The Impact of Smart Glasses on the Usability and Satisfaction of Operating an Environmental Control System or Communication Aid
Phase: NA
Conditions: Neurologic Disorder
Sponsor: NHS Lothian

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Non-CTIMP Study Protocol 
 
The impact of smart glasses on the usability and satisfaction of 
operating an environmental control system or communication aid 
 
Co-Sponsors 
The University of Edinburgh and/or Lothian Health Board 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
 
Protocol authors 
Graham Henderson, Michael Dolan 
Funder 
N/A 
Funding Reference Number 
N/A 
Chief Investigator 
Graham Henderson 
Sponsor number 
AC24008 
REC Number 
 24/NW/0057 
Version Number and Date 
V1.1 07/03/2024 

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CONTENTS 
1 
INTRODUCTION .......................................................................................................... 5 
1.1 
BACKGROUND ................................................................................................... 5 
1.2 
RATIONALE FOR STUDY ................................................................................... 5 
2 
STUDY OBJECTIVES.................................................................................................. 6 
2.1 
OBJECTIVES ...................................................................................................... 6 
2.1.1 Primary Objective ............................................................................................. 6 
2.2 
ENDPOINTS ........................................................................................................ 6 
2.2.1 Primary Endpoint .............................................................................................. 6 
3 
STUDY DESIGN .......................................................................................................... 6 
4 
STUDY POPULATION ................................................................................................. 7 
4.1 
NUMBER OF PARTICIPANTS ............................................................................ 7 
4.2 
INCLUSION CRITERIA ....................................................................................... 7 
4.3 
EXCLUSION CRITERIA ...................................................................................... 7 
4.4 
CO-ENROLMENT................................................................................................ 7 
5 
PARTICIPANT SELECTION AND ENROLMENT ........................................................ 7 
5.1 
IDENTIFYING PARTICIPANTS ........................................................................... 7 
5.2 
CONSENTING PARTICIPANTS .......................................................................... 7 
5.2.1 Withdrawal of Study Participants ...................................................................... 7 
6 
STUDY ASSESSMENTS ............................................................................................. 8 
6.1 
STUDY ASSESSMENTS ..................................................................................... 8 
6.2 
LONG TERM FOLLOW UP ASSESSMENTS ...................................................... 8 
6.3 
STORAGE AND ANALYSIS OF SAMPLES ......................................................... 8 
7 
DATA COLLECTION ................................................................................................... 8 
7.1 
Source Data Documentation ................................................................................ 8 
7.2 
Case Report Forms ............................................................................................. 9 
8 
DATA MANAGEMENT ................................................................................................ 9 
8.1 
Personal Data ...................................................................................................... 9 
8.2 
Data Information Flow .......................................................................................... 9 
8.3 
Data Storage ..................................................................................................... 10 
8.4 
Data Retention ................................................................................................... 10 
8.5 
Disposal of Data ................................................................................................ 10 
8.6 
External Transfer of Data ................................................................................... 10 
8.7 
Data Controller .................................................................................................. 10 
8.8 
Data Breaches ................................................................................................... 10 
9 
STATISTICS AND DATA ANALYSIS ........................................................................ 10 
9.1 
SAMPLE SIZE CALCULATION ......................................................................... 10 
9.2 
PROPOSED ANALYSES ................................................................................... 10 
10 
ADVERSE EVENTS ................................................................................................... 11 
11 
OVERSIGHT ARRANGEMENTS ............................................................................... 11 
11.1 
INSPECTION OF RECORDS ............................................................................ 11 
11.2 
STUDY MONITORING AND AUDIT .................................................................. 11 

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12 
GOOD CLINICAL PRACTICE .................................................................................... 11 
12.1 
ETHICAL CONDUCT ......................................................................................... 11 
12.2 
INVESTIGATOR RESPONSIBILITIES ............................................................... 12 
12.2.1 Informed Consent ........................................................................................... 12 
12.2.2 Study Site Staff ............................................................................................... 12 
12.2.3 Data Recording ............................................................................................... 12 
12.2.4 Investigator Documentation ............................................................................ 12 
12.2.5 GCP Training .................................................................................................. 12 
12.2.6 Data Protection Training ................................................................................. 12 
12.2.7 Information Security Training .......................................................................... 13 
12.2.8 Confidentiality ................................................................................................. 13 
12.2.9 Data Protection ............................................................................................... 13 
13 
STUDY CONDUCT RESPONSIBILITIES ................................................................... 13 
13.1 
PROTOCOL AMENDMENTS ............................................................................ 13 
13.2 
MANAGEMENT OF PROTOCOL NON COMPLIANCE ..................................... 13 
13.2.1 Protocol Waivers ............................................................................................. 13 
13.2.2 Management of Deviations and Violations ...................................................... 13 
13.3 
SERIOUS BREACH REQUIREMENTS ............................................................. 14 
13.4 
STUDY RECORD RETENTION ......................................................................... 14 
13.5 
END OF STUDY ................................................................................................ 14 
13.6 
CONTINUATION OF TREATMENT FOLLOWING THE END OF STUDY ......... 14 
13.7 
INSURANCE AND INDEMNITY ......................................................................... 14 
14 
AUTHORSHIP POLICY ............................................................................................. 15 
15 
REFERENCES ........................................................................................................... 15 
 

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LIST OF ABBREVIATIONS 
 
ACCORD 
Academic and Clinical Central Office for Research & Development - Joint office for The 
University of Edinburgh and Lothian Health Board 
CI 
Chief Investigator 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
PI 
Principal Investigator 
QA 
Quality Assurance 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 

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1 
INTRODUCTION 
1.1 
BACKGROUND 
Upper limb mobility impairments are a common problem for people with neurological 
conditions.  These impairments can have a detrimental effect of individual’s lives and can 
limit access to everyday technology within the home environment.  Consequently, 
environmental control systems (ECS) have been developed to facilitate access to a range of 
devices in the home including televisions, alarm systems, and telephones.  These systems 
consist of an access method for example a switch or eye gaze, the controller itself which 
houses the electronics to control various devices and the output devices themselves.  Due to 
the development of tablet based ECS the software that is used for environmental controls 
can also be used for the purposes of communication.   
A previous study has demonstrated that ECS tend to increase independence and increase 
the ability of individuals to carry out ADL, socialise and increase quality of life (Brandt et al. 
2011). There are however concerns over their design and ease of use (Etinger et al. 2018, 
Myburg et al. 2017).  One particular problem is that the majority of communication aid and 
environmental control systems aimed at high end users require a screen to be mounted in 
front of the user.  The limitations with this are that the user is only able to control their 
environment or speak when they are in front of the screen and it is difficult to achieve 
independent access to the device when the user has been driving their wheelchair, or is 
moving between a wheelchair and another chair/bed. 
Smart glasses technology has been developed in the last decade with Google unveiling their 
first Google Glass edition in 2012 and subsequently companies such as Epson, Microsoft 
and Sony also releasing devices (Kim and Choi 2021).  Smart glasses consist of a pair of 
glasses which are equipped with a see-through optical display that enables the user to see 
both their environment and also a virtual display (Lee and Hui 2018).  By using smart 
glasses, displays are accessible to the user in any location in their environment and this 
could provide an effective solution for increasing the independent use of communicate aids 
and environmental control systems. 
The existing NHS Lothian environmental control service 
(https://www.smart.scot.nhs.uk/service/environmental-control/) has approximately 100 
service users.  Smart glasses potentially have the benefit of allowing users who would not be 
able to use environmental controls to access one.  There are no significant risks of harm to 
users identified.  
1.2 
RATIONALE FOR STUDY 
 
The research question for this study is - what are the impact of smart glasses on the usability 
and satisfaction of operating an ECS or communication aid.   
 
The outcomes from the study could lead to new ECS/communication aids being developed 
that incorporate smart glasses as a user display.  If this is realised then it could lead to a 
reduction in the barriers to smart glasses by removing the mounting requirement for a 
screen.  It could also improve how users interact with others by removing a visible screen 
displaying what the user is writing ahead of it being spoken and therefore increasing privacy.  
There is also a potential cost benefit to NHS services due to the high costs of specialist 
mounting bracketry. 

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2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objective 
To explore the impact of smart glasses on the usability and satisfaction of operating ECS and 
communication aids. 
2.2 
ENDPOINTS 
2.2.1 Primary Endpoint 
Quest 2.0 
3 
STUDY DESIGN 
The evaluation is to be conducted by a UK based NHS Rehabilitation Engineering 
department.  Individuals who currently have an ECS or communication aid on long term loan 
will trial the device and provide feedback.  Questionnaires and interviews will evaluate the 
usability and the satisfaction that smart glasses provide. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The QUEST 2.0 questionnaire will be used to explore the user’s satisfaction both with their 
existing setup and with the use of the smart glasses. 
A semi-structured interview will be used to explore the usability of the smart glasses. 
 
At the end of study participants will not be able to keep the smart glasses.  The service will 
review the results from the study to inform future provision. 
 
3 week follow up – interview and 
QUEST 2.0 obtained for smart 
glasses use 
Invitation letter/email sent to 
eligible participants 
If participant interested then 
demonstration of smart glasses 
and QUEST 2.0 for current setup 
obtained 

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4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
The participants will be recruited from the population served by NHS Lothian’s Environmental 
Control Service.  The number of participants will be determined by how many participants it is 
possible to recruit within 12 months – it is expected to be <20. The participants will be referred 
to service as normal and the clinical intervention (supply of an environmental control system) 
will proceed irrespective of their participation or otherwise in the study. The only difference to 
the normal service provision and pathway is the application of the baseline and follow up 
questionnaires.  
4.2 
INCLUSION CRITERIA 
i. 
Existing environmental control system user (age 18-80).   
ii. 
Neurological condition. 
iii. 
Cognitive ability to answer the questions and to give consent. 
iv. 
Current environmental control system is compatible with smart glasses display.  
4.3 
EXCLUSION CRITERIA 
i. 
Current environmental control system or communication aid is not compatible 
with smart glasses display.   
ii. 
Rapidly deteriorating condition  
4.4 
CO-ENROLMENT 
Co-enrolment will not be allowed in any circumstances. 
5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
Participants will be identified by Clinical Scientists (who are in the patient’s direct care team) working in 
NHS Lothian’s Environmental Control Service (ECS) from a database of existing patients. The patient 
will be contacted by a Clinical Scientist via telephone, to ask if they wish to take part in the study.  
5.2 
CONSENTING PARTICIPANTS 
Informed consent will be collected by a Clinical Scientist at the initial setup in the form of a consent 
form. The participants will be sent the information sheet at least 1 week in advance of the initial setup 
appointment.  
5.2.1 Withdrawal of Study Participants 
Participants are free to withdraw from the study at any point or a participant can be withdrawn by the 
Investigator. If withdrawal occurs, the primary reason for withdrawal will be documented in the 
participant’s case report form if possible. The participant will have the option of withdrawal from: 
 
(i) all aspects of the study but continued use of data collected up to that point. To safeguard rights, the 
minimum personally-identifiable information possible will be collected. 
 

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6 
STUDY ASSESSMENTS 
6.1 
STUDY ASSESSMENTS 
The participant will be provided with a set of smart glasses as an alternative display for their existing 
environmental control system.  Training will be provided on how to operate the smart glasses. The 
initial setup and questionnaire will take between 2-3 hours.  Further questionnaires will be completed 
at a second appointment and will take approximately 1 hour to complete.  
 
Assessment  
Screening  
Baseline  
3 weeks following loan of smart 
glasses 
Assessment of 
Eligibility Criteria  
☒ 
☐ 
☐ 
Written informed 
consent  
☐ 
 ☒ 
☐ 
Demographic data, 
contact details 
☒ 
☐ 
☐ 
Questionnaire 
☐ 
☒ 
☒ 
Interview 
☐ 
☐ 
☒ 
6.2 
LONG TERM FOLLOW UP ASSESSMENTS 
The longest follow up will be 3 weeks. 
6.3 
STORAGE AND ANALYSIS OF SAMPLES 
N/A 
7 
DATA COLLECTION 
All data will be collected by a Clinical Scientist within NHS Lothian’s Environmental Control Service.  
 
1. Participant will complete initial questionnaire QUEST 2.0 (completed in person at initial 
appointment)  
2. Participant will complete follow up questionnaire QUEST 2.0 and study specific semi-
structured interview (completed in person at follow up appointment)  
 
7.1 
Source Data Documentation 
Source data is defined as all information in original records and certified copies of original records or 
clinical findings, observations, or other activities in a clinical study necessary for the reconstruction and 
evaluation of the study. Source data are contained in source documents. 
Source documents are original documents, data and records where source data are recorded for the 
first time. 
1. QUEST 2.0 
2. Study specific semi-structured interview 

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7.2 
Case Report Forms 
Data will be collected on a structured form. –  
8 
DATA MANAGEMENT 
8.1 
Personal Data 
The following personal data will be collected as part of the research: 
 
• 
Name, ReTIS number (this is 6 digit identifier used by the ReTIS database – the system used 
for patient management within the SMART Centre for issuing wheelchairs and environmental 
control systems etc.), Phone number, Home address, health conditions.  This information is 
collected from the ReTIS database record.  
 
Personal data will be stored by the research team on ReTIS (Local data management software) which 
is password protected. A mapping spreadsheet will be created to map between the ReTIS number 
and the participant’s study specific code. Personal data will be stored for as long as they are a patient 
of the Environmental Control Service.  
 
8.2 Data Information Flow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Existing patient on 
ReTIS  
Personal data (Phone number) 
used to contact patient to 
recruit. 
Personal data (Home address) 
used to contact patient to set 
up initial appointment.   
Personal data (Phone number) 
used to contact patient to follow 
up / questionnaire 
Personal data 
deleted when 
patient leaves 
the service*   
Personal data kept 
on ReTIS whilst 
patient continues 
to receive care 
from the service   
End of patient participation 

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* After a fixed period in accordance with the retention of health records requirements. 
8.3 Data Storage 
The results of the QUEST 2.0 scores will be recorded on handwritten forms.  The results from the semi-
structured interview will be recorded on a secure NHS approved device.  
A study spreadsheet will be created for saving the results of the QUEST 2.0 scores and the semi-
structured interview.  This will be on secured NHS Lothian network shared drive accessible only to the 
study investigators.  Handwritten forms will be kept locked in cabinet in the lead investigators office – 
once transcribed they will be destroyed using the confidential waste.   
The semi-structured interview data will be transcribed by the lead researcher onto the spreadsheet.  
After this the recordings will be deleted from the device.  
 
8.4 Data Retention 
Personal data will be stored for the duration of the study and for additional time for the study to be 
written up – this will be 3 years from the end of the study. 
8.5 Disposal of Data 
Data will be deleted from the shared drive.   
Handwritten forms will be destroyed using the confidential waste. 
8.6 External Transfer of Data 
Data collected or generated by the study (including personal data) will not be transferred to any external 
individuals or organisations outside of the Sponsoring organisation(s). 
8.7 Data Controller 
A data controller is an organisation that determines the purposes for which, and the manner in which, 
any personal data are processed. 
The University of Edinburgh and NHS Lothian are joint data controllers along with any other entities 
involved in delivering the study that may be a data controller in accordance with applicable laws (e.g. 
the site). 
8.8 Data Breaches 
Any data breaches will be reported to the University of Edinburgh (dpo@ed.ac.uk) and NHS Lothian 
(Lothian.DPO@nhslothian.scot.nhs.uk) Data Protection Officers who will onward report to the relevant 
authority according to the appropriate timelines if required. 
9 
STATISTICS AND DATA ANALYSIS 
9.1 
SAMPLE SIZE CALCULATION 
Due to the small number of participants expected, data will be analysed with descriptive methods and 
therefore no sample size calculations are required. 
9.2 
PROPOSED ANALYSES 
Incomplete datasets will be removed before undertaking the analysis. 

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The data will be analysed with descriptive methods with a focus on clinical significance.   
 
Correlation analysis will be conducted to determine relationships between the device use and social 
context and the satisfaction outcome measures.  
For all of the outcome measures the following data will be reported: mean, change in mean between 
intervals and standard deviation.  
Statistical tests will be used to analyse the significance of the relationship between variables. 
10 
ADVERSE EVENTS 
The NHS Lothian Adverse Event Management Policy and Operational Procedure will be followed for 
recording and dealing with adverse incidents. 
11 
OVERSIGHT ARRANGEMENTS 
11.1 INSPECTION OF RECORDS 
Investigators and institutions involved in the study will permit study related monitoring and audits on 
behalf of the Sponsor, REC review, and regulatory inspection(s). In the event of audit or monitoring, the 
Investigator agrees to allow the representatives of the Sponsor direct access to all study records and 
source documentation. In the event of regulatory inspection, the Investigator agrees to allow inspectors 
direct access to all study records and source documentation. 
11.2 STUDY MONITORING AND AUDIT 
The ACCORD Sponsor Representative will assess the study to determine if a study specific risk 
assessment is required.  
If required, a study specific risk assessment will be performed by representatives of the Sponsor(s), 
ACCORD monitors and the QA group, in accordance with ACCORD governance and sponsorship 
SOPs. Input will be sought from the Chief Investigator or designee. The outcomes of the risk 
assessment will form the basis of the monitoring plans and audit plans.  
If considered necessary, ACCORD clinical trial monitors, or designees, will perform monitoring activities 
in accordance with the study monitoring plan. This will involve on-site visits and remote monitoring 
activities as necessary. ACCORD QA personnel, or designees, will perform study audits in accordance 
with the study audit plan. This will involve investigator site audits, study management audits and facility 
(including 3rd parties) audits as necessary (delete where not required). 
12 
GOOD CLINICAL PRACTICE 
12.1 ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the International Conference on 
Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP). 
Before the study can commence, all necessary approvals will be obtained and any conditions of 
approvals will be met. 

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12.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for the overall conduct of the study at the site and compliance with the 
protocol and any protocol amendments. In accordance with the principles of ICH GCP, the following 
areas listed in this section are also the responsibility of the Investigator. Responsibilities may be 
delegated to an appropriate member of study site staff. 
Delegated tasks must be documented on a Delegation Log and signed by all those named on the list 
prior to undertaking applicable study-related procedures.   
12.2.1 Informed Consent 
The Investigator is responsible for ensuring informed consent is obtained before any study specific 
procedures are carried out. The decision of a participant to participate in clinical research is voluntary 
and should be based on a clear understanding of what is involved. 
Participants must receive adequate oral and written information – appropriate Participant Information 
and Informed Consent Forms will be provided. The oral explanation to the participant will be performed 
by the Investigator or qualified delegated person, and must cover all the elements specified in the 
Participant Information Sheet and Consent Form. 
The participant must be given every opportunity to clarify any points they do not understand and, if 
necessary, ask for more information. The participant must be given sufficient time to consider the 
information provided. It should be emphasised that the participant may withdraw their consent to 
participate at any time without loss of benefits to which they otherwise would be entitled. 
The participant will be informed and agree to their medical records being inspected by regulatory 
authorities and representatives of the Sponsor(s). 
The Investigator or delegated member of the study team and the participant will sign and date the 
Informed Consent Form(s) to confirm that consent has been obtained. The original will be signed in the 
Investigator Site File (ISF). The participant will receive a copy of the signed consent form and a copy 
will be filed in the participant’s medical notes. 
12.2.2 Study Site Staff 
The Investigator must be familiar with the protocol and the study requirements. It is the Investigator’s 
responsibility to ensure that all staff assisting with the study are adequately informed about the protocol 
and their study related duties. 
12.2.3 Data Recording 
The Principal Investigator is responsible for the quality of the data recorded in the CRF at each 
Investigator Site.  
12.2.4  Investigator Documentation 
The Principal Investigator will ensure that the required documentation is available in local Investigator 
Site files (ISFs). 
12.2.5 GCP Training 
For non-CTIMP (i.e. non-drug) studies all researchers are encouraged to undertake GCP training in 
order to understand the principles of GCP. This is not a mandatory requirement unless deemed so by 
the Sponsor. GCP training status for all investigators should be indicated in their respective CVs. 
12.2.6 Data Protection Training 
All University of Edinburgh employed researchers and study staff will complete the Data Protection 
Training through Learn. 
NHS Lothian employed researchers and study staff will comply with NHS Lothian mandatory Information 
Governance Data Protection training through LearnPro. 

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Non-NHS Lothian staff that have access to NHS Lothian systems will familiarise themselves and abide 
by all NHS Lothian IT policies, as well as employer policies 
12.2.7 Information Security Training 
All University of Edinburgh employed researchers, students and study staff will complete the Information 
Security Essentials modules through Learn and will have read the minimum and required reading setting 
out ground rules to be complied with. 
NHS Lothian employed researchers and study staff will comply with NHS Lothian mandatory Information  
Governance IT Security training through LearnPro. 
Non-NHS Lothian staff that have access to NHS Lothian systems will familiarise themselves and abide 
by all NHS Lothian IT policies, as well as employer policies 
12.2.8 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records must be identified in a manner 
designed to maintain participant confidentiality. All records must be kept in a secure storage area with 
limited access. Clinical information will not be released without the written permission of the participant. 
The Investigator and study site staff involved with this study may not disclose or use for any purpose 
other than performance of the study, any data, record, or other unpublished information, which is 
confidential or identifiable, and has been disclosed to those individuals for the purpose of the study. 
Prior written agreement from the Sponsor or its designee must be obtained for the disclosure of any 
said confidential information to other parties. 
12.2.9 Data Protection 
All Investigators and study site staff involved with this study must comply with the requirements of the 
appropriate data protection legislation (including the General Data Protection Regulation and Data 
Protection Act) with regard to the collection, storage, processing and disclosure of personal information.  
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. 
13 
STUDY CONDUCT RESPONSIBILITIES 
13.1 PROTOCOL AMENDMENTS 
Any changes in research activity, except those necessary to remove an apparent, immediate hazard to 
the participant in the case of an urgent safety measure, must be reviewed and approved by the Chief 
Investigator. 
Proposed amendments will be submitted to the Sponsor for classification, review and authorisation. 
Amendments to the protocol must be submitted in writing to the appropriate REC and local R&D for 
approval prior to implementation and prior to participants being enrolled into the amended protocol. 
13.2 MANAGEMENT OF PROTOCOL NON COMPLIANCE 
13.2.1 Protocol Waivers 
Prospective protocol deviations, i.e. protocol waivers, will not be approved by the Sponsors and 
therefore will not be implemented, except where necessary to eliminate an immediate hazard to study 
participants. If this necessitates a subsequent protocol amendment, this should be submitted to the 
REC and local R&D for review and approval if appropriate. 
13.2.2 Management of Deviations and Violations 

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Deviations and violations are non-compliance events discovered after the event has occurred. Protocol 
deviations will be recorded in a protocol deviation log and logs will be submitted to the Sponsors every 
3 months. Each protocol violation will be reported to the Sponsor within 3 days of becoming aware of 
the violation. 
Deviation logs will be maintained for each site in multi-centre studies. 
Deviation logs/violation forms will be transmitted via email to QA@accord.scot. Only forms in a pdf 
format will be accepted by ACCORD via email. Forms may also be submitted by hand to the office. 
Where missing information has not been sent to ACCORD after an initial report, ACCORD will contact 
the Investigator and request the missing information. The Investigator must respond to these requests 
in a timely manner. 
13.3 SERIOUS BREACH REQUIREMENTS 
A serious breach is a breach which is likely to effect to a significant degree: 
(a) the safety or physical or mental integrity of the participants of the study; or 
(b) the scientific value of the study. 
If a potential serious breach is identified by the Chief investigator, Principal Investigator or delegates, 
the Sponsor(s) (qa@accord.scot) must be notified within 24 hours. It is the responsibility of the 
Sponsor(s) to assess the impact of the breach on the scientific value of the study, to determine whether 
the incident constitutes a serious breach and report to research ethics committees as necessary. 
13.4 STUDY RECORD RETENTION 
All study documentation will be kept for a minimum of 3 years from the protocol defined end of study 
point. When the minimum retention period has elapsed, study documentation will be destroyed with 
permission from the Sponsor. 
13.5 END OF STUDY 
The end of study is defined as the last participant’s last visit. 
The Investigators and/or the Sponsor(s) 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 REC, and R&D Office(s) and Sponsor(s) within 90 days, or 
15 days if the study is terminated prematurely. The Investigators will inform participants of the premature 
study closure and ensure that the appropriate follow up is arranged for all participants involved. End of 
study notification will be reported to the Sponsor(s) via email to researchgovernance@ed.ac.uk. 
A summary report of the study will be provided to the REC within 1 year of the end of the study. 
13.6 CONTINUATION OF TREATMENT FOLLOWING THE END OF STUDY 
The participant will continue to be provided their environmental control device in line with NHS Lothian’s 
service provision.  
 
13.7 INSURANCE AND INDEMNITY 
The Sponsor(s) are responsible for ensuring proper provision has been made for insurance or indemnity 
to cover their liability and the liability of the Chief Investigator and staff. 
The following arrangements are in place to fulfil the Sponsor(s)' responsibilities: 
• 
The Protocol has been designed by the Chief Investigator and researchers employed by the 
University and collaborators. The University has insurance in place (which includes no-fault 
compensation) for negligent harm caused by poor protocol design by the Chief Investigator 
and researchers employed by the University. 

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• 
Sites participating in the study will be liable for clinical negligence and other negligent harm 
to individuals taking part in the study and covered by the duty of care owed to them by the 
sites concerned. The Sponsor(s) require individual sites participating in the study to arrange 
for their own insurance or indemnity in respect of these liabilities. 
• 
Sites which are part of the United Kingdom's National Health Service will have the benefit of 
NHS Indemnity. 
• 
Sites out with the United Kingdom will be responsible for arranging their own indemnity or 
insurance for their participation in the study, as well as for compliance with local law applicable 
to their participation in the study. 
14 
AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team. 
15 
REFERENCES 
Brandt, A. et al. (2011). Activity and participation, quality of life and user satisfaction 
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