Validation of a Computational Model to Estimate Patient Anterior-posterior Dimension From an Abdominal Radiograph
Conditions: Testing a Computational Model to Estimate Patient Size
Sponsor: NHS Tayside

 
 
Doc Ref_098_NCTIMP Protocol Template 
 
 
Version: 2.0 
 
 
Effective Date 28/01/2014  
 
 
 
 

Doc Ref_098_NCTIMP Protocol 
Version 2.0 
Effective Date 28/01/2014 
Study Protocol 
Validation of a computational model to estimate patient anterior-posterior dimension 
from an abdominal radiograph 
 
Study Acronym 
VocMepAdar 
Sponsor 
University of Dundee and NHS Tayside 
Sponsor R&D Number 
2017RA01 
Chief Investigator 
Principal Investigator 
Sarah Vinnicombe 
Mark Worrall 
 
REC Number 
237832 
Clinicaltrials.gov ID 
NCT03341546 
Version Number and Date 
1.1, 22nd December 2017 
 
 
 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
PROTOCOL APPROVAL .......................................................................................................... 3 
LIST OF ABBREVIATIONS ....................................................................................................... 4 
INTRODUCTION ....................................................................................................................... 5 
1.1 
BACKGROUND ............................................................................................... 5 
1.2 
RATIONALE FOR STUDY ............................................................................... 5 
2. 
STUDY OBJECTIVES ............................................................................................... 5 
2.1 
OBJECTIVEs ................................................................................................... 5 
2.1.1 
Primary Objective .................................................................................. 5 
2.1.2 
Secondary Objectives ............................................................................ 6 
2.2 
OUTCOMES .................................................................................................... 6 
2.2.1 
Primary Outcomes ................................................................................. 6 
2.2.2 
Secondary Outcomes ............................................................................ 6 
3. 
STUDY DESIGN ........................................................................................................ 6 
3.1 
STUDY DESCRIPTION ................................................................................... 6 
3.2 
STUDY FLOWCHART ..................................................................................... 8 
 
8 
3.3 
Study Matrix ..................................................................................................... 8 
4. 
STUDY POPULATION .............................................................................................. 8 
4.1 
NUMBER OF PARTICIPANTS ........................................................................ 8 
4.2 
INCLUSION CRITERIA .................................................................................... 9 
4.3 
EXCLUSION CRITERIA .................................................................................. 9 
5. 
PARTICIPANT SELECTION AND ENROLMENT ..................................................... 9 
5.1 
IDENTIFYING PARTICIPANTS ....................................................................... 9 
5.2 
CONSENTING PARTICIPANTS ...................................................................... 9 
5.3 
SCREENING FOR ELIGIBILITY .................................................................... 10 
5.4 
INELIGIBLE AND NON-RECRUITED PARTICIPANTS ................................ 10 
5.4.1 
Withdrawal procedures ........................................................................ 10 
6. 
STUDY & SAFETY ASSESSMENTS ...................................................................... 10 
7. 
DATA COLLECTION & MANAGEMENT ................................................................ 10 
7.1 
Data Collection ............................................................................................... 10 
7.2 
Data Management System ............................................................................ 10 
8. 
STATISTICS AND DATA ANALYSIS ..................................................................... 11 
8.1 
SAMPLE SIZE CALCULATION ..................................................................... 11 
8.2 
PROPOSED ANALYSES ............................................................................... 11 
8.3 
Missing data ................................................................................................... 11 
8.4 
TRANSFER OF DATA ................................................................................... 11 
9. 
STUDY MANAGEMENT AND OVERSIGHT ARRANGEMENTS ........................... 11 
9.1 
STUDY MANAGEMENT GROUP .................................................................. 11 
9.2 
STUDY MANAGEMENT ................................................................................ 11 
9.3 
STUDY STEERING COMMITTEE ................................................................. 11 
9.4 
DATA MONITORING COMMITTEE .............................................................. 12 
9.5 
INSPECTION OF RECORDS ........................................................................ 12 
10. 
GOOD CLINICAL PRACTICE ................................................................................. 12 
10.1 
ETHICAL CONDUCT OF THE STUDY ......................................................... 12 
10.1.1 
Confidentiality ...................................................................................... 12 
10.1.2 
Data Protection .................................................................................... 12 
10.1.3 
Insurance and Indemnity ..................................................................... 12 
11. 
STUDY CONDUCT RESPONSIBILITIES................................................................ 13 
11.1 
PROTOCOL AMENDMENTS, deviations and breaches ............................... 13 
11.2 
STUDY RECORD RETENTION .................................................................... 13 
11.3 
END OF STUDY ............................................................................................ 13 
12. 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ................... 13 
12.1 
AUTHORSHIP POLICY ................................................................................. 13 
12.2 
PUBLICATION ............................................................................................... 13 
12.3 
PEER REVIEW .............................................................................................. 13 
13. 
REFERENCES ......................................................................................................... 14 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
 
PROTOCOL APPROVAL 
Validation of a model to estimate patient anterior-posterior dimension from an 
abdominal radiograph 
 
Signatures 
By signing this document I am confirming that I have read, understood and approve the 
protocol for the above study. 
 
Dr Sarah Vinnicombe 
 
 
 
Chief Investigator 
Signature 
 
Date 
 
 
 
 
Mark Worrall 
 
 
 
Individual 
Responsible 
for 
Statistical Review 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
 
LIST OF ABBREVIATIONS 
 
 
GCP 
Good Clinical Practice 
SMF 
Study Master File 
SOP 
Standard Operating Procedure 
CNORIS 
Clinical Negligence and Other Risks Scheme 
AP 
Anterior-posterior 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
INTRODUCTION 
1.1 
BACKGROUND 
Exposure to ionising radiation is understood to be associated with a small increase in the risk 
of developing cancer later in life.  Therefore, all medical exposures need to be justified to 
ensure that the benefits from the exposure outweigh the risk, and optimised to ensure that the 
exposure is as low as reasonably practicable consistent with the intended purpose of the 
exposure. 
  
Patient dose audit is an important part of the optimisation process.  It gives information as to 
the level of dose received on average for an examination on one x-ray machine, allowing a 
comparison between multiple x-ray machines on the same site and between sites.  For all 
commonly undertaken examinations, national reference levels exist; these are created from 
local data from all over the UK.  Any institution is able to compare their local performance 
against these national values and determine if they are in line with average national 
performance of if urgent optimisation is required. 
 
Whereas a patient dose audit for adult x-ray examinations requires only limited information 
relating to the exposure factors used and the amount of radiation measured by the equipment 
as delivered to the patient, the method for paediatric patient dose audit also requires a 
measurement of patient size to be made.  This measurement should be either the anterior-
posterior or lateral depth of the patient, depending on the examination projection.  
Alternatively, a measurement of height and weight can be made, from which can be estimated 
the equivalent cylindrical diameter of the patient, which is equivalent to the measured depth. 
 
National data collection exercises have revealed that these measurements are not being 
routinely made for paediatric patients undergoing x-ray examinations however.  This has 
meant that no national reference levels have been proposed for paediatric x-rays since 2000.  
Since 2000, there have been significant technological improvements to the equipment used 
for x-ray imaging throughout the UK, so these reference values are out of date. 
 
The lack of up to date reference values is affecting efforts to optimise paediatric x-ray 
exposures across the UK, despite this being the patient cohort for whom optimisation is most 
important. 
 
1.2 
RATIONALE FOR STUDY 
A non-commercial computational model has been developed in-house to estimate the 
patient’s anterior-posterior or lateral depth using the radiographic image and the known 
exposure factors with which it was undertaken.  This model has been tested using single 
composition phantoms and found to be accurate.  If it was found to be accurate for real 
clinical examinations, this would automate the measurement of patient size and give local 
institutions the additional estimate of patient size required for local patient dose audit.  In turn, 
this would provide the national data required to propose national reference values for 
paediatric x-ray examinations, which would give all local institutions an important comparator 
for their performance.  This would lead to optimisation in those sites most requiring it; 
nationally, paediatric x-ray imaging would improve in time. 
 
This pilot study is necessary to determine if the computational model is accurate enough to be 
relied upon. 
 
2. 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objective 
To determine how accurate the computational model is at determining the patient’s anterior-
posterior abdomen depth using the radiographic image and the known exposure factors with 
which it was acquired.  Accuracy will be determined by comparing this result with an actual 
measurement of the patient’s anterior-posterior abdomen depth made at the time of the 
examination. 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
 
2.1.2 Secondary Objectives 
Any systematic inaccuracy found in the study could be used to further improve the values 
used in the computational model. 
 
2.2 
OUTCOMES 
2.2.1 Primary Outcomes 
A measure of the accuracy with which the computational model estimates the anterior-
posterior depth of patients undergoing abdominal x-ray examinations. 
 
2.2.2 Secondary Outcomes 
Any identified systematic inaccuracy could be used to further improve the values used in the 
computational model. 
 
3. 
STUDY DESIGN 
3.1 
STUDY DESCRIPTION 
Willing volunteers will be found from patients who have been referred for an AP abdomen x-
ray examination in the Radiology department at Ninewells Hospital.  Any patient suffering 
severe abdominal pain when attending for the examination will be excluded as it will be 
necessary for light physical contact to be made with the patient’s abdomen.  Any patient that 
has had an injection of contrast media within the previous 24 hours will be excluded from the 
study as the computational model is not equipped to work with the presence of contrast media 
at present. 
 
When the patient reports to main reception, if their attendance is for an AP abdomen x-ray the 
receptionist will give them the PIS and a reply slip saying that if they wish to take part in the 
study after having read the PIS they should inform the receptionist.  The receptionist will then 
contact the PI who will be in the radiology department. 
 
When it is time for the volunteer’s examination, a radiographer will collect them from the 
waiting area as normal and bring them to the x-ray room as normal.  Their examination will be 
performed on the Fuji Digital Radiography mobile x-ray machine in room D of main radiology 
at Ninewells Hospital.   
 
Each patient will be assigned a unique numerical study ID that will be used to correlate the 
measurement of their anterior-posterior depth with their anonymised image. 
 
The patient will lie on the x-ray couch in room D in the examination position, as directed by 
the radiographic staff.  A measurement of the patient’s AP abdomen depth will be made using 
a device that will attach to the side of the x-ray couch.  This device is non-commercial and 
made in-house.  It is not CE marked.  Physical contact with the patient will be minimal; a 
wooden bar will rest gently on their abdomen.  This will allow the AP abdomen depth to be 
read on the scale that is affixed to the x-ray couch. 
 
This measurement will be recorded alongside the clinical indication for the patient under an 
anonymous and unique participant ID on a patient study form.  
 
The AP abdominal x-ray examination will be undertaken by radiographic staff in accordance 
with local protocol and with no influence from this study.  On completion, the patient’s x-ray 
image will be transferred to PACS as normal, where it will be available for radiologist 
reporting.  The patient will leave the department as normal with no additional request made of 
them for this study. 
 
The anonymised patient’s x-ray image will be removed directly from the x-ray equipment 
using an NHS password protected USB memory stick.  During this transfer, the software on 
the x-ray equipment will anonymise the image.  This process has been checked using test 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
patients – the anonymisation process is complete – no patient identifiable information will be 
left on the image or within the electronic header. 
 
The image will be transferred from the USB memory stick to an NHS Tayside password 
protected computer.  From there, the necessary measurements will be made to allow the 
computational model to be used to estimate the patient’s AP abdomen depth.  This estimate 
will be compared to the physical measurement of AP abdomen depth made for the 
corresponding patient as recorded on the patient study form – this will determine the accuracy 
of the estimate. 
 
There is no need for any patient follow up.  Individual patients will only participate in the trial 
once.  As this is a pilot study, 20 patients will be recruited in total.  This will be enough as an 
initial cohort to determine whether the computational model is accurate enough to merit 
further clinical investigation, or if it is in need of adjustment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
3.2 
STUDY FLOWCHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3 
STUDY MATRIX 
Time 
At the time of the x-ray exam 
Measurement of AP abdomen depth 
x 
 
 
4. 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
As this is a pilot study, 20 patients will be required after any drop outs.  This will be enough as 
an initial cohort to determine whether the computational model is accurate enough to merit 
Location: 
Radiology, Ninewells 
 
                 Medical Physics, Ninewells 
 
 
 
 
 
       Yes 
 
 
No 
Patient arrives at reception and is 
given PIS and asked to indicate if 
they wish to participate in the trial 
Patient meets the PI 
in the x-ray room; 
opportunity for 
questions; patient is 
consented and given 
unique study ID 
Patient exam 
proceeds as normal 
With the patient in the examination position, 
a physical measurement of their anterior-
posterior abdomen depth is made by the PI 
Examination is undertaken by NHS 
Tayside radiographer using local protocol 
Image is sent to PACS for 
evaluation as normal 
The anonymised image is taken directly 
from the x-ray machine (anonymised 
during this process) and stored on an NHS 
Patient pathway continues as 
normal, unaffected by this study 
Computational model applied to 
image, estimate of patient anterior-
posterior abdomen depth made 
Predicted anterior-posterior 
abdomen depth compared against 
measured value for each patient in 
the study 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
further clinical investigation, or if it is in need of adjustment.  It would be prudent to aim for an 
even male/female split.   
As there is no patient follow-up, the patient’s trial recruitment ends when they leave the 
Radiology department having had their abdomen x-ray examination. 
If any participant chooses to withdraw from the study after their x-ray examination, their data 
will be deleted from the study database.  These participants will be replaced to ensure 20 
participants overall. 
 
4.2 
INCLUSION CRITERIA 
Any ambulatory patient attending Ninewells Hospital’s Radiology department for an AP 
abdomen x-ray who does not have contrast media present. 
Patients must be over 16 years old. 
 
4.3 
EXCLUSION CRITERIA 
Patient’s presenting with severe abdominal pain at the time of their examination, patients who 
have had contrast media injected within the last 24 hours and patients who are unable to give 
their consent. 
 
5. 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
Willing volunteers will be found from patients who have been referred for an AP abdomen x-
ray examination in the Radiology department at Ninewells Hospital.  When the patient reports 
to main reception, if their attendance is for an AP abdomen x-ray the receptionist will give 
them the PIS and a reply slip that should be completed if they wish to take part in the study 
after having read the PIS given back to the receptionist.  The receptionist will then pass a 
reply slip to the PI who will be in the radiology department. 
 
5.2 
CONSENTING PARTICIPANTS 
When it is time for the volunteer’s examination, a radiographer will collect them from the 
waiting area as normal and bring them to the x-ray room as normal.  Their examination will be 
performed on the Fuji Digital Radiography mobile x-ray machine in room D of main radiology 
at Ninewells Hospital.  In the privacy of the x-ray room, the PI will answer any questions 
relating to the study and consent the patient,  
Although there isn’t much time between the patient receiving the PIS and being consented (a 
minimum of half an hour), the PIS for this study is not lengthy or complex and the details of 
what the study entails are not difficult to explain or understand.  The patient’s only interaction 
with the PI is at the time of their AP abdomen examination.  For all of these reasons, it is felt 
that the reduced time period between the patient being given the PIS and being consented is 
appropriate and that it will not impact upon the patient’s ability to give informed consent. 
 
In addition, since the patients who attend for AP abdomen x-ray examinations at Ninewells 
Hospital are referred from all over the Hospital and the wider Dundee area, there is no 
controlled means of delivering the PIS to the patient at any prior stage.  
This is proportionate and commensurate with the research being undertaken 
 
Where a participant requests to speak with a physician from the study team the consent process 
will not be completed until the participant has spoken to the physician and had all their questions 
answered to their satisfaction. 
 
 
The informed consent process will be conducted in compliance with TASC SOP07: Obtaining 
Informed Consent from Potential Participants in Clinical Research. 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
5.3 
SCREENING FOR ELIGIBILITY 
Any patient who is undergoing an AP Abdomen x-ray examination in the main radiology 
department at Ninewells Hospital is eligible to participate as long as they are not in acute 
abdominal pain at the time of the examination and have not had an injection of contrast media 
within the previous 24 hours. 
 
5.4 
INELIGIBLE AND NON-RECRUITED PARTICIPANTS  
Patients who are in acute abdominal pain, who have had an injection of contrast media within 
the previous 24 hours or who decline to take part in the study will have their AP Abdomen x-
ray examination as normal with no involvement from the principal investigator. 
 
5.4.1 
Withdrawal procedures 
Study recruitment only lasts as long as it takes to perform an AP Abdomen x-ray examination; 
withdrawal will not be necessary for any patient. 
If a patient were to change their mind about participation after their examination, their study 
data will be removed from the anonymised research database. 
 
 
6. 
STUDY & SAFETY ASSESSMENTS 
There are no specific safety assessments necessary for participation in this study; the 
measurement of AP abdomen depth does not pose any risk and the patient will simply 
undergo an AP Abdomen x-ray examination as per their referral. 
 
 
7. 
DATA COLLECTION & MANAGEMENT 
7.1 
DATA COLLECTION 
The patient’s sex and clinical indication (i.e. the reason given for the AP abdomen x-ray 
examination on the request) will be recorded along with the physical measurement of their AP 
abdomen depth. 
These 3 variables will be recorded at the time of the x-ray examination by the principal 
investigator on the patient study form.  The patient’s x-ray image will be taken directly from 
the x-ray equipment by the principal investigator; the image is anonymised during this transfer 
process. 
 
 
7.2 
DATA MANAGEMENT SYSTEM 
As there is no complex analyses necessary, the anonymised data will be stored on a 
Microsoft Excel spreadsheet on an NHS Tayside computer. 
 
Data management will be conducted in compliance with TASC SOPs on Data Management, 
including TASC SOP53 Data Management Systems in Clinical Research and TASC SOP48 
Data Management in CTIMPs using Excel. 
The data management system (DMS) will be Excel as approved by Sponsor. The DMS will be 
based on the protocol and Participant Study Form for the study and individual requirements of 
the investigators. The Participants Study Form will collect only information that is required to 
meet the aims of the study and to ensure the eligibility and safety of the participant. The study 
database will be compliant with TASC SOP53.  
 
The database is managed in line with all applicable principles of medical confidentiality and UK 
law on data protection, namely, the Data Protection Act 1998, which brought UK law into line 
with the EU Data Protection Directive. The Data Controller will be the NHS Tayside and the 
Data Custodian will be the PI. 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
The CI may delegate Participant Study Form completion but is responsible for completeness, 
plausibility and consistency of the Participant Study Form. Any queries will be resolved by the 
CI or delegated member of the study team.  
Database lock will be conducted in compliance with TASC SOP32 Locking Clinical Study 
Databases 
 
8. 
STATISTICS AND DATA ANALYSIS 
8.1 
SAMPLE SIZE CALCULATION 
 
The sample size for this pilot study will be 20 patients.  There is no statistical aim or 
calculation in deriving this number; 20 is simply a high enough number as to allow for 
confidence in the computational model where all or most results are found to be individually 
accurate. 
 
8.2 
PROPOSED ANALYSES 
Analyses is straightforward; the difference between the computationally predicted AP 
abdomen depth and that measured for each individual participant will be expressed as a 
percentage.  Some statistical analyses will be undertaken on the 20 individual results 
(average, median, minimum and maximum deviations).  A t-test will be used to compare 
predicted and measured results. 
All analyses will be undertaken by the principal investigator using Microsoft Excel and IBM 
SPSS. 
 
8.3 
MISSING DATA 
It is not reasonably foreseeable that there will be any missing data.  What little data there is to 
be recorded will not leave Ninewells Hospital and will be input into an electronic record very 
soon after it is acquired. 
 
8.4 
TRANSFER OF DATA 
Data will not leave Ninewells Hospital, either physically or electronically. 
 
 
9. 
STUDY MANAGEMENT AND OVERSIGHT ARRANGEMENTS 
9.1 STUDY MANAGEMENT GROUP 
The study will be co-ordinated by a Study Management Group, consisting of the chief 
investigator and the principal investigator. 
 
9.2 STUDY MANAGEMENT 
The principal investigator will oversee the study and will be accountable to the CI. The PI will 
be responsible for checking the study data forms for completeness, plausibility and consistency. 
However, this remains the overall responsibility of the CI. Any queries will be resolved by the 
CI or delegated member of the study team.  
A study-specific Delegation Log will be prepared for each site, detailing the responsibilities of 
each member of staff working on the study.  
 
9.3 
STUDY STEERING COMMITTEE  
A Trial Steering Committee (TSC) will be established to oversee the conduct and progress of 
the study. The terms of reference of the TSC, the draft template for reporting are detailed in 
Appendix 1. 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
9.4 
DATA MONITORING COMMITTEE 
An independent Data Monitoring Committee (DMC) will be established to oversee study 
progress. The terms of reference of the DMC are detailed in Appendix 2. 
 
9.5 
INSPECTION OF RECORDS 
The CI, PIs and all institutions involved in the study will permit study related monitoring, audits, 
and REC review. The CI agrees to allow the Sponsor or, representatives of the Sponsor, direct 
access to all study records and source documentation. 
 
10. GOOD CLINICAL PRACTICE 
10.1 ETHICAL CONDUCT OF THE STUDY 
The study will be conducted in accordance with the principles of good clinical practice (GCP). 
In addition to Sponsorship approval, a favorable ethical opinion will be obtained from the 
appropriate REC and appropriate NHST R&D approval will be obtained prior to commencement 
of the study. 
 
10.1.1 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain participant confidentiality. All records will be kept in a secure 
storage area with limited access to study staff only. Clinical information will not be released 
without the written permission of the participant, except as necessary for monitoring and 
auditing by the Sponsor or its designee. The CI and study staff involved with this study will not 
disclose or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the study. 
Prior written agreement from the Sponsor or its designee will be obtained for the disclosure of 
any said confidential information to other parties. 
 
 
 
10.1.2 Data Protection 
The CI and study staff involved with this study will comply with the requirements of the Data 
Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles. The CI and study staff will also adhere, if 
appropriate, to the current version of the NHS Scotland Code of Practice on Protecting Patient 
Confidentiality.  Access to collated participant data will be restricted to the CI and appropriate 
study staff. 
Computers used to collate the data will have limited access measures via user names and 
passwords. 
Published results will not contain any personal data that could allow identification of individual 
participants. 
 
10.1.3 Insurance and Indemnity 
The University of Dundee and Tayside Health Board are Co-Sponsoring the study. 
 
Insurance – The University of Dundee will obtain and hold a policy of Public Liability Insurance 
for legal liabilities arising from the study. 
 
Tayside Health Board will maintain its membership of the Clinical Negligence and Other Risks 
Insurance Scheme (“CNORIS”) which covers the legal liability of Tayside in relation to the study. 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
Where the study involves University of Dundee staff undertaking clinical research on NHS 
patients, such staff will hold honorary contracts with Tayside Health Board which means they 
will have cover under Tayside’s membership of the CNORIS scheme. 
 
Indemnity The Co-Sponsors do not provide study participants with indemnity in relation to 
participation in the Study but have insurance for legal liability as described above. 
 
11. STUDY CONDUCT RESPONSIBILITIES 
11.1 PROTOCOL AMENDMENTS, DEVIATIONS AND BREACHES 
The CI will seek approval for any amendments to the Protocol or other study documents from 
the Sponsor, REC and NHS Tayside R&D Office. Amendments to the protocol or other study 
docs will not be implemented without these approvals.  
In the event that a CI needs to deviate from the protocol, the nature of and reasons for the 
deviation will be recorded in the SMF, documented and submitted to the Sponsor. If this 
necessitates a subsequent protocol amendment, this will be submitted to the Sponsor for 
approval and then to the appropriate REC and lead NHS R&D Office for review and approval.  
In the event that a serious breach of GCP is suspected, this will be reported to the Sponsor 
immediately using the form “Notification to Sponsor of Serious Breach or Serious Deviation”.  
 
11.2 STUDY RECORD RETENTION 
Archiving of study documents will be for five years after the end of study. 
 
11.3 END OF STUDY 
The end of study is defined as last patient last visit (LPLV).  The Sponsor, CI and/or the TSC 
have the right at any time to terminate the study for clinical or administrative reasons.  
The end of the study will be reported to the Sponsor and REC within 90 days, or 15 days if the 
study is terminated prematurely. The CI will ensure that any appropriate follow up is arranged 
for all participants. 
A summary report of the study will be provided to the Sponsor and REC within 1 year of the 
end of the study. 
 
12. REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS 
12.1 AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team and their respective 
employers. On completion of the study, the study data will be analysed and tabulated, and a 
clinical study report will be prepared.  
 
12.2 PUBLICATION 
The clinical study report will be used for publication and presentation at scientific meetings. 
Investigators have the right to publish orally or in writing the results of the study. 
Summaries of results will also be made available to Investigators for dissemination within their 
clinical areas (where appropriate and according to their discretion). 
 
12.3 PEER REVIEW 
The protocol will be subject to critical review by the academic and clinical supervisors on behalf 
of the University of Dundee as majority funder of the research. 
The PhD was reviewed and accepted by a University of Dundee PhD committee before the 
principal investigator commenced work. 
 

Validation of a model to estimate patient anterior-posterior dimension from an abdominal radiograph 
v1.1, 22nd December 2017 
 
 
 
13. REFERENCES 
 
1. Hart D, Wall B F, Shrimpton P C, Bungay D R, Dance D R.  R318-Reference Doses 
and Patient Size in Paediatric Radiology, NRPB 2000 
2. IAEA human health series.  Report 24 – Dosimetry in Diagnostic Radiology for 
Paediatric Patients, IAEA 2013 
3. Hart D, Hillier M C, Wall B F.  W14 – Doses to patients from medical x-ray examinations 
in the UK – 2000 review.  NRPB 2002. 
4. Hart D, Hillier M C, Wall B F.  29 – Doses to patients from radiographic and fluoroscopic 
x-ray imaging procedures in the UK – 2005 review.  HPA 2007. 
5. Hart D, Hillier M C, Shrimpton P C.  34 – Doses to patients from radiographic and 
fluoroscopic x-ray imaging procedures in the UK – 2010 review.  HPA 2012