CONTACT INFORMATION

How can I contact the STRATA Central Research Team (UK)?

The Central Research Team (UK) is based at the University of Bristol. The team email address is: strata-rct@bristol.ac.uk, and the phone number is 0117 428 3001.

Information about STRATA, including the research team and other useful contact details, can be found on the study website.

 

UNITED KINGDOM (UK) AND AUSTRALIA CONSIDERATIONS

STRATA is an international study taking place in the UK and Western Australia. Due to the potential variation in patient pathways (and processes) between the two countries, study set-up and conduct should be adapted according to local arrangements, in discussion with the Central Research Team (UK).

We acknowledge that the healthcare system in Western Australia is different to that of the UK; specifically, that a Psychiatrist (rather than General Practitioner (GP)) typically oversees the care of the study population group. In such cases, where GP is referred to, it is acceptable for suitable equivalent healthcare professionals to perform relevant assessments and/or processes. Other significant differences between the UK and Western Australia are highlighted throughout the Protocol.

If in doubt, contact the Central Research Team (UK) to discuss.

 

CORONAVIRUS (COVID-19) CONSIDERATIONS

How will the trial be conducted in light of COVID-19?

To enable STRATA to continue during the coronavirus pandemic, the study has been designed taking key legislation and/or guidance into consideration; full details are provided in the protocol (Appendix 2). Critically, STRATA offers flexibility around assessment and communication methods with (potential) participants. If/where necessary, all appointments can be conducted remotely through a range of methods to suit an individual’s contact preferences (e.g., Sponsor/NHS-approved video call, phone call, etc).

Are face-to-face appointments feasible?

If face-to-face appointments are requested, research staff should assess feasibility and follow the organisation guidance at the time regarding face-to-face contact, including, for example, use of personal protective equipment (PPE) and cleaning procedures. The safety of participants and staff are the priority; neither you nor patients will be asked to do anything that you feel uncomfortable with.

Should I wear a face covering when meeting participants (e.g., during an in-person appointment)?

Where the law indicates, face coverings should be used. The safety and comfort of participants and staff are the priority; neither you nor patients will be asked to do anything that you feel uncomfortable with, so it is important to discuss in advance with participants.

Of note, in the UK (at time of writing; May 2021), several exemptions currently apply, which may apply to the researcher and/or the participant. For example, a researcher or participant may be exempt for the reasons stated in government guidance, or may need to remove their face covering if “speaking to or providing assistance to someone who relies on lip reading, clear sound or facial expressions to communicate”. You should discuss this with the person when deciding how to proceed. Please be mindful that proof of exemption is not required. Relatedly, individuals with exemptions must not be treated differently as a result (for example, asking them to sit closer to a window or to undertake assessments outdoors).

 

SITE IDENTIFICATION AND SET UP (INCLUDING PERSONNEL)

What is the setting for STRATA?

STRATA will be delivered through autism services in regional centres in the UK and Western Australia that provide services for eligible patients. Recruiting sites may include those within mental health and/or learning disability service providers, social enterprises, primary care, University primary care/disability services, community organisations, and charities.

Details about participating sites can be found here.

Who can act as a Principal Investigator (PI) for STRATA?

A principal investigator (PI) at each Site for STRATA will be an experienced doctor who is able to take on the overall responsibility of delivering the study at the Site. They will need to have a valid certificate of Good Clinical Practice and relevant qualifications. The PI can identify other colleagues/team members (such as Co-PI’s, study investigators or prescribers) to whom they can delegate duties related to the study.

Do the Principal Investigator (PI)/Team Members need to provide a GCP certificate and CV?

Yes. For all team members (i.e. anyone listed on the site delegation log), UK and Western Australia sites will need to provide the Central Research Team (UK) with: (1) a valid Good Clinical Practice (GCP) certificate that is completed within 3-years of site start date, and (2) a research CV.  Recruitment cannot begin at the participating site until the Central Research Team have reviewed these.

Do staff members (who are NOT on the delegation log) introducing the study to patients require GCP training?

No. All individuals on the site delegation log must have updated GCP training, but this does NOT apply to trust staff members who are simply introducing the study to potential participants throughout the course of their clinical duties, for example passing on a flyer and/or contact details for the local site team, putting up recruitment posters in waiting rooms, handing out flyers, etc.

Are Co-Principal Investigators (Co-PIs) permitted on this trial to spread workload?

Yes, the Principal Investigator (PI) can be supported by a local team of clinicians which may be designated as Co-PIs, site investigators or prescribers.

Who can prescribe study medication as part of the STRATA protocol?

The Principal Investigator (PI)/Co-PI and delegated study prescribers. All prescribers must be registered medical practitioners with a current licence to practice.

How will study training be provided to participating sites (staff)?

In the interests of time and flexibility, training is self-directed. All training materials are available via a dedicated section on the study website. Guidance is provided about what training is required, according to your role in the study. After staff complete the appropriate training modules, they will be asked to complete a brief online ‘Training Log’ form (record) that is available here.

Once essential training has been completed, the Central Research Team (UK) will arrange a (remote) meeting to review and discuss your (site’s) understanding of the study and finer details about local practicalities. When satisfied, the Sponsor (University of Bristol) will then confirm when recruitment can begin at the participating site and site study teams will receive access to the online study-specific data collection systems.

Who decides when recruitment can begin at participating sites?

In the UK, individual Trusts are responsible for assessing and confirming capacity and capability. A signed contract is also required. The Sponsor (University of Bristol) will then confirm when recruitment can begin at a participating site. See the FAQs section CONTRACTING below for further information.

 

CONTRACTING

What site agreement (contract) is used and can we negotiate the terms of this contract?

STRATA uses a model non-commercial agreement (mNCA) and it is only possible to negotiate the recruitment target.

Will sites have contract recruitment targets?

Sites should recruit 2-4 participants per month, but this target can be negotiated and may depend upon the profile of the services provided at the site.

Should recruitment data for STRATA be uploaded by sites to Local Portfolio Management Systems (LPMS)?

No. The Central Research Team (UK) will upload recruitment data to the Central Portfolio Management System (CPMS).

 

REGULATORY INFORMATION

Where can I see the regulatory and ethical approval documentation for STRATA?

All ethical and regulatory documents are available in the Investigator Site File.

 

DOCUMENTATION AND DATA

What types of data are collected for the STRATA study?

See protocol (Section 12) for information.

Source data for this trial will consist of electronic and/or paper versions of:

• preliminary screening and expression of interest forms
• consent forms
• participant and carer completed questionnaires
• Case Report Forms (CRFs)

Local teams must keep a hard copy of trial and carer participants’ Participant Information Leaflets and Consent Forms in their Investigator Site File, regardless of the method of data collection. To enable working remotely, electronic records will suffice until a time when they can be printed and filed.

Please note that:

• Where data has been collected on paper, these data must be entered onto the STRATA database as soon as practical by local research teams (see FAQs section DATABASE)
• Paper documents containing identifiable information must be stored in a locked filing cabinet only accessible to members of the local research team.

How do I collect data during ‘remote’ appointments?

It is anticipated that the majority of the trial appointments will be conducted remotely. Therefore, (e)Consent and questionnaires are available online, via posted paper copies, or to be completed over the telephone. All participant data will be entered into the REDCap database. Please note that access to the internet is required when conducting appointments remotely.

Where can I obtain the documentation required for STRATA?

All documents relating to the study are available on the study website. This is intended to be a single point of access for all study documents and information and will be updated if new documents/document versions are introduced. A single document will also be included detailing the latest version of the study documents.

Where can I find the protocol?

As noted in the above FAQ, study documentation is available on the study website.

Will participating sites require an Investigator Site File (ISF)? If so, how will this be arranged?

Investigator Site Files will be initially provided electronically. Updates to study documents will be available on the study website. You will be notified of updates to study documents when they occur.

Do Patient Information Leaflets (PIL)/Informed Consent Forms (ICF) and/or any other associated documents require localisation?

Yes. Sites should localise their patient study invitation pack.

Will a delegation log be made available for use by the site team?

Yes. Each participating site will be required to maintain a ‘STRATA Participating Site Delegation Log’ and retain a copy in the local ISF. A copy should also be provided to the Central Research Team (UK) for monitoring purposes.

Is it possible to provide study documentation in other languages?

We will not be able to enrol individuals who cannot adequately understand verbal explanations or written information in the English language. The study questionnaires include instruments validated in English, but if translated to another language, may not be validated. Furthermore, essential safety checks need to be carried out by members of the research team who will need to converse with participants in English; access to interpreters is not available.

Are the data collection Case Report Forms (CRFs) available in paper-form, or should data be added directly to the online STRATA REDCap database?

As default, data should be entered directly to the online STRATA REDCap database.

If, however this is not feasible, then paper copies are available for capturing the information. Site Staff should proceed to enter the data to the database as soon as feasible. The paper CRF should be retained in the local Investigator Site File (ISF). Any paper documents containing identifiable information must be stored in a locked filing cabinet at the site, which only members of the local research team have access to.

How are the data archived?

Local teams will be responsible for ensuring that all study records held at their site are archived appropriately when notified to do so by the Sponsor/Central Research Team, University of Bristol).

Data will be retained for at least 5 years after the end of the trial in the UK, and 15 years in Australia. At the end of the archiving period, data will be destroyed confidentially (except for a final dataset). The approval of University of Bristol, the trial Chief Investigator, and equivalent lead of the Western Australia centre will be sought prior to data destruction.

Further details will be provided to participating sites (centres) when available.

 

DATABASE

What is the online study database system?

Study data are collected and managed using an online database system called REDCap (Research Electronic Data Capture, Harris PA, et al. J Biomed Inform. 2009 Apr;42(2):377-81) hosted at the University of Bristol (UK).

There are two study-specific databases:

1. The STRATA Admin Database collects confidential patient identifiable data; and
2. The STRATA Clinical Database collects non-identifiable data.

How do I access (log in) to the online study database system?

You will be provided with a unique username and password to both the STRATA Admin Database and the STRATA Clinical Database.

• You can access the STRATA Admin Database here
• You can access the STRATA Clinical Database here

You may wish to bookmark these links for future ease of access.

Please note: ‘University of Bristol Associate Status’ is required before you can access restricted sections of the database; see FAQ below, ‘What steps do I need to take to access the online study database system?’.

What extra steps do I need to take to access the online study database system?

The Admin Database is access-controlled because it contains confidential patient identifiable information. Staff who require access to this system (e.g. those with medication prescribing responsibilities and RAs) will be provided ‘University of Bristol Associate Status’ before database log-ins can be provided. Once the University of Bristol has granted you associate status, the Central Research Team (UK) will be able to provide you with user log-in details. If you have an active substantive or honorary appointment with the University of Bristol, then you will not need associate status.

To request ‘University of Bristol Associate Status’ you will need to action the following:

1. Complete Section A of the Associate Status Request Form and then email it to strata-rct@bristol.ac.uk

Please note: the processing of Associate Status Request Forms can take 2-3 weeks.

In addition, when accessing the admin database, you will need to be logged in to the University of Bristol Remote Desktop, accessed via the instructions available in Module 12 Introduction to the STRATA databases located in Site Training and this link. Sign in with your University of Bristol username (username@bristol.ac.uk) and password (note these will be received once you have been granted Associate Status).

I am having trouble logging in to the online database system. What should I do?

If you cannot log in to the admin database, please check that you:

• Have the required University of Bristol Associate Status
• Are logged in to the University of Bristol Remote Desktop (download available in Module 12 Introduction to the STRATA databases located in Site Training)
• Are using the correct username and password

See FAQ above; What extra steps do I need to take to access the online study database system?

Here’s a summary of the networks and databases you may need to use, and their access requirements:

University of Bristol IT Network

• Employee of University of Bristol or holder of University of Bristol Associate Status
• University of Bristol Remote Desktop Portal
• University of Bristol IT Unique Username and Password

STRATA Admin Database

• Logged-in to the University of Bristol IT Network
• REDCap Admin Unique Username and Password

STRATA Clinical Database

• REDCap Clinical Unique Username and Password

STRATA Randomisation System

• Sealed Envelope Unique Username (registered email) and password

Is it possible to do some further training to better understand how to use the STRATA database system?

Yes. We appreciate that the remote nature of this study relies upon successful use of the online STRATA database system. We have included guidance within our training materials and we have a “development” version of the Admin and Clinical databases available for users to practice on before they use the “live” systems. If additional training would be useful to you (and/or members of your site team), we are happy to provide this. Please contact the Central Research team (UK) for more information: strata-rct@bristol.ac.uk

 

IDENTIFICATION OF POTENTIAL PARTICIPANTS AND INVITATION TO TAKE PART

Who is eligible to take part in STRATA?

If a patient is 18 years or older, has an autism diagnosis, experiences anxiety for which they would consider medication treatment, and are not currently taking sertraline or other SSRI treatments, they may be eligible.

The full list of inclusion/exclusion criteria are available in the protocol (section 5 – Eligibility Criteria).

What is the study treatment (intervention)?

In STRATA, we want to find out whether the medication sertraline is an effective treatment to reduce anxiety in adults with a diagnosis of autism.

People who take part will receive either sertraline, or a placebo (inactive) medication in capsule form. They will be asked to take it for up to one year. Please note that the medication capsules may contain gelatine which may not be suitable for vegans.

How often are participants contacted during the study?

Participants will be contacted briefly by trained study staff via video call, telephone, text or email (whichever method they prefer) at 1 to 2, 4, 8, 12 and 36 weeks after they join the study; this is to see how they are getting on with the study medication.

Participants will be also asked to complete questionnaires (no appointment necessary) at baseline (week 0), 16, 24 and 52 weeks after they join the study. The questionnaires will ask about their anxiety, other symptoms, and healthcare usage; a £10 gift voucher in the UK, or $20 gift voucher in Australia, will be offered upon receipt of each completed questionnaire.

Can STRATA participants change their mind about taking part after they have joined the study?

Yes. See FAQs section CHANGE OF PERMISSIONS / WITHDRAWAL FROM THE STUDY for further details.

Can STRATA participants also take part in other studies?

Competing study (e.g. randomised controlled trial, interventional study): Co-enrolment in STRATA and another competing study should be avoided due to potential impact on the study objectives and patient burden and safety.

If you become aware that a participant has enrolled in a ‘potentially competing study’ whilst taking part in STRATA, you should inform the Central Research Team (UK): strata-rct@bristol.ac.uk who will evaluate whether it is appropriate for them to continue in STRATA.

Non-competing study (e.g. one-off interviews or questionnaires): If a participant informs you they are interested in enrolling in other ‘non-competing studies’, you should advise them to consider the potential burden to them, social support, travelling distances, etc. However, it is the participant’s decision. If you become aware that they have taken part, you should inform the Central Research Team (UK): strata-rct@bristol.ac.uk.

Can a participant access other treatment and/or interventions whilst taking part in STRATA?

STRATA is a pragmatic study. Usual care can continue without restriction, including for example referrals to psychological therapies, such as Improving Access to Psychological Therapies (IAPT) services. GPs/clinicians can also prescribe other medication as necessary but are asked to exercise caution in prescribing drugs that may interact with the study medication, sertraline.

How/when can I identify potential participants and invite them to take part in STRATA?

Full details are provided in the protocol (Section 6); Figure 3 presents an overview of the identification and screening of potential participants, including what study documents need to be completed.

In brief, potential participants can be identified from any of the following pathways:

• clinical appointments and/or lists (including clinic lists or mailing lists for newsletters or information);
• research registers; or
• via self-referral.

Local site staff may discuss the study with potential participants and proceed with preliminary screening and expression of interest there and then. Alternatively, site staff can provide them with a STRATA Study Invitation Pack (can be found in your Investigator Site File) and refer them to the (online) STRATA Preliminary Screening and Expressions of Interest Form (available here). Site staff should also complete a STRATA Referral Form (available here) so that the local research team can update their site STRATA Screening Log record.

What information can I send to potential participants?

When contacting potential participants for example by newsletter, mailing list, research registers, databases etc., you should send them a STRATA Study Information Pack (can be found in your Investigator Site File).

This information pack contains: the study invitation letter, Patient Information Leaflet (PIL) and easy-read PIL, paper Expression of Interest (EOI form [but individuals will be encouraged to complete the online EOI form, see FAQ below]), freepost envelope (for returning EOI Form if using paper-form), and a GDPR Using Patient Data Information sheet.

Alternatively, potential participants may be directed to view the key documents via the study website.

How can I and/or a potential participant express interest in taking part in STRATA?

Individuals who are interested in taking part in STRATA should complete the STRATA Preliminary Screening and Expression of Interest Form; this can be done with a clinician during a clinical appointment, or by the individual at a convenient time.

We encourage individuals/you to use the online version of the Expression of Interest form (available here), as the default method where feasible.

If required, however, a paper version is also available.

Where can I find the online Expression of Interest (EoI) form?

You can access the online EOI form here.

A potential participant is not registered with a GP (doctor)/GP Practice. Can they take part?

No. It is essential that a potential participant is registered with a GP/GP Practice so that the research team can complete a mandatory ‘GP Patient Safety Check’ as part of the STRATA eligibility screening process.

If an individual is not currently registered with a GP/GP Practice, but wants to take part, they could be advised to consider registering with one.

I am awaiting the response of a ‘GP Patient Safety Check’. How do I chase this up?

Local research teams are responsible for monitoring GP responses for their potential participants. If you are awaiting a response, site staff can use the approved ‘reminder’ email/letter to contact GP/GP Practices. Alternatively, you may wish to call and speak with the Practice directly, or contact your local Clinical Research Network (CRN) for help. If reminder/contact attempts are unsuccessful, a medical summary can be requested from the surgery, and the PI can complete the safety check using this information. Please contact the Central Research Team (UK) to explore other options if required: strata-rct@bristol.ac.uk.

 

QUINTET RECRUITMENT INTERVENTION (QRI) [UK SITES ONLY]

I am at a site in Australia. Should we be audio recording discussions with participants for the Quintet Recruitment Intervention (QRI)?

No, the QRI is only applicable to UK sites.

How do I audio-record an in-person appointment?

You should use an encrypted audio-recorder during relevant discussions with (potential) participants. If you intend on conducting in-person appointments and require an encrypted audio-recorder, please email us strata-rct@bristol.ac.uk.  If an encrypted audio-recorder is used, this should be securely stored in a locked drawer/cabinet when not in use.

Please note that staff recording discussions with potential participants for the QRI need to complete the QRI Staff Consent form here.

How do I audio-record a remote appointment?

You should use Sponsor/NHS-approved video-conferencing tools for appointments with (potential) participants.  Where a video-call is to be recorded, where possible (for example in Zoom), you should select audio recording only; where this is not possible (for example in Microsoft Teams), software should be used to extract only the audio from the recording. The QRI team will discuss with each site individually how best to record and transfer files; email us strata-rct@bristol.ac.uk.

How do I store audio recordings?

As above, either audio-only recording should be used via Sponsor/NHS-approved video-conferencing tools, or where this is not possible (e.g., in Microsoft Teams), software should be used to extract only the audio from the recording for saving to the database. The QRI team will discuss with each site individually how best to record and transfer files. Audio files should be uploaded to REDCap once written consent has been obtained (see important instructions below):

• Verbal consent to audio-record the appointment will be recorded in the clinical referral form (via the online eConsent system)
• Audio files should be temporarily saved using the format: STRATA_[Your name]_[Appointment date]_[Patient name]_[DOB]
• Only audio files should be uploaded to REDCap using participant ID number (when assigned after EOI is submitted)
• Where applicable, if an audio-recorder is used, this should be securely stored in a locked drawer/cabinet when not in use.

I need to use a standard audio recorder for in-person appointments – can I request one?

If you intend on conducting in-person appointments and require an encrypted audio-recorder, please email us strata-rct@bristol.ac.uk. Where applicable, if an encrypted audio-recorder is used, this should be securely stored in a locked drawer/cabinet when not in use.

 

BLINDING AND EMERGENCY UNBLINDING

Who is blinded to treatment allocation?

The research team (including the PI/prescribers/recruiters/other research staff), the participant, and their Doctor (GP) will remain blinded to treatment allocation throughout the study. See also, When can the participant be made aware of their treatment allocation (unblinding)?

Who is aware of treatment allocation?

The unblinded randomisation code will be held by the study pharmacies and selected members of the Bristol Randomised Trials Collaboration, only. If you become aware of a participants treatment allocation during the study (and/or at study end) please do not inform the Central Research Team, who should remain blinded throughout.

How can I conduct emergency unblinding?

See section 6.15 of the Protocol. The central research team at the University of Bristol should be notified if emergency unblinding occurs: email strata-rct@bristol.ac.uk. In the event of a medical emergency, the participant’s treating doctor can contact the relevant central pharmacy for unblinding (available 24/7):

• UK: University Hospitals Bristol and Weston NHS Foundation Trust (UHBW): The direct number for UHBW Pharmacy trials, manned 08:30-17:00 Monday to Friday, is +44 (0)117 342 4175. Outside these hours, call the UHBW hospital switchboard on +44 (0)117 923 0000 and ask for the “on-call pharmacist”
• Australia: Fremantle Hospital (FH) (Fiona Stanley Hospital Fremantle Group (FSHFG)) Pharmacy: The direct number for FH Pharmacy trials, manned 08:30-17:00 Monday to Saturday (except public holidays), is +61 (0)8 9431 2587. Outside these hours, call the Fremantle Hospital (FSHFG group) on call pharmacist on +61 (0) 4 1033 2943

Who is responsible for making participants aware of their treatment allocation (unblinding) after participation?

If this information is requested by the participant, then the responsibility for revealing treatment allocation rests with their Doctor (GP), not the Central University of Bristol study team, nor Site Teams. This is to ensure the research team remains blinded to treatment allocation. Participants and Doctors (GPs) are informed about this option in the relevant letter(s) sent when a participant either completes their participation in the STRATA trial (>52 weeks post-randomisation), or withdraws entirely from the study (when treatment allocation must not be revealed until >16 weeks post-randomisation).

Participants only withdrawing from taking the study medication but who are continuing to complete follow-up questionnaires must not be unblinded until after they complete their participation in STRATA (>52 weeks post-randomisation). This is to ensure unblinding does not bias their subsequent responses to any questionnaires. This rationale can be explained to the patient where necessary.

 

MONITORING (INCLUDING GCP/PROTOCOL DEVIATIONS)

What study monitoring procedures do I need to be aware of?

Full information on study monitoring is available in the protocol (Section 14).

In brief:

• The study will be monitored and audited in accordance with the Sponsor’s policy, which is consistent with the UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) Regulations (UK) and the National Health and Medical Research Council (NHMRC) (Australia).

• All study related documents (e.g. local Investigator Site File (ISF)) should be kept up to date and made available for monitoring and audit/inspection upon request

How do I report a protocol deviation?

Information about ‘Protocol Compliance’ is available in the protocol (Section 14.2).

To report a protocol deviation, you must use the ‘STRATA Protocol Deviation Report Form’; a blank template can be found in your Investigator Site File (ISF) and from the online documentation resource.

Once the form is complete: you should retain the original in your ISF, and copies should be emailed to the following:

• Central Research Team (UK): strata-rct@bristol.ac.uk;
• Chief Investigator: dheeraj.rai@bristol.ac.uk;
• Sponsor: research-governance@bristol.ac.uk

What is considered a “serious breach” of Good Clinical Practice (GCP) and/or the protocol?

As noted in the protocol (Section 14.3), a “serious breach” is a breach which is likely to effect to a significant degree:

• The safety or physical or mental integrity of participants; or
• The scientific value of the study.

The Central Research Team (UK) will notify the Sponsor immediately of any breaches, who will determine the seriousness of the breach.

 

CARER STUDY

How are potential carer study participants recruited?

A Carer Study Information Pack (can be found in your Investigator Site File) will be provided to the STRATA participant after their Baseline appointment to give to their carer, including:

• Carer Invitation Letter
• Carer Participant Information Leaflet
• Carer Consent Form
• Carer Baseline Questionnaire and Freepost envelope (please note that online responses are preferred)

See Module 12 Carer Study, and Protocol section 8 for detailed information about the carer study.

Who can be considered a carer for participation in the carer study?

It is up to the STRATA participant to define who their carer is; where feasible, it would be one carer who knows them well and is likely to continue caring for them over the 52-week trial period.

What is involved with regard taking part in the carer study?

The carer study aims to explore how the treatment of anxiety for adults with a diagnosis of autism affects their carer. In brief, carer participants will be asked to complete a questionnaire three times; when the person they care for starts taking part in the study, and then at around 16 weeks later, and again at 52 weeks later. The questionnaires will ask about care giving responsibilities, health, and any support received, as well as some questions about the person they care for. See Module 12 Carer Study, and Protocol section 8 for detailed information.

A potential carer study participant has not returned their consent form and first questionnaire. What do I do?

Local teams should ask the STRATA participant if they have provided their carer with the study information at the 1-2 week safety check appointment. If not, they can be reminded up to once.

Can the carer continue participation in the carer study if the STRATA participant withdraws from the main trial?

The carer can continue involvement if the participant withdraws from the main trial. Similarly, the participant is still able to participate in the trial if carers do not wish to participate, or if there is no carer.