ISRCTN42955626
Confidential once completed
Please answer all the questions
eGFR-C Biological Variability Study
Laboratory Data Collection Form
(To be used for samples with Study Number starting Bxxxxx only)
Assessment visit (please tick)
20 patient study of intra-individual biological variability (Canterbury only)
iiLii Baseline
iiLii Week 2
iiLii Week 3
iiLii Week 4
Part A: Identifying Details
Study No.:
ii I ii I ii I ii
ii I ii
CRF completed by: (Please PRINT):
……………………………………..………………
Date of completion:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Patient’s DOB:
iMi Mi iMi / Yii iYii iYii iYii
Part B: Analysis Results
Code /
Colour
LSCr /
Yellow
Test
Result
Date
Serum
Creatinine
(mass
spectrometry)
ANALYSIS 1
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ii I ii I ii I i
.
i
(μmol/L):
LSCr /
Yellow
Serum
Creatinine
(mass
spectrometry)
ANALYSIS 2
ii I ii I ii I i
.
i
(μmol/L):
KSCy /
Yellow
Serum
Creatinine
(enzymatic)
ANALYSIS 1
ii I ii I ii I i
.
i
(μmol/L):
KSCy /
Yellow
Serum
Creatinine
(enzymatic)
ANALYSIS 2
ii I ii I ii I i
.
i
(μmol/L):
KSCy /
Yellow
KSCy /
Yellow
Cystatin C
(mg/L):
Cystatin C
(mg/L):
ANALYSIS 1
i I i .. ii I ii
ANALYSIS 2
i I i .. ii I ii
Please enter data online at https://www.trials.bham.ac.uk/egfrc or return form to: eGFR-C Office, Birmingham Clinical Trials Unit, College of
Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
eGFR-C – BVS Lab Data Collection Form
Page 1 of 5
Version 1.0 14th Feb 2014
ISRCTN42955626
KUACR
/Neutral
KUACR
/Neutral
Confidential once completed
Albumin
Creatinine
Ratio (ACR,
mg/mmol):
ANALYSIS 1
Albumin
Creatinine
Ratio (ACR,
mg/mmol):
ANALYSIS 2
ii I ii I ii I i
ii I ii I ii I i
.
i
.
Please answer all the questions
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
i
eGFR
The Chief Investigator will be notified if any of
the GFR estimates are <15 mL/min/1.73 m2.
eGFR (mL/min/1.73 m2):
MDRDcreatinine – ANALYSIS 1
I ii I ii I i
.
ii
MDRDcreatinine – ANALYSIS 2
I ii I ii I i
.
ii
CKD-EPIcreatinine – ANALYSIS 1
I ii I ii I i
.
ii
CKD-EPIcreatinine – ANALYSIS 2
I ii I ii I i
.
ii
CKD-EPIcystatin – ANALYSIS 1
I ii I ii I i
.
ii
CKD-EPIcystatin – ANALYSIS 2
I ii I ii I i
.
ii
CKD-EPIcystatin-creatinine – ANALYSIS 1
I ii I ii I i
.
ii
CKD-EPIcystatin-creatinine – ANALYSIS 2
I ii I ii I i
.
ii
mGFR (reference GFR measurement by iohexol)
Code
Sample time
Iohexol (mmol/L)
point (mins)
ANALYSIS 1
KIH5 /
Green
KIH5 /
Green
5
I ii I ii I i
.
ii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ANALYSIS 2
5
KIH120 120
I ii I ii I i
ANALYSIS 1
.
ii
Please enter data online at https://www.trials.bham.ac.uk/egfrc or return form to: eGFR-C Office, Birmingham Clinical Trials Unit, College of
Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
eGFR-C – BVS Lab Data Collection Form
Page 2 of 5
Version 1.0 14th Feb 2014
ISRCTN42955626
/ Green
Confidential once completed
I ii I ii I i
KIH120
120
/ Green
.
ii
KIH180
180
/ Green
I ii I ii I i
.
KIH240
240
/ Green
I ii I ii I i
.
ii
LIH5 /
Green
5
I ii I ii I i
.
LIH120
/ Green
I ii I ii I i
.
ii
LIH180
/ Green
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ANALYSIS 2
I ii I ii I i
.
ii
I ii I ii I i
.
ii
ANALYSIS 2
5
I ii I ii I i
.
ii
120
I ii I ii I i
.
ii
ANALYSIS 2
120
I ii I ii I i
.
ii
ANALYSIS 1
LIH180
/ Green
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ii
ANALYSIS 1
LIH120
/ Green
Date of Analysis:
ANALYSIS 2
ANALYSIS 1
LIH5 /
Green
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ii
ANALYSIS 1
KIH240
240
/ Green
Date Received:
ANALYSIS 2
ANALYSIS 1
KIH180
180
/ Green
Please answer all the questions
180
180
I ii I ii I i
.
ii
ANALYSIS 2
Please enter data online at https://www.trials.bham.ac.uk/egfrc or return form to: eGFR-C Office, Birmingham Clinical Trials Unit, College of
Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
eGFR-C – BVS Lab Data Collection Form
Page 3 of 5
Version 1.0 14th Feb 2014
ISRCTN42955626
Confidential once completed
I ii I ii I i
.
ii
ANALYSIS 1
LIH240
/ Green
LIH240
/ Green
I ii I ii I i
240
.
Please answer all the questions
ii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
ANALYSIS 2
240
I ii I ii I i
.
ii
KENT USE ONLY: GFR (mL/min/1.73 m2):
The Chief Investigator will be notified if the value is <15 mL/min/1.73 m2.
ANALYSIS 1
I ii I ii I i
.
ii
.
ii
ANALYSIS 2
I ii I ii I i
LONDON USE ONLY: GFR (mL/min/1.73 m2):
The Chief Investigator will be notified if the value is <15 mL/min/1.73 m2.
ANALYSIS 1
I ii I ii I i
.
ii
.
ii
ANALYSIS 2
I ii I ii I i
Part C: Biomarkers
Sample Code
Sample
KUBM /
Neutral (first
sample)
Urine:
KUBM /
Neutral
(second
Urine:
Date
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Please enter data online at https://www.trials.bham.ac.uk/egfrc or return form to: eGFR-C Office, Birmingham Clinical Trials Unit, College of
Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
eGFR-C – BVS Lab Data Collection Form
Page 4 of 5
Version 1.0 14th Feb 2014
ISRCTN42955626
Confidential once completed
sample)
LUBM /
Neutral
KPBM / Purple
LPBM / Purple
KSBM / Yellow
LSBM / Yellow
Urine:
Plasma:
Plasma:
Serum:
Serum:
Please answer all the questions
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Sample taken:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date Received:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Date of Analysis:
iDi iDi / Mi iMi iMi / Yii iYii iYii iYii
Thank you for completing the eGFR-C Laboratory Data Collection Form. Please enter data online:
eGFR-C Online Data Entry: https://www.trials.bham.ac.uk/egfrc (24hrs) or return to:
eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences,
Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT
Tel: 0121 415 9130 Fax: 0121 415 9135
eGFR-C Study Website: http://www.birmingham.ac.uk/egfrc
eGFR-C Study Mailbox: eGFR-C@trials.bham.ac.uk
Please enter data online at https://www.trials.bham.ac.uk/egfrc or return form to: eGFR-C Office, Birmingham Clinical Trials Unit, College of
Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
eGFR-C – BVS Lab Data Collection Form
Page 5 of 5
Version 1.0 14th Feb 2014