Guide to site and document types

There are four streams of PLORAS documents:

1. Host Organisation: PLORAS Research Team (PRT)

Involved in the whole participant process (recruitment, screening, overall consent, X-rays, MRI scanning, language assessment and follow-up).

2. External Sites+ (S)

ONLY University College London Hospitals NHS Foundation Trust and Newcastle Upon Tyne Hospitals NHS Foundation Trust are in this category.
Involved in recruitment, screening and consent only.
Provide their participants' hospital scans to the PLORAS Research Team (no MRI needed at our research centre).
Identified by an S in the document reference.

3. External Sites (E)

ALL SITES are in this category, EXCEPT those listed under External Sites+.
Involved in recruitment, screening and consent only.
Hospital scans are not provided (though these may be separately requested for certain participants following participant's agreement via a consent form).
Identified by an E in the document reference.
See flowchart below for basic outline of recruitment process.

4. PIC Sites (Pi)

Currently, there are no PIC Sites for PLORAS.
Involved in recruitment only (passing contact details to the PLORAS Research Team).
Screening is not performed and formal consent is not taken.
Hospital scans are not provided (though these may be separately requested for certain participants following participant's agreement via a consent form).
Identified by a Pi in the document reference.

Within the above streams, for many documents there are three versions:

Standard

For participants with intact reading ability.

Picture Support

For participants with reading difficulty: simplified wording, pictures, and aphasia-friendly format.
Identified by a -P in the document reference.

Consultee

Same information as the standard version, however referring to the participant in the third person and the consultee is invited to think about what the participant would want.
Identified by a -C in the document reference.

We have listed all documents below for reference and to assist you with gaining local approval, however, please note which documents each type of site needs to use in the 'Used by' column.

NB: Document references in bold refer to documents which need to be localised by sites before use.

Recruitment Resources

Ref		Used by
1a	PLORAS A5 Booklet Simple booklet outlining the main points of the study. Please contact us if you would like printed copies. Sites can use a sticker to add local contact details.	PRT, S, E, Pi
1b	PLORAS A4 Recruitment Poster Sites can use a sticker to add local contact details.	PRT, S, E, Pi
1c	Poster Advertising Talk at Stroke Group Can be edited with the time and date and sent to stroke group organisers to advertise scheduled presentations.	PRT
1d	PLORAS Invitation for Trust or GP Patients Invitation letter for suitable patients on Trust/GP database where this is available. See our CRN FAQs on costs for details of what is covered for sending this document. This document is part of Substantial Amendment 3 and later updated as part of Substantial Amendment 4 and Substantial Amendment 7.	S, E, Pi
1d-P	PLORAS Invitation for Trust or GP Patients Picture version of document 1d. See our CRN FAQs on costs for details of what is covered for sending this document. This document is part of Substantial Amendment 3 and later updated as part of Substantial Amendment 4 and Substantial Amendment 7.	S, E, Pi
1e	PLORAS Advert Used in relevant publications/newspapers.	PRT
1f	PLORAS Other Studies Invitation Letter A covering letter for previous participants who consented to being contacted about taking part in other studies. This document is part of Substantial Amendment 5.	PRT
1g	PLORAS Clinical Scan On Hold Letter	PRT
1h-P	PLORAS Follow-Up Invite NBoL A covering letter for previous participants (who were consented to the Neural Basis of Language) inviting them to take part in the study again. This document is part of Substantial Amendment 7.	PRT
1i-P	PLORAS Follow-Up Invite A covering letter for previous participants inviting them to take part in the study again. This document is part of Substantial Amendment 7.	PRT

Information Sheets

Ref		Used by
2	PLORAS Participant Information Sheet Detailed information on all aspects of the study. Researchers must give this to potential participants/read it through with them before they complete the screening questionnaire. NB: This information sheet has the UCL header as the PLORAS Research Team also use this document. Sites can delete this header and insert their own Trust logo. This document was updated as part of Substantial Amendment 7.	PRT, E, Pi
2a	PLORAS Data Protection Information Sheet A supplementary information sheet to be given to patients alongside the study information sheet. This includes text that has been provided by the HRA. NB. This information sheet was created to satisfy the additional transparency requirements introduced by the General Data Protection Regulation (GDPR) which came into effect on 25th May 2018.	PRT, E, S, Pi
2-P	PLORAS Participant Information Sheet Picture support version of document 2. NB: This information sheet has the UCL header as the PLORAS Research Team also use this document. Sites can delete this header and insert their own Trust logo. This document was updated as part of Substantial Amendment 7.	PRT, E, Pi
2-C	PLORAS Consultee Information Sheet Consultee version of document 2. NB: This information sheet has the UCL header as the PLORAS Research Team also use this document. Sites can delete this header and insert their own Trust logo. This document was updated as part of Substantial Amendment 7.	PRT, E, Pi
2S	PLORAS Participant Information Sheet External+ Version of document 2 adapted for External Sites+. This document was updated as part of Substantial Amendment 7.	S
2S-P	PLORAS Participant Information Sheet External+ Picture support version of document 2S. This document was updated as part of Substantial Amendment 7.	S
2S-C	PLORAS Consultee Information Sheet External+ Picture support version of document 2S. This document was updated as part of Substantial Amendment 7.	S
2G	PLORAS GP Information Sheet Condensed version of document 2 which participants can give to their GP or the PLORAS Research Team can provide following participant consent to contact GP (such as when checking surgical history for MRI safety). Optional for sites to localise.	PRT, S, E, Pi
2X	PLORAS Participant Information Sheet for X-Rays Information on why participants may need an X-ray and what it involves. Only given to participants for whom the PLORAS Research Team are concerned that they may have a contraindication for MRI (e.g. metal in their eye) and we not been able to obtain the relevant medical records for more details.	PRT
2X-P	PLORAS Participant Information Sheet for X-Rays Picture support version of document 2X.	PRT
2X-C	PLORAS Consultee Information Sheet for X-Rays Consultee version of document 2X.	PRT

Screening Questionnaires

Ref		Used by
3	PLORAS Participant Screening Questionnaire and Initial Consent Completed by the participant or consultee (or researcher in discussion with participant/consultee). Used to establish whether the participant is suitable for the study, and assess safety for a research MRI brain scan. The participant is invited to consent to the PLORAS Research Team accessing medical records for safety checking, and accessing clinical brain scans if not suitable for a research scan. This document was updated as part of Substantial Amendment 7.	PRT
3-P	PLORAS Participant Screening Questionnaire and Initial Consent Picture version of the questions on document 3 to assist researchers/consultees or family members when filling the questionnaire out with patients who have aphasia. This document was updated as part of Substantial Amendment 7.	PRT
3S	PLORAS Participant Screening Questionnaire External+ Version of document 3 adapted for External Sites+. This document was updated as part of Substantial Amendment 7.	S
3S-P	PLORAS Participant Screening Questionnaire External+ Picture version of the questions on document 3 to assist researchers/consultees or family members when filling the questionnaire out with patients who have aphasia. This document was updated as part of Substantial Amendment 7.	S
3E	PLORAS Participant Screening Questionnaire External Version of document 3 adapted for External Sites. This document was updated as part of Substantial Amendment 7.	E
3E-P	PLORAS Participant Screening Questionnaire External Picture version of the questions on document 3E to assist researchers/consultees or family members when filling the questionnaire out with patients who have aphasia. This document was updated as part of Substantial Amendment 7.	E

Consent Forms

Ref		Used by
4	PLORAS Participant Information and Consent Used on day of appointment for verifying and confirming safety for an MRI brain scan, obtaining study consent, and consent/confirmation for other aspects where applicable (X-ray, metal exposure disclaimer, obtaining results from and sharing results with speech and language therapists, obtaining and using existing brain scans). This document was updated as part of Substantial Amendment 7.	PRT
4-P	PLORAS Participant Information and Consent Picture support for document 4. This document was updated as part of Substantial Amendment 7.	PRT
4-C	PLORAS Declaration Consultee version of document 4. This document was updated as part of Substantial Amendment 7.	PRT
4S	PLORAS Consent External+ Version of document 4 adapted for External Sites+. This document was updated as part of Substantial Amendment 7.	S
4S-P	PLORAS Consent External+ Picture support for document 4S. This document was updated as part of Substantial Amendment 7.	S
4S-C	PLORAS Declaration External+ Consultee version of 4S. This document was updated as part of Substantial Amendment 7.	S
4E	PLORAS Consent External Version of document 4 adapted for External Sites. This document was updated as part of Substantial Amendment 7.	E
4E-P	PLORAS Consent External Picture support for document 4E. This document was updated as part of Substantial Amendment 7.	E
4E-C	PLORAS Declaration External Consultee version of document 4E. This document was updated as part of Substantial Amendment 7.	E
4Pi	PLORAS Consent to Contact for PIC Sites Used to obtain consent for the PLORAS Research Team to contact patients referred from a PIC site.	Pi
4Pi-P	PLORAS Consent to Contact for PIC Sites Picture version of document 4Pi.	Pi
4Cs	PLORAS Consent for Previous Clinical Scans Used for participants who expressed interest in taking part in study 00/N032 prior to new ethics submission, but have not been able to be scanned due to research scanning safety guidelines. A copy of a clinical scan will be used instead. For new participants there is now a section for consent to obtain previous clinical brain scanson the screening questionnaire.	PRT
4Ph	Consent for Photos Not used with every participant but in the case of special events, e.g. participant coffee morning, visit to stroke group.	PRT
4V	Consent for Video and Audio Recording For situations other than standard appointments where we may need to do this (e.g. video to show participant procedures).	PRT

Additional Information

Ref		Used by
5a	Guide to MRI Safety Checks Provided prior to appointment. Explains to participants why the PLORAS Research Team need to do thorough safety checking to ensure it is safe for them to have a research MRI scan.	PRT
5b	MRI Information Sheet Provided prior to appointment. Explains to participants the procedure for having an MRI scan.	PRT
5c	Key Points to Outline on the Day Provided with appointment letter and verbally on day of appointment.	PRT

Follow-Up Information

Ref		Used by
6a	Scan Images Template Provided to participants who request a printed picture of their scan - to show stroke site on scan.	PRT
6b	Brain in Brief Provided with participant's MRI brain scan images to provide some basic knowledge of regional brain function for interest and understanding.	PRT
6c	Guide to Working with Images in MRIcron Provided to participants who request their scan images on CD. This enables participants to access their password-protected scan images and view and manipulate them within scan viewing software (also provided).	PRT

Additional Questionnaires and Forms

Ref		Used by
7a	PLORAS Aphasia Recovery and Therapy Questionnaire Provided to participants during/after their PLORAS appointment. This questionnaire asks participants about their speech and language abilities after stroke. This document is part of Substantial Amendment 7.	PRT
7b	PLORAS Carer Aphasia Recovery and Therapy Questionnaire Provided to family members/carers of participants after their PLORAS appointment. This questionnaire asks about the participant's speech and language abilities after stroke. This document is part of Substantial Amendment 7.	PRT
7c	PLORAS Bilingual Language History Questionnaire Completed with multilingual participants during their PLORAS appointment. This questionnaire asks how their stroke affected other languages they speak. This document is part of Substantial Amendment 7.	PRT
8a	PLORAS Tattoo Form Used for participants that have disclosed having one or more tattoo(s) during our pre-scan safety checks. Participants are asked to sign this form (to confirm their tattoos meet our local safety guidelines) prior to their scan with us. This document is part of Substantial Amendment 7.	PRT
8a-P	PLORAS Tattoo Form Picture version of document 8a. Used for participants that have disclosed having one or more tattoo(s) during our pre-scan safety checks. Participants are asked to sign this form (to confirm their tattoos meet our local safety guidelines) prior to their scan with us. This document is part of Substantial Amendment 7.	PRT