eCRF Completion Guidelines – Version 2and EDC FAQs

eCCG Updates per Version 2 and FAQs

• New/Changed eCRFs per Protocol Version C• DVA/Lensometry at Baseline• Cycloplegic BCDVA/MR

• Ocular History• Randomization• Biometric Measurements• Dispensation and Accountability Logs and Med Use Adherence• Adverse Event Outcomes• Data Entry for Screen Failed Subjects• Data Entry for Early Termination• “Hidden” Data Fields

New BL Distance Visual Acuity/Lensometry CRF per Protocol Version C

• This new eCRF now appears in the Baseline Visit.

• It should be present for all subjects enrolled under Protocol Version C (approved 19 Sept 2019) but may or may not be present for those enrolled under B.

Cycloplegic BCDVA/MR – an Optional eCRF per Protocol Version C

• Cycloplegic BCDVA/MR is now optional.

• eCRF is available at each visit in Ocular Exams – check box if done, leave blank if not done.

History Conditions and Associated Medications

• If a medication is taken for an existing condition, that condition must be recorded on a History eCRF first so it can then appear to be linked on the Con Meds form.

Conditions Under Study

• Please do not record “Myopia” or “Astigmatism” on Ocular History

Which eCRFs must be completed to Enable Randomization?

• Screening Visit must be entered in its entirety first, so that Eyenovia may verify subject eligibility.

• The following eCRFs must be completed with appropriate responses in the Baseline Visit to enable the Randomization eCRF to appear:• Visit Date• Inclusion/Exclusion Summary• Demonstration of Proficiency• Medication Use Adherence

Randomization Time in RAVE is displayed in UTC (GMT)

Randomization Time appears in UTC = GMT

EST = GMT-4 hrsCST = GMT-5 hrsMST = GMT-6 hrsPST = GMT-7 hrs

This may also affect the Randomization Date, depending on your time zone

Biometric Measurements eCRF

K1 = Horizontal (steep meridian)

Mean Corneal Radius -Use K2 (vertical) axis

K2 = Vertical (flat meridian)

EDC FAQs – Biometrics eCRF

If time is unknown, enter UN:UN

If assessment was Not Done or Unknown, enter “ND”

Two decimal places for measurements in mm or Diopters, whole number for degrees.

EDC FAQs – Biometrics eCRF• This page contains several “range” edit checks

• These are checks to confirm that values are entered correctly (no typos)

• If the value entered is correct, simply reply to the query “value confirmed”.

Measurement Lower Range Upper Range Unit

Mean Axial Length 21.00 28.00 mm

Mean Corneal Radius - Ks 42.00 55.00 Diopters

Mean Corneal Radius Axis 0 180 degrees

Mean Lens Thickness 3.20 3.60 mm

Mean Anterior Chamber Depth 3.00 4.20 mm

When do I use Re-dispensing vs. Unscheduled Dispensing?

• If a new kit is dispensed at the same visit, “Do you wish to redispense items at this visit?” should be checked YES on the Dispensation eCRF at that visit.

• If a new kit is dispensed on a different day, an Unscheduled Visit eCRF should be entered and “Study Drug Dispensation” checked to enable the Dispensation eCRF.• An Unscheduled visit eCRF must be entered to enable

payment for an Unscheduled dispensation

Study Drug Accountability Logs – Treatment Kit

• Located in the “PSAL” folder and used to track Study Medication Packers.

• The Treatment Kit Accountability Log is partially pre-populated by the RTSM dispensing system. Return information needs to be entered.

• Auto queries will generate for Return info as soon as the product is dispensed. Please leave these queries “Open” until the product is returned.

• If Item Condition is “Damaged” or Status is “Lost” please provide information in the Comments field.

Study Drug Accountability Logs – Base Unit & Welcome Kit

• Located in the “PSAL” folder and used to track Bases and Welcome Kits.

• All fields need to be completed by the site.

• Select the Item Type - Welcome Cartridge or MiDD Base Unit and complete the relevant fields which generate.

• Auto queries will generate for Return info as soon as the log is entered. Please leave these queries “Open” until the product is returned.

• Upon return, If Item Condition is “Damaged” or “Deficient” , please enter relevant details in the Comments section.

Medication Use Adherence eCRF• A running log of the subject’s

medication usage.

• All dispensation visit eCRFs (that is, all scheduled visits except M1) include fields for First and Last Dose from the Kit Returned at that Visit. The dates should follow from the previous dispensation.

• Unscheduled Visit: If a kit was returnedat an unscheduled visit, we’d expect this form to be completed and a first and last dose recorded. Then the dates would pick up again at the next scheduled visit.

Visit Med Used Since Last Visit? Date of First Dose from Kit Date of Last Dose from Kit

Baseline / Day 1 - 1 AUG 2019 Yes 15 JUL 2019 31 JUL 2019

Month 1 - 26 AUG 2019 Yes N/A N/A

Month 6 - 3 FEB 2020 Yes 01 AUG 2019 2 FEB 2020

Dispensation Notification Emails for Medidata

• Note that the “Visit” referenced in the email refers to the last scheduleddispensing visit

• If drug is dispensed at an Unscheduled Visit, the “Visit” in the email will still reference the previous scheduled dispensing visit.

AE Outcomes

• Fatal

• Not Recovered/Not Resolved

• Recovered/Resolved

• Recovered/Resolved with Sequelae (Specify sequelae)

• Recovering/Resolving

• Unknown

Please note that an Outcome of “Unknown” means there is no longer any information concerning the AE and is typically only used for subjects who

have been Lost to Follow Up. For Ongoing AEs, please consider “Not Recovered/Not Resolved” or “Recovering/Resolving”.

eCRFs to Enter for Screen Failed Subjects - Screening

If a subject Screen Fails at the Screening Visit, please enter:

• Visit Date

• Demographics

• Inclusion/Exclusion Summary

• Inclusion/Exclusion

• eCRFs for any visit assessments conducted at the Screening Visit

• End of Study

• Adverse Events Summary

• Prior/Concomitant Medications Summary

eCRFs to Enter for Screen Failed Subjects - Baseline

If a subject Screen Fails at the Baseline Visit, please enter:

• Visit Date• eCRFs for any visit assessments conducted at the Baseline Visit• Inclusion/Exclusion Summary• Inclusion/Exclusion• End of Study• Adverse Events Summary• Prior/Concomitant Medications Summary

Please note the full Screening Visit should also be entered.

Early Termination Visit Assessments (In Clinic Visits)

• If termination is prior to the 12 Month Visit, complete the 48M safety assessments

• If termination is at or after the 12 Month Visit, complete the 48M safety and efficacy assessments

Early Termination Visit Data Entry

• Whether an Early Termination Visit occurs at a Scheduled Visit or an Unscheduled Visit, please enter “Yes” for “Was this visit an Early Termination Visit” on the corresponding visit date form.

• Any additional safety or efficacy assessments not present on a regular visit eCRF may be entered using an Unscheduled Visit with the same date.

Please do not record data on the 48M Visit eCRF if it’s not a 48M visit.

“Hidden” Data Fields in Rave

•When a “parent” field is deleted or changed in RAVE, the “child” or “dependent” field remains. It’s hidden from view but still recorded in the database. •This occurs when changes are made to the “parent” data but not all data in the “child” or “dependent” field is deleted.•Therefore, unwanted data can get “stuck” in the database

“Hidden” Data Fields in Rave: Example

Here is how the original CRF was completed, with Other checked, a Specify text entered, and a dependent field (“East Asian?”) completed:

“Hidden” Data Fields in Rave: Example

Here is the field which was updated by “unchecking” Other. However, the specify text and response to “East Asian?” are still in the database! They are simply hidden from view by this change.

Viewing & Removing “Hidden” Data Fields in Rave

To view and remove the “old” data, Race first needs to be changed back to Other by checking Other. This allows the dependent fields to re-appear:

Don’t

save

yet

Viewing & Removing “Hidden” Data Fields in Rave

Place your cursor in text fields to delete the old data:

Viewing & Removing “Hidden” Data Fields in Rave

For radio buttons, click the response to clear the old data:

Once all old

data are

cleared,

click “Save”

Viewing & Removing “Hidden” Data Fields in Rave

Go back to the original parent field, and again remove or change the response to match the correct response.

Click “Save”

Documentation of eCCG Version 2 Training

You will soon be receiving a PDF copy of the eCCGs and a training form via Docusign.

Please electronically sign the training form at your earliest convenience.

Thank you!