IVRS User Manual
Contents
1. Page 3 of 38 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 3 IWRS Login Your Username and Password A unique Web Username and a Password will be sent to the user via email if an email address is available If an email address is not available the Username and Password will be made available from the Study Manager If you do not receive your Username and Password via email please contact your Study Manager or Bracket Technical Support 3 1 Frequently asked Username and Password Questions What do I do if I never received or I lost my Username and Password Contact your Study Manager You can also contact Bracket Technical Support to receive your IWRS Username and Password if information is forgotten The next time you log on you will be prompted to change your Password to a new Password Also check your email spam folder in the event your email system filtered out the email from Bracket I received the IWRS message You have exceeded the allowable number of attempts to access the system What does that mean The IWRS will show this message if you attempted to access the system 5 times within a thirty minute window using the incorrect Password You will not be able to access the IWRS 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 Username and Password You should never use someone else s Usernam2. Bracket Roche GO29058 Study IWRS RTSM Site User Instruction Manual For Site Users Only Version 1 0 05 Mar 2015 Bracket Roche GO29058 RTSM Site User Instruction Manual TABLE OF CONTENTS 1 Overview Interactive Web Response System WRG A 3 2 IWRS User TYPES reed rine EES ENEE 3 3 IWRS Login Your Username and Password usessseseseseseseseseseee nenne nennen nennen rennen nene 4 3 1 Frequently asked Username and Password Questions eene nennen 4 3 2 Training EE 5 3 3 IWRS EIrSE Time UE enges eegene eege Ee RES 5 4 IWRS Overview LOG Rh 2 eeuu actu nk tn rh Fux ER Rua ines Ex SR ER ERR ENS DOR BERE CURVE eR ECKE SER PAK DS ENEE 6 4 1 IWRS Main GET PN 8 4 2 IWRS Screening VSM iiio m itid e ene ott aai d Ces da crx a Fa eu vega E E a 9 4 3 IWRS Randomizatioh srasni suede ses ete ena P e aka Deb Xe ARE PER MERO N Saa aaa aa S aaia 10 4 4 IWRS Medication Assignment Visit A 12 4 5 IWRS Unscheduled Medication Assignment Visit Au 14 4 6 IWRS Treatment Discontinuation KEREN 16 4 7 IWRS Lost or Damaged Medication Blinded AAA 17 4 8 IWRS Lost or Damaged Medication Open Label 19 4 9 IWRS Create Patient Update Reguest AAA 21 4 10 IWRS Screen FallUre iios eaae eoru enr en euer apr ea nese ca ENEE Fe TE MM NY eR OVE ENEE CY SY EN ANEN 23 4 11 IWRS Rescreening eiii eroe aaan EERSTEN EERSTEN 24 4 12 IWRS Patient Companion
3. 420 2 2888 1339 Czech Republic 888 794 0122 Czech France 0800 99 00 11 888 794 0122 French Germany 0800 225 5288 888 794 0122 German English Greece 00 800 1311 888 794 0122 Greek Italy 800 172 444 888 794 0122 Italian English Japan 00 539 111 00 663 5111 Japanese 0034 811 001 888 794 0122 Mexico 01 800 288 2872 888 794 0122 Spanish Netherlands 0800 022 9111 888 794 0122 Dutch Peru 0 800 50 288 888 794 0122 Spanish Poland 0 0 800 111 1111 888 794 0122 Polish English Portugal 800 800 128 888 794 0122 Portuguese Romania 0808 03 4288 888 794 0122 Romanian 8 495 363 2400 812 363 2400 495 363 2400 8 10 800 120 1011 PR 8 10 800 110 1011 8 812 363 2400 rom 888 794 0122 00 729 11 00 369 11 cialis 00 309 11 888 794 0122 Korean Spain 900 99 0011 888 794 0122 Spanish Sweden 020 799 111 888 794 0122 Swedish Turkey 0 811 288 000 1 888 794 0122 Turkish United States of America 888 794 0122 English TMP PM 053 Controlled Document Copyright Bracket RTSM v0 4 Rev 5 Page 37 of 38 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual Bracket Technical Support Email Address All countries support bracketglobal com When contacting Bracket Technical Support please be prepared to provide the following Name Roche GO29058 Phone Number Site ID Patient Number Drug Shipment Number Details of the Issue TMP PM 053 Rev 5 Controlled Document Cop
4. v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 15 IWRS Patient Unblinding Authorized Site Unblinders Only To Unblind a Patient 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 system home page 4 Click Unblinding from the Investigator tab 5 Confirm you wish to Unblind a Patient and click Next to continue ROCHE Welcome Joel Kramer LOG OFF BZ GO29058 Bracket REPORTS Unblinding Investigator Site gt Unblinding UNBLINDING Site ID 999997 Unblind a Patient Confirmation You have chosen to unblind a patient To confirm that you wish to unblind a patient please click on next 2015 Bracket CONTACT US SUPPORT 6 Select the Patient Number from the drop down menu and click Next to continue 7 Confirm the Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender 8 Please re enter your Password to authorize the transaction Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Unblinding transaction 9 A success page will confirm your completed Unblinding transaction as well as provide the treatment the Patient has been randomized to TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 31 of 38 RTSM v0 4 Confidentia
5. hormones Number of prior lines of therapy in the metastatic setting Tumor Assessment 8 A confirmation page will be displayed with the Patient s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Patient Companion Diagnostics transaction 9 A success page will display the Patient s data TMP PM 053 Controlled Document Copyright O Bracket RTSM v0 4 Rev 5 Page 26 of 38 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 13 IWRS Acknowledgement of Receipt To record an Acknowledgement of Receipt 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 system home page 4 Click Acknowledgement of Receipt from the Investigator Site tab 5 Select the Update button of the Consignment Number you wish to acknowledge from the In Transit Consignment Summary table ROCHE Welcome Anthony Jang LOG OFF EZ GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Label Unscheduled Medication Assignment 2 Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Acknowledgement of R
6. Gender ES ROCHE Welcome Anthony Jang LOG OFF e GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Label Unscheduled Medication Assignment x Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Screening SCREENING Site ID 999995 Patient Information Collection Please select the information for the patient that you are screening and then click Next to continue Initial First Initia v Middle Ini Last Initial v Date of Birth Year of Birth pay s Month Ill vest v Gender select one v P 2015 Bracket CONTACTUS SUPPORT Select the Informed Consent Date from the pop up calendar and click Next to continue Select the Visit Date from the pop up calendar and click Next to continue A confirmation page will be displayed with the Patient s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Patient Screening 10 A success page will display the Patient s data as well as provide the ten digit Screening Number NOTE All Germany sites will only collect Patient s Year of Birth All non Germany sites will collect Patien
7. Next to continue e Quantity of Damaged Medication e Quantity of Missing Medication 10 Please re enter your Username and Password to authorize the transaction Change any data entered by clicking Previous to return to the previous screen or click Next to continue 11 A confirmation page will display the Consignment s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Acknowledgement of Receipt 12 A success page will confirm your completed Acknowledgement of Receipt transaction TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 28 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 14 IWRS Quarantine Medication To record Quarantine Medication 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 system home page 4 Click Quarantine Medication from the Investigator Site tab 5 Select the following from the drop down menus and click Next to continue e Site Number e Quarantine By a If Medication Number is selected skip steps 7 and 8 b If Open Label Medication is selected skip step 6 ROCHE Welcome Anthony Jang LOG OFF e GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of
8. locally by your site 10 Confirm the Dose Modified To and click Next to continue 11 Select if the Patient should be dispensed Fulvestrant from the drop down menu and click Next to continue 12 A confirmation page will be displayed with the Patient s data and study data information Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Medication Assignment Visit 13 A success page will display the Patient s data and study data information as well as provide the Kit number s for Taselisib Placebo and Batch ID and Quantity assigned to the Patient for Fulvestrant NOTE If Fulvestrant is supplied locally by your site then Step 11 will not appear Please follow local procedures TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 13 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 5 IWRS Unscheduled Medication Assignment Visit To record an Unscheduled Medication Assignment Visit 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 system home page 4 Click Unscheduled Medication Assignment Visit from the Investigator Site tab 5 Select the Patient Number from the drop down menu and click Next to continue ROCHE Welcome Anthony Jang LOG OFF P GO29058 Bracket REPORTS Sc
9. must be deactivated through Screen Failure branch 7 Select the Visceral Disease from the drop down menu and click Next to continue e Visceral disease Metastatic Disease in the lung liver adrenal glands brain heart pericardium pleura peritoneum or other end organs of the chest abdomen and pelvis e Non visceral disease Absence of metastatic disease in visceral organs Pleural effusions ascites disease involving lymph nodes and disease involving bone are not considered to be visceral disease TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 10 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 8 Select the Endocrine Sensitivity from the drop down menu and click Next to continue e Sensitivity vs Non Sensitivity to the Patient s most recently administered endocrine therapy o Sensitive Fulfilling either of the criteria below For patients with no endocrine treatment in the advanced or metastatic setting at least 24 months of adjuvant endocrine therapy prior to disease recurrence Documented clinical benefit CR PR or SD 24 weeks to most recent endocrine treatment in the advanced or metastatic treatment setting o MNon sensitive Not satisfying criteria listed as Sensitive 9 Please re enter your Password to authorize the transaction Change any data entered by clicking Previous to return to the previous screen or click Save to co
10. 0 A success page will display the Patient s data TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 23 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 11 IWRS Rescreening To record a Rescreening visit 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 system home page 4 Click the Investigator Site link on the horizontal menu bar at the top of the web page 5 Click Rescreening from the Investigator Site tab 6 Select the Screening Number from the drop down menu and click Next to continue ROCHE Welcome Anthony Jang LOG OFF EZ GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Ped Label Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Rescreening RESCREENING Site ID 999995 Patient Identification Please select the Screening Number and then click Next to continue Screening Number _ select one v 2015 Bracket CONTACTUS SUPPORT 7 Confirm the following Patient Demographics and click Next to continue e Date or Yea
11. Diagnostics cll nn ee ne a nennen nnne nnne nnne nnne nna 25 4 13 IWRS Acknowledgement of Receipt Au 27 4 14 IWRS Quarantine Medication ssseseeeee eee nennen nennen nnn nnne nnn nn nnne nnne nna 29 4 15 IWRS Patient Unblinding Authorized Site Unblinders Only AAA 31 5 IWRS Web Pep M 32 6 IWRS Web Help SeCctiOF iiiiiis aate etudes cene rone eodein ceu ei eoe noch Geen vo niacin aes 33 7 IWRS Study Documentation sissit nainii XRA RR IRRE EAR ERE EIER KR ESL EE EE ERR ER as eR EU 33 98 System Notifications Dee etn en D kn OR EREXEUDXRK ka Cx EX eR EE SERERE EE EEN ENNEN 33 9 Data Change FOFIIS 5 22 rnac ra Ek EXE NAKAA EXE XXE EX KA RRRRRE CER RRKEK EGE AAE a ERSS KAE innii 35 10 Frequently Asked Questions 12eeeeeeee nennen nennen nnne nnn nnn nn nnns sa arent enun uan 36 11 Bracket Technical Support 12 21eeeeseeeineeieeaeiesen ena iran ka nk anna a RENE RR RR RR D AREA RR RR a da KEREN 37 TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 2 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 1 Overview Interactive Web Response System IWRS Bracket provides an Interactive Web Response System IWRS for the management of Patient and inventory data for the Roche GO29058 Study The Roche GO29058 IWRS will record the following The IWRS for the Roche GO29058 s
12. RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 1 IWRS Main Menu After you enter your IWRS Username and Password you will be taken to the home page For Site Users Under the Investigator Site tab at the top of the screen you will see options for the following Screening Randomization Medication Assignment Visit Unscheduled Medication Assignment Visit Treatment Discontinuation Lost or Damaged Medication Blinded Lost or Damaged Medication Open Label Create Patient Update Request Screen Failure Rescreening Patient Companion Diagnostics Acknowledgement of Receipt Quarantine Medication For Site Unblinders Under the Investigator Site tab at the top of the screen you will see options for the following Unblinding TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 8 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 2 IWRS Screening Visit To record a Screening Visit 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 system home page Click Screening from the Investigator Site tab Select the Screening Date from the pop up calendar and click Next to continue Select the following from the drop down menus and click Next to continue e Initials e Date or Year of Birth e
13. Receipt Lost or Damaged Medication Open Quarantine Medication Label Medication Assignment Visit Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investgstor Site gt Quarantine Medication QUARANTINE MEDICATION Site ID 999995 Quarantine Medication Site Selection amp Medication Type Please specify the information below and press Next to continue Site Number _ select one EN Quarantine By select one v p 2015 Bracket CONTACTUS SUPPORT 6 Select the Kit Number s from the check boxes and click Next to continue 7 Select the Medication Parameters and click Next to continue e Material Description of the Quarantined Medication e Manufacturing Batch e Batch ID 8 Select the Quantity of Packages to Quarantine from the drop down menu and click Next to continue TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 29 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 9 Please re enter your Username and Password to authorize the transaction Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Quarantined Medication 10 A success page will confirm the completed Quarantined Medication transaction TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 30 of 38 RTSM
14. UATION Site ID 999995 Patient Identification Please select the Patient Number and then click Next to continue Patient Number select one E p 2015 Bracket CONTACT US SUPPORT 6 Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender 7 Select the Treatment Discontinuation Date from the pop up calendar and click Next to continue 8 A confirmation page will be displayed with the Patient s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Treatment Discontinuation 9 A success page will confirm your completed Treatment Discontinuation transaction TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 16 of 38 RTSM v0 4 Confidential 4 7 Bracket Roche GO29058 RTSM Site User Instruction Manual IWRS Lost or Damaged Medication Blinded To record a Lost or Damaged Medication Blinded 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 system home page 4 Click Lost or Damaged Medication Blinded from the Investigator Site tab 5 Select the Kit Number from the drop down menu and click Next to continue 6 7 8 a If Assigned proceed to next step b If Available or Quarantined skip to step 8 ROCHE Welco
15. andomization Status Update Sent following the opening closing of the site s Randomization Confirmation status Sent following the recording of a Screening transaction Sent following the recording of a Screen Failure transaction Sent following the recording of a Rescreening transaction Sent following the recording of an Randomization transaction Sent following the recording of a Medication Assignment Visit transaction Sent following the recording of an Unscheduled Medication Assignment Visit transaction Treatment Discontinuation Sent following the recording of a Treatment Discontinuation transaction Patient Update Request Created Sent following the recording of a Create Patient Update Request transaction Patient Update Request Updated Sent following the updating of the Patient Update Request Patient Update Request Updated and Sent following the updating and approving of the Patient Approved Update Request Patient Update Request Approved Sent following the approving of the Patient Update Request TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 33 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual Patient Update Request Rejected Sent following the rejection of the Patient Update Request Confirmation transaction Patient Companion Diagnostic Confirmation transaction RIMM Notifications Dispatch Advice Confirmation Sent following a Dispatch Advise transaction A
16. atus of the kit and then click Next to continue Kit Status select one v p 2015 Bracket CONTACTUS SUPPORT 6 Select the Patient Number from the drop down menu and click Next to continue 7 Confirm the Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender 8 Select whether or not a replacement kit is required from the drop down menu and click Next to continue 9 Select the following from the drop down menus and click Next to continue e Batch ID e Quantity TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 19 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 10 Select the Kit Status from the drop down menu and click Next to continue 11 A confirmation page will display the medication status and the Patient s data if applicable Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Lost or Damaged Medication Open Label 12 A success page will confirm your completed Lost or Damaged Medication Open Label transaction NOTE Replacement medication can only be requested for an active Patient s Most Recent Visit TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 20 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 9 IWRS Create Patient Update Requ
17. cation Assignment Visit MEDICATION ASSIGNMENT VISIT Site ID 999995 Patient Selection Please select the Patient Number and then click Next to continue Patient Number _ select one v CONTACTUS SUPPORT 6 Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender 7 Confirm the Patient s Visit Number and click Next to continue a If the Visit is Cycle 1 Day 15 and only Fulvestrant will be dispensed skip steps 8 9 and 10 b If the Visit is not Cycle 1 Day 15 proceed to next step 8 Select if the Patient should be dispensed Taselisib Placebo from the drop down menu and click Next to continue a Des proceed to next step b If No Dose Hold skip to step 10 TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 12 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual C If No Treatment Discontinued Note both IWRS provided Taselisib Placebo and Fulvestrant cannot be discontinued from this branch at the same time If patient is no longer receiving both medications by the IWRS please discontinue Patient via the Treatment Discontinuation branch 9 Select the Dose Modification of Taselisib Placebo Required from the drop down menu and click Next to continue a If Yes proceed to next step b If No skip to step 11 Please skip to step 12 if Fulvestrant is supplied
18. cations 8 Lam a site level user and I no longer want to receive notifications e Contact your Study Monitor or Sponsor who will initiate the request to remove receipt of email and or fax notifications 9 How do I update my PI Name Site Address Site Fax Site Details e Contact your Study Monitor or Sponsor to request that the Study Management team update this information All site user and site information are maintained by the study Sponsor TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 36 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 11 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 number and email address are specified below Bracket Technical Support Access Numbers Location Access Number Language 1 800 881 011 1 800 551155 p Australia 888 794 0122 English Austria 0 800 200 288 888 794 0122 German Bulgaria 00 800 0010 888 794 0122 Bulgarian Canada 1 888 794 0122 English French Columbia 01 800 911 0010 888 794 0122 Spanish 00 800 222 55288
19. cknowledgment of Receipt Confirmation Sent following an Acknowledgement of Receipt transaction Quarantine Medication Confirmation Sent following medication at a site being marked as Quarantined Release Reject Quarantined Medication Sent following a Release Reject Quarantined Medication Confirmation transaction Late Acknowledgement of Receipt Alert Sent when a site has not acknowledged receipt of medication before the Latest Acceptable Time Time of Arrival and Unpacking Do Not Dispense Alert Sent a pre determined number of days before DND has passed Use By Alert Sent when the Use By Date has been reached for any medication Frequently asked Notification questions e How do I get 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 Monitor to request a notification re generation from Bracket TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 34 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 9 Data Change Forms If the wrong information was entered in the IWRS 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 Bracket will process ONLY completed and signed Data Change For
20. cs PATIENT COMPANION DIAGNOSTICS Site ID 111179 Patient Identification Please select the Screening Number and then click Next to continue Screening Number _ select one v p 2015 Bracket CONTACTUS SUPPORT Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender e Informed Consent Date Select or enter the following information from the drop down menus or text fields and click Next to continue Ethnicity Race American Indian or Alaska Native Race Asian Race Black or African American Race Native American or Other Pacific Islander Race White TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 25 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual Unknown Height cm Weight kg ECOG Score Tobacco Use Histologic Subtypes Ductal Histologic Subtypes Lobular Histologic Subtypes Other Classifications of Breast Primary Tumor Classifications of Breast Regional Lymph Nodes Classifications of Breast Distant Metastasis Sites of Metastatic Disease Bone Sites of Metastatic Disease Liver Sites of Metastatic Disease Lung Sites of Metastatic Disease Other ER Test 9o Positive Cells 1 100 Most recent tumor progesterone receptor status PR test Positive Cells 1 100 Neoadjuvant or adjuvant therapy includes chemo radiation
21. e GO29058 RTSM Site User Instruction Manual 11 A success page will display the Patient s data and study data information as well as provide the Kit number s for Taselisib Placebo assigned NOTE Only one Unscheduled Medication Assignment Visit is allowed between Medication Assignment Visits NOTE Unscheduled Medication Assignment Visits will only dispense Taselisib Placebo treatment TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 15 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 6 IWRS Treatment Discontinuation To record a Treatment Discontinuation 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 system home page 4 Click Treatment Discontinuation from the Investigator Site tab 5 Select the Patient Number from the drop down menu and click Next to continue ROCHE Welcome Anthony Jang LOG OFF E GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Lost or Damaged Medication Open Quarantine Medication Label Medication Assignment Visit Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Treatment Discontinustion TREATMENT DISCONTIN
22. e and Password as these are equivalent to your written electronic signature Please contact your Study Manager to request your own Username and Password What do I do if the Password sent in the Bracket email no longer works Remember the first time you log into the IWRS you are required to reset your Password The new reset Password will work for all subsequent IWRS logins You can contact Bracket Technical Support to have your Password reset and provided to you The next time you login you will be prompted to change your Password to a new one TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 4 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 3 2 Training User The training module allows users the ability to practice transactions without saving any data in the IWRS To access this Training System please login here https rtsm bracketglobal com To practice IWRS Transactions IWR Training Username IWR Training Password GO29058 Training123 3 3 IWRS First Time User Please record your IWRS User Name here e Web Username e Password Confidential Do NOT write your Password here Your IWRS login codes are equivalent to your written signature Please do NOT share your login information TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 5 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM S
23. eceipt ACKNOWLEDGEMENT OF RECEIPT Site ID 999995 Acknowledgement of Receipt of Consignment Click on the consignment number you would like to register the acknowledgement of receipt for In Transit Consignment Summary Previous Page 1 of 1 Next 5 bel Consignment Number Status Update 6 Select and confirm the following e Actual Date of Arrival and Unpacking at the site Use pop up calendar to select the actual date on which the Consignment was unpacked at the site e Actual Time of Arrival and Unpacking at the site In the free text field enter the actual time at which the Consignment was unpacked at the site The format must be HH MM two digit hour value two digit minute value in 24 hour format with no punctuation e Medication Damaged Missing from Consignment i If Yes proceed to next step ii If No skip to Step 10 TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 27 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 7 Select the Damaged Missing Medication Type from the drop down menu and click Next to continue a Ifthe Medication Type is Medication Numbers skip step 9 b Ifthe Medication Type is Open Label Medication skip step 8 8 Select the Damaged Missing Medication Numbers in the check boxes and click Next to continue 9 Select and confirm the following from the drop down menus of the Damaged Missing Medication and click
24. est To Create a Patient Update Request 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 system home page 4 Click Create Patient Update Request from the Investigator Site tab 5 Select the following from the drop down menu and click Next to continue e Site ID e Screening or Patient Number ROCHE Welcome Anthony Jang LOG OFF n A GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Lost or Damaged Medication Open Quarantine Medication Label Medication Assignment Visit Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Creste Patient Update Request CREATE PATIENT UPDATE REQUEST Site ID 999995 Patient Selection Please select the site and patient identifier of the patient whose information is to be updated and then click Next to continue Site ID _ select one Patient Number select one Je P 2015 Bracket CONTACTUS SUPPORT 6 A Patient information update page will display the Patient s current data Confirm the Patient s current Demographics e Initials Date or Year of Birth Gender Patient Status Screening Date Screen Failure Date if applicable Rescreening Date if appl
25. he web login address Enter your Username and Password You will be automatically directed to the system home page Click Screen Failure from the Investigator Site tab Select the Screening Number from the drop down menu and click Next to continue ROCHE Welcome u u LOG OFF n GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Se S Label Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigstor Site gt Screen Failure SCREEN FAILURE Site ID 111179 Patient Identification Please select the Patient Number and then click Next to continue Screening Number select one x B 2015 Bracket CONTACTUS SUPPORT Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender Select the Screen Failure Date from the pop up calendar and click Next to continue Select up to three Screen Failure Reason Codes from the drop down menus and click Next to continue A confirmation page will be displayed with the Patient s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Patient Screen Failure 1
26. icable TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 21 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual Randomization Date if applicable Treatment Discontinuation Date if applicable All Medication Assignment Visits if applicable All Unscheduled Medication Assignment Visits if applicable e Unblinding Date if applicable 7 Select from the following options the data that you wish to update for this Patient from the drop down menus and click Next to continue e Initials Date or Year of Birth Gender Screening Date Screen Failure Date if applicable Rescreening Date if applicable e Treatment Discontinuation Date if applicable 8 A confirmation page will display the Patient s Current Values as well as the New Values that are being requested Change any data entered by clicking Previous to return to the previous screen or click Save to Create the Patient Update Request 9 A success page will confirm your completed Create Patient Update Request transaction and assigned Patient Update Request Identifier XXXXXXXXXXXXX TMP PM 053 Controlled Document Copyright O Bracket RTSM v0 4 Rev 5 Page 22 of 38 Confidential 4 10 Bracket Roche GO29058 RTSM Site User Instruction Manual IWRS Screen Failure To record a Screen Failure Visit in the IWRS 6 7 8 9 Log into the web system using t
27. ite User Instruction Manual 4 IWRS Overview Login You will be sent your Web Username and Password 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 Monitor or Bracket Technical Support You can sign in to the Roche GO29058 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 rtsm bracketglobal com Secondary https rtsm2 bracketglobal com Note Internet Explorer is the only supported web browser BRACKET RTSM Bracket Welcome to Bracket Login Page Randomization and Trial Supply Management System To access the system for your clinical trial s please enter your username and password and click Sign In User Name Password Forgot Password Language English United States v For assistance with logging in please contact Bracket Support TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 6 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual The first time you access the IWRS Website the system will prompt you to change the temporary Password to a new confidential Password that is easy for you to remember When prompted to do so enter and confirm the new Password The
28. l Bracket Roche GO29058 RTSM Site User Instruction Manual 5 IWRS Web Reports The IWRS website provides detailed reports filtered for your site Patients 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 CSV or PDF 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 Roche GO29058 Study Website Site Summary Summary of specific site data as well as Patients at the selected site Site Detail Details specific site data as well as Patients at the selected site Patient Summary Summary of Patients enrolled in the study All Patient IDs may be selected to drill down to more detailed patient information Patient Detail Blinded Details of specific Patients and visits Patient Update Request Summary High level overview of Patient Update Requests and their statuses Patient Update Request Detail Details of a selected Patient Update Request Companion Diagnostic Report All information collected via the Companion Diagnostic branch Site Inventory Report Blinded A summary of inventory available at all sites Site Consignment Information Summary Summary of Consignments Site Consignment Information Detail Detailed information for a single selected Consignmen
29. me Anthony Jang LOG OFF a GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Lost or Damaged Medication Open Quarantine Medication Label Medication Assignment Visit Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Lost or Damaged Medication Blinded LOST OR DAMAGED MEDICATION BLINDED Site ID 999995 Kit Selection Please select the lost or damaged kit number and then click Next to continue Kit Number select one el 2015 Bracket CONTACT US SUPPORT Confirm the Patient Demographics and click Next to continue e Patient Number e Date or Year of Birth e Initials e Gender Select whether or not a replacement kit is required from the drop down menu and click Next to continue Select the Kit Status from the drop down menu and click Next to continue TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 17 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 9 Aconfirmation page will display the medication status and the Patient s data if applicable Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Lost or Damaged Medication Blinded 10 A success page will confi
30. mplete the Randomization 10 A success page will display the Patient s data assign a Patient Number provide a Kit Number s Taselisib Placebo Batch ID and Quantity assigned to the Patient for Fulvestrant NOTE Patient s PIK3CA Mutation Status from HistoGeneX must be received before Randomization can take place NOTE If Fulvestrant is supplied locally by your site it will not be dispensed by the IWRS Please follow local procedures TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 11 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 4 IWRS Medication Assignment Visit To record a Medication Assignment Visit 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 system home page 4 Click Medication Assignment Visit from the Investigator Site tab 5 Select the Patient Number from the drop down menu and click Next to continue ROCHE Welcome Anthony Jang LOG OFF a GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Unscheduled Medication Assignment gen Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Medi
31. ms Note Bracket will not accept e signatures on these forms Below is a summary of the Data Change Form Submission Process TEE Enter Data Process into Form 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 IWRS data change questions e How do I find out if my Data Change Form has been processed To be provided with that information on the DCF check the Box next to Please check here to regenerate the relevant notification s with this updated information You can also ask your Study Monitor 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 Monitor or download the worksheets or Data Change Forms via the study website under the Help Documentation link on the home screen You may also contact Bracket Technical Support to have them emailed to you TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 35 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Man
32. picture below provides a snapshot of the IWRS Study Website Change Password screen Note This new Password must be at least 8 characters in length and contain at least 1 capital letter and 1 number or symbol CHANGE PASSWORD The password you entered is a temporary one or has expired Please enter a new password The password must be atleast 8 characters in length and contain at least 1 capital letter and 1 number or symbol User Name sweet Current Password New Password New Password Confirm Change Password You will then be prompted to select 3 security questions These questions and answers should be known only to you and will be used for security purposes SECURITY QUESTIONS SETUP Should you need to reset your password in the future the system will confirm your identity by asking you 2 of 3 questions to which only you know the answer Please select which 3 questions to be asked and specify an answer for each These questions and answers should be known only to you and will be used for security purposes only Question select one Answer Question select one Answer Question select one S Answer For assistance with the system please contact Bracket Support Use this new Password along with the assigned Username each time the Roche GO29058 IWRS Study Website is to be accessed in the future TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 7 of 38
33. r of Birth e Initials e Gender 8 A confirmation page will be displayed with the Patient s data Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Patient Rescreening 9 A success page will display the Patient s data as well as provide a new ten digit Screening Number NOTE Patients are only allowed to be rescreened no more than once TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 24 of 38 RTSM v0 4 Confidential 4 12 Bracket Roche GO29058 RTSM Site User Instruction Manual IWRS Patient Companion Diagnostics To update Patient Companion Diagnostics in the IWRS 6 7 Log into the web system using the Web login address Enter your Username and Password You will be automatically directed to the system home page Click Patient Companion Diagnostics from the Investigator Site tab Select the Screening Number from the drop down menu and click Next to continue ROCHE Welcome u u LOG OFF e A GO29058 Bracket Screening Lost or Damaged Medication Patient Companion Diagnostics Blinded Randomization Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Acknowledgement of Receipt Label Unscheduled Medication Assignment Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Patient Companion Diagnosti
34. reening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Label Unscheduled Medication Assignment T Visit Create Patient Update Request Treatment Discontinuation Screen Failure Rescreening Investigator Site gt Unscheduled Medication Assignment Visit UNSCHEDULED MEDICATION ASSIGNMENT VISIT Site ID 999995 Patient Selection Please select the Patient Number and then click Next to continue Patient Number _ select one v E 2015 Bracket CONTACTUS SUPPORT 6 Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender 7 Confirm the Patient s Unscheduled Visit Number and click Next to continue 8 Select the Dose Modification of Taselisib Placebo Required from the drop down menu and click Next to continue 9 Select the Quantity of Taselisib Placebo to Dispense from the drop down menu and click Next to continue 10 A confirmation page will be displayed with the Patiente data and study data information Change any data entered by clicking Previous to return to the previous screen or click Save to complete the Unscheduled Medication Assignment Visit TMP PM 053 Rev 5 Controlled Document Copyright Bracket Page 14 of 38 RTSM v0 4 Confidential Bracket Roch
35. rm your completed Lost or Damaged Medication Blinded transaction NOTE Replacement medication can only be requested for an active Patient s Most Recent Visit TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 18 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 8 IWRS Lost or Damaged Medication Open Label To record a Lost or Damaged Medication Open Label 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 system home page 4 Click Lost or Damaged Medication Open Label from the Investigator Site tab 5 Select the Kit Status from the drop down menu and click Next to continue a If Assigned proceed to next step b If Available or Quarantined skip to step 9 ROCHE Welcome Anthony Jang LOG OFF BZ GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Lost or Damaged Medication Open Quarantine Medication Label Create Patient Update Request Medication Assignment Visit Unscheduled Medication Assignment Visit Treatment Discontinuation Screen Failure Rescreening Investigstor Site gt Lost or Damaged Medication Open Labe LOST OR DAMAGED MEDICATION OPEN LABEL Site ID 999995 Kit Selection Please identify the current st
36. t Medication Assignment Report List of all Medications assigned to all Patients at your site May be filtered by specific Patient information TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 32 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 6 IWRS Web Help Section The Bracket Technical Support contact information can be obtained by clicking on the Contact Us or Support links at the bottom right of each webpage 2012 Bracket CONTACT US SUPPORT 7 IWRS Study Documentation Study specific documentation can be downloaded by clicking Help Documentation from the Home Screen You can print out documentation and make photocopies if you need additional copies of the training documentation 8 System Notifications Notification Event New Site Added Confirmation Active Sent following the activation of your site in the system New Site Added Confirmation Inactive Sent following the addition of an inactive site Site Status Update Confirmation Sent following the site status update confirmation transaction Site Resupply Status Update Confirmation Sent following the site resupply status update confirmation transaction Site Supply Strategy Update Confirmation Sent following the site supply strategy update confirmation transaction Site Screening Status Update Confirmation Sent following the opening closing of the site s screening status Site R
37. t s Date of Birth TMP PM 053 Rev 5 Controlled Document Copyright O Bracket Page 9 of 38 RTSM v0 4 Confidential Bracket Roche GO29058 RTSM Site User Instruction Manual 4 3 IWRS Randomization To record a Randomization Visit 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 system home page 4 Click Randomization from the Investigator Site tab 5 Select the Screening Number from the drop down menu and click Next to continue ROCHE Welcome u u LOG OFF n GO29058 Bracket REPORTS Screening Lost or Damaged Medication Patient Companion Diagnostics Randomization Blinded Acknowledgement of Receipt Medication Assignment Visit Lost or Damaged Medication Open Quarantine Medication Label Create Patient Update Request Unscheduled Medication Assignment Visit Treatment Discontinuation Screen Failure Rescreening Investigstor Site gt Randomizstion RANDOMIZATION Site ID 111179 Patient Identification Please select the Patient Number and then click Next to continue Screening Number select one v 2015 Bracket CONTACTUS SUPPORT 6 Confirm the following Patient Demographics and click Next to continue e Date or Year of Birth e Initials e Gender a If Patient s HistoGeneX Mutation Status is Invalid or Test Failed then Patient cannot be randomized and
38. tudy also includes a training system for the IWRS The training system Screening Randomization Medication Assignment Visit Unscheduled Medication Assignment Visit Treatment Discontinuation Lost or Damaged Medication Blinded Lost or Damaged Medication Open Label Create Patient Update Request Screen Failure Rescreening Patient Companion Diagnostics Acknowledgement of Receipt Quarantine Medication Unblinding Authorized Site Unblinders Only provides users the opportunity to practice each of the above transactions without saving any data 2 IWRS User Types The IWRS provides for four types of users 1 2 3 Site User User at a site who is authorized to access Screening Randomization Medication Assignment Visit Unscheduled Medication Assignment Visit Treatment Discontinuation Lost or Damaged Medication Blinded Lost or Damaged Medication Open Label Create Patient Update Request Screen Failure Rescreening Patient Companion Diagnostics Acknowledgement of Receipt and Quarantine Medication branches Site Unblinder User authorized to make unblinding transactions into the IWRS Unblinding transactions cannot be practiced in the training system Training User User is authorized to make practice transactions into the IWRS except Unblinding and Create Patient Update Request No data will be saved during these transactions TMP PM 053 Controlled Document Copyright O Bracket RTSM v0 4
39. ual 10 Frequently Asked Questions 1 What information do I need to reset my Password if it cannot be reset online e Protocol Study Name Site ID Primary Investigator Name if Site ID is not known Access Type Web User name 2 Where can I find a Data Change Form DCF e The DCF is located within the Bracket Study website under Help gt Documentation 3 How do I get a an addition copy of site manuals e Worksheets and site manuals are available in PDF format within the Bracket Study website under Help Documentation 4 I work at Site XXXXXX and need a user account How do I get one e Contact your Study Monitor or Sponsor who will initiate a request to create your access to the system 5 Iam a site level user and my account is Inactive How can my account be activated e Contact your Study Monitor or Sponsor and advise them that your account has been confirmed as Inactive They will initiate a request to activate your access to the system 6 How do I know when my Data Change Form DCF is completed e To be provided with that information on the DCF check the Box next to Please check here to regenerate the relevant notification s with this updated information You can also ask your Study Monitor to verify the data change on the study website 7 Iam a site level user how can I receive notifications e Contact your Study Monitor or Sponsor who will initiate a request to allow you receipt of email and or fax notifi
40. yright O Bracket Page 38 of 38 RTSM v0 4 Confidential
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