Automated Check-in Data Collection Study
Conditions: Primary Care
Sponsor: Keele University

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PROTOCOL 
 
 
 
 
 
 
 
 
Version 2.0 dated 5th November 2018 
 
 
This protocol has regard for the HRA guidance and order of content 

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RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 248316
 
 
Sponsor Number: RG-0275-18
 
 
ISRCTN Number: ISRCTN82531292
 
 
 

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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the trial in compliance with the approved protocol, GCP guidelines, the 
Sponsor’s SOPs, and other regulatory requirements as amended. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the clinical investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent account 
of the study will be given; and that any discrepancies from the study as planned in this protocol will be 
explained. 
 
 
 
 
Chief Investigator: 
 
Signature: ........................ ......................................................... 
 
Date: 05/11/2018 
 
Name: ………………Professor Christian D Mallen…………….. 
 
 
 
 
 
 
 
 
 

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LIST OF CONTENTS 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
1 
RESEARCH REFERENCE NUMBERS 
 
2 
SIGNATURE PAGE 
3 
LIST of CONTENTS  
4 
LIST OF ABBREVIATIONS 
5 
KEY STUDY CONTACTS  
6 
STUDY SUMMARY 
7 
STUDY FLOW CHART 
 
8 
SECTION  
1. BACKGROUND 
 
9 
2. AIM & OBJECTIVE  
10 
3. STUDY DESIGN 
11 
4. STUDY SETTING 
12 
5. STUDY PROCEDURES 
13 
6. STATISTICS AND DATA ANALYSIS 
17 
7. DATA HANDLING 
18 
8. MONITORING & AUDIT 
18 
9. ETHICAL AND REGULATORY CONSIDERATIONS 
20 
10. DISSEMINATION POLICY 
22 
11. REFERENCES 
22 
 

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LIST OF ABBREVIATIONS 
 
CCG 
Clinical Commissioning Group 
CI 
Chief Investigator 
CRN: WM 
NIHR Clinical Research Network: West Midlands 
EMIS 
Egton Medical Information Systems 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
GPSoC 
General Practice System of Choice 
HCP 
Health Care Professional 
ONS 
Office for National Statistics 
PI 
Principal Investigator 
PIC 
Participant Identification Centre 
PIL 
Participant Information Leaflet 
QOF 
Quality Outcomes Framework 
REC 
Research Ethics Committee 
RUG 
Research User Group 
SAP 
Statistical Analysis Plan 
SMF 
Study Master File 
SMG 
Study Management Group 
SNOMED 
Systematized Nomenclature of Medicine - Clinical Terms 
SOP 
Standard Operating Procedure  
TECS 
Technology Enabled Care Services 
 

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KEY STUDY CONTACTS 
 
Chief Investigator 
Professor Christian Mallen 
Arthritis Research UK Primary Care Centre 
Research Institute for Primary Care & Health Sciences 
Keele University, 
Staffordshire, ST5 5BG 
Tel:  01782 734879 
c.d.mallen@keele.ac.uk 
Principal Investigator 
Sarah Lawton 
Arthritis Research UK Primary Care Centre 
Research Institute for Primary Care & Health Sciences 
Keele University, 
Staffordshire, ST5 5BG 
Tel:  01782 734887 
s.a.lawton@keele.ac.uk 
Sponsor 
Dr Clark Crawford 
Head of Research Integrity, Directorate of Engagement & 
Partnerships, Innovation Centre 2, Keele University, 
Staffordshire, ST5 5NH  
01782 733371 
research.governance@keele.ac.uk  
Funder 
Professor Christian Mallen: NIHR Research 
Professorship (NIHR-RP-2014-04-026)  
Study Management 
Arthritis Research UK Primary Care Centre 
Research Institute for Primary Care & Health Sciences 
Keele University, Staffordshire, ST5 5BG 
01782 734887 
s.a.lawton@keele.ac.uk 
Lead Statistician 
Dr Sara Muller 
Senior Research Fellow: Epidemiology and Applied Statistics 
Arthritis Research UK Primary Care Centre 
Research Institute for Primary Care & Health Sciences 
Keele University, 
Staffordshire, ST5 5BG 
Tel: 01782 734842 
s.muller@keele.ac.uk 
Key Protocol Contributors 
- Dr Toby Helliwell, GP Partner & NIHR Academic Clinical 
Lecturer in General Practice 
- Simon Wathall, Health Informatics Specialist 
 
Arthritis Research UK Primary Care Centre 
Research Institute for Primary Care & Health Sciences 
Keele University, 
Staffordshire, ST5 5BG 
Tel: 01782 734887 
 
 
 

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STUDY SUMMARY 
 
Study title 
Automated Check-in Data Collection Study 
Internal ref. number (or short title) 
AC DC STUDY 
Study design 
Pilot feasibility 
Study participants 
Patients consulting in general practice, completing an 
automated check-in screen prior to their consultation. 
Planned sample size 
Approximately n=1166 per participating general practice 
(depending on practice list size and number of consulting 
clinicians during recruitment period). 
Total sample size n=9604, ~11 general practices 
Planned recruitment period 
3 weeks in each participating general practice. 
 
Objectives 
Outcome measures 
Primary 
 
To assess patient 
acceptability of answering 
two research questions in the 
general practice waiting room 
using an automated check-in 
screen. 
 
Percentage of completed 
automated check-in screens 
with entered research data. 
 
 
 
 
 
 

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STUDY FLOW CHART 
Flow chart demonstrating recruitment of participants into the study. 
 
 
 
 
 
 
 
 
 
 
 
 
           Patient answers 
 
 
                                          
 
 
 
 
                                     
  
       Patient answers  
 
  
 
 
 
 
 
      
 
 
 
 
 
After a short delay 
 
     After a short delay 
 
 
 NIHR CRN: West Midlands general practices using EMIS Web and 
with automated arrival check-in facilities, recruited for the study. 
General practices recruit patients for a period of three weeks. 
Eligible patients (=>18 years) with a booked appointment and self-
completing an automated check-in screen to confirm their attendance at 
the general practice, receive the additional research questions. 
How much bodily pain have you had during the past 4 weeks? 
Patients takes no further action 
Would you be happy for your practice to contact you 
about any future research studies which are relevant to 
your health, to improve care for patients in the NHS? 
Yes / No
Automated check-in screen confirms patient attendance and returns to the ‘Home screen’. 
End. 
After three weeks, study recruitment ceases and an EMIS search and report is downloaded at four weeks. 
Patients takes no further action 
1-6 scale degree of pain 
Skip 
Skip

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1 
BACKGROUND 
Instead of patients needing to speak to the receptionist, it has now become commonplace for general 
practice waiting rooms to host an automated check-in screen. Practice waiting rooms typically display a 
notice, directing patients arriving for a booked appointment, to self-check-in. In a time where primary 
care is underfunded1, self-check-in is a cost effective process which frees up receptionist time for other 
tasks2. Whilst this automated process provides an efficient solution to the completion of a practice 
administrative function, it may also be possible to quickly collect additional information about the 
consulting patient. There is little evidence available in the literature to describe the use of automated 
check-in screens for the collection of additional patient data and therefore an assessment of patient 
acceptability for providing additional information for the purposes of research, whilst self-completing an 
automated check-in screen is to be piloted. 
In order to support the delivery of health and social care, the role of technology enabled care services 
(TECS) are gaining increasing recognition3.  We can provide parallels in how people have converted to 
using technology in their everyday lives, for example in banking, shopping and communications, with 
how people receive delivery of health and social care4. The use of TECS support the transformation of 
new models of care delivery and allow patients to meet their needs and preferences, together with the 
provision of efficiencies for general practice.  Improving digital literacy across the health and social care 
landscape needs to be embedded in organisations and individuals5.  An automated check-in screen 
which displays additional health related questions is also one way of providing patients with the ability 
to take control of their choices and how their personal data are managed. 
The EU General Data Protection Regulation (GDPR) replaced the Data Protection Directive 95/46/EC 
on 25th May 2018. As part of this new regulation there is the right of the data subject to obtain from the 
data controller, confirmation as to whether or not personal data concerning them is being processed, 
where and for what purpose6. General practices are data controllers, of patients’ (data subjects) 
healthcare data. This new legislation allows data subjects to have control over how their data is 
processed by the controller. The invitation to participate in healthcare research and the percentage 
conversion rate into participants recruited is variable, with many comprehensible and confounding 
factors affecting recruitment success rates. Collecting data on whether patients are happy to be 
contacted about research would provide general practices with efficiencies in resource, improved 
accuracy in sampling and provide patients with more control of how their data are used.  
Increasingly, patients are living with multiple, long-term chronic conditions, both physical and 
psychological - and at the same time general practitioners are being asked to do more routine health 
checks, ask more questions and give more advice as standard during consultations. The standard 10-
minute appointment is simply inadequate to deal with this7. Pain is commonly neglected by patients and 
not prioritised by general practitioners. Although effective pain management interventions and 

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programmes exist, provision of these services is inconsistent, and chronic pain is not given the priority 
it requires in view of the extent of its burden on individuals and society8. There being a prompt for 
patients to complete at checking in for a booked consultation at the general practice, with regards to the 
patient’s recent experiences of pain, might then encourage them to highlight this in a consultation. This 
data collected can additionally be entered straight into the patient’s medical record and can facilitate the 
impending consultation, making an efficient use of the 10-minute consultation.  
The electronic Clinical Record Management system which each general practice uses, is dictated by 
their local Clinical Commissioning Group (CCG). The general practice systems of choice (GPSoC) are 
EMIS Health, TPP SystmOne, Vision, and Microtest Health. These systems are used by 56%, 36%, 7% 
and 1% respectively, of general practices within England9. These GPSoC are now designed to include 
optional extras for general practices; patients can be provided with information, provide feedback for 
service evaluation and book future appointments using the interoperability functions of these sytems10. 
Some have a questionnaire module, which can be used to gain responses from specific patient groups 
in order to improve services or collect Quality and Outcomes Framework (QOF) data. In addition, all of 
these systems now integrate with automated check-in screens. Patients can notify the general practice 
of their arrival for a consultation more efficiently. A few presses on a touch screen kiosk updates the 
GPSoC of the patient’s arrival for their consultation and the patient receives confirmation of their 
appointment in seconds, without administration staff having to take any action.  
EMIS is the clinical system of choice used by 67% of practices across the NIHR Clinical Research 
Network: West Midlands (CRN WM) and the customisable options it offers, provides us with an 
opportunity to pilot its use in the collection of additional, brief research data from consulting patients.  
 
2 
AIM & OBJECTIVES 
The aim of this study is to examine patient acceptability, for providing brief research information, whilst 
self-completing an automated check-in screen prior to any general practice consultation. 
Primary objective 
The specific objectives of this study fall into two categories; research evaluation and process evaluation. 
By piloting the use of the automated check-in screen to collect additional research data, the answers to 
these objectives will then provide feasibility information on the future use of the automated check-in 
screens for the identification of potentially eligible participants that would be happy to be contacted about 
future research studies relevant to their health and with information on patient acceptability of answering 
simple research questions, within the general practice waiting room.   

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Research evaluation objectives:  
1. 
To examine completion rates of the two additional research questions on the automated check-in 
screen. 
2. 
To estimate the number of patients that would be happy to be contacted about future research 
studies relevant to their health. 
3. 
To estimate the number of patients reporting degrees of pain and which severities of pain.  
4. 
To explore any demographic variances in completion responses.  
5. 
To estimate research question completion rate feasibility, for future use of automated check-in 
screens in the collection of research data. 
Process evaluation objectives; 
1. 
To assess patient acceptability of answering an additional two research questions within the waiting 
room, whilst completing an automated check-in screen. 
2. 
To explore research question completion rates depending on the time differences between; check-
in completion, booked appointment time and actual consultation time.  
3. 
To assess the impact of check-in completion for general practice operationalisation. 
4. 
To describe the quantity and detail of any participant queries, made as a result of asking two 
additional research questions on the patient automated check-in screen. 
 
3 
STUDY DESIGN 
This pilot feasibility study will examine patient acceptability of completing two research questions 
following automated check-in, within participating general practices. 
Ethical approval will be sought for the collection and analysis of the additional two pieces of research 
data collected at the point of automated check-in by the patient, together with associated simple 
operational and demographic data. In line with the definition outlined in Article 4(11) of the GDPR 
guidance, “any freely given, specific, informed and unambiguous indication of the data subject’s wishes 
by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing 
of personal data relating to him or her”6, participants will be recruited to this study. Consent to participate 
will be implied by question completion. An invitation poster will be displayed next to the automated 
check-in screen providing general information on the study, together with participant information leaflets 

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providing details on how any affirmative action made can be changed and will also contain contact 
details for the AC DC study team, should the patient wish to ask any questions about the study.  
3.1 
Study population 
All patients of age 18 and over, who can read and respond in English and with a booked appointment, 
consulting with any Health Care Professional (HCP) at their general practice, during the recruitment 
period will be eligible to participate.  All patients are required to confirm their attendance at the general 
practice by using the automated check-in screen. If the patient completing the automated check-in 
screen is 18 years of age or over, the additional research questions will appear for completion. The 
additional research questions will not appear on any subsequent appointment check-in screen during 
the recruitment period, for those participants who have already completed the questions. 
3.1.1 Eligibility    
Inclusion criteria 
 
Patients 18 years of age or over attending participating general practices for a consultation with 
any healthcare professional. 
 
Patients registered with the participating general practice during the specified recruitment period. 
 
Patients able to read and respond in English. 
Exclusion criteria 
 
Patients under the age of 18 attending the general practice for a consultation with a healthcare 
professional. 
 
4 
STUDY SETTING 
Selected general practices within NIHR Clinical Research Network: West Midlands (CRN WM) whose 
GPSoC is EMIS, will host the additional two research questions on their automated check-in screen, 
within the patient waiting room area, for a period of 3 weeks recruitment per practice. The general 
practice EMIS system will require Automated Arrival facilities, to include a Questionnaire Module and 
an automated arrivals check-in touchscreen. This will enable any answer to a displayed question to 
have a Read / SNOMED code applied directly into the patient record without the need for administrative 
input. The study Health Informatics Specialist will coordinate the installation of the required software in 
participating practices (where a Questionnaire Module is not already available) and programme the 
check-in function to provide the additional research questions.  

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The average list size of CRN WM general practices is 7,500 and the minimum required appointments 
required per week, per 1,000 patients is 7211.  This will provide the study team with enough data to 
understand patient acceptability of completing two research questions in the general practice waiting 
room following automated check-in, per practice.  
 
5 
STUDY PROCEDURES  
5.1 
Recruitment 
Patients book appointments for consultations with multiple HCPs at their registered general practice by 
either telephoning the practice and booking an appointment, physically attending the practice and booking 
an appointment or by booking appointments using the practice on-line services (if available). The 
management and administration of this process at a general practice, is coordinated by the Practice 
Manager alongside the practice administration team. Once patients attend for their booked appointment, 
the automated check-in screen provides efficiencies for the practice administration team, as patients are 
empowered to self-check-in. 
5.2   Patient identification 
During the recruitment period for each participating practice, all patients 18 years of age or over and able 
to read and respond in English attending for a booked appointment and completing an automated check-
in screen confirming their attendance will be eligible to participate in the study.  
The study will be advertised at each participating general practice during the 3-week recruitment period. An 
invitation poster will be on display informing patients of the study and Participant Information Leaflets (PIL) 
will be available next to the automated check-in screen for patients to take away if they wish. The poster 
and PIL will provide general information on the study, together with contact details for the research study 
team should the patient wish to ask any questions about the study or clarify the research process before 
deciding whether or not to participate. The PIL will also contain information on how patients can withdraw 
any information provided for the study.  
Following a patient using an automated check-in screen to confirm their attendance for a booked 
appointment by selecting the day of the month they were born, the month they were born and then the first 
letter of their surname (as standard), the additional research questions will appear for completion. Only 
once the research questions have either been answered, ‘skipped’ or sufficient time has elapsed without a 
response, will the check-in screen provide confirmation of the patient’s attendance. 
 

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5.3   Screening 
The two research questions will not appear for patients checking-in for a booked appointment who are 
under the age of 18 years or for those that have already answered the research questions during the 
recruitment period. 
5.4   Research questions 
Following entry of the standard identification items, to confirm attendance for a booked appointment, a 
patient will be presented with the first research question for completion. The first research question to 
appear on the check in screen will be; 
“How much bodily pain have you had during the past 4 weeks?” 
With options for completion of; 
“None”, “Very mild”, “Mild”, “Moderate”, “Severe”, “Very severe” 
or  
“Skip question” 
Once a response to the question has been selected, the second research question will appear; 
“Would you be happy for your practice to contact you about any future research studies which are 
relevant to your health, to improve care for patients in the NHS?” 
With options for completion of; 
“Yes, I’d be happy for you to contact me about research of relevance to me”, “No, thank you” 
or  
“Skip question” 
If the patient takes no further action once the first research question appears, the screen awaits a response 
and after sufficient time has elapsed without a response, the automated check-in screen will return to the 
‘Home’ screen, after confirming checked-in attendance for the booked appointment. The second question 
will therefore not be displayed. 
If the patient answers the first research question however takes no further action once the second research 
question appears, again the screen awaits a response and after sufficient time has elapsed without a 
response, the automated check-in screen will return to the ‘Home’ screen, after confirming checked-in 
attendance for the booked appointment.  

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5.5   Consent 
Consent to participate in this study will be obtained, in line with the definition outlined in Article 4(11) of 
the GDPR guidance, “any freely given, specific, informed and unambiguous indication of the data 
subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement 
to the processing of personal data relating to him or her”6. Consent to participate will therefore be implied 
by question completion. The study invitation poster and PIL (displayed alongside the automated check-
in screen for the period of recruitment) will explain the purpose of the study, what is involved and what 
will happen to data that the participant supplies. No patient identifiable information will be collected. 
Completion of the research questions will be taken as consent to participate in the study.  
5.6   Data collection 
A psuedonymised data extraction, for all booked appointments scheduled and attended during the three-
week recruitment period at each participating practice, for those patients of age 18 years or older, will 
be downloaded. Data to be included in the download will include; patient demographic data (gender and 
age), date and times (of patient check-in, booked appointment and consultation), check-in ID (system 
user / practice) and self-reported answers to the two research questions. These items will form the basis 
of the quantitative data collection, see Table 1 for data items and from where the quantitative data will 
be collected.  
For each participating practice, metadata to include; practice list size, demographic data (gender and 
age), deprivation score and total number of practice based consultations booked over the three-week 
recruitment period, will also be collected at aggregate level. 
Participant data provided in terms of check-in queries, made as a result of the two additional research 
questions on the patient automated check-in screen will be anonymously logged by practice 
administration staff, to assess the impact of check-in completion for general practice operationalisation. 
The log of queries will be populated for a total of 4 weeks. Three weeks, during recruitment to the study 
and for one week following the end of recruitment. 
Automated check-in data collection  
Patients will be asked to complete two self-report research questions during automated check-in for a 
booked appointment at their general practice. The data entered will be appended to their electronic 
medical record and psuedonymised data will be downloaded, for all patients for whom the research 
questions appeared. This data will consist of unique study identifiers, gender, age, times (check-in, 
booked and consultation), check-in ID (system user / practice) and the study research coded entries.  
 

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Table 1: Data items and method of data collection 
Data items 
Description 
Method of data 
collection 
Patient demographics 
Gender 
EMIS data extraction 
Age 
Date and time of: 
Check-in 
Booked appointment 
Consultation 
Check-in ID 
Dichotomous: ‘System user’ or 
‘Practice’ 
Degree of bodily pain experienced 
during the past 4 weeks. 
Single question: 1-6 point scale – 
degree of pain 
Patient self-reported 
Consent to contact about future 
research studies of relevance. 
Dichotomous: Yes or No 
 
5.7  Long term use of data collected 
Data collected on the degree of bodily pain experienced during the past 4 weeks will be retained at the 
general practice. The response provided as to whether the patient would be happy for their practice to 
contact them about any future research studies relevant to their health, will be a clinical coded entry retained 
in the patient’s electronic medical record, unless the patient requests to amend their response or if 
processing operations or purposes evolve14.  
5.8 
Withdrawal criteria  
Patients will be able to withdraw data provided for the study by either contacting a member of the AC 
DC study team or by informing practice administration staff of the amendment they would like to make 
to entered data. This therefore provides patients with up to a 4 week ‘cooling off’ period (before 
psuedonymised data is downloaded) should they wish to retract or amend their participation in the study. 
Patients will be able to amend their response at any time in the future, to whether they are happy for 
their practice to contact them about any future research studies which are relevant to their health. To 
amend their response to this question they will need to inform the practice administration staff. 
5.9 
End of study 
At each participating practice, recruitment will be ongoing for 21 consecutive days and a psuedonymised 
data extraction will be made for the 21-day recruitment period on or after day 28. The psuedonymised 
data extraction and meta data will be extracted by practice administration staff and securely transferred 
via nhs.net email to the Research Institute for Primary Care and Health Sciences (iPCHS). The study 
will last for 21 days at each participating general practice, after which time the additional two research 
questions will be removed from the automated check-in screen and the invitation poster and PILs 
removed from the general practice waiting room. The AC DC participant query log populated by general 

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practice administrative staff will be maintained for a period of 4 weeks at each participating general 
practice.  
The end of the study is defined as the collection of data from the last participating practice. The HRA 
will be notified of the end of the study in accordance with Keele University SOPs. 
 
6 
STATISTICS AND DATA ANALYSIS 
6.1 
Sample size calculation 
The average list size of CRN WM general practices is 7,500 patients, of which approximately 6,000 
(80%) will be 18 years of age or over. With the minimum required appointments, per week, per 1,000 
patients being 7211. Assuming the same rate of appointment use in those under and over 18 years, there 
will be an average of 432 appointments per week for those aged 18 years of age or over. Over three 
weeks therefore, discounting an approximate 10% of patients who have either; >1 appointment booked 
within the three-week period, lack capacity to complete the automated check-in screen, or the 
appointment is for either a telephone appointment or a home visit, the practices can expect 
approximately 1166 eligible participants.  
One of the outcomes of this study is to estimate the proportion of people who are happy for their practice 
to contact them about any future research studies which are relevant to their health. Assuming that 
approximately 50% will respond positively to this question, 9604 people will need to respond to the 
question in order to estimate a 95% confidence interval for this proportion formally with a precision of 
0.01. Assuming that 80% of those who use the automated check-in complete the additional questions, 
this would require approximately 12005 people to complete an on-screen check-in in order to achieve 
sufficient responders. This equates to approximately 11 practices displaying the questions for 3 weeks 
each, dependent on practice size and actual use of the automated check-in screens.  
One AC DC participant check-in query log per practice, completed by practice administration staff, with 
regards to queries made as a result of the two additional research questions on the patient automated 
check-in screen, will allow the study team to assess the impact of check-in completion for general 
practice operationalisation. 
6.2 
Statistical analysis plan 
Simple descriptive statistics will be used to compare any demographic differences between responders 
and non-responders and to characterise the study sample. This is a descriptive study and we will 
determine frequencies and percentages of responses to the 2 questions, stratified by age, gender and 
practice. Mean or median times (as appropriate) between check-in, booked appointment and time of 

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consultation will be calculated in responders and non-responders separately. In the production of and 
reporting on subgroups, ONS guidance will be followed on statistical microdata, to ensure the 
confidentiality of individual persons is protected13.  
Thematic content analysis will be used to interpret the participant data logged by practice administrative 
staff. 
In accordance with Keele University SOPs, a Statistical Analysis Plan (SAP) will be completed prior to 
the end of recruitment. 
 
 
7 
DATA HANDLING 
Data management will be carried out in accordance with a Study Data Management Plan, in accordance 
with Keele University Standard Operating Procedures (SOPs). The study data extracted will contain 
only psuedonymised data, which will be stored on Keele University servers and password protected. All 
confidentiality arrangements adhere to relevant data protection regulations and guidelines (General 
Data Protection Regulation (GDPR), Caldicott, General Medical Council (GMC), Medical Research 
Council (MRC) UK Policy) and the Chief Investigator and Study Statistician (Data Custodian) have 
responsibility to ensure the integrity of the data and that all confidentiality procedures are followed. At 
the end of the study, data will be securely archived in line with the Sponsor’s procedures for a minimum 
of 10 years after publication of the main findings and until the sponsor authorises destruction. Archiving 
will be carried out in accordance with Keele University SOPs. 
Any subsequent requests for access to the data from anyone outside of the research team (e.g. 
collaboration, joint publication, data sharing requests from publishers) will follow the Keele University 
SOP data sharing procedure.  
 
8 
MONITORING & AUDIT 
8.1 
Study Management 
The study Chief Investigator (CI) is responsible for the conduct of the study and will convene a Study 
Management Group (SMG) comprising members of the research team. Study management will be 
carried out in accordance with Keele University SOPs. The SMG will meet at regular intervals throughout 
the study and will be responsible for the set-up, ongoing management and monitoring and for the 
interpretation of the results. The SMG will oversee: the protocol completion; obtaining regulatory 
approval and site set-up; reporting of unexpected events to the REC and Sponsor; monitoring of 

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screening and recruitment procedures; data collection and software development; completing regulatory 
reporting requirements.  
The CRN WM, will co-ordinate the general practice identification process and co-ordinate local 
implementation and study set-up for the study team.  
8.2  
Monitoring arrangements 
Study monitoring will be carried out in accordance with a Study Monitoring Plan and Keele University 
SOPs which lay out the procedures for monitoring the data collection, protocol compliance and data 
management procedures.  
On day 3 of recruitment, an export will be downloaded by general practice administration staff and 
securely sent to iPCHS via nhs.net email, as a monitoring arrangement to confirm data collection 
functionality.  
8.3 
Safety Reporting 
No serious or unexpected adverse events are expected as a result of this study. 
Data entered with regards to bodily pain experienced over the last 4 weeks will be filed chronologically 
in the patients’ medical record, accessible to the HCP the patient is booked to consult with. The time 
frame between a patient reporting any bodily pain and being seen by a HCP will be minimal and HCPs 
will be aware of the study and that the pain score is being collected.  
8.4 
Study timeline 
May 2018 – June 2018: 
Finalise study documentation and study technological 
requirements. 
July 2018: 
 
 
 
NIHR Clinical Research Network Portfolio adoption. 
Liaison with general practices. 
Obtain ethics and regulatory governance approvals. 
November 2018 – April 2019: 
Recruitment 
May 2019 – July 2019: 
 
Data cleaning and data analysis. 
From July 2019: 
 
 
Dissemination 
 
 

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9  
ETHICAL AND REGULATORY CONSIDERATIONS 
Health Research Authority (HRA) approvals will be applied for and sought before the study commences. 
HRA Approval is the process for the NHS in England that brings together the assessment of governance 
and legal compliance, with independent Research Ethics Committee opinion provided through the UK 
Health Departments’ Research Ethics Service.  
9.1  
Research Ethics Committee (REC) review and reports 
The study will be submitted to and approved by a Research Ethics Committee (REC) under 
proportionate review and the appropriate Site Specific Assessor for each participating site prior to 
entering participants into the study. 
Following initial approval from the REC, the REC will be updated of the study progress in line with Keele 
University SOPs. 
9.2  
Patient and Public Involvement and Engagement 
In the UK there is a clear policy directive to involve patients and the public in research12. Such 
involvement will lead to research that is of greater relevance and of better quality. Keele University have 
an established Research User Group (RUG) who provide advice and feedback on study/trial conduct 
and offer patient and public representation on studies. 
Patient involvement pre-study (April 2018) 
8 patients from Keele’s RUG have helped to develop the study in the following ways: 
RESEARCH DESIGN: 
Question development 
Patients have assessed the proposed research questions (and discussed the required patient facing 
documentation) in terms of content, layout, style, order of questions, and overall length. 
Data collection processes 
Patients have helped to ensure presentation, content and functionally are acceptable for use within a 
general practice waiting room. 
DISSEMINATION: 
Results from the pilot feasibility study will be presented back to the RUG as they are interested in the 
acceptability of the intervention and would like to be involved in any amendments that are required 
should the study methodology be rolled out further for future research. 

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9.3  
Regulatory compliance 
Before any site can enrol patients into the study, the CI or designee will apply for HRA approval. For 
any amendment see section 9.7.  
9.4  
Protocol compliance  
All instances of protocol deviations will be assessed for severity by the CI (or their delegate), in 
accordance with the study protocol and using the Sponsor’s GCP and Protocol Deviations FOR25.1 
Initial Report. 
Both Corrective and Preventative actions should be considered to both correct the deviation and/or 
prevent the deviation from occurring again. 
9.5  
Data protection and patient confidentiality  
All information collected during the course of the study will be kept strictly confidential.  Information will 
be held securely and managed electronically by Keele University and in accordance with Keele 
University SOPs. 
9.6  
Indemnity 
This study is sponsored by Keele University and Keele University will be liable for negligent harm caused 
by the design of the study.   
The NHS has a duty of care to patients treated, whether or not the patient is taking part in a clinical 
research study, and the NHS organisation remains liable for clinical negligence and other negligent 
harm to patients under this duty of care. 
9.7  
Amendments  
The need for any potential protocol amendment will be raised with the CI and will be discussed with both 
the SMG and Sponsor prior to being agreed. Updated versions of the protocol will not be circulated for 
use until the appropriate regulatory parties have approved the amendment, at which point every effort 
will be made to implement this updated protocol as soon as is practicably possible, superseding the 
previous version and documenting the date at which the new protocol was implemented. 
 
 
 
 

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10  
DISSEMINATION 
10.1  Dissemination policy 
The Research Institute for Primary Care and Health Sciences (iPCHS) has a dedicated infrastructure, 
linked to strong regional, national and international health care and academic networks, which facilitate 
dissemination of our research findings to key policy, commissioning clinical, health education and patient 
stakeholders. The research team will be able to access our dedicated infrastructure to identify and 
promote research outputs that lend themselves to translation by health providers. Our strong regional 
partnership with the NHS (formalised through the Primary Care Research Consortium) and our 
leadership of the Person Centred Care programme of the West Midlands’ Academic Health Sciences 
Network provides further mechanisms to secure effective dissemination of our research findings at 
national and European levels, through access to the European Innovation and Technology funding 
streams. The study findings will be published in a peer-reviewed journal and made available via open 
access. 
10.2  Dissemination plan 
Dissemination will focus upon results addressing each of the study objectives. Results will be presented 
at relevant national conferences (e.g. Society of Academic Primary Care) and international conferences 
(e.g. World Organisation for Family Doctors). Findings will be disseminated to HCPs from participating 
general practices via a newsletter. Dissemination will also take place through the iPCHS Twitter account 
and blog. The study team will also work with the Keele RUG to provide lay summaries which will be sent 
to the patient panels at each of the participating primary care general practices. 
 
11 
REFERENCES 
1. NHS England, 2016. General Practice Forward View. 
2. Williamson, C. (2016). Electronic self check-in for patients: the costs and consequences. The 
British Journal of General Practice, 66(644), 145.  
3. Chambers, R. (2017). Code of practice for technology enabled care services for Staffordshire 
Local Digital Roadmap. Staffordshire Digital Design Authority (SDDA).  
4. Chambers R, Schmid M. Making technology-enabled health care work in general practice. British 
Journal of General Practice 2018, Vol. 68, Issue 668, March 2018 
5. Health Education England, Royal College of Nursing. (2017) Improving digital literacy (RCN, 
London). 
6. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and on the free 

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movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). 
Official Journal of the European Union, L 119/1. 
7. Irving G, Neves AL, Dambha-Miller H, et al International variations in primary care physician 
consultation time: a systematic review of 67 countries BMJ Open 2017;7:e017902. doi: 
10.1136/bmjopen-2017-017902 
8. Phillips C, Main CJ, Buck R, Aylward M, Wynne-Jones G, Farr A. Prioritising pain in policy 
making: the need for a whole systems perspective. Health Policy. 2008;88:166–175.  
9. NHD Digital, Freedom of information request NIC-105967-B8X4C, May 2017. 
10. www.emishealth.com 
11. British Medical Association. Safe working in general practice. 2016. 
12. NHS Executive. Health Service Circular 1999/210 Patient and public involvement in the new NHS. 
Leeds; NHS Executive Quality and Consumers Branch. 1999. 
13. Office for Statistics Regulation. Code of Practice for Statistics. Edition 2.0, February 2018. 
14. Information Commissioner’s Office. Consultation: GDPR consent guidance. 2017.