Localising Patient Information. Documents

Transcription

1 Localising Patient Information Research Documents SOP Title Localising Patient Information Research Documents SOP No. SOP 22 Authors Consulted Departments Lead Manager Helen Ayre (Research Manager) Lincolnshire Clinical Research Facility, Research and Development and Research staff Professor Tanweer Ahmed, MBA, FICR Director of Lincolnshire Clinical Research Facility, Interim Joint Director of Research & Development & IP Lead Sign and Print Name (Signature on File) Original date of publication 22/06/2017 Date current version published 22/06/2017 Review date of SOP 22/06/2019 Page 1 of 7

2 1. Purpose: The following guidance is intended to ensure the quality and consistency of local information added to patient / participant facing research documentation ( localisation / localising ) prior to use within ULHT. Compliance with this SOP will ensure that only local administrative changes, permitted in accordance with research governance arrangements, are made to research documents and that changes not permitted, such as those constituting minor or substantial amendments, are avoided. This guidance should be applied to patient documents that have already received Research Ethics and / or Health Research Authority approval. For guidance on the development of research participant information and consent documents prior to initial submission to a Research Ethics Committee / Health Research Authority, please see guidance produced by the Health Research Authority; available at the following link: 2. Applies to: Research & Development Staff LCRF (Research Delivery Team) Staff Any personnel responsible for the development / provision of localised research documents for use within ULHT (e.g. Research Sponsors; MSc, PhD Students; Academic researchers etc.) 3. Relevant SOP documentation: SOP 10 Version Control of Study Specific Documents SOP 7 - Trial Master File SOP 9 Training Record 4. Definitions: R&D Research & Development LCRF Lincolnshire Clinical Research Facility HRA Health Research Authority REC Research Ethics Committee ULHT United Lincolnshire Hospitals Trust PIL Participant Information Leaflet (used interchangeably with PIS) PIS Participant Information Sheet (used interchangeably with PIL) Page 2 of 7

3 ICF Informed Consent Form PALS Patient Advice and Liaison Service 5. Procedure: The following patient documentation must be presented on Trust headed paper: Participant Information Sheet/Leaflet Consent Form GP Letter Any other documentation, at Sponsor request only Occasionally studies may utilise posters & flyers to advertise the study, as well as other patient targeted documentation. Please consult the R&D department to find out if these need to be localised as well. Please consult the Research & Development Department if you require any guidance when completing Patient documentation: R&D comments and guidance are in green italics throughout. Actual wording to be inserted is in normal black text Trust Headers Copy and paste the Trust Logo into the header of your patient document. The full address as applicable to the hospital site (detailed below) must appear below the ULHT Logo on the first page of Patient Information Sheets, Invitation Letters and GP letters, formatted with text aligned to the right, as per standard letter writing convention. Only the logo header is required on additional pages; in any alignment suited to the document formatting. Only the logo header is required on Consent Forms and any other documents; in any alignment suited to the document formatting. If formatting issues prevent the above guidance from being followed, please seek advice from the R&D department. Lincoln County Hospital Greetwell Road Lincoln LN2 5QY Tel: Page 3 of 7

4 Pilgrim Hospital Sibsey Road Boston PE21 9QS Tel: (01205) Grantham & District Hospital 101 Manthorpe Road Grantham Lincolnshire NG31 8DG Tel: Where hospital-specific information is not to be used, the following Trustspecific information should be added: Complaints Details Trust Headquarters Lincoln County Hospital Greetwell Road Lincoln LN2 5QY Tel: Where provision is made in the body of the Participant Information Leaflet, the PALS contact details should be added along with the standard complaints paragraph; for example: If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions [contact number]. If you remain unhappy and wish to complain formally, you can do this by contacting [insert details e.g. NHS Complaints Procedure or Private Institutional arrangements]. Details to be entered in the highlighted section are as follows: Patient Advice and Liaison Service (PALS) Lincoln County Hospital. Located near Main Reception. Telephone: (01522) pals@ulh.nhs.uk Or Page 4 of 7

5 Patient Advice and Liaison Service (PALS). Grantham and District Hospital. Telephone: (01476) /2 or (01522) Or Patient Advice and Liaison Service (PALS). Pilgrim Hospital. Located in Main Reception. Telephone: (01205) /4. Or Where hospital-specific information is not to be used, the following Trustspecific information can be added: United Lincolnshire Hospitals NHS Trust s Patient Advice and Liaison Service (PALS). Telephone: (01522) pals@ulh.nhs.uk Where no provision is made to edit / amend the text in the body of the Participant Information Leaflet, the PALS contact details should be added along with the full address on the first page of the PIL. E.g. Lincoln County Hospital Greetwell Road Lincoln LN2 5QY Tel: PALS (Queries & Complaints) - (01522) pals@ulh.nhs.uk Contact details for study: Principal Investigator: Please enter PI name, title and contact telephone number (normally their secretary or research secretary) Research Nurse / assistant / Officer : Please enter name and title and contact telephone number Independent Contact for information about taking part in research studies The PALS department are the designated independent contact point. Where provision is made in the body of the Participant Information Leaflet, the PALS contact details should be added as detailed above for Complaints. Page 5 of 7

6 Consent Form Insert the Trust Logo at the top of the page. If the Consent form and the PIS are one document, please ensure the Trust Logo is present at the top of the Consent Form. You do not need to enter the address as well. GP Letter Insert the Trust Logo and hospital address (as detailed in the Trust Headers section above) at the top of the GP letter (and any other patient correspondence as advised by the R&D office). Ensure that the Principal Investigator s name, title and contact telephone number is provided at the bottom of the letter. General Guidance Do not make any substantial alterations to the layout of the document nor any changes to the content other than where indicated. Follow the example format for the original approval or the guidance provided by the trial centre. If there are any queries relating to content or version numbers the trial centre and /or R&D can provide further guidance. It is permissible, and advisable, to add a date to letters of invitation and/or GP letters. 6. Responsibilities 6.1 The R&D team require generic (non-localised) documents only during the process of capacity and capability assessment for new and amended studies 6.2 It is the responsibility of the PI and research delivery team to ensure that documents are localised prior to use and in accordance with this SOP For CRN Portfolio adopted studies this responsibility will be fulfilled by the LCRF Research Delivery team For non-portfolio studies the PI / research team will be responsible for ensuring this process is completed in collaboration with the R&D department. 6.3 R&D are responsible for conducting a 3-monthly audit of randomly selected localised documents as part of ongoing quality assurance measures. 6.4 Any personnel involved with the localisation of research documents are responsible for ensuring they do so in accordance with this SOP and have Page 6 of 7

7 provided evidence to the R&D department of having read and understood this SOP. This SOP will be reviewed every 2 years unless changes to legislation require otherwise Current versions of all SOPs are located on the LCRF website users are responsible for ensuring that they are using the most up-to-date version. Page 7 of 7