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?


The eCRF System

Works withany browser

Works on any PC/laptop

Reputation forsite friendlinessNothing stored

locally on thelaptop

On-lineWeb-based


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


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 [email protected]

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



Example 4: Out of range

Example 3: Future date



Example 5: Programmed queries


User generated queries

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


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


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 12649AeCRF study specific


The eCRF folder structure


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)


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

Calculated depending on end time of IMP administration

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


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

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


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.


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)

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”


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


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


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


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

1 US Investigator Meeting DIAS-4, Chicago, July 2011 Introduction to eCRF Study 12649A.

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Transcript of 1 US Investigator Meeting DIAS-4, Chicago, July 2011 Introduction to eCRF Study 12649A.