1 us investigator meeting dias-4, chicago, july 2011 introduction to ecrf study 12649a

1 US Investigator Meeting DIAS-4, Chicago, July 2011

Introduction to eCRFStudy 12649A

2US Investigator Meeting DIAS-4, Chicago July2011

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

What should you expect from us?

3US Investigator Meeting DIAS-4, Chicago July2011

The eCRF System

Works withany browser

Works on any PC/laptop

Reputation forsite friendlinessNothing stored

locally on thelaptop

On-lineWeb-based

4US Investigator Meeting DIAS-4, Chicago July2011

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!

INTERNETINTERNET

5US Investigator Meeting DIAS-4, Chicago July2011

Training

Performed on site by your CRA

Mandatory in order to get access to the study eCRF!

Takes a couple of hours

6US Investigator Meeting DIAS-4, Chicago July2011

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

7US Investigator Meeting DIAS-4, Chicago July2011

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

8US Investigator Meeting DIAS-4, Chicago July2011

eCRF general introduction

9US Investigator Meeting DIAS-4, Chicago July2011

Data entry

10US Investigator Meeting DIAS-4, Chicago July2011

Edit data

11US Investigator Meeting DIAS-4, Chicago July2011

Decimal value in the eCRF

Decimal value is entered with« . » instead of a « , »

E.g: Temperature=37.1…

12US Investigator Meeting DIAS-4, Chicago July2011

Additional comments

13US Investigator Meeting DIAS-4, Chicago July2011

Inactivate a Comment

14US Investigator Meeting DIAS-4, Chicago July2011

Partial dates

Unknown day

= Unknown month

15US Investigator Meeting DIAS-4, Chicago July2011

Unknown date

Leave date blank and enter “unknown” when resolving query

16US Investigator Meeting DIAS-4, Chicago July2011

System generated queries 1/3

Example 1: Missing data

Example 2: Non-conformant data

17US Investigator Meeting DIAS-4, Chicago July2011

System generated queries 2/3

Example 4: Out of range

Example 3: Future date

18US Investigator Meeting DIAS-4, Chicago July2011

System generated queries 3/3

Example 5: Programmed queries

19US Investigator Meeting DIAS-4, Chicago July2011

User generated queries

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

20US Investigator Meeting DIAS-4, Chicago July2011

System Query

User generated Query

Update data

Query Comment field is only used when data is not updated!

Query comment field is always completed (if present)

How to resolve a query

Update data, if applicable

21US Investigator Meeting DIAS-4, Chicago July2011

Log line 1/4

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

22US Investigator Meeting DIAS-4, Chicago July2011

Log line 2/4

Important to SAVE after each row

23US Investigator Meeting DIAS-4, Chicago July2011

Add Log line 3/4

24US Investigator Meeting DIAS-4, Chicago July2011

Inactivate Log line 4/4

The log-line cannot be deleted but inactivated

25US Investigator Meeting DIAS-4, Chicago July2011

Dynamic Forms

Available for data entry if a precondition is fulfilled.

26US Investigator Meeting DIAS-4, Chicago July2011

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!

27US Investigator Meeting DIAS-4, Chicago July2011

Study 12649AeCRF study specific

28US Investigator Meeting DIAS-4, Chicago July2011

The eCRF folder structure

29US Investigator Meeting DIAS-4, Chicago July2011

Calendar

After follow-up (12-24 h) a visit calender is calculated, based on:1. The date of IMP administration (0h)2. The date of temperature assessment at follow-up (12-24h)

30US Investigator Meeting DIAS-4, Chicago July2011

IMP Administration

Maximum of 10 ml

31US Investigator Meeting DIAS-4, Chicago July2011

Study specific log-lines

• Medical and Surgical history• Adverse Event/Serious Adverse Event• Concomitant non-drug therapy• Concomitant medication

32US Investigator Meeting DIAS-4, Chicago July2011

Medical and Surgical history

Medical and Surgical History is predefined with 7 items.

additional diagnosis

33US Investigator Meeting DIAS-4, Chicago July2011

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

34US Investigator Meeting DIAS-4, Chicago July2011

FORM folder

35US Investigator Meeting DIAS-4, Chicago July2011

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

36US Investigator Meeting DIAS-4, Chicago July2011

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)

37US Investigator Meeting DIAS-4, Chicago July2011

Vital Signs page vs. Blood Pressure page

Calculated depending on end time of IMP administration

Blood Pressure page (Follow-up (0.5-9h) and (12-24h) )

38US Investigator Meeting DIAS-4, Chicago July2011

Adverse Event (AE)

For all Adverse Events, two forms should be filled out:

- Adverse Event/Serious Adverse Event

- Categorisation of hemorrhagic events

39US Investigator Meeting DIAS-4, Chicago July2011

For all AEs, two forms to fill out

If not a hemorrhagic event, choose « Other »

Form 1: Adverse Event/Serious Adverse Event

Form 2: Categorisation of adverse event *

* recent change, training database not updated

40US Investigator Meeting DIAS-4, Chicago July2011

Unscheduled folder

Imaging Information

If Imaging is done before 12h after IMP administration the imaging information should be reported in the UNSCHEDULED folder

NIHSS

UNSCHEDULED NIHSS may be performed to access a change in the patient’s neurological status.

41US Investigator Meeting DIAS-4, Chicago July2011

Discharge folder

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

42US Investigator Meeting DIAS-4, Chicago July2011

Discharge visit (7 days)

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”

If patient is discharged before or at the follow-up (7d or discharged) the following remaining visits should be performed:

43US Investigator Meeting DIAS-4, Chicago July2011

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)”

Type of visit ”Patient discharged previously”

Pages in Discharge folder needs be entered

44US Investigator Meeting DIAS-4, Chicago July2011

Screening failure

The following pages should at minimumbe filled out:

- Informed Consent- Date of Visit- Demographics- Inclusion and exclusion criteria- Screening failure yes/no- Reason for screening failure

45US Investigator Meeting DIAS-4, Chicago July2011

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’’

46US Investigator Meeting DIAS-4, Chicago July2011

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.

47US Investigator Meeting DIAS-4, Chicago July2011

On line demo…

https://lundbeck.mdsol.com

48US Investigator Meeting DIAS-4, Chicago July2011

What do we expect from you?

Available for training

Data entry right after patient visit

Regular attention to queries

Share your experience with us

49US Investigator Meeting DIAS-4, Chicago July2011

Any questions?

50US Investigator Meeting DIAS-4, Chicago July2011

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

51US Investigator Meeting DIAS-4, Chicago July2011

Thank you for your attention

and

Participation