CRN Frequently Asked Questions

As sites are not required to carry out MRI scans or clinical interventions, from PLORAS's point of view, the PI does not have to be a medical doctor - they could also be, for example a nurse or a therapist.  Please check with your Trust, however, as local rules may apply.

No.  This is up to individual sites to provide if required by your Trust.  

(A delegation log is used to record who is performing certain research tasks and ensure they are qualified and authorised to do so).

No.  This is up to individual sites to provide if required by your Trust.

(A site file is used by sites to store all documentation relevant to a study).

We are not conducting formal Site Initiation Visits (SIVs) or teleconferencing but do hope to visit as many sites as possible over the course of the project.

Please see below under 'Training' for details of how sites will receive training.

No extra equipment is necessary.

No.

Yes - if the speech and language therapist chooses to complete the CAT for clinical purposes we would not want to discourage this and disrupt the patient's assessment schedule.

Equally, we would not want to ask them to administer the CAT specifically for research purposes as we are not set-up to fund this.

We have a section in the consent form where we ask for consent to obtain language assessment results from the participant's health professionals.

If the patient is happy with this and completes this part of the consent form, the speech and language therapists could potentially share the results of the CAT and other relevant assessments with us. Reciprocally, we also ask participants if they are happy for us to share the data we collect (language assessment results/brain scan) with their health professionals.

CVs and GCP training should be approved locally by the Trust's R&D department as required - the PLORAS Research Team do not need copies.

We do require a copy of your NHS permission letter, and the Data Sharing Agreement must also be in place (see below under 'When can sites start recruiting?' and 'Contracts').

Following Substantial Amendment 4, there are now allowances for this, outlined in Version 3 of the Protocol (page 9).

Previously, the consent form had to be done face-to-face for all participants, and the consent form needed to be fully completed and signed before the participant goes to UCL in order for the research site to receive the recruitment point.

However, now participants can be consented only by the PLORAS Research Team on the day of appointment when it is not practical to consent participants face-to-face (e.g. participant contacted hospital following media broadcast/article but does not live locally; participant recruited at stroke event or via invitation letter but not due to attend clinic).

In these cases, the research team at the study site should arrange for completion of the screening questionnaire to be returned to their site, and then transferred to the PLORAS Research Team.  Study sites should notify the PLORAS Research Team of these cases as they arise.

Before sites can start recruiting, we need to have the following:

• Data Sharing Agreement (DSA) in place (signed by both parties), and confirmation that you have received the fully executed copies.  A e-mail confirming receipt to our Data Manager is sufficient.  (See more on the DSA under 'Contracts' below).
• NHS permission letter with all correct documents approved.  (Please send copy to ploras@ucl.ac.uk).
• Name and postal address of main contact in your research team, who we then send an opening letter/pack to (and cc. the site PI).

The opening pack contains:

• Final information on what research teams need to have in place/completed, i.e: GCP training, the PLORAS quiz, the PLORAS training video, and read through the PLORAS FAQs and model answers to patient questions on the website.

• Further information on data transfer, including our nhs.net address.
• Copies of the PLORAS A5 booklet (document 1a) to get you started - these are to provide your patients with a basic overview of the study.  Please contact us if you need more of these.
• PLORAS recruitment flashcards - these are to keep with you when recruiting and list key points about the study for your reference.

Once you have received the opening pack, and satisfy all the stated requirements, you can begin recruiting for PLORAS!

As a minimum, we require the following, fully completed:

• PLORAS Participant Screening Questionnaire (3E).
• PLORAS Participant Information and Consent (4E).

(Or picture/consultee versions of above, where appropriate).

These MUST be transferred using the methods outlined in the Data Sharing Agreement (see below under 'Contracts' for more information on the DSA).

Please also see your site opening letter for instructions on how to label files.

For DSA queries, please contact Marina Anderson (marina.anderson@ucl.ac.uk).

Sites must ONLY transfer data using the agreed methods outlined in the Data Sharing Agreement (DSA).  See below under 'Contracts' for more information on the DSA.

Whilst you can download the DSA from our website, we would strongly recommend research teams ensure they have a copy of their site's signed DSA in their site file (as there are minor variations in the agreement for some sites).

If you do not already have a copy of your site's DSA, contact your Information Governance team.

[Added 23/08/2017]

The optimum scenario for patients taking part in PLORAS is undertaking both the behavioural assessment and research MRI brain scan at our centre in London.

However, we are aware that for some patients, travelling to London is not possible, and there may be contraindications to having a research scan with us (e.g. if the patient has a metallic implant we cannot scan).  We therefore have flexibility in the options for taking part, as we want to ensure we don't exclude stroke survivors who may be otherwise eligible (and therefore have a representative sample of the stroke population).

Please see below for the hierarchy of what is ideal for PLORAS.  If patients are keen to take part but fall lower down the hierarchy, please let them know you can recruit them, but they will be lower priority at present.

1. Behavioural testing at our Centre, research MRI brain scan at our Centre

2. Behavioural testing at our Centre, MRI brain scan from another source

3. Behavioural testing at home (by PLORAS Team), MRI brain scan from another source

When we have established CT scans are predictive, the next steps will be:

4. Behavioural testing at our Centre, CT brain scan from another source.

5. Behavioural testing at home (by PLORAS Team), CT brain scan from another source.

Please note also that PLORAS is currently funded to 2022, so you can let patients know that if they do not feel able to travel to London at present, we would be happy to receive the referral and keep them on hold until they are ready.

• The research practitioner from the site should first contact the patients to check they have 1) had a clinical MRI since their stroke, and 2) would consent to the PLORAS team obtaining this.
• If the answer to 1) and 2) is yes, the research practitioner will then need to see the patient to complete the PLORAS screening questionnaire (3E/3S) and consent form (4E/4S).
• These forms should then be transferred to the PLORAS team using the approved methods.
• Once we receive the forms, if all inclusion criteria are met, we will attempt to obtain the patient's clinical MRI scan.
• If we receive the clinical MRI scan, we will then assess the quality of the scan to ensure it's sufficient for our analysis and reaches our criteria for home language assessment.
• *Please inform patients (ideally at first contact after receiving reply slip) who live far away from London that they may not be able to be included in PLORAS following review of the scan (if this is the case they will be kept on record for any future opportunities).*
• Note that sites will still receive a recruitment point if the patient does not proceed to the language assessment stage (providing all inclusion criteria were met and forms completed and transferred adequately).

[Sent to sites 30/05/2017; added to website 08/01/2018]

We plan to continue recruiting to PLORAS for many years to come.

If you need to record the recruitment end date on your systems (e.g. CPMS), we advise you use 30/07/2022.  This is the date we currently have funding secured to, and have entered to CPMS as the planned closure date.

We plan to renew in 5 year cycles until it is deemed by us or our funding agencies that there is nothing further to gain from recruitment.

Our 'Planned end date' on IRAS is stated as 20/08/2027 (Question A69-1).

You can download them from the Local Information Pack page of the CRN Practitioners section of our website.

There is information on which documents need to be localised on the Guide to site and document types page.

Yes - this is document 2G.  This is a condensed version of document 2 which participants can give to their GP.

The PLORAS Research Team do not routinely provide this letter to participants' GPs but may provide it following participant consent to contact GP, such as when checking surgical history for MRI safety.

The pre-paid envelopes must be addressed back to the research site.

We can cover costs for the reply slips as part of invitation letters (document 1-d and 1d-P) upfront, by sending sites batches of stamps and envelopes on request.

If you use these documents, please contact us with an idea of how many stamps/envelopes you require.  This replaces the former invoice process.

Please see the PLORAS Centre Codes document on the General documents page for your site's code.  Please use this code on all documents which have a box for 'Centre Code'.
 

The Participant Number will be allocated by the Research Practitioners as you recruit each patient.  Please use the convention as follows: 0001 for the first participant recruited from your site, 0002 for the second, etc.
 

When we upload the recruitment data to the​ UKCRN portfolio database we will then use the combination of the Centre Number and Participant Number for each patient recruited, e.g. CHS/CUH0001.
 

These codes will also be used to provide information to sites regarding which patients you recruited subsequently entered the study.
 

When sending the completed forms as e-mail attachments, please use a combination of the Centre Code and Participant Number, plus the document ID, e.g. CHS/CUH0001_3E (for External Sites questionnaire).

We prefer for the information sheets to have just our contact details as is probably easiest for patients to ring us directly with questions.  However, it is fine for sites to add theirs on too if this is a Trust requirement.

If you are giving out information to, e.g. outpatients who will need to get back in touch with you about taking part, it's obviously good if they can have your contact details somewhere.  We suggest that sites can add a sticker with local contact details to the PLORAS A5 Booklet or PLORAS Recruitment Poster for this.

The PLORAS team do not routinely provide the GP information sheet to participants' GPs, but may provide it following participant consent to contact GP, such as when checking surgical history for MRI safety.  This document is optional for sites to localise.  If it is your Trust requirement to notify the GP that their patient has consented to a study, you could give the document to the participant to give to their GP.

We prefer for the information sheets to have just the PLORAS contact details, as it's easier for participants to ring us directly with questions.

However, if it is a requirement from your Trust R&D department to add the details, our Research Ethics Committee have advised that this would be a minor change which would not require approval by the sub-committee, and the change can be implemented immediately.

If you are giving out information to, e.g. outpatients who will need to get back in touch with you about taking part, it's obviously good if they can have your contact details somewhere.  We suggest that sites can add a sticker with local contact details to the PLORAS A5 Booklet or PLORAS Recruitment Poster for this.

All arrangements for participant travel are made directly between the PLORAS Research Team at UCL and the participant.

Typically, participants book their tickets and pay for them and are then reimbursed by UCL either in cash on the day or via bank transfer.

The process is made as stress-free for participants as possible, for example the PLORAS Research Team can make the booking if this arrangement is preferred by the patient.

We can pay for participants' journey to us (up to £150 providing we have receipts for the travel expenses), including parking and taxis to/from train stations.

Travel budgets are flexible and special arrangements, e.g. minibus booking can be made for groups of participants wishing to travel together.

Sites will not need to book appointments or arrange travel for participants.

Yes.  We are recruiting all patients who have had a stroke which caused symptoms that lasted at least a few weeks.

It is important that there are symptoms which are or were clearly present for at least this length of time since our study is looking at long-term recovery.

If you are recruiting in the acute setting we understand that it may be less than a few weeks since the patient had their stroke.  In this case they can be recruited to the study if they have had a stroke and still currently have clear symptoms of stroke.  The PLORAS Research Team at UCL will make contact with the patient and decide at a later stage whether they will be included.  Accrual data will still be given in recognition of the recruitment.

If there is a need to prioritise within recruitment, e.g. due to time limitations we request that patients with aphasia are prioritised for inclusion in the study over those without.  Where patients have severe aphasia it may be valuable to involve their speech and language therapist in the consent process, use the pictorial supports sheets provided for the study and/or take consent via a consultee if it has been established that the patient is unable to consent for themselves.

Note that, patients with brainstem strokes, sub-arachnoid haemorrhage and subdural haematoma are currently excluded.

The stroke must be in the main tissue of the brain (cerebral or cerebellar).

The following strokes are excluded:

• Brainstem stroke (only), subdural haematoma, subarrachnoid haemorrhage, Transient Ischemic Attack (TIA), or lacunar stroke.
• Stroke symptoms lasting fewer than seven days (if the patient is being screened before this seven day cut off, then they can be referred if the consenting professional believes it is likely that symptoms will still be present after seven days).

Please refer to the Protocol (Version 3) for additional inclusion/exclusion criteria.

There is no upper time limit since stroke - because we are researching recovery over time it is important for us to include everyone along the scale from a very recent stroke to a stroke many decades ago.

YES!   We include patients with strokes that damage the brain, even if they also have a stroke or a lesion to the brain stem.

No.

Meningiomas aren't automatically excluded but:

• If the participant is aphasic and if we can conclude the aphasia is because of the stroke and not the meningioma removal, the participant can be included.
• If it's difficult to interpret whether the participant is aphasic because of the operation or the stroke, they should not be included. This might be the case in most cases. 

A Clinical Trial Agreement (CTA) is not necessary as PLORAS is a non-CTIMP.

The PLORAS study has a Data Sharing Agreement (DSA) which stipulates how data will be transferred, stored and used.

The DSA must be signed by the Information Governance leads at both the site and UCL.  Sites can only begin recruitment once this is in place, NHS permission for the study has been obtained, and we have sent you a site Opening Pack (see above, 'When can sites start recruiting?').

See the Data Sharing Agreement on the General Documents page.

No.  The Model Non-Commercial Agreement is not fit for purpose for this study, that's why the tailored Data Sharing Agreement has been prepared.  See the Data Sharing Agreement on the General Documents page.

This is the only agreement to be put in place with each UK site.

Yes, unless each site name has been incorporated into the Trust name on both pages 1 and 13.

For example, 'XYZ Hospital NHS FOUNDATION TRUST,…full postal address..(with 2 sites at ABC Hospital and LMN Hospital)' ('the Provider').

Training will be provided in a number of different ways, including:

• A PLORAS video.
• A PLORAS quiz.
• PLORAS flashcards.

We are not conducting formal Site Initiation Visits (SIVs) or teleconferencing but do hope to visit as many sites as possible over the course of the project.

See the Training Resources section for further details.

A recruitment point will be awarded for every valid recruitment incidence, i.e. a participant who meets the study inclusion/exclusion criteria and has completed the Participant Screening Questionnaire and Information and Consent Form satisfactorily and had these transferred via the agreed methods to the PLORAS Research Team.

Please note, however that if we receive documents with missing information more than once for a site we will in future not award the recruitment point for a referral with missing information.  (This is due to the time it takes for our team to follow up on missing information, and to encourage full completion of documents for more efficient processing).

The PLORAS Research Team will keep records of the recruitment activity of each site.  These will be uploaded to the Central Portfolio Management System (CPMS) on a monthly basis.

The entry date we enter into the the Central Portfolio Management System (CPMS) for each participant recruited will be the date on the consent form - not the date they actually take part.

In some cases patients will drop out following consent due to not meeting our MRI scanning guidelines - in this case a recruitment point will still be awarded as long as the participant meets the main study criteria and all forms were fully completed.

We understand that sites are keen to keep track of which of their recruited patients became study participants and subsequently contributed data to the project.

Please follow the procedure below to ensure we can track your patients' participation.

• On the screening questionnaire and consent form documents you will see a box for Site Code and Participant Number.
• Please see PLORAS Site Codes under General Documents for your code.
• Please use this code on all documents which have a box for 'Site Code'.
• The Participant Number will be allocated by the research practitioners as you recruit each patient.  Please use the convention as follows: 0001 for the first participant recruited from your site, 0002 for the second, etc.
• When we upload the recruitment data to the Central Portfolio Management System (CPMS) we will then use the combination of the Site Code and Participant Number for each patient recruited, e.g. CHS/CUH0001.
• These codes will also be used to provide information to sites regarding which patients you recruited subsequently entered the study.
• When sending the completed forms as e-mail attachments please use a combination of the Site Code and Participant Number e.g. CHS/CUH0001 plus the document ID number e.g. CHS/CUH0001_3E (for External Sites questionnaire).

Unfortunately, due to the number of sites we are working with, we are not able to provide individual recruitment/participant status figures ad-hoc.

We send approximately six-monthly summaries on the number of patients recruited by each site, and of those recruited, identify who has subsequently taken part.

You can see recruitment summaries sent to date on the Recruitment Updates page.

• The upload to CPMS takes place at the end of each month.
• The upload reflects those participants who have been received in that month that meet our inclusion criteria.
• Recruits with missing essential information or insufficient paperwork (e.g. incorrect forms or no signatures) are not processed further (and may not be included in the upload) until this has been received. 
• If it is unclear whether a participant meets our inclusion criteria, we may request further information. In these cases, we will await the requested information before processing further.
• Once all missing information and/or outstanding queries are resolved for a participant, we will include them in the next upload to CPMS. (The date of entry, however, is the date the participant consented at your site).

If you need to establish an agreement with your radiology department for providing clinical scans to PLORAS and they require reimbursement, please advise them that we can cover costs up to £30 for MRI scans only. We will contact the imaging department directly and settle the bill with them.

We can cover costs for the reply slips as part of invitation letters (document 1-d and 1d-P) upfront, by sending sites batches of stamps and envelopes on request.

If you use these documents, please contact us with an idea of how many stamps/envelopes you require.  This replaces the former invoice process.

The pre-paid envelopes must be addressed back to the research site.

We can cover costs for the reply slips as part of invitation letters (document 1-d and 1d-P) upfront, by sending sites batches of stamps and envelopes on request.

If you use these documents, please contact us with an idea of how many stamps/envelopes you require.  This replaces the former invoice process.

No, however if costs are an issue, sites can encrypt and transfer the documents electronically using the method described in clause 2.2 of the Data Sharing Agreement (DSA).  The encryption password is provided in the site opening pack.  We will advise sites once we have an operational nhs.net address and the method described in clause 2.3 of the DSA can be used.

No, as the X-rays are not carried out at the Study Site.

Please Contact Us if you need evidence of this from our R&D department.

They are carried out at the National Hospital for Neurology and Neurosurgery via the PLORAS Research Team.

In general, we are happy with co-enrolment, providing other studies do not involve drugs which are likely to affect cognitive function and impact on the behavioural assessments we do.

Another consideration is ensuring it is not a burden on the participant, i.e. the combination of travelling to London for PLORAS and also being part of another study.  We can be very flexible with appointment dates for our participants, and are happy to co-ordinate with the other study the patient is taking part in, to ensure appointments are well-spaced.

Please Contact Us if there are any studies you are considering co-enrolling with PLORAS, so we can give a definite answer on a case-by-case basis. 

As the role of PLORAS study sites is purely to screen participants and complete an initial questionnaire and consent form with them, then provide the PLORAS Research Team with these, we are continuously carrying out monitoring by checking every form that we receive to ensure that they have been appropriately completed and that participants are being recruited in line with the inclusion and exclusion criteria in our protocol.

Any inappropriate referrals or poorly completed forms are flagged up with the study team at the site by a member of the PLORAS Research Team at UCL.

In addition to this, we submit annual progress reports to our REC.  (If you require a copy, you can download the first report from General Documents).