boehringer-ingelheim 1230.14 polo-aml-2 eresearchtechnology, inc. (ert) centralized digital 12-lead...
TRANSCRIPT
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: [email protected]
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