Site Specific Information Form Completion

Transcription

1 Site Specific Information Form Completion The IMPROVE ethics application has been received by England and Scotland ethics committees. We now need to submit a Site Specific Information form (SSI) for each site taking part in the trial. In order to complete the SSIs, each site will need to do the following: Allocate a trial coordinator to gather & collate information for the SSI The trial coordinator will need NRES or IRAS account. These are the central ethics websites. If the coordinator already has an account with NRES they do not need to set up a new account. If you don't already have an ethics account, please: o go to o o click on Enter, go to CREATE ACCOUNT at the top of the page and then follow instructions to register o When you have an NRES or IRAS account, please Trial Manager Dr Pinar Ulug at p.ulug@imperial.ac.uk or improvetrial@imperial.ac.uk with the address the account is registered to so the SSI may be transferred for site completion. Once the form is completed: o click on the "Navigate" button o click on the "submission" tab o click "print for submission" this will lock the form, create a site specific code and a pdf of the form which may be saved and printed o when you have printed the form please sign it and submit the original signed copy, along with the PI's 2-page summary CV to your Comprehensive Local Research Network / Research & Development department.

2 General guidance on the SSI form The Site-Specific Information Form (SSI) Form is a combined form for NHS review (for any research where the site is within the NHS) and for site-specific assessment (SSA) to support ethical review, where required. Some of the answers in the SSI Form will have appeared automatically and will be identical to the answers the Chief Investigator gave to earlier questions in Parts A and B. Question 2 Principal Investigator/ Local Collaborator The PI should also submit a summary CV with the application. It is recommended that applicants use the CV template available in IRAS or, if not, the CV should include the areas of information in this template. For example, it should give evidence of previous research in the same field of study, and other relevant experience and training. The length should be a maximum of 2 pages of A4. The CV should be signed and dated prior to submission. Local Collaborators do not need to submit a CV. Tip: It is helpful to show you have had GCP training. Question 3 Research locations The information supplied in this question should be in sufficient detail to allow the location(s) and scale of the research to be assessed. Explain which parts of the research will take place in each location, and give details of any major equipment or facilities that will be used. Question 5 Members of local research team List other members of the research team for this research at this site who will have a significant research role (e.g. other clinical investigators, trial nurses, staff who will interview participants). Include a complete list of investigators who will be accountable to the named Principal Investigator for the site. Any staff, e.g. clinical trial administrators, who will have access to participant identifiable information should be included in this section. Indicate the individual s role in the research team Do not give names of individuals whose involvement in the research is limited to carrying out their normal clinical or administrative duties. Researchers and research nurses should also submit a summary CV with the application. The CV must include the information in the recommended template CV. Tip: It is helpful to show you have had GCP training.

3 Question 6 Conflict of interest Any potential conflicts of interest should be raised here. The SSA will consider whether the issues raised pose any ethical concerns for the project. NHS R&D will consider the business implications for the NHS organisation. Question 7 Local study dates Give the proposed start date and the proposed end date of the research within the NHS organisation. You may not know these dates exactly, but a rough estimate should be supplied. Allow sufficient time in the start date for your applications to all bodies who need to approve the research. The end date is the date on which all procedures specified in the protocol are concluded. Questions 8-2 & 9-2 Local variations in study procedures The table has been populated with information from Part A, completed by the CI. Please insert details of the local members of the research team who will conduct procedures. If any variation is proposed in the study procedures to be undertaken at this site, for example related to the local standard of care, select Yes. This will allow you to make alterations to the information in the table. The review will check that any variation is permitted within the terms of the protocol and the full application submitted to the main REC. If not, the PI should advise the CI to notify the main REC and seek ethical review of a protocol amendment applicable to the site and, if appropriate, the local version of the participant information sheet. Question 10 Number of participants Give details of the planned number of participants locally. The sample for the research may include participants who are not approached but whose records or samples are to be studied. Question 11 Identifying potential participants Explain how potential participants will be identified and approached locally. Who will review registers, lists or medical records to identify participants? Question 12 Obtaining informed consent This question only applies to research where consent will be sought.

4 The review will check that the person(s) taking informed consent locally are appropriate for the task. They should be fully informed about the nature of the study. They should be aware of the process of taking consent, including any specific issues relating to consent with the potential participant population, and familiar with best practice. Any specific training received should be described. This person should have sufficient time and expertise to answer questions that might be raised by the research participants. Questions 13-2 to 4 Adults with incapacity Explain what local arrangements will be made to for adults unable to consent for themselves. Different legal arrangements apply in each of the countries in the UK. Research involving adults unable to consent for themselves For guidance on the legal and ethical implications of conducting research with adults with incapacity see Question 14 Research involving emergency treatment This question only applies in England, Wales and Northern Ireland. Explain what local arrangements will be made to for adults unable to consent for themselves where the research involves urgent treatment. Question 15 Independent contact point It is good research practice to inform potential participants where they may obtain independent information or advice about their rights as research subjects or about being involved in this particular research study. Provision for independent advice may already be included in the generic information sheet. However, if there is an appropriate local source this should be cited here and added to the information sheet locally. Members of the research team should not be named as sources of independent advice. It is not essential for the independent advisor to be a clinician. It is the role of the study doctor (or other healthcare professional on the research team) to provide clinical advice. The role of the independent advisor is to enable the participant to weigh up the decision whether or not to participate, taking into account the information provided about the study. RECs should not be cited here. It is not the role of NHS RECs to give direct advice or support to participants in this way. If there is no appropriate individual or agency, please answer No.

5 Question 16 Local version of the participant information sheet The R&D office will check that relevant site-specific information has been included in the local version to make it suitable for local participants. It is a requirement of Good Clinical Practice that participants should be able to find out more information about the proposed research should they wish to do so. Details must be included in the local version submitted for review. Participants should be informed how they may make a complaint, if necessary, about the way they have been approached or treated in the course of the research. The contact point for complaints must be included on the local version. This may be the local NHS complaints mechanism. It is important that the participant information sheet and any other correspondence should be on official headed paper. The official headed paper of the NHS organisation (e.g. a Trust or a GP practice) should be used. Electronic versions of headers may be available to coordinating offices that are assisting in preparation of study paperwork. Private (personal) headed paper is not sufficient. Question 17 Language issues The local Principal Investigator should describe here how he/she will implement those approved generic arrangements locally. Where use of interpreters is desirable, the PI should describe the proposed local arrangements for their availability. Question 18 Information for professional carers The review will check that those responsible for the professional care of a participant are told of their involvement in the research. Sufficient details should also be recorded in the patient s medical records, to ensure that the future treatment of the patient is compatible with their involvement in the study. Question 19 Facilities and staffing The review will check that the local facilities and staff are adequate for the research to be undertaken safely in relation to the procedures to be undertaken. State what arrangements have been made to deal with potential risks, to minimise harm to participants and to respond to emergencies. Question 21 Funding This question relates to the funding provided to the local site. Overall project funding should have been discussed between the Chief Investigator and the lead NHS organisation at an early stage in planning, as part of the preparation of a grant application or arrangements for funding, to ensure that local NHS costs have been adequately addressed. For multi-site studies some of the overall project funding may be allocated to collaborating centres and this is described as

6 local funding. Principal Investigators should record details of this local funding in this section. If not commercially sponsored, give details of any funding for the research at this site, e.g. NIHR, health department, charities, collaborative R&D funded by industry. Include funding to the NHS organisation and/or partner university for this research at this site. This will allow the relevant organisations to ensure appropriate allocation of funds to cover their costs. Funding may be paid to the NHS organisation or to a university account or both. Where the funding is to be paid to an organisation other than the care organisation and there will be costs incurred by the care organisation, appropriate contracts or agreements between the organisations must be in place to ensure the care organisation is able to reclaim its costs Question 23 Authorisations This section must be completed in accordance with the NHS organisation's internal guidance. The method of internal authorisation varies in NHS organisations. In some cases authorisation by, for example, line managers, support department managers or finance managers, should be obtained on the SSI Form. The NHS organisation should provide clear guidance on which individuals have authority to sign this section. Where university employers have arrangements in place with partner NHS organisations, authorisation from the university to the NHS organisation can be provided in this section. In some NHS organisations a central system may coordinate all authorisations, and signatures should not be obtained on this form. Researchers should note that where a central process is in place in the NHS organisation, attempts to obtain signatures or authorisations independently may cause delay to review and permission. Where authorisations are required on the SSI Form, all sections should be completed by the authoriser. NHS organisations should provide guidance to authorisers on the text to describe the type of authorisation and what the authorisation means. The required number of authorisation sections can be created by ticking the box for further authorisations. Once the appropriate number of authorisation pages has been created, the form should be printed off for completion by the authorisers. Examples of the type of authorisation that may be required are: clinical directors, student clinical supervisors, line managers, service managers, support department managers, pharmacy, data protection officers or finance managers, depending on the nature of the research. Managers completing this section should confirm in the text what the authorisation means, in accordance with the guidance provided by the NHS organisation Declaration Please read the bullet points carefully. By signing this, the Principal Investigator is legally agreeing to its contents.

7 Flow diagram of trial Care algorithm Patient with suspected raaa for ambulance transfer Direct to vascular centre offering 24/7 Arrival in hospital A&E or receiving unit A&E or receiving unit clinical diagnosis of raaa Randomisation (telephone/web) n=600 Immediate CT eevar strategy n=300 raaa n=15 Not raaa n=15 Normal care with open raaa n=300 raaa eevar if possible n~180 EVAR, ~105 open repair Other specialist referral laparotomy open repair n=285 Primary end point 30-day mortality Secondary endpoints: 24h, in-hospital & 1y mortality, major morbidities, reinterventions, costs, cost-effectiveness modelling