Kit press 3 If the Inventory Management Module is chosen the user will be presented with the following 1 To record an Acknowledgement of Receipt press one 2 To record Medication as Quarantined press two Remember to always use and pre fill your IVRS worksheets when calling into the system TMP PM 046 Controlled Document Copyright Bracket Version 3 0 Rev 1 Page 8 of 34 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 2 IVRS Tissue Pre Screening To Tissue Pre Screen a Subject in the IVRS 1 Obtain a new Tissue Pre Screening worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 1 To Tissue Pre Screen a Subject 5 Enter if the visit occurred today 1 Yes O No a If No enter the visit date DD MM YYYY 6 Enter and confirm the Subject s Date of Birth MM YYYY 7 Enter and confirm the date Subject or legal guardian signed informed consent for tissue collection DD MM YYYY 8 Enter and confirm the number of prior lines of therapy for this
28. nment A success page will display the Subject s data an Assignment Number as well as provide the quantity of Erlotinib and MetMab or placebo Kits assigned to the Subject and which Lot Number s to dispense the Kits janagement Medication Assignment Visit Please select the subject number and then click next to continu terisk indica Medication Assignment Visit Site ID 100000 Subject Number select one TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 26 of 34 Version 3 0 Confidential 6 9 Bracket Genentech OAM4971g Site User Instruction Manual IWRS Unscheduled Medication Assignment Site Pharmacist Only To record a Unscheduled Medication Assignment in the IWRS Log into the web system using the Web login address Enter your Username and Password You will be automatically directed to the Main Menu web page Click Unscheduled Medication Assignment from the menu bar Select the Subject Number from the drop down menu and click next to continue Select the current visit from the drop down menu Change any data by clicking modify to return to the previous screen or click next to continue Select the Subject s Erlotinib Dose from the drop down menu Change any data by clicking modify to return to the previous screen or click next to continue A success page will display the Subject s data provide the quantity of Erlotinib Kits assigned to the Subject an
29. noted on your IVRS Coversheet 2 Enter your six digit IVRS UserID 3 Enter your four digit temporary IVRS PIN The first time you interact with the IVRS you will be asked to change your assigned temporary PIN 4 Enter and confirm your new PIN After successfully entering your UserID and PIN the IVRS will present the Genentech OAM4971g Main Menu TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 6 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 4 5 Repeat User To log on to the Genentech OAM4971g IVRS 1 Dial the IVRS telephone number noted on your IVRS Coversheet 2 Enter your six digit IVRS UserID 3 Enter your four digit IVRS PIN After successfully entering your UserID and PIN the IVRS will present the Genentech OAM4971g Main Menu NOTE PINs expire after 90 days Users who log on to the system with an expired PIN will be prompted to enter a new unique four digit PIN TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 7 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 IVRS Call Details This portion of the IVRS User Manual details each of the calls users may place using the IVRS 5 1 IVRS Main Menu After you enter your IVRS UserID and PIN you will be presented with the following main menu options For Site Users 1 To Tissue Pre Screen a Subject press 1 2 To Scree
30. nsignment Number TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 29 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 6 12 IWRS Quarantine Medication NOTE Lot Number and Batch Number may be interchangeable To record Medication as Quarantined in the IWRS 1 Log into the web system using the Web login address 2 Enter your UserName and Password 3 Choose Inventory Management Module from the study list 4 You will be automatically directed to the Main Menu web page 5 Select Quarantine Medication from the left navigation panel 6 Select the following from the drop down menu and click next to continue e Site Number e Quarantine By Open Label 7 Select the following and click save to continue e Medication e Manufacturing Batch e Barcode Number e Quantity of Packages to Quarantine 8 Select submit to complete the Quarantine Medication Quarantine Medication Main Menu Acknowledgement of Protoc ti Cenesiinck QAMAUTIQ Receipt Quarantine Medication Site Selection amp Medication Type Site Number 100000 _ E Quarantine By select one i submit cancel TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 30 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 7 IXRS Web Reports The IXRS website provides detailed reports filtered for your site Subject
31. o return to the main menu press 1 To end the call press 9 Upon completion of the call a Screening notification will be faxed and or emailed to your Site This notification will serve as a record of the Screening call Upon receipt please place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 9 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 4 IVRS Screen Failure To Screen Fail a Subject in the IVRS 1 Obtain a new Screen Failure worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 3 To Screen Failure a Subject 5 Enter and confirm the six digit Screening Number XXXXXX 6 Confirm Subject s Date of Birth 12 Yes O No a For Subject Status Screened proceed to next step b For Subject Status Tissue Pre Screened Re Screened Screen Failed Rescreened skip to step 8 7 Enter and confirm if the Subject will Re Screen 1 Yes O No a For Yes this call is successfully recorded b For No proceed to next step 8 Enter and confirm Subject s Gender 1 Female 2 Male 9 Enter and confirm Subject s Race 1 American Indian or Alaska Native 2 Asian 3 Black or African American 42 Native Hawaiian or Other Pacific Islander 5 White 6 Other Race 10 Enter and confirm Subject s tobacco use history 12Never 2 Current
32. or damaged followed by the pound or hash key 7 Enter and confirm the number of Kits contained in the Lot number to be marked lost or damaged followed by the pound or hash key Skip to step 12 8 Enter and confirm the five digit Subject number XXXXX 9 Confirm the Subject s Date of Birth MM YYYY 10 To dispense a replacement Kit to the Subject press 1 If the Subject does not need a replacement Kit press 2 11 Enter the numeric portion of the Lot Number of the Kit to be marked Lost or Damaged followed by the pound or hash key 12 Enter and confirm if these should be marked as Lost or Damaged 1 Lost 2 Damaged a If Replacement Kit is needed proceed to next step b If no replacement Kit is needed or the Kit is available this call is successfully recorded 13 The IVRS will instruct you to assign an Assignment Number for the replacement Kit as well as a replacement Kit from a Lot Number Record the Assignment Number and Lot Number and re enter in the IVRS to confirm 14 Upon completion to return to the main menu press 1 To end the call press 9 Upon completion of the call a Lost or Damaged Kit notification will be faxed and or emailed to your site This notification will serve as a record of the Lost or Damaged Kit call Upon receipt place the notification with the Subject s source documents if the Kit was assigned to a Subject 5 11 IVRS Acknowledgement of Receipt NOTE Lot Number and Batch Number may be interchangeable
33. ose skip to Erlotinib Dispensation b If changing dose proceed to next step Enter and confirm the Subject s Erlotinib Dose e 150 mg e 100 mg e 50 mg e Omg b If 50mg 100mg or 150mg proceed to next step c If Omg this call is successfully recorded 9 The IVRS will dispense Kit s to this Subject Record the Lot Numbers on your worksheet 10 To confirm re enter the numeric portion of the Lot Number Upon completion of the call an Unscheduled Medication Assignment notification will be faxed and or emailed to your site This notification will serve as a record of the Unscheduled Medication Assignment call Upon receipt place the notification with the Subject s source documents if the Kit was assigned to a Subject TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 15 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 5 10 IVRS Lost or Damaged Kit Site Pharmacist Only To record a Lost or Damaged Kit in the IVRS 1 Obtain a new Lost or Damaged Kit worksheet from your site file 2 Dial the IVRS telephone number noted on the Coversheet 3 Enter your UserID and PIN 4 Select Option 2 To record a Lost or Damaged Kit 5 To record available Kits as Lost or Damaged press 1 Proceed to the next step To record an assigned Kit as Lost or Damaged press 2 Skip to step 8 6 Enter and confirm the numeric portion of the Lot Number of the Kits to be marked lost
34. ost or Damaged Kit Site Pharmacist Only nnne nnns 28 6 11 IWRS Acknowledgement of Receipt sssssseseseeeee eene enn 29 6 12 IWRS Quarantine Medication ou eene nennen enne nnne nnnnnn nnn nnne nnn nnn nnne nnn nn nnns 30 7 IXRS Web RepoFts 5 reiten rette notan n3 aE ERR a EFRER EN FRE EAE SRRRXR ERERERUSYR RMRAR Y ERERRACEPRER 31 8 IXRS Web Help Section 1 111seeeeeeee nennen nennen nnn nnn nnn nnn nnn nena anne n nnn nnn n nnn 32 9 IXRS Study Documentationys ccesscecsessecsciiessscccty sess tinea renean ea tk parua vxo caca sa aaa kPa YR a Da aeai 32 10 System Notifications hee LEER 32 11 Data Change FOFIms eiie ceri ores era ese e RR Resa x a oye danaa diotaad Tandun ERR 2TRPDNRRRNRR dana esdan 33 12 Bracket Technical Support ssssseseseeeee eene nennen nennen nene nnn nnn nnne nnns n aan enne nnn 34 TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 2 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 1 Overview Interactive Voice Response System and Interactive Web Response System IXRS Bracket provides an Interactive Voice Response System IVRS and Interactive Web Response System IWRS for the management of Subject and inventory data for the Genentech OAM4971g Study The Genentech OAM4971g IXRS will record the following Tissue Pre Screening Screening Screen Failure Re Screening Randomization M
35. rom the drop down menus and click next to continue e Gender e Race e Tobacco Use History e Line Number of Eligibility Criterion Not Met NOTE For subjects screened on initial protocol dated 11Jun2011 range 01 29 will be used NOTE For subjects screened on protocol amendment dated 23May2012 range 30 59 will be used Other Screen Failure Reason Not related to I E Criteria Not Met Previous NSCLC Treatment ECOG Score Disease Staging at Screening Disease State Met IHC Clinical Score EGFR Activating Mutation Histology NOTE displays only for tissue pre screened Subjects Tumor Assessment Non squamous histology type NOTE displays if Histology Non Squamous e If Non Squamous Histology type Unknown please follow up with your monitor 8 Aconfirmation page will be displayed with the Subject s data Change any data entered by clicking modify to return to the previous screen or click save to complete the Screen Failure 9 A success page will display the Subject s data and confirm the Screen Failure transaction Patient Management Screen Failure TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 22 of 34 Version 3 0 Confidential 6 5 Bracket Genentech OAM4971g Site User Instruction Manual IWRS Re Screening To record a Re Screening in the IWRS Log into the web system using the Web login address Enter your Username and Password You will be automatically directed to the Main Menu we
36. s shipments and drug inventory Data in these reports are updated and displayed in real time All reports are printable and many are exportable to Excel Clicking on any underlined column header will allow users to sort report data by category The web reports will be filtered to display data only for your site The following reports may be accessed via the Genentech OAM4971g Study Website e Site Detail Details specific site data as well as Subjects at the selected site e Subject Summary Summary of Subjects enrolled in the study All Subject Numbers may be selected to drill down to more detailed patient information e Subject Detail Details of specific Subjects and visits e Screen Failure Summary Report A Summary of Screen Failures recorded at your site TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 31 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 8 IXRS Web Help Section The Bracket Technical Support contact information can be obtained by clicking Help on the top of each IXRS web page at any time 9 IXRS Study Documentation Study documentation can be downloaded from our study website by clicking Documentation under the IXRS Help section You can print out documentation and make photocopies if you need additional copies of the training documentation 10 System Notifications Notification Event Site Activation Deactivation Sent following the
37. t 5 Enter and confirm the six digit Screening Number XXXXXX 6 Confirm the Subject s Date of Birth MM YYYY 7 Enter if the visit occurred today 1 Yes O No a If No Enter the date of visit DD MM YYYY 8 Enter and confirm Subject s weight in kilograms followed by the pound or hash key Use the star key as a decimal point XXX X 9 Enter and confirm the date Subject or legal guardian signed informed consent DD MM YYYY 10 Enter and confirm the Subject s number of prior lines of therapy 1 One 2 Two 11 The IVRS will indicate the Subject s histology Value Squamous Non Squamous 12 The IVRS will assign a six digit Screening Number Record the Screening Number on the worksheet and re enter in the IVRS to confirm XXXXXX 13 Subject Screening is successfully recorded 14 To return to the main menu press 1 To end the call press 9 Upon completion of the call a Re Screening notification will be faxed and or emailed to your Site This notification will serve as a record of the Re Screening call Upon receipt place the notification with the Subject s source documents TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 12 of 34 Version 3 0 Confidential 5 6 Bracket Genentech OAM4971g Site User Instruction Manual IVRS Randomization To Randomize a Subject in the IVRS Obtain a new Randomization worksheet from your site file Dial the IVRS telephone number noted on the Coversh
38. tinuation from All Study Treatment 8 A success page will confirm your completed Discontinuation from All Study Treatment transaction Discontinuation from All Study Treatment m 200000 lect one SG gt Discontinuation from All Study Treatment TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 25 of 34 Version 3 0 Confidential 6 8 Bracket Genentech OAM4971g Site User Instruction Manual IWRS Medication Assignment Site Pharmacist Only To record a Medication Assignment in the IWRS 7 8 9 Log into the web system using the Web login address Enter your Username and Password You will be automatically directed to the Main Menu web page Click Medication Assignment from the menu bar Select the Subject Number from the drop down menu and click next to continue Select the following from the drop down menus Change any data entered by clicking modify to return to the previous screen or click next to continue e Discontinue MetMab or Placebo e Subject s Erlotinib Dose Select and confirm the Infusion Schedule from the drop down menu Change any data entered by clicking modify to return to the previous screen or click next to continue A confirmation page will be displayed with the Subject s data and study data information Change any data entered by clicking modify to return to the previous screen or click save to complete the Medication Assig
39. to change your PIN password to a new one IVRS Study Worksheets Your Study Manager will provide your IVRS worksheets The Coversheet lists country specific IVRS access and Bracket technical support phone numbers The worksheets are to be used as a guide and reference when entering data into the IVRS and recording data assigned by the IVRS TMP PM 046 Rev 1 Controlled Document Copyright Bracket Page 5 of 34 Version 3 0 Confidential Bracket Genentech OAM4971g Site User Instruction Manual 4 3 Training User The training module allows users the ability to practice calls transactions for all branches without saving any data in the IXRS To access this Training System please enter the following To practice IVRS Calls IVR Training UserID IVR Training PIN TBD 1111 To practice IWRS Transactions IWR Training Username IWR Training Password OAM4971 Training123 4 4 IVRS First Time User For those Site Users receiving their access information via email the Bracket domain from which the email will be sent is the following support bracketglobal com Please record your IVRS UserID here e UserID Six Digit Number e Caller PIN Confidential Four Digit Number Do NOT write your PIN here Your IVRS login codes are equivalent to your written signature Please do NOT share your login information To log on to the Genentech OAM4971g IVRS 1 Dial the IVRS telephone number
40. to the Main Menu web page Select Acknowledgement of Receipt from the left navigation panel Select the consignment number for which you would like to register the acknowledgement of receipt Select the following e Actual Date of Arrival and Unpacking at Site A pop up calendar will display with which the user must select the actual date on which the consignment was unpacked at the Site e Actual Time of Arrival and Unpacking at Site A free text field is displayed in which the user must enter the actual time at which the consignment was unpacked at the Site The format must be hhmm two digit hour value two digit minute value in 24 hour format with no punctuation e Medication Damaged Missing from Consignment Jf No skip to Step 10 Select the Damaged Missing Medication Type Open Label and click submit to continue Select the following and click save to continue e Medication e Manufacturing Batch e Barcode Number e Quantity of Packages e New Status A table will display with the above information Click submit to continue 10 Please re enter your UserName and Password 11 A success page will display to confirm your Acknowledgement of Receipt Main Menu Acknowledgement of Receipt Q Quarantine Consignment Summary s Acknowledgement of Receipt Protocol Genentech OAM4971g Click on the consignment number you would like to register the acknowledgement of receipt for Medication Co
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