Table of Contents
Advertisement
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)
o
Age: 99
o
Timepoint: TE
o
3.0 Subject Identification Number
Each participant will be uniquely identified by an 8-digit number where the first six digits represent the site number, a
hyphen and the following four digits represent the number assigned to the participant. The example below
represents subject 0001 at site 001.
Enter the 8 digit participant identification number into the ECG machine under Subject ID.
4.0 Acquisition Timepoints
ECGs should be obtained at study specific timepoints as described in the current protocol as shown in this
section. Please note there are different BTR timepoints to be entered depending on if the participant if in a
food effect cohort or not.
4.1 Non-Food Effect Cohort
TPS-SM-72/ v: 1.1/ ed:30Nov2018
Example: 001-0001
Non-Food Effect Cohort
Visit
Description
Screening
Day -14 to -1
Baseline
C1D1 predose
C1D1 2 hr post
Baseline
dose
C1D15
Cycle 1
predose
C1D15 2 hr
Cycle 1
post dose
Cycle 3
C3D1 predose
Cycle 5
C5D1 predose
Cycle 7
C7D1 predose
Cycle 9
C9D1 predose
C11D1
Cycle 11
predose
ECG Acquisition Guide
BTR Timepoint
1
2
4
5
7
8
10
11
13
14
16
17
19
20
22
23
25
26
28
29
Page 6 of 17
3
6
9
12
15
18
21
24
27
30
TM-79602-01 / v: 1.0 / ed: 27Apr2022
Advertisement
Table of Contents
