Introduction to eCRF Study 12649A

What should you expect from us? A user friendly system Timely supply of equipment The right amount of training, at the right time Support from a helpdesk in case of problems

The eCRF System On-line Web-based Works on any PC/laptop Works with any browser Reputation for site friendliness Nothing stored locally on the laptop

Supply of Equipment No demand to use a Lundbeck laptop Equipment provided on per need basis Supply through the company C3i Your CRA will unpack and install equipment – and collect it when the study is over So, please save the boxes it comes in! INTERNET

Training Performed on site by your CRA Mandatory in order to get access to the study eCRF! Takes a couple of hours

Helpdesk for System Functionality and Equipment Same provider as for equipment supply: C3i Japanese, Spanish, Italian, German, French, English spoken Helpdesk will not answer clinical questions You can always contact your CRA

Getting access to the eCRF If this is your first Lundbeck Rave study: Once SIV is completed, access will be requested by CRA You will receive an account activation email from noreply@mdsol.com Your CRA will guide you trough the activation process if needed

eCRF general introduction

Data entry

Edit data

Decimal value in the eCRF Decimal value is entered with « . » instead of a « , » E.g: Temperature=37.1…

Additional comments

Inactivate a Comment

Partial dates Unknown day = Unknown month

Unknown date Leave date blank and enter “unknown” when resolving query

System generated queries 1/3 Example 1: Missing data Example 2: Non-conformant data

System generated queries 2/3 Example 3: Future date Example 4: Out of range

System generated queries 3/3 Example 5: Programmed queries

User generated queries Queries can also be raised by eCRF users i.e. CRAs, Clinical Data Managers, Medical Monitors

How to resolve a query System Query User generated Query Query Comment field is only used when data is not updated! System Query Update data User generated Query Update data, if applicable Query comment field is always completed (if present)

Log line 1/4 Log line = Tabular forms where several records are listed on the same screen

Log line 2/4 Important to SAVE after each row

Add Log line 3/4

Inactivate Log line 4/4 The log-line cannot be deleted but inactivated

Dynamic Forms Available for data entry if a precondition is fulfilled.

Hidden fields The first page of each visit must always be completed before any other pages of that visit, since it might trigger some hidden fields to be visible. Date of visit is often a trigger point!

Study 12649A eCRF study specific

The eCRF folder structure

Calendar After follow-up (12-24 h) a visit calender is calculated, based on: The date of IMP administration (0h) The date of temperature assessment at follow-up (12-24h)

IMP Administration Maximum of 10 ml

Study specific log-lines Medical and Surgical history Adverse Event/Serious Adverse Event Concomitant non-drug therapy Concomitant medication

Medical and Surgical history Medical and Surgical History is predefined with 7 items. additional diagnosis

Dynamic forms in this study Adverse Event/Serious Adverse Event Asian Specification Categorisation of hemorrhagic events Concomitant medication Concomitant non drug therapies Informed re-consent Medical and Surgical History Pregnancy test Reason for withdrawal Screening failure

FORM folder

Informed Re-Consent page If another person has signed on behalf of the patient, a re-consent page should be signed by the patient before the end of the trial

Vital Signs page vs. Blood Pressure page Vital Signs page for baseline, Treatment (0h), Follow-up (72h), (7d or discharge), (30d), (90d or early withdrawal)

Vital Signs page vs. Blood Pressure page Blood Pressure page (Follow-up (0.5-9h) and (12-24h) ) Calculated depending on end time of IMP administration

Adverse Event (AE) For all Adverse Events, two forms should be filled out: - Adverse Event/Serious Adverse Event - Categorisation of hemorrhagic events

For all AEs, two forms to fill out Form 1: Adverse Event/ Serious Adverse Event Form 2: Categorisation of adverse event * If not a hemorrhagic event, choose « Other » * recent change, training database not updated

Unscheduled folder Imaging Information NIHSS UNSCHEDULED NIHSS may be performed to access a change in the patient’s neurological status. Imaging Information If Imaging is done before 12h after IMP administration the imaging information should be reported in the UNSCHEDULED folder

Discharge folder The Discharge folder only need to be entered if the patient is discharged between visits (and which is outside visit window)

Discharge visit (7 days) If patient is discharged before or at the follow-up (7d or discharged) the following remaining visits should be performed: Follow-up (7d or discharged) Follow-up (Day 30) Follow-up (Day 90/ early withdrawal) Type of visit ”Discharge visit” Type of visit ”Patient discharged previously” Type of visit ”Patient discharged previously”

Discharge visit folder If the patient is discharged e.g. day 41 between visit « follow-up Day30 » and « follow-up Day90 » Follow-up (7d or discharged) Follow-up (Day 30) Discharge visit folder Follow-up (Day 90/early withdrawal) Type of visit ”7 days follow-up (patient is still hospitalized since day of IMP administration)” Type of visit ”30 days follow-up (patient is still hospitalized since day of IMP administration)” Pages in Discharge folder needs be entered Type of visit ”Patient discharged previously”

Screening failure The following pages should at minimum be filled out: Informed Consent Date of Visit Demographics Inclusion and exclusion criteria Screening failure yes/no Reason for screening failure

Early withdrawal If the patient withdraws from study the site will stop entering data for that visit and instead fill out all forms in the visit ‘‘Early Withdrawal’’

Screening failure or withdraw from study If a patient is a Screening failure or withdraw from the study, the visits not completed will be inactivated by Clinical Data Manager and will not appear in the folders anymore.

On line demo… https://lundbeck.mdsol.com

What do we expect from you? Available for training Data entry right after patient visit Regular attention to queries Share your experience with us

Any questions?

Now let’s practice CRAs will distribute mock patient data Please log on to the training site and enter data provided as if it was a real patient ASK QUESTIONS… you have all our undivided attention User login Password Role T12649 SC password1 Study Coordinator

Thank you for your attention and Participation