RIVRS User Manual Version: 1.0 Page 1 of 18
Table of Contents General Information: 3 Accessing the IxRS 4 IVRS - Call the telephone number for your country 4 IWRS - Go to https://www.wwctrials.net/bmsiwrs 4 First time access to the IxRS 5 Demonstration System 6 Frequently Asked s 6 Menu Options 8 Visit Registration Information 9 Screening 9 Enrolment 9 Randomization Day 1 10 Non-Visit Registrations 12 Site Drug Management - Confirm Receipt of a Shipment 12 Site Drug Management - Report Damaged or Missing Drug 12 Site Drug Management - Obtain a Replacement Container 12 Order Non-Drug Supplies 12 Demographic Data Change 13 3rd Party Data Entry 13 Emergency Unblinding: 13 Change Password/PIN 14 Notification Request 14 IVRS Help Desk: 14 Step-by-step Instructions 16 IVRS Worksheets 17 Revision Log 18 Version: 1.0 Page 2 of 18
General Information: System Access Contact your monitor for questions about the specific user roles for a study. o Primary Investigator at Site: Access to all system options o *Please note that the IVRS does not have a Sub-Investigator or Coordinator User Type. Sub-Investigators and Coordinators will be added as Investigator (INV) Users. o Pharmacist: Access to Site Drug Management, Change Password, Notification Request and Transfer to System Support All successful calls will generate a confirmation document, which will be faxed or emailed to you, depending on your preference, upon completion of the call. If you did not receive a confirmation document, please phone the helpdesk to obtain a duplicate copy of your confirmation document or request a notification for a visit to be re-sent by IVRS option 13 or via the IWRS Main Menu. The System is available 24 hours/day, 7 days/week. System support is also available 24 hours/day, 7 days/week. Complete corresponding Worksheet before logging into the IVRS System. Please note that for most inputs required by the user, only 3 attempts are allowed. The date format is DDMMYYYY After each question within the IVRS, the user is asked to confirm their entry. 1=Yes, 2=No. While in the telephone system, you may do the following actions at any time: o Press the pound or hash (#) key to return to the main menu o Press the star (*) key to return to the previous question o Press zero to be connected to an IVRS System Support representative at any time Version: 1.0 Page 3 of 18
Accessing the IxRS Once BMS has activated your User ID in IVRS, the User ID and PIN document will be forwarded to your site. IVRS - Call the telephone number for your country Country Toll Free/Free Phone Number Country Toll Free/Free Phone Number Argentina 08002221539 Japan (KDD Provider) 00531440244 Australia 1800048365 Japan (NTT Provider) Requested Austria 0800296824 Korea 007984427853 Belgium 080081086 Mexico 018001233449 Brazil 08007611123 Netherlands 08000234312 Canada 18773924114 New Zealand 0800 632304 Chile 800201762 Norway 80014138 Colombia Requested Poland 080054676 Czech Republic 800143871 Puerto Rico 008004421220 Denmark 80883118 Russia 81080025261044 Finland 0800918424 South Africa 0800983711 France 0800904792 Spain 900813011 Germany 08001821158 Sweden 020796071 Greece 0080044149039 Singapore 8004481753 Hong Kong 800905587 Switzerland 0800837094 Hungary 0680019498 Taiwan 00801444442 India 0008004401945 UK 08000286030 Ireland 1800812921 USA 18668093924 Italy 800874717 In the event of a problem with the above numbers, please use the direct number: +44 (0)115 9051240 IWRS - Go to https://www.wwctrials.net/bmsiwrs Use one of the following browsers: Mozilla Firefox; Google Chrome; Internet Explorer; Safari You must also have Cookies and JavaScript enabled. If you experience technical difficulties with this, please contact your local IT Support department. After a period of 5 minutes of inactivity, the IWRS will temporarily lock. Version: 1.0 Page 4 of 18
First time access to the IxRS Before calling IVRS, please have your User ID number and Personal Identification Number (PIN) readily available. The first time you access the system, you must change your PIN to a number that is more personal to you. This number must be 6 digits. You will be asked to select your preferred language upon your first call into the system. Language Options English 01 Greek 13 Ukrainian 25 European Spanish 02 Turkish 14 Canadian French 26 European French 03 Russian 15 Cantonese 27 German 04 Brazilian Portuguese 16 Estonian 28 European Portuguese 05 South American Spanish 17 Flemish 29 Italian 06 Romanian 18 Croatian 30 Dutch 07 Hungarian 19 Hebrew 31 Danish 08 Norwegian 20 Lithuanian 32 Finnish 09 Mandarin Chinese 21 Latvian 33 Swedish 10 Japanese 22 Slovak 34 Polish 11 Thai 23 Slovenian 35 Czech 12 Korean 24 Do not share your User ID with anybody. Please contact your Site Manager if you need to receive an additional User ID and PIN for your site. The System will prompt you to change your PIN every 90 days. Keep your PIN in a safe place! Version: 1.0 Page 5 of 18
Demonstration System The demonstration mode is available for both IVRS and IWRS. Site staff personnel who are provided with User ID and PIN may have access to the IxRS demo system at any time. To access the demonstration mode for IWRS, the user should enter their User ID and the password should be 000000 As a suggestion, the user may wish to test their connectivity to the IWRS, prior to their anticipated use of the system, by using Demonstration Mode. This should highlight any potential firewall issues. By using Password 000000, you will not make any changes to the Live System Select a language - see list of options (IWRS is English only). You only need to do this the first time that you call. Change your Password - select a new 6 digit Password (you only need to do this the first time that you call or if your Password has expired) During practice sessions, no data is stored and no treatment information will be provided. PLEASE BE CAREFUL TO USE THE PASSWORD 000000 IF YOU ARE PRACTICING! Frequently Asked s How can I contact system support? If you are experiencing urgent problems using the IxRS and you require immediate assistance you can contact the 24-hour system support by selecting option 14 from the IVRS Main Menu. A translation service is available, if required. If you are having difficulty reaching system support or are using the IWRS, you can call directly on +44 (0)7968 989 063. For non-urgent and general enquiries please contact the IRT Support Team by completing the IxRS Helpdesk - Assistance Form located at www.worldwide.com/ixrshelpdesk. The IxRS Helpdesk webpage offers IWRS links, User Guides, helpful tips, and standard forms. The system says my password is not valid If this is not the first time that you have accessed the IxRS, remember that you changed your password on first access. If you cannot find your new password call system support on +44 (0)7968 989 063 or complete an IxRS Helpdesk Assistance Form located at www.worldwide.com/ixrshelpdesk I have not received a confirmation notification for a call I made to the system You can request a notification for a visit to be re-sent by IVRS option 13 or via the IWRS Main Menu. For any other notifications, contact the 24-hour system support if Version: 1.0 Page 6 of 18
urgent. For non-urgent enquiries please contact the IRT Support Team by completing the IxRS Helpdesk - Assistance Form located at www.worldwide.com or contact your Site Manager or monitor. How do I get access to the IxRS? Your site manager or monitor will inform you whether the telephone (IVRS) and/or web (IWRS) system is available for your study. You will be provided with an IVRS Registration document containing your User ID Number and your Password (for use with IVRS or IWRS). I do not see any options offered in the main menu? This may be due to an incorrect role assignment. System Support can confirm your role assignment, but cannot correct it. If you have an incorrect study role in the IVRS, please notify your BMS site manager to request to have your study role corrected. What do I do if my site has not been activated in the System? System Support can confirm if your site is or is not activated, but cannot change your site status. If your site status needs to be activated, please notify your BMS site manager to activate your site in IVRS. I do not know which IVRS option (e.g. enrolment, randomization) to select? System Support or your BMS site manager can assist you with selecting the correct option in IVRS. What do I do if my subject was screen-failed or discontinued in error? Contact your BMS site manager to request a corrected subject status. I incorrectly entered the date of birth or gender for my subject. Select Option # 09. This option will allow you to correct a Date of Birth or Gender that may have been entered incorrectly at the Enrolment Visit. The System is not offering the visit I was expecting (for example, the randomization visit) or does not allow any visit at this time. The System may not allow a visit because of insufficient drug supply at your site, or because data from the central laboratory have not transferred. Please call System Support to help identify the issue. This delay may take up to one day to resolve, depending where your site is located. The System will not allow a visit because 3rd Party laboratory data are pending. There may be laboratory results that have not transferred from the central laboratory to the IVRS. Please contact your BMS site manager so the delay can be corrected. This delay may take up to one day to resolve, depending where your site is located. I receive an error message that there is insufficient drug to dispense to my subject, but there is sufficient drug in my pharmacy. One of your drug shipments may not be registered in IVRS. System Support or your BMS site manager can determine if you have unregistered drug shipments. Version: 1.0 Page 7 of 18
Menu Options The following options will be available for you from the Main Menu. Menu Option Number Menu Descriptions Sub Menu (Where applicable) 01 Screening Menu 02 Enrolment Menu 03 Randomization Menu 04 Subject Status Change Menu (Enrol Fail, Discontinue, Complete) 05 Subsequent Visit 06 Enter Subject into Alternate Study Phase 07 Site Drug Management 01 Confirm Receipt of a Shipment 02 Report Damaged/Missing Drug 03 Obtain a Replacement Container 04 Order Drug Supplies 08 Order Non-Drug Supplies 09 Demographic Data Modification (Change Date of Birth) 10 3rd Party Data Entry 11 Emergency Unblinding 12 Change Password 13 Additional Notification Request 14 Transfer to System Support HOT KEYS During your IVRS call, the following functions apply: # Return to Main Menu * Return to previous question 0 Contact System Support Version: 1.0 Page 8 of 18
Visit Registration Information Screening Select Option # 01 and follow the prompts for Enrollment (below). Enrolment Select Option # 02. You will be asked to enter the subject s gender and date of birth. You will be asked if informed consent has been obtained for this subject. You will be asked what method was used for identifying this subject for enrolling into this trial. You will be asked the method by which this subject was identified for enrollment. Press 1 if the subject was identified from within the department. Press 2 if the subject was identified from outside the department. If you press 1 for identified from within the department, you will be asked to select one of the following: Press 1 if identified through database or medical record search. Press 2 if identified through an in-hospital advertisement. Press 3 if identified through physician referral. If you press 2 for identified from outside the department, you will be asked to select one of the following: Press 1 if identified through website advertisement. Press 2 if identified through site advertisement. Press 3 if identified through physician referral. Press 4 if identified through journal advertisement. Press 5 if identified through pharmacy advertisement. Press 6 if identified through direct mail advertisement. Press 7 if identified through advocacy group or patient community. The system will assign a five digit the subject number and a confirmation document will be sent. Version: 1.0 Page 9 of 18
Randomization Day 1 Select Option # 03. You will be asked to enter the subject number and date of birth. You will be asked to verify that the subject meet eligibility criteria for Randomization? Press 1 for Yes Press 2 for No You will be asked to enter the subject s weight to the nearest whole kilogram (within range of 40-200 kg) followed by the pound or hash key. The system will randomize the subject, the system will announce treatment arm and dose and then assign container numbers and send a confirmation document. Subject Status Change - Enrolment Fail, Discontinuation, Completion, Select Option # 04. You will be asked to enter the subject number and the subject s date of birth. The system will offer a sub-menu to register: Enrolment Fail, Discontinuation (reason required), Completion, Report Date and Time of Transplant or Report a Switch in Treatment (type) based upon the subject s current status and the visits that have been registered in the IVRS. The system will provide a confirmation document upon successfully registering the Subject Status Change. Subsequent Visits Select Option # 05. You will be asked to enter the subject number and the date of birth. The system will retrieve the current treatment arm (either as assigned at the Randomization visit or the updated treatment arm if a treatment switch has been reported). Scheduled For C02 visit only, the system will prompt for Thymoglobulin dispensation need and dose (1mg/kg or 0.5mg/kg). For all visits you will be asked to enter the subject s weight to the nearest whole kilogram (within range of 40-200 kg) followed by the pound or hash key. If the weight has changed by +/- 10 %, this weight becomes the subject s new baseline weight and will be used for determining the current Belatacept and Thymoglobulin (if applicable) dose. Version: 1.0 Page 10 of 18
If the subject is being treated with Everolimus, the system will prompt for the number of packs of 0.75mg and 0.25mg required (Maximum number of 0.75mg packs = 4, maximum number of 0.25mg packs = 2) The system will announce the calculated dose of Belatacept and Thymoglobulin (if applicable) and then assign all container numbers and send a confirmation document Unscheduled If available for your study, this option may be used to dispense medication between scheduled visits. You may be asked for information such as weight, dose level, or other options. The system will then assign container numbers and send a confirmation document. Enter Subject into Alternate Study Phase Select Option # 06 Version: 1.0 Page 11 of 18
Non-Visit Registrations Site Drug Management - Confirm Receipt of a Shipment Select Option # 07, Sub-Menu Option # 01. You will be asked to enter the Drug Order Number and if all containers arrived in usable condition. If any containers are damaged, you will be prompted to enter those container numbers. If the shipment contains non-drug supplies, you will be asked to confirm that you have received all ancillary supplies according to the packing list After successfully acknowledging receipt of drug, container numbers will be made available for dispensing through the system and a confirmation document will be sent. If any container numbers were entered as damaged, a drug shipment will be requested to replace those containers and a confirmation document will be sent. Site Drug Management - Report Damaged or Missing Drug Select Option # 07, Sub-Menu Option # 02. This option is used to register container numbers as damaged or missing that have already been activated in the Acknowledge Receipt of Drug call, but not yet assigned to a subject. Upon successfully reporting damaged drug, a shipment of drug will be requested to replace those containers and a confirmation document will be sent. Site Drug Management - Obtain a Replacement Container Select Option # 07, Sub-Menu Option # 03. This option is used to register container numbers as damaged that have already been assigned to a subject. You will be asked to enter the subject number, date of birth, and the container number to be replaced. The system will assign a new container number to the subject and a confirmation document will be sent. Site Drug Management Order Drug Supplies If available for your study, this option will be used to order study medication for your site. If you need to order study drug using the IWRS in time to arrive at your site for dispensing, please keep in mind that the standard lead (shipping) time is up to 5 days, and may be longer depending on your location and the location of the nearest warehouse. Please contact your monitor for more specific information about lead time. Order Non-Drug Supplies Select Option # 08. If your study supplies non-drug supplies, such as filters, syringes, IV pumps, etc., this option is used to order these items. You will be asked to enter the quantity of the items required. Once confirmed, the system will send a confimation with the details of the order. Version: 1.0 Page 12 of 18
Demographic Data Change Select Option # 09. This option will allow you to correct a Date of Birth or Gender that may have been entered incorrectly at the Enrolment Visit. Date of Birth: Sub-Menu Option # 01. For Date of Birth you will be asked to enter the Subject Number, confirm the Original Date of Birth entered, and then enter the correct Date of Birth. Gender: Sub-Menu Option # 02. For Gender you will be asked to enter the Subject Number and then enter the correct Gender. A confirmation document will be generated and sent to your site upon successful registration of the demographic change. 3rd Party Data Entry Select Option #10 Emergency Unblinding: Select Option #11. This option can be used to unblind a subject in an emergency. The system will ask for the subject number and date of birth, then ask the following questions: It is recommended that situations that may require unblinding be discussed with the responsible medical monitor prior to breaking the blind. Breaking the blind mandates discontinuation of study drug for that subject. Do you wish to continue? (you must answer yes to continue) Has it been determined that breaking the blind for this subject is necessary to immediately manage the subject's condition? Has this potential unblinding been discussed with the BMS Medical Monitor? Breaking the blind for this subject will generate an alert to BMS indicating that the blind has been broken. Breaking the blind for this subject mandates discontinuation of study drug for this subject. Do you wish to continue? (you must answer yes to continue) You will be given one of three options, depending on how your study is designed. Follow the prompts for whichever option is presented to you. 1. Unblind by subject. The system will read out the dose or treatment currently assigned to the subject, then if applicable the system will read out the dose or treatment previously assigned to the subject. 2. Unblind by container. The system will ask for the container number. Note that the system will allow you to unblind a container given to a subject in error i.e. not assigned to the subject by the system. If the container you wish to unblind was assigned by the system to the subject you are unblinding, the system will read out the dose or treatment of the container. If the container you wish to unblind was Version: 1.0 Page 13 of 18
not assigned to the subject you are unblinding, the system will read out the dose or treatment of the container and the dose or treatment currently assigned to the subject. 3. Unblind by subject or container: If you opt to unblind by subject, the system will read out the dose or treatment currently assigned to the subject, then if applicable the system will read out the dose or treatment previously assigned to the subject. If you opt to unblind by container, the system will ask for the container number. Note that the system will allow you to unblind a container given to a subject in error i.e. not assigned to the subject by the system. If the container you wish to unblind was assigned by the system to the subject you are unblinding, the system will read out the dose or treatment of the container. If the container you wish to unblind was not assigned to the subject you are unblinding, the system will read out the dose or treatment of the container and the dose or treatment currently assigned to the subject. Change Password/PIN Select Option # 12. This option is used to update your password after it has expired. You will first enter your original PIN, you will then be asked to enter and confirm your new PIN. Notification Request Select Option # 13. Notification Request allows you to request a confirmation to be resent to your site. The system will ask for the subject number and date of birth, then create a menu of all visits registered for this subject and ask to select the confirmation to be resent. You will also be given the option to have all confirmations generated for this subject to be resent. The selected confirmation document(s) will be resent to you. Transfer to System Support Select Option #14. IVRS Help Desk: For any questions or problems, please call our toll-free System Support number at any time. Support is available 24 hours/day. The IxRS System Support can give you assistance with any IVRS-related issue, for example if you forgot your IVRS user ID or PIN. We cannot offer any advice on other parts of the protocol. Please refer to your site manager for any clinical queries. The most common questions addressed by System Support are in the Frequency Asked s Table on pages 6 and 7 of this manual. If you call the System Support, a member of IxRS staff will answer in English. If you prefer to speak in your own language, you just need to tell the IxRS Version: 1.0 Page 14 of 18
System Support representative, and we will arrange for a translator to join the telephone conversation. This takes about 1-2 minutes. Version: 1.0 Page 15 of 18
Step-by-step Instructions 1) Complete the IVRS Worksheet for the call you want to perform. (See Below) 2) Call the IVRS system with the number provided or log into the IWRS at the web address provided 3) System will prompt you to enter your UserID. ( Please enter your IVRS assigned UserID ) 4) System will prompt you for your PIN. 5) Main Menu will be played. 6) Select the appropriate option in the main menu and follow the instructions that are given to you by the system. Please Note: Do not enter the pound or hash (#) key after completing the entry of a subject s date of birth in the system, this will return you back to the main menu. Version: 1.0 Page 16 of 18
IVRS Worksheets The following are examples of the types of worksheets that are provided. Those that are relevant to your study will be given to you separately. IVRS Worksheets are available only if your study has IVRS. Please make a copy of the appropriate worksheet and complete it prior to making your call. Then save a copy of the worksheet for the study file. o Enrolment o Randomization o Subsequent Visits o Subject Status Change: Enrolment Fail, Discontinuation, Report Date and Time of Transplant, Report a Switch in Treatment o Demographic Data Modification o Order Non-Drug Supplies o Obtain Replacement Container Version: 1.0 Page 17 of 18
Revision Log Version Revision Date Page(s) Affected Description of Revision 1.0 11-Apr-2016 All Draft 1 of Generic User Guide, to be applicable to all RIVRS studies Version: 1.0 Page 18 of 18