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ECG Acquisition Guide for
Revolution Medicines RMC-6236-001
(BTR 79602)
Protocol RMC-6236-001
Phase 1/1b Multicenter Open-Label Study of RMC-6236 in Subjects with Advanced Solid Tumors
Harboring Specific Mutations in KRAS
Subjects will receive a triplicate 12-lead ECGs during Non-Food Effect Cohort and Food Effect Cohorts on
a Mortara ELI 150 machine.
Philips BioTel Research, 155 Corporate Woods, Suite 180,
Rochester, NY 14623 USA
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Related Manuals for Philips BioTel ELI 150
Summary of Contents for Philips BioTel ELI 150
- Page 1 Phase 1/1b Multicenter Open-Label Study of RMC-6236 in Subjects with Advanced Solid Tumors Harboring Specific Mutations in KRAS Subjects will receive a triplicate 12-lead ECGs during Non-Food Effect Cohort and Food Effect Cohorts on a Mortara ELI 150 machine. Philips BioTel Research, 155 Corporate Woods, Suite 180, Rochester, NY 14623 USA...
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Page 2: Table Of Contents
Table of Contents 1.0 EQUIPMENT RECEIPT ............................3 2.0 EQUIPMENT SET-UP ............................3 2.1 O ELI 150 ........................ 3 VERVIEW OF THE 2.1.1 Front and Side View ......................3 2.1.2 Rear View ........................4 2.1.3 Keyboard Overview ......................4 2.2 D ...................... -
Page 3: Equipment Receipt
The ELI 150c machine has been provided to your site for use in this study. Study protocol information has been pre-programmed into the unit(s) by Philips BioTel Research. You will receive your equipment and study supplies in one shipment. This will include your ELI 150c machine(s) and standard supplies such as electrodes, paper, razors, and prep pads. -
Page 4: Rear View
2.1.2 Rear View 2.1.3 Keyboard Overview TPS-SM-72/ v: 1.1/ ed:30Nov2018 ECG Acquisition Guide Page 4 of 17 TM-79602-01 / v: 1.0 / ed: 27Apr2022... -
Page 5: Date And Time Verification
2.2 Date and Time Verification Verify the date and time for all equipment received from Philips BioTel Research and ensure the times match the dosing clock exactly. BTR will contact each site when there is an international change in time such as Daylight Savings Time. -
Page 6: Subject Identification Number
Test 2 (Recommended) • Record a TEST ECG on a human volunteer and transmit to Philips BioTel Research (refer to section 7.2) • The demographics for the human test should be: Subject ID: SSS-9999 (use your site number for SSS) -
Page 7: Food Effect Cohort
C13D1 Cycle 13 predose C15D1 Cycle 15 predose C17D1 Cycle 17 predose C19D1 Cycle 19 predose C21D1 Cycle 21 predose C23D1 Cycle 23 predose C25D1 Cycle 25 predose C27D1 Cycle 27 predose C29D1 Cycle 29 predose Within 30 days of last dose Unscheduled 4.2 Food Effect Cohort... -
Page 8: Subject Preparation
C11D1 Cycle 11 predose C13D1 Cycle 13 predose C15D1 Cycle 15 predose C17D1 Cycle 17 predose C19D1 Cycle 19 predose C21D1 Cycle 21 predose C23D1 Cycle 23 predose C25D1 Cycle 25 predose C27D1 Cycle 27 predose C29D1 Cycle 29 predose Within 30 days of last dose... -
Page 9: Electrode Placement
5.2 Electrode Placement Proper electrode placement is crucial to obtaining a good quality ECG. Standard 12-Lead Electrode Placement 5.2.1 Quality Checks After positioning the leads, the waveform and lead quality checks must be performed. Failure to check the quality of the waveforms or leads may result in loss of data. Review 12-Leads •... -
Page 10: Entering Subject Demographics On The Eli 150 Machine
Look for Notifications • Examine the display for any notification messages Leads Off – displays when subject is not connected Lead Fault – displays faulty leads (re-prep and replace electrodes as needed to improve recording quality) Electrode Wrong Position – displays an error message when a lead is connected incorrectly or is in the wrong location (e.g. -
Page 11: Ecg Acquisition And Submission
7.0 ECG Acquisition and Submission 7.1 Acquiring the ECG on Local Equipment • Press the ECG button on the ECG equipment or on the AM12 module to acquire an ECG The real time view will change to the acquired ECG view A hardcopy ECG automatically prints out •... -
Page 12: Ecg Transmission
The analog method of ECG transmission uses an analog telephone line to transmit ECG data from your provided ECG machine to Philips BioTel Research. To transmit ECGs using this method, you must use the analog telephone line the site identified on the Site Information Form. Generally, most fax lines use analog technology and a common best practice is to use a fax line on-site to transmit ECG data. -
Page 13: Usb Transmission
After logging in to CardioPortal locate the ELI LINK in the dashboard and proceed to upload the .uni files. 7.2.4 Courier Please contact Customer Support (see Appendix 1) if an ECG record needs to be sent to Philips BioTel Research by courier. TPS-SM-72/ v: 1.1/ ed:30Nov2018... -
Page 14: Site Queries And Data Notifications
Queries will be sent to your site via email within 5 business days of receipt at Philips BioTel Research. We will follow-up with your site once a week until the queries are resolved. If your site is unresponsive or the issue has not been resolved after three follow-up attempts, approximately 21 days, the issue will then be escalated to the Sponsor study team for further direction. -
Page 15: Appendix 1: Contact Information
Appendix 1: Contact Information Philips BioTel Research provides full Cardiac Safety services and is pleased to have the opportunity to work closely with you, to help ensure the success of this study. We have provided the call-in and direct email contact list to meet all your needs. -
Page 16: Email Contact List
Email Contact List Email lists are available depending on the inquiry or form you are submitting to Philips BioTel Research. Please reference the list below: Email Contact Action ECG@gobio.com Send .uni file via USB drive for ECG processing BTRreturns@gobio.com Study close out questions, replace shipping box, or return label shipments@gobio.com... -
Page 17: Appendix 2: Study Close Out Procedures
At the end of the study, please gather all the study supplies. • Dispose of all open study materials as per your clinic’s policy and/or procedures. • Unused razors, prep pads, and electrodes should be returned to Philips BioTel Research along with the equipment.