1. Introduction to eCRF Study 12649A

2. 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

3. 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

4. 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

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

6. 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

7. 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 from
Your CRA will guide you trough the activation process if needed

8. eCRF general introduction

9. Data entry

10. Edit data

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

12. Additional comments

13. Inactivate a Comment

14. Partial dates
Unknown day
= Unknown month

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

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

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

18. System generated queries 3/3
Example 5: Programmed queries

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

20. 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)

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

22. Log line /4
Important to SAVE after each row

23. Add Log line 3/4

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

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

26. 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!

27. Study 12649A
eCRF study specific

28. The eCRF folder structure

29. 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)

30. IMP Administration
Maximum of 10 ml

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

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

33. 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

34. FORM folder

35. 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

36. 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)

37. 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

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

39. 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

40. 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

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

42. 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”

43. 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”

44. 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

45. 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’’

46. 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.

47. On line demo…

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

49. Any questions?

50. 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

51. Thank you for your attention
and
Participation