Boehringer-Ingelheim1230.14 POLO-AML-2

eResearchTechnology, Inc. (ERT)

Centralized Digital 12-Lead ECG Services

Toronto 23 February 2013

Investigator’s Meeting

ECG Recorded at

site

Transmitted to ERT for Analysis

Results reported to the site via My

Study Portal

The ECG Process

ECG to be checked by investigator for pathological results

General reminder

• When? • Screening visit

• Before start EACH infusion of Volasertib/ Placebo

• Just before the end of EACH infusion of Volasertib/ Placebo

• EOT visit

• Remind:• Before PK sampling or any blood sampling

• Recorded on ECG Machine delivered to your site by ERT

• Triplicate

• Checked locally immediately

Observations safety ECG

• ECG to be checked by investigator for pathological results• Report any relevant change as an AE • and possibly action taken related to study medication (please refer to protocol

section)

• Print outs are signed and dated, filed as SD

• Once transmitted: centralized evaluation done by ERT

ECG reading report from ERT will be available on webportal

• Objective is evaluate relation between PK‘s and ECG‘s• Record „exact“ time• Use the same watch for the ECG and the PK (use the ECG clock time to document

PK sampling time or make sure the watch used to document PK sampling time shows the same clock time as the ECG machine) to allow correlation of ECG and PK

Resting ECG Requirements

The subject has to be at rest in a supine position for at least 5 minutes

The subject should breathe normally

Please avoid talking to the subject during the relaxation phase

Subject should not be touched until the recording has finished

Any ambient noise should be kept to a minimum

Turn off any electrical devices which are not needed and which transforms electrical current

ERT MYSTUDYPORTAL website

Ordering re supply (more ECG paper/electrodes) OR call or email the helpdesk

View and or print ECG reports or tracings

Answering queries: site personnel receives email alerting to a query => logon to the portal to resolve the query

Two Web-Based training courses available to the sites (optional): Training certificate to be printedOne is patient preparation Second is the ELI 150 course

My Study Portal – access site staff

Actions on Equipment Arrival

Check contents on arrival• ELI 150 ECG machine• Power Cable, Patient Cable, Telephone Cable• Electrodes & ECG paper• Laminated Quick Reference Guides• Training CD

Plug machine in• Confirm date and time (Very Important) • Recommended to Power Cycle equipment

on a monthly basis

ERT recommends completing a test transmission

A test ECG will already be stored on each machine for this purpose

Sites should contact ERT customer care if

Your Site

This procedure allows ERT to confirm successful ECG transmission from your site, and to assist with any issues prior to first ECG capture

ERT

Test Transmission – to be performed at SIV

ERT recommends completing a test transmission

A test ECG will already be stored on each machine for this purpose

Sites should contact ERT customer care if there are any problems transmitting the test ECG

Customer Care

Your Primary Contact Point for ERT Questions

Machine Technical Support Result Inquiries Site Information Updates Transmission Problems Web Based Training Inquiries Dial the toll free number for your country and press option 1 for cardiac safety

assistance

Dedicated Toll-Free Phone and Fax Numbers World-wide

Available 24 hours a day, 7 days a week, 365 days a year

Multilingual Support

E-mail address: customercare@ert.com

Supplied Quick Guides

Copies of the ERT Guides and Manuals are posted on My Study Portal

Any modified versions will also be posted here

My Study Portal Quick Guides

1230.14

SUBJECT NUMBER: (000001)

DOB: (MM/DD/YYYY)

AGE: (99)

GENDER: (MALE/FEMALE)

PERIOD: Cycle 1

VISIT: V1

TIMEPOINT: ECG 1

Press F6 (DONE) key after last entry

Entering Patient Demographics

Press F1 (ID) key to enter patient demography

Check the LCD screen to ensure quality

Recording ECGs

Press AUTO key to record the ECG (one ECG at a time) triplicate ECG needed hit the auto key 3 times (interval of 2 to 3 minutes between each ECG, as per protocol).

Press F6 (DONE) key after printing

Recording ECGs

Review for

Quality &

Accuracy

ECG Print out

Standard tracing with 10 second Lead II strip• 2 copies of each ECG will print out• Z-Fold Heat Sensitive Paper• We recommend you take a photocopy for your permanent records or print a

copy from My Study Portal• Machine interpretation is given as a guide only• Assessment by the investigator must be done to determine if volasertib/

placebo can be administrated or not and if relevant AE

The unit will ask “Save ECG?” Press (F1) to Save Press (F3) to Delete

Save ECG?

Save

Delete

Saving ECGs

Plug the device into the phone line Press the XMT key (Transmit key) Press the (F1) key to Batch Transmit Transmit everyday

Transmitting ECGs

Sites are able to respond to active queries online using

My Study Portal

Access the “Electronic Query resolution” portlet

Click the pencil icon to access the query

Responding to ERT Queries – My Study Portal

The ECG Analysis Report will be provided to the investigator site via My Study Portal within 72 hours

This excludes weekends and holidays

ECG Results Reporting

My Study Portal ECG reports and waveforms

Site Supply Ordering

Sites can order study supplies online using My Study Portal

Click “Supply Ordering” in the Equipment and Supply Information portlet and click “New Order”

Enter the amount required and click “Continue”

To confirm the order click the checkbox, enter your login and password and click confirm order to submit the request to ERT

Site Info

Supplies

Quantity

•Confidential © Almac Group 2012