1. CONDUCTING THE TRIAL AT
A series of randomised controlled N-of 1 trials in patients who have discontinued or are considering discontinuing statin use due to muscle-related symptoms to assess if atorvastatin treatment causes more muscle symptoms than placebo
CONDUCTING THE TRIAL AT
YOUR SITE
Trial protocol code: ISRCTN
Version 1, 17 November 2016

2. Making the trial a success
Questions to answer before the trial starts
Strong StatinWISE team
Training your StatinWISE team
Managing the trial at your practice
How to ensure ongoing recruitment
Celebrate success

3. 1. Questions to address before the trial starts
How to create a strong trial team?
How to deal with colleagues who are not supportive of the trial – what are the issues?
Anxieties about putting patients into a research trial – have you given enough information to your staff, including potential risks and benefits?
How to keep recruitment going?
Incentive to recruit – why should your team take on additional trial related work?

4. Getting your colleagues to support the trial
Create a strong StatinWISE team; members should be fully informed and enthusiastic about the trial so they can talk about it to others. Plenty of training materials are available – please ensure your team has access to them.
Spread the word; talk about the trial with your colleagues – ideally before it starts – so that as many people as possible know your site is participating.
Promotion; the trial will be most successful if supported by all relevant team members.
THE TRIAL BELONGS TO ALL COLLABORATORS.
SUCCESS DEPENDS ON EVERY PERSON IN YOUR TEAM.

5. 2. How to create a strong StatinWISE team?
Identify people to be responsible for specific trial processes – they must be interested in the trial
Provide information and training to all team members
The CTU is also part of your team
Good communication is essential
Ask for help and advice if needed
Share your successes and difficulties – we may have experience in dealing with them
A strong, dedicated team is essential to making the trial a success
Roles may include
OR Staff at Site may include:
Principal Investigator
Practice Manager
Practice Administrator
Research Nurse
Practice Nurse
Nominate someone to be responsible in your absence

6. Alleviating concerns about the trial
The trial has been approved by relevant ethics committees
It will be easier for your team members to carry out the procedures if they are fully trained
Training materials can be found in the Study File and on the trial website
The genetic study is optional – only the particular variant thought to be involved in pain will be looked for, no other analysis will be conducted. All instructions and materials required for this have been provided to site

7. Alleviating concerns about the trial
Good Clinical Practice (GCP): is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
StatinWISE trials follows GCP guidelines
Free online training via our LSHTM website:
A certificate will be issued upon successful completion
All staff involved should complete prior to the study starting at your practice

8. Either Log in or Create new account

9. Alleviating concerns about the trial – Trial Specific Training
MANUAL OF OPERATING PROCEDURES (MOP)
Overview of the trial processes for principal investigators (PI), nurses, practice managers, monitors, other people with responsibilities in the trial
Important that all personnel involved are familiar with the sections relevant to their duties
PI needs to be familiar with the complete MOP
PRESENTATIONS
A selection of PowerPoint presentations explaining the trial procedures
SITE INITIATION VISITS
The CTU will organise face to face or remote training to explain the trial and its procedures prior to recruitment starting

10. 3. Training your StatinWISE team
We will provide all relevant training to staff at your site including:
Investigator Site file and training materials
Search list in your practice’s system
DOCMAIL posting system
Blood sample test tubes for optional genetic study
Treatment packs logistics as the CTU will post those tp participants
We can provide a small filling cabinet to store the ISF and materials. Let us know if your site needs one!
Remember: the CTU Team are always available to answer any questions throughout the trial

11. 4. Managing the trial at your practice
Ensure your whole team knows:
who is responsible if key team members are not there (e.g. lead research nurse / PI); identify key people; let CTU know
how to assess eligibility
consent procedures
how data should be completed
where Investigator Site File is kept and who is responsible for maintaining it
what to do if trial materials run out
what to do if team members need advice about the trial
what to do if there is an adverse event

12. 5. How to ensure ongoing recruitment
THE CTU WILL HOLD REGULAR MEETINGS WITH THE TEAM AT YOUR SITE
TO ENSURE THE StatinWISE TRIAL IS ON THE AGENDA
Things we’ll discuss:
Current status of the trial: Ensure all team members are aware of the current status i.e. how many patients recruited nationwide / at your site
Recruitment strategies: Patient searches can be repeated monthly. Personal experiences of the trial  resolution of any problems
Motivation: Encouragement – keep team motivated
Training: Train new staff – refresh team members on trial procedures
Collaboration : This is a collaborative effort and will be most successful if everyone works together
Support: Network Research Nurse support may be available in your area
Remember to arrange holiday cover if key members of the team are planning to be away from the site so that randomisation into the trial can continue in their absence.

13. 6. Celebrating Success
Feedback: all team members should receive feedback about their contribution to the trial
Praise: all team members should be congratulated for their hard work
Incentives: CTU can provide incentives and certificates. Please share these between the team members
Please provide the CTU with names, addresses and phone numbers of all team members – we would like to thank them personally
The CTU will feature teams in the trial newsletter and the website. Send us a photo of your team and let us know of any trial related news or other achievements that we might like to mention.

14. StatinWISE aims to: Answer an important question for public health
Answer the question for individual
patients
Bring together research and
care
As little work as possible for
GPs Practices

15. CONTACT US London School of Hygiene & Tropical Medicine
Room 180, Keppel Street, London WC1E 7HT
Tel +44(0)
Fax +44(0)