General Updates

Sent 21/03/2018

133939 PLORAS - Notification of Substantial Amendment 7; Amendment Category A

Dear Study Sites and local R&D teams,

RE: 133939; PLORAS; Substantial amendment 7

We have submitted an amendment for the above referenced study. 

You can find the amendment package and key correspondence on the Substantial amendments page of the CRN section of our website (http://www.ucl.ac.uk/ploras/clinical-research-network/crn-practitioners/amendments/substantial-amendments).  Please note: the validation/categorisation email and letter are not yet available - as soon as I have these I will upload to the website along with the other documents.

Please read the documents carefully as these provide information on how this amendment should be implemented, as well as what the amendment entails.

I have pasted below the access details to the CRN section of our website:

• Go to: http://www.ucl.ac.uk/ploras/clinical-research-network
• Click on the 'PLORAS documents, CRN FAQs, training resources, and much more!' link on the right hand side.
• Username is PLORAS_SRN
• Password is #*NboL++
• NB: Please do not share this password with anyone - if any of your colleagues require it, please ask them to contact us so that we can keep a record of who has access.

If you have any trouble accessing it using the above steps, try the following:

• Try using a different web browser - using Google Chrome resolves problems in most cases.
• Copy and paste the password rather than free-typing.
• When you copy the password, make sure that you only copy the characters - not any spaces before or after.
• Make sure Caps Lock is not on.
• If still not able to access after the above - try with another computer/contact your IT department.

When will this amendment be implemented?

This amendment has been categorised as category A.  In line with the HRA categorisation email and UK wide policy on the handling of amendments, your site has 35 calendar days from the date of this notification to raise an objection about the amendment.  If we do not hear from you by 25/04/2018, we will assume that the amendment may be implemented at your site.  If you need more time to consider the amendment please contact us prior to the 35 day deadline and we will assist with any queries you may have.  If you are able to notify us ahead of this date that you are able to accommodate this amendment it will enable us to potentially implement sooner. We will send an amendment implementation email after this date if we have received no objections. Please do not implement this amendment until this communication is received.

What is the impact on research activities at sites?

This amendment impacts the research activities undertaken at NHS organisations. Many of the changes have been made to further improve the participant experience and facilitate recruitment procedures for our sites.  The main changes for attention are:

• Protocol: Changes to inclusion and exclusion criteria.  We now have plenty of strokes resulting in brief/mild impairments, and want to increase our focus on strokes that have more substantial effects.  We have amended the criteria to reflect this and made further additions for inclusion clarity.  Please see pp.20-22 of the Protocol for full details and a screening flowchart.  
  
• Consultee information sheets: Added note for consultees regarding completing the safety screening questions on behalf of the Participant.
  

• Screening questionnaires:
  

  • Removed requirement for signature on front page.
  • Added note for consultees regarding completing the safety screening questions on behalf of the Participant.
  • Made the section for details on symptoms less open and more structured.
  • Added box for NIHSS scores (where available).
  • Added co-enrolment section.
  • Added confirmation of attaching scan report.
  • Made it clear that access to medical records includes imaging.
  • More picture support and guidelines for using the picture support document.

• Consent/declaration forms:

  • Added note for consultees regarding completing the safety screening questions on behalf of the Participant.
  • Reworded the metal exposure disclaimer.
  • Guidelines for using the picture support document.

Is there any impact on funding/agreements?

This amendment does not impact any funding/agreements that have previously been agreed.

What is the HRA Approval status of the amendment?

We have received HRA Approval for the amendment. You can download this from our website using the details above.

If you need to discuss the impact of the amendment at your site please do not hesitate to contact us.

Kind regards,

Rachel Bruce

On behalf of the PLORAS Research Team

Sent 09/01/2018

PLORAS Update: Brief recruitment update Oct 2017 - Dec 2017

Dear All,

In our last update to sites, we advised that we plan to send more regular, briefer recruitment updates throughout the year, with the usual more comprehensive update once a year.

Please find attached here the first of our brief recruitment updates, along with the Site Codes document.

As this is the first brief update we have sent, we'd appreciate any feedback on how useful it is to you, and where possible we'll make any necessary changes for future reports.

Very best wishes,

Rachel Bruce

Sent 28/11/2017

PLORAS Insurance Certificate 2017-18

Dear All,

We've just received our insurance certificate for the current year.

Please find attached here for your records.

Very best wishes,

Rachel Bruce

On behalf of the PLORAS Research Team

Sent 13/06/2016

PLORAS Update: Inclusion criteria | Invitation letters | Notifications | Reports (pdf)

Sent 04/04/2016

PLORAS Update: Substantial Amendment 6

Dear All,

We have recently had Substantial Amendment 6 approved by our REC and processed via CSP.

This amendment mainly relates to a process that may be followed by the PLORAS Team for patients who can only take part using their clinical scan, including an additional letter.  The Protocol has been amended to outline this process.  The amendment has been classed as Category A, affecting all sites - and will therefore need to be reviewed by your R&D teams.  (Please note, however, that the new letter [document 1g] will not be used by your site).

The amendment has been made available to sites via CSP, and you can also find relevant documents on the 'Amendments' page of the CRN section of our website.

The date of implementation and conditions we received are below:

Subject to the three conditions below, you will be able to implement the amendment on 26 April 2016, at all sites already in receipt of NHS Permission:

• You may not implement this amendment until and unless you receive, and forward to us, all required regulatory approvals (where applicable)
• You may not implement this amendment at any site which informs you that they require additional review time, until they notify you that this review has been satisfactorily completed.
• You may not implement this amendment at any site that withdraws its NHS Permission.

I have attached here the Aphasia Recovery and Therapy Questionnaire (AR&TQ) which was also requested by our REC.

NB: This e-mail has not been sent to the R&D contacts we have for your site as they are likely out of date - please forward as necessary.

If your site does have any comments or objections, please ensure they are sent to this address (ploras@ucl.ac.uk), not my personal work address.

Don't hesitate to ask if you have any questions.

Many thanks,

Rachel Bruce

​On behalf of the PLORAS Research Team

Sent 21/01/2016

PLORAS Update: Clinical scans | UKSF presentation | Recruitment update | NHS.net address | Missing information | REC progress report | Amendments

Dear All,

Happy New Year from all at the PLORAS team!  

We have a few updates below - as usual, please do take some time to read through and contact us if anything's not clear.

Clinical scans

We have recently conducted a review of clinical scans we have received for patients who either cannot travel to London, or for whom we cannot carry out a research scan for safety reasons.

The conclusion is that at present, we are not able to use these for our analyses, but we plan to revisit these in future when more resources are available.  We will contact patients who can only take part in PLORAS by use of their clinical scan, and advise that we will be in contact if we are in a position to include them in PLORAS.  These patients will be 'on hold', rather than declined at present.

The option for patients to be referred to PLORAS using the clinical scan route only is still open to sites, if patients are not willing/able to have a research scan but are keen to take part.  (NB: External Sites+ provide clinical scans as routine).

UK Stroke Forum Conference presentation

Please find attached a version of the presentation we delivered at the UKSF conference last month.

Next recruitment update

We hope to send the next recruitment update in February/March.  This will include a breakdown of recruitment by site, including numbers of patients in each stage of the process.

NHS.net address

We are close to receiving another nhs.net address and will inform you as soon as this becomes available.

Missing information

Thank you for assisting us with processing referrals efficiently with full completion of documents.  Just a reminder that if we receive a questionnaire with missing information more than once for a site, we will in future not award the recruitment point for another referral with missing information, 

REC progress report

We plan to send our annual progress report to our REC this week, after which it will be available on our website in the 'General Resources' section.

Substantial Amendment

We have recently submitted a substantial amendment (#5) to our R&D department, which once authorised, we will submit to our REC.  The amendment is for an invitation letter for participants who gave consent for the PLORAS team to contact them about other studies.  This letter will only be used by the core PLORAS Research Team, not our External Sites/External Sites+.  We will therefore not inform you of further details on the amendment, but hope the information above is useful in case your R&D departments are notified of the change and query this with your teams.

Change to REC/R&D form

We have recently been requested by a site conducting their medical exposure review to amend section A19 in IRAS.  Column 2 in the procedures table for the number of scans which are part of standard of care was previously left blank.  We have now changed this to '0' for clarity.  There is no change to any procedures.  Please let us know if this change to the form will affect your approvals in any way.

We hope the above is clear, but don't hesitate to contact us if further clarification is needed on anything.  And once again thank you for all your valued support!

Very best wishes,

Rachel Bruce, 

On behalf of the PLORAS Research Team

Sent 30/06/2015

PLORAS Update: Clinical scans | PLORAS processes | Documents | Co-enrolment

Dear All,

Please find attached to this e-mail our second recruitment update for all sites open to PLORAS.  We hope it's a useful summary and as before, please let us know if there's any information you'd find helpful for the next update, and we'll include this if possible.

There are also several important points to make you aware of below - please take a read and let us know if you have any queries on any of the information.

Clinical scans

In our latest protocol (V3, page 16), we discussed how we are testing using clinical scans (MRI/CT) for generating predictions.  We now know from CT scans we have since obtained that unfortunately they are not of sufficient quality for us to use at this time.

For this reason, we are requesting that you no longer recruit participants who are only able to take part by using a clinical CT scan (e.g. if the patient wants to take part but cannot travel for a research scan, and has only had a CT scan post-stroke).  With the next amendment, we will update the protocol to reflect this.  In the meantime, please view this as an additional exclusion criteria.

We are still accepting referrals for patients who can only take part using their clinical MRI scan, but please note that for External Sites (who do not provide these as routine), we do prefer to obtain a research scan where possible.  Therefore, the option of taking part using a clinical scan should be reserved only for patients who are unable/unwilling to travel to London but very keen to take part.

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.  Note also that we make the request directly to the imaging department.

PLORAS processes

A couple of sites have queried the time taken from PLORAS receiving a referral to inviting patients for an appointment​.  To explain why we often cannot arrange appointments immediately, below we have outlined the general process for us on receipt of the referral:

STAGE 1:   A relatively quick decision about suitability for study.   At the end of this stage, patients receive a letter thanking them for volunteering and indicating either (A) that they have been declined with a reason; or (B) we hope to include them and are carrying out safety checks and this might take a long time (and we enclose a leaflet with more information on the checks (document 5a).   Patients are also encouraged to contact us in the meantime if they have any questions. If the patient is declined at this stage and no recruitment point given (e.g. they did not meet the inclusion criteria), we let the site know.

STAGE 2:   Safety checks.  As a research centre, we have very strict guidelines and are required to obtain medical records for surgeries and procedures, in order for our Lead Radiographer to determine compatibility with our research scanners.  This process can take some time, especially if there are several surgeries at different hospitals. Only once the patient has passed the safety checks are we in a position to make an appointment.   If we need to decline a patient after this process, e.g. if they do not pass our safety checks, they are sent a decline letter at that point.  The site still receives the recruitment point in these cases.

So that patients are aware they may not take part immediately from the outset, it would be helpful if when consenting you advise that it may be some time before they are able to take part, but they can contact the PLORAS team at any time to ask for an update on their status.

Documents

The list below indicates some points noted when processing some of our referrals.  We'd be very grateful if you could note these and action accordingly - this will ensure we are able to process referrals quicker and more efficiently.

• Missing information - we have received several questionnaires where we do not have enough information to process the referral (i.e. determine eligibility/conduct safety checks).  Specifically: 
• i) Location of the stroke in the brain. Sometimes this field is left empty or states only left side/right side.  Please state the location of stroke with as much information as possible, as some types are excluded from PLORAS.
• ii) List of hospitals and years where all surgeries took part (end of document 3E).  Sometimes this section is not completed at all, which means the team cannot commence the process of obtaining medical records for surgeries without first contacting the research team/patient for this information.
• Legibility.  Please ensure that all documents are completed clearly by the research team.
• Signed consent.  Please check that the patient has signed every necessary section of the form.  Specifically, sometimes the first page of the screening questionnaire is signed, but the last page is not signed, and vice versa.  In addition, sometimes there is no signature under consent to share clinical scans, even though the patient has ticked 'yes' to this point.
• Metal Work Disclaimer (part of document 4E/4E-C).  Please note that this section only needs to be completed if the patient answered 'yes' to questions about working in the metal working industry/exposure to metal dust.  If the patient answered 'no' to these questions, either score through the section and write 'N/A' (on version 2) or tick the 'N/A' box (on version 3).
• Previous MRIs and CTs.  If listing multiple CTs and MRIs, please denote as clearly as possible which dates refer to which type of scan/hospital.

If we receive a questionnaire with missing information, we will contact the research practitioner to request this.  Please note, however that if this occurs more than once for a site we will in future not award the recruitment point for a referral with missing information, as per our guidelines listed on the website FAQs: '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 also that referrals sent to Louise Lim's NHS.net account since 14/5/2015 are likely to not have been accessed owing to leave prior to her final day.  If you think you have transferred data to this account since this date, it would be worth re-transferring via one of the other methods outlined in the DSA (see PLORAS mail dated 03/06/2015) for more details. 

Co-enrolment

Our position on co-enrolment is that in general, we are happy 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.  As noted above, we can be very flexible with appointment dates, 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.  We currently have a list of studies we have approved co-enrolment with, including any conditions.  This will be published on the website shortly for your reference - after which point you need only check with us for studies which are not listed.  

If you are then co-enrolling a PLORAS patient with an approved study, please indicate this on a covering note/e-mail with the referral, including any conditions imposed by the co-enrolled study or other considerations (e.g. dates when they should not take part in PLORAS, etc).

Finally...

A very big thank you for your continued support of and enthusiasm for PLORAS.  Do let us know if there's anything we can do to facilitate your recruitment processes or anything else that would be helpful when discussing the study with your patients.

Very best wishes,

Rachel Bruce

Sent 03/06/2015

PLORAS update: team changes and nhs.net mail

Dear All,

I'm writing to advise you that this week is Louise Lim's last week with the PLORAS Team, as she moves on to new ventures.

From today, please do not sent any further referrals to louise.lim@nhs.net. 

Myself and my colleague Deborah have been in the process of obtaining an nhs.net address for several months, but unfortunately we have not received them yet.  Other staff are also starting the process of obtaining an address.  We will notify you as soon as someone in the team has one - but in the meantime, please use one of the other two methods below outlined in the Data Sharing Agreement for transferring data.

2.2 NHS Trust or NHS.net e-mail to ploras@ucl.ac.uk via an attachment which is encrypted to AES256 and for which the password is provided by a separate means to which the Data itself is sent (i.e. if the Data are sent via e-mail attachment the password must not be sent via e-mail but communicated via telephone/SMS message/post/fax). Encryption software that would meet AES256 standard include 7-Zip, TRUECRYPT or Sophos. The password should conform to the same rules as set out under points 3.5 and 4.2.

2.4 Post which is sent by Special Delivery and marked 'Private and Confidential' and sent to PLORAS Research Team, Wellcome Trust Centre for Neuroimaging, 12 Queen Square, London, WC1N 3BG.  Large (>5) numbers of records must not be sent in the same envelope.

We have also welcomed three new members to the team - Speech and Language Therapist Sophie Roberts and two Patient Coordinators, Emilia Molimpakis and Shamima Khan.

I will be sending the latest recruitment update with a breakdown of figures for all open sites in the next few weeks, along with some other updates.

With very best wishes,

Rachel

Sent 20/03/2015

PLORAS Substantial Amendment 4 implementation

Dear All,

I am pleased to confirm that all three conditions listed in the mail from 20/02/2015 below have been met, and you can therefore now implement PLORAS Substantial Amendment 4, once you have your local approval in place.

One thing to note - it has come to our attention that there are a couple of discrepancies in what is listed in the Version Control documents dated 23/12/2014 and 10/02/2015 - part of Substantial Amendment 4, and what has been changed in the actual documents.

I have been advised by our REC that as the documents that were reviewed for amendment 4 have not changed in terms of detail/information and only the Version Control document has been updated to stay in line with the approved documents, then this would not require a substantial amendment.  They do not need to be notified of minor amendments, so therefore no further action is required in terms of REC approval for this.

The discrepancies, listed below, have now been removed from the Version Control document.  A new Version Control document, dated 09/03/2015, is attached.  I will submit the new Version Control document in IRAS as a non-substantial amendment, which the CSP team will then make available to your R&D departments - but I have been advised that this will not require local approval.

The new documents as part of Substantial Amendment 4 will replace previous versions on the 'PLORAS Recruitment Documents' page of the website in due course.

Thank you for your patience whilst this amendment was being processed, and we hope that you find the new provisions and changes helpful.

NB: This e-mail has not been sent to the R&D contacts we have for your site - please inform the relevant personnel of the above information if required.

Best wishes,

Rachel Browne

Sent 20/02/2015

PLORAS Substantial Amendment 4 implementation date

Dear All,

Just to advise you of recent communication I have had with our contact at CRN North Thames, regarding the implementation date for PLORAS Substantial Amendment 4.

The PLORAS Research Team are able to implement the amendment on 18/03/2015, providing we have:

1.     REC approval

2.     Our local R&D approval

3.     We have not had objections from any other sites by that date - but we do not need to have full confirmation from every site by then.

Our External Sites and External Sites+ are subject to the same 3 conditions above, and the date of 18/03/2015, but please liaise with your R&D departments to see if any other conditions/implementation dates apply locally.

We have so far not received any objections to the amendment.  I will let you know whether or not this is still the case on 18/03/2015.

NB: This e-mail has not been sent to the R&D contacts we have for your site - please inform the relevant personnel if required.

Best wishes,

Rachel Browne

Sent 06/02/2015

PLORAS Substantial Amendment 4

Dear All,

Following our e-mail of 19/11/2014, just a brief update to let you know that we received confirmation from our REC yesterday that PLORAS Substantial Amendment 4 has been approved.

This includes allowances for our external recruiting sites to recruit from stroke groups, changes to the exclusion criteria, and several other changes to facilitate recruitment procedures, some at the request of our sites.

I will provide full details to you next week of the amendment, and put all associated correspondence and documents on our website for you to download for your local approvals.

Many thanks again for your patience whilst this amendment was being processed - more details to come!

Best wishes,

Rachel Browne

Sent 30/09/2014

PLORAS Data Sharing Agreement (DSA) reminder

Dear All,

I thought I'd send out a quick reminder to all sites, in particular to those who are now recruiting for the PLORAS study. It's important that I do this now as we currently have over 50 sites who have fully signed up.

Firstly, if your site is fully signed up and you are recruiting for us, can I ask that the PIs/Research Governance colleagues provide details of the Data Sharing Agreement to your respective Stroke Research Nurses/Operative(s). We've had a number of queries regarding the mechanism for transferring data to us, and for ease of communication, I thought I'd state those here as well in order to minimise these queries.  

From the DSA (see attached copy), we had agreed the following means for Data Transfer:

2. Data transfer

2.1 Data will be transferred from the Provider to the Sponsor/the PLORAS Research Team by the following means:

2.2 NHS Trust or NHS.net e-mail to ploras@ucl.ac.uk via an attachment which is encrypted to AES256 and for which the password is provided by a separate means to which the Data itself is sent (i.e. if the Data are sent via e-mail attachment the password must not be sent via e-mail but communicated via telephone/SMS message/post/fax). Encryption software that would meet AES256 standard include 7-Zip, TRUECRYPT or Sophos. The password should conform to the same rules as set out under points 3.5 and 4.2.

2.3 Correspondence sent from nhs.net to nhs.net accounts are secure and so additional encryption is not required. Once the nhs.net e-mail address of the PLORAS team has been confirmed it will be provided.

2.4 Post which is sent by Special Delivery and marked 'Private and Confidential' and sent to PLORAS Research Team, Wellcome Trust Centre for Neuroimaging, 12 Queen Square, London, WC1N 3BG.  Large (>5) numbers of records must not be sent in the same envelope.

I am also attaching a guidance document from Newcastle University showing you how to encrypt/decrypt electronic copies using 7-Zip, if method 2.2 above is adopted: the password to use will be made available in the site opening pack. Of course if there are still any problems then by all means feel free to contact me.

Finally, if you have still yet to sign the DSA, then we would still welcome new sites joining us and again the attached document should be signed and returned to me. Please note,  you will only be able to send data to us if we have a fully executed DSA in place and your site has sent us a copy of your NHS permission letter.

Kind Regards,

Elnas  

PS: Apologies if this mail is not relevant to you.  Future e-mails not regarding the DSA will not include our R&D contacts, so it would be appreciated if PIs and study teams could please ensure that they are made aware of relevant information as it arises. Also, this message has been Bcc'd to avoid further e-mails internally.

Sent 08/09/2014

PLORAS update: training video, recruitment summaries, opening, scan reports, invoices, filenames

Dear All,

Many thanks to everyone for your continued hard work in setting up PLORAS!  We are delighted that 33 sites are now open and the processes are running smoothly.  We have several points to update you on below, so please take a look and contact us if anything is unclear.

1. Training video

The long-awaited PLORAS staff training video is here!  The video is intended for researchers/health professionals who are recruiting patients for the PLORAS study.  It is intended as a guide to how we envisage recruitment taking place at sites, to give an overview of the study aims and to show what is involved for patients in participating in PLORAS.  We hope you enjoy watching it and find it informative and helpful.  Please contact the PLORAS team with any specific questions regarding recruitment and participation and check the FAQ section of our website regularly.  This is a private training resource and the password to access it must only be provided by the PLORAS team and must not be shared.  The video should not be shown to participants as language testing items are included.

You can access the video here: 

You will need to enter the password: 

2. Recruitment summaries

Unfortunately we are not able to notify sites as each individual patient takes part, but do plan to send approximately six-monthly summaries on the number of patients recruited by each site, and of those recruited, identify who has subsequently taken part.  If patients contact you for information on their appointment once recruited, please direct them to us.

3. Sites awaiting opening

In order for sites to be ready to open, the following need to be in place:

• NHS permission letter - please send this to Elnas Patel (e.patel@ucl.ac.uk).
• Confirmation that you have received back copies of the fully executed DSA - an e-mail to Elnas is sufficient.
• Send Elnas the name and postal address of the lead research practitioner dealing with recruitment.​

Once the above are in place, we will send an opening pack to the research team, which includes a letter confirming that you can recruit and send us data along with final instructions, copies of the A5 booklet (document 1a) and recruitment flashcards.

Once you have recruited a patient, please send us document 3E (3S for External Sites+) and 4E (4S for External Sites+) - or the equivalent consultee versions.  Please refer to the Data Sharing Agreement for the approved methods of transfer.  Our NHS.net e-mail address is provided in the opening letter.

4. MRI/CT head scan reports

Some sites have sent us copies of patients' MRI reports which we have found extremely useful.  We would therefore like to request that if possible, all sites could include post-stroke MRI or CT head reports, and send along with the screening questionnaire and consent form.  Patients who have signed the consent form have given permission for researchers to have access to this information, as per the statement on the screening questionnaire:

In signing the consent form for our study...you are consenting to access to your medical records by responsible individuals in the research team for necessary information.

Please let us know if you forsee any difficulties in providing these reports, and note that, whilst they are very useful to us, it is not an absolute requirement.

5. Invoices

You can now send your invoices for stamps and envelopes for the reply slips to our Finance team.  Please e-mail them to Alison Ryan (alison.g.ryan@ucl.ac.uk) and copy in ploras@ucl.ac.uk.  Alison will check whether you are already an approved supplier for UCL and if not you will be sent a form to complete so that she can set you up as a supplier.

6. Filenames for completed questionnaires and consent forms

Please can we kindly request that sites sending completed questionnaires and consent forms via e-mail send one attachment for the questionnaire and one attachment for the consent form (on the same e-mail). Please use the format of SITE ID/participant number/document identifier e.g. PSPH0001_3E (for questionnaire) and PSPH0001_4E (for consent form) - this helps prevent things getting muddled our end and means we can more easily ensure we don't miss any participants and overlook adding them to our accrual data.  Please ensure you also complete the participant ID box on each page of the forms themselves.

With very best wishes,

The PLORAS Research Team​

Sent 06/08/2014

PLORAS coverage on BBC Look East

Dear all,

PLORAS featured on BBC Look East last night, in a piece covering Peterborough City Hospital's involvement in the project. Many thanks to the team there for their work in setting this up. 

You can watch the piece on iPlayer for the next 10-days. It starts at around 7 minutes in:

http://www.bbc.co.uk/iplayer/episode/b04cfy6b/look-east-west-05082014

If you are interested in getting some coverage of the work you are doing at your site we would be very happy to support this. We would suggest that you also get in touch with your local PR team who can link in with local media contacts.

We are able to provide a PLORAS media briefing document that can be used as the template for a press release and are happy to discuss filming and interview opportunities. Please can you let us know if you plan to do any work with local (or national) media relating to PLORAS.

Best wishes,

Zula Haigh 

Sent 27/06/2014

PLORAS Update

Dear All,

Many thanks for all the work you are doing to set up PLORAS at your site - we are very pleased that several sites have now obtained NHS permission.  

As some of you are now in a position to recruit patients, we are writing with important information about the process.  Please read the information carefully and don't hesitate to contact us if anything is not clear.  Please note that you will not be able to transfer any data to us until the Data Sharing Agreement is in place with your Trust and us.

Centre Number and Participant Number

• On the screening questionnaire and consent form documents you will see a box for Centre Number and Participant Number.
• Please see attached document for your Centre Number.
• Please use this code on all documents which have a box for 'Centre Number'.
• 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 Number and Participant Number plus the document reference, e.g. CHS/CUH0001_3E (for External Sites questionnaire).
• 
  
• Recruitment points

• 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.
• The entry date we enter into the UKCRN portfolio database 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 will e-mail you with the Participant Numbers of all forms received on a particular day so that you know to destroy the paperwork at your site.

Website

The CRN section of our website provides lots of useful information which is updated regularly, including FAQs.  We welcome your queries but please check first that your question is not answered there.  As a reminder, we have pasted below the access details.

• Go to: http://www.ucl.ac.uk/ploras/health-professionals/get-involved/recruitment
• Click on the 'Click here for information on PLORAS set-up' link on the right hand side.
• Username is PLORAS_SRN
• Password is
• NB: Please do not share this password with anyone - if any of your colleagues require it, please ask them to contact us so that we can keep a record of who has access.

If you have any trouble accessing it using the above steps, try the following:

• Copy and paste the password rather than free-typing.
• When you copy the password, make sure that you only copy the characters - not any spaces before or after.
• Make sure caps lock is not on.
• If still not able to access after the above - try with another computer.

Training

On the Training Resources section of the website you will find information on how sites will receive training.  The training quiz is ready for you to start and we will upload the training video shortly (we will let you know once this has been done).

Once again, we look forward to working with your Trusts and don't hesitate to contact us if anything is not clear.

Very best wishes,

The PLORAS Research Team

Sent 04/06/2014

DSA 0.2

Dear All,

Firstly, many thanks for all of your valuable input and comments over the last few months on DSA_0.1. We have tried to incorporate as many of those as possible and addressed individually where we could not, to hopefully a mutually agreeable solution.

Attached you will find the latest version of the DSA_0.2 along with a copy of the Tracked Changed version of the DSA_0.1. Below I have tried to summarise some of the key changes:

A.  Background: We have added in text to specify the purpose of the Study.

B. Operative Provisions:

1. Compliance with DPA 1998: We have changed the references to UCL as the Sponsor and the Study sites as the Provider in the title and reflected this throughout the document. As already mentioned in a previous e-mail we have also changed the Sponsor to being the Data Controller in 1.1. Also in Appendix A we have defined the Information Asset Owner (IAO) as referenced in 1.1.

2. Data Transfer: In 2.2 we have specified the encryption software that meet the standards required. In 2.3 we do not expect documents to be encrypted if sent from an NHS.net email to an NHS.net e-mail.  We have tried to simplify 2.5:  currently this only refers to UCLH but if we had to access image data from other sites we have stated how we and the sites will act.

3. Data Storage: Under this 3.6 was the main change. It reflects the need for the PLORAS team to have the ability to access the database remotely and we are stating how, the encrypted equipment that we will use and using standard operating procedures that the team will follow.

4. Data Analysis/Handling: We have removed the vagueness in Clause 4.1. The other 2 main changes are in 4.5, where we have stated that UCL will be the Data owners once it is received and in 4.6, where we have fleshed out the IG toolkit implementation and the level that we expect to achieve.

5. Security: Minor changes made under this section.

6. Personnel: 6.2 added as a new clause.

7. Purposes and Procedure for Sharing Information: Minor changes made under this section including those already stated in 1 above.

9. Transferring and/or Processing Personal Data outside the European Economic Area: We've think this statement is a better reflection of what we will not do.

10. Providing Assistance: Under this section 10.4 was the major change, where we have condensed and added in the standards and security measures we will take. The others 2 are minor ones.

12. Ending this Agreement:  12.3c was deleted as we do not need sites to archive study data once we have it. To balance this we have added a clause 18.1.7 to ask Providers to only keep the data until we have confirmed that we have received it.

The remaining changes are in Appendix A where we have added some new definitions, reworded some and have made some presentational changes.

I hope that the above summary proves to be useful when reviewing matters. Please do not hesitate to contact me if you have any queries on this.

I appreciate that most sites having been waiting for some time to push ahead on this and I hope that we will all now be in a position to agree and sign.  Please can you send me your acceptance/objection to the DSA 0.2 no later  than Monday 16th June 2014 10.00 AM?

I look forward to a favourable outcome for all.

Kind Regards,

Elnas