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Inventory Management and Randomization Training
EYENOVIA, INC.
Study Number: EYN-MYO-AT-31
Study Name:
A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Atropine 0.1% and 0.01% Ophthalmic Solutions Administered with a Micro Dose Dispenser for the Reduction of Pediatric Myopia Progression
Date Originated: 28-May-2019
Last Revision: N/A
Version Number: Version 1.0
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Table of Contents 1. Revision History ............................................................................................................................... 3
2. Purpose ............................................................................................................................................... 3
3. Accessing RTSM .............................................................................................................................. 3
4. Receiving Inventory ......................................................................................................................... 3
5. Subject Randomization and Kit Assignments (Rave EDC) ................................................... 6
6. Unscheduled Kit Assignment (Rave EDC) .............................................................................. 14
7. IP Return for Depot Destruction ................................................................................................. 17
8. Subject Unmasking – PI User Role ............................................................................................ 18
9. IRT Help Desk Support .................................................................................................................. 20
IRT Training EYENOVIA, INC. Protocol: EYN-MYO-AT-31
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1. Revision History
Version Date Revised Revised By Section Changes
Version control will commence after the release of the initial finalized Inventory Management and Randomization Training. 2. Purpose The Inventory and Randomization functionality within the study website will be utilized for subject randomization, Kit assignments, and if needed, emergency unmasking. This training guide has been developed to familiarize site users with the Rave RTSM database. The process of Subject randomization, inventory receipt and kit assignments will be covered in detail, so site users feel comfortable entering and retrieving information on the EYN-MYO-AT-31 study website. 3. Accessing RTSM You will receive access within Medidata to Rave RTSM for the EYN-MYO-AT-31 study. Access Medidata via https://login.imedidata.com/login and select the Rave RTSM once you are logged in.
4. Receiving Inventory IP shipments will be shipped to your site by Catalent Pharma Solutions. Each shipment needs to be acknowledged as received within the study database upon receipt. Only Kits received and placed in an ‘Available’ status will be available for subject assignment. To acknowledge an Inventory shipment within the study website, access the Inventory area within Rave RTSM. Navigate to the Management Shipments tab and select the appropriate Shipment ID from the list of available shipments under the Name (number) column.
Confirm Packer #s received, and report any/all damaged or missing items by
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unchecking them from the confirmation page. • If Damaged, record the reason the Packer Kit #(s) are Damaged.
Enter the quantity received for the Welcome and/or Resupply Kits.
Click ‘Confirm’ once you have confirmed the data entered is correct. If items are OUT OF TEMPERATURE RANGE: To check if shipment temperature was in required range, please check the shipment temperature device first prior to confirming receipt of the shipment in Rave RTSM. Access the Inventory area within Rave RTSM. Navigate to the Management Shipments tab and select the appropriate Shipment ID from the list of available shipments under the Name (number) column.
Click the ‘Quarantine’ button. Confirm item(s) received as QUARANTINED in the shipment are selected.
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Enter the reason the item(s) are quarantined, confirm Total Items to Quarantine and select the ‘Quarantine’ button.
A quarantine notification will be generated if any or all the kits are quarantined by the
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site. Quarantined Kits may not be assigned until notification of release has been received. 5. Subject Randomization and Kit Assignments (Rave EDC) Once a subject is registered and met Inclusion/Exclusion at the Screening Visit, the Dispensation CRF will be available for completion (example view):
Within the Dispensation CRF at Screening, select Yes to ‘Do you want to dispense items at this visit’ and save.
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A Welcome Kit is Assigned.
If a replacement Welcome Kit is required, select the Replace Unnumbered Kit link within the Dispensation CRF at Screening.
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Select the Welcome Kit to be replaced, along with quantity of 1, and select the Replace button to receive a replacement Welcome Kit.
Once the required data entry has been completed for a subject, the Randomization CRF will be enabled at the Baseline/Day 1 Visit.
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If the Subject is eligible to randomize, select Yes to Do you wish to randomize this subject? After all required fields have been entered, and values entered confirmed to be correct, select Save. Once the subject is randomized, the Randomization Date, Randomization Time, Randomization Number and Subject Packer Kit # Dispensed will be displayed read-only on the Randomization CRF. Dispense the Packer Kit # assigned to the Subject.
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At the following Scheduled Visits, the Dispensation CRF will be enabled:
Month 6 Month 12 Month 18 Month 24 Month 30 Month 42 (post re-randomization visit at Month 36)
Select the Dispensation CRF link to be taken into the Form.
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Select Yes to Do you wish to dispense items at this visit and save.
Upon Save, the Packer Kit # and, depending on scheduled visit, resupply Kit will be dispensed.
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Month 6 example: Packer Kit # Assigned.
Month 12 example: Packer Kit and Resupply Kit #s Assigned.
If a Replacement Kit is needed for the subject, after the scheduled Kit Assignment and prior to the next scheduled Kit Assignment, select the Replace Numbered Kit within the applicable Randomization or Dispensation CRF.
Select the Damaged or Missing Kit(s) to replace and select Replace.
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The Kit replacement(s) will be displayed.
Once the required data entry has been completed for a subject, the Re-Randomization CRF will be enabled at the Month 36 Visit.
If the Subject is eligible to re-randomize, select Yes to Do you wish to randomize this
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subject? After all required fields have been entered, and values entered confirmed to be correct for the subject, select Save. Once the subject is randomized, the Randomization Date, Randomization Time, Randomization Number and Subject Packer Kit # Dispensed will be displayed on the Re-Randomization CRF. Dispense the Packer Kit # assigned to the subject.
6. Unscheduled Kit Assignment (Rave EDC)
If an unscheduled Kit assignment is required, access the Unscheduled Visit from Add Event on the Grid View.
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Select ‘Add’ to create a new Unscheduled Visit within the Unscheduled Visits folder.
Complete the Unscheduled Visit CRF checking ‘Study Drug Dispensation’ and save.
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Complete the Unscheduled Dispensation CRF.
Complete the CRF selecting ‘Yes’ to ‘Do you wish to dispense items at this visit and Save. The Kit(s) to be dispensed are displayed.
Note: The inventory type (Welcome Kit, Packer Kit, Resupply Kit) will match the last scheduled dispensation visit.
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7. IP Return for Depot Destruction Sites are responsible for documenting the material to be returned to Eyenovia by the monitor. Both used and unused Packer Kits returned to Eyenovia must be documented. To return used and unused packer kits, complete the following steps:
• Navigate to the Inventory section in Rave RTSM • Select the ‘By Item’ button
• Select the Packer Kit #s to be returned to Eyenovia. • Once all the Packer Kit #s to be returned have been selected, click ‘Mark for
Destruction’
• Click ‘Yes’ to Confirm Mark for Destruction
• Select ‘Create Destruction Shipment’
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• Verify the following: o Packer Kit Numbers are correct o Destination is correct o Tracking Info (optional)
• Click ‘Create Destruction Shipment’ o Note: If you need to make any changes (information displayed is not
correct), click the ‘Cancel’ button to cancel the destruction shipment and start the IP Return for Depot Destruction process over.
• Once the Return for Destruction shipment has been created, you will receive an email confirmation from iMedidata.
• All Return for Destruction shipments will be displayed in the Shipments section with a black flame signal next to them.
• The monitor will package and ship the material to Eyenovia.
8. Subject Unmasking – PI User Role
The site PI must consult with the study safety monitor for approval prior to unmasking. Once approval has been given for unmasking , the PI will complete the following steps in the Rave RTSM system:
• Log into https://login.imedidata.com/login • Access Rave RTSM • Access EYN-MYO-AT-31 • Navigate to “Subjects” tab • Select the Subject ID link for the Subject to be unmasked • Select ‘Unblind Subject’ button in the upper right-hand corner
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• Enter the Reason for Unblinding and click ‘Confirm’ button
Rave RTSM will display the subject randomized treatment (Sample screenshot).
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A notification will be sent to the Study Admin team notifying them of the emergency unmasking, and the subject will be discontinued. 9. IRT Help Desk Support If you have any questions regarding the IRT Functionality, please contact Rave RTSM Technical Support 24/7:
• Toll Free: #866-633-4328 • Email: [email protected]
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