HRA Approval: Question and Answers

Transcription

1 HRA Approval: Question and Answers This document is split into sections to help you find the answer to your question more easily. As the HRA Approval Programme develops, we will update this document add new questions/answers and redefine some answers. Each question shows the date it was published, with questions highlighted as new or updated. If you have any questions not addressed, please contact We will endeavour to address your query and update this document. 1 Benefits Background and implementation HRA Approval process HRA assessment Amendments R&D functions Staffing IT systems Updated: 8 January 2015 Page 1 of 13

2 1 Benefits 1.1 How will HRA Approval benefit researchers? (07/10/2014) Researchers will benefit from the elimination of duplicate application routes and a reduction of paperwork, shortening the time to complete the overall approvals process. This will enable researchers to set up studies more quickly and efficiently, and work on establishing research sites, recruiting participants and completing studies on time. 1.2 How will HRA Approval benefit NHS organisations hosting research? (07/10/2014) HRA Approval will allow local research teams to focus on the set up and delivery of studies at NHS organisations. The removal of duplicate checks will free up time for NHS support staff and managers to undertake more front line clinical delivery and support more research studies. NHS R&D and CRN staff will be released from dealing with checks at a local level, allowing them to concentrate on developing and assessing capacity and capability, enabling the successful delivery of research. 1.3 How will HRA Approval benefit sponsors commercial and non-commercial? (07/10/2014) Both commercial and non-commercial sponsors will benefit from reduced complexity and increased consistency. With less time required to negotiate multiple permission processes, sponsors should be better placed to focus on local feasibility and study set up across multiple sites. 2 Background and implementation 2.1 What is HRA Approval? (06/06/2014) Updated HRA Approval is the new approval that will be required for research to commence in the NHS in England. It is a new process that comprises a review by a Research Ethics Committee as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. Although HRA Approval will include a study-wide review in line with UK wide agreed standards, the assessment will go beyond this to include new standards and assurances (for example, assessment will include the coordination of clinical support assurances for pharmacy and medical exposure). When HRA Approval is fully rolled out, it will remove the need for NHS Permission to be issued by each participating organisation and as such will replace local R&D Approval processes. Roll out will be by study type through During roll out mechanisms will be in place to make it clear which studies require HRA Approval and which still require NHS Permission during this time. HRA Approval will support and complement local processes relating to assessing, arranging and confirming local capacity and capability to undertake the study. When HRA Approval is in place and local capacity and capability confirmed, sites will be able to confirm with the sponsor their readiness to recruit and the study will start at site. 2.2 What will HRA Approval include? (06/06/2014) Updated HRA Approval will include the REC review and an assessment. The assessment will consider the following components: Participant interests Contract assurance Compliance and delivery Updated: 8 January 2015 Page 2 of 13

3 Clinical support assurances for pharmacy and medical exposure HR Good Practice requirements The clinical support assurances will include additional opportunities for a single review of technical elements that are currently duplicated across the NHS. The HRA assessment will confirm compliance with standard contracts, agreements and templates to improve consistency and avoid delays resulting from negotiation of sponsor-specific or site-specific preferences. The REC opinion will itself draw on and take assurance from the assessment. Assessments will be made and/or coordinated by staff within the HRA. Clinical support assurances will be managed through the HRA using expert assessors in the NHS e.g. pharmacy and medical exposure. The assessments that are relevant to the REC opinion will be provided to the REC to enable the committee to focus on ethical aspects of the study. 2.3 What will be the status of HRA Approval? (06/06/2014) Updated HRA Approval will be a formal approval of research for the whole NHS in England. It will not mean that NHS organisations will be required to participate in studies where they are named as potential sites, but it does mean that the decision to participate will be made on local consideration of capacity and capability alone. HRA Approval will provide authoritative assurance to NHS organisations about the suitability, compliance and quality of research proposals. 2.4 Why is HRA Approval needed? (06/06/2014) Updated The HRA undertook a root cause analysis of reported issues and delays in current research approval systems, and reviewed the areas regarded as performing well. We identified that individual components may perform well and a number of improvement programmes had been successfully implemented through NIHR CSP, REC and MHRA. However, it was clear that inconsistency across the NHS remains and even across those components of the system that are functioning well there can be unnecessary repetition. Although arrangements for coordination between regulators are in place, issues remain at the interfaces between regulatory systems and NHS systems. The HRA will implement a new approval process that builds on the strengths of existing individual components but takes a holistic approach across the whole journey, to radically streamline and simplify how studies are set up in the NHS. HRA Approval will meet the Government commitments in the Plan for Growth, and address the concerns raised by the Academy of Medical Sciences and the recent Select Committee Report on Clinical Trials. HRA Approval will make it easier to do good quality research in the NHS. 2.5 What are the current strengths and weaknesses of approval process in the NHS? (06/06/2014) Updated The current processes place responsibilities and accountabilities across a number of organisations. Many individual elements meet target timelines and are continuing to improve in isolation. Many local R&D staff accept assurances from the study-wide review and ethics opinion. However, there are stages that are not currently measured where there is significant anecdotal evidence of variations, like the time taken to make the submission of local SSI applications. Updated: 8 January 2015 Page 3 of 13

4 Different parts of the system suspend timelines for different reasons so measured timelines may meet targets, but elapsed timelines across the whole journey can be lengthy. The need to coordinate parallel or sequential processes can cause delay. Even where timelines are short, there is considerable duplication of effort by applicants in providing the same information to multiple systems and responding to multiple requests for information, so there is considerable investment required to get sites set up. Sponsors report having to adopt phased approaches to site set-up due to the work involved. In short, there is good practice to build on and the HRA has built a detailed understanding of current strengths and weaknesses to inform the implementation of a new streamlined process that will radically improve the approval processes for research in the NHS. 2.6 How is this approach consistent with the Research Governance Framework that requires NHS organisations to give permission for research they host? (06/06/2014) Updated The Research Governance Framework recognises the importance of good management and oversight of research by organisations hosting research activity. The current Research Governance Framework describes this as issuing permission for research. However, the Framework is written for a context in which ethical review and legal review have been undertaken entirely separately. This has resulted in NHS organisations repeating local legal and compliance reviews. For some studies, systems that coordinate permissions through a single study-wide review have addressed these issues to some extent. HRA Approval is a further radical step, which provides an integrated system by an authoritative body, so that NHS organisations can fully rely on the assurances from the HRA. From 1 January 2015, the HRA has legal responsibility for issuing guidance, including the replacement for the Research Governance Framework. The HRA is preparing to revise the Research Governance Framework during 2015 to describe a clear new framework consistent with the principles of HRA Approval. This will mean that the policy framework and operation of that policy will sit with the same organisation with considerable potential to reduce complexity and improve efficiency. 2.7 How and when will HRA Approval be implemented? (06/06/2014) Updated The HRA has established a programme team to plan and manage the process. Once plans and timetables are agreed with relevant stakeholders, HRA Approval will be rolled out, on a study type basis. The HRA will start with studies that have minimal impact on patient care and clinical services. Roll out will then move to studies in primary care where, increasingly, support for research is being offered through large geographical clusters. The HRA will also look to include in the early phases of implementation other specific study types where current processes present particular difficulties e.g. rare diseases. In the meantime, work will continue on standardising the requirements for clinical support assurances for pharmacy, medical exposure, and the use of standard contracts. The implementation approach is intended to maximise acceptance of the principles early on, so that additional layers of complexity can be brought in over time. Roll out is anticipated to be completed by the end of 2015 and will be for all studies in the NHS in England within a UK-wide coordinated framework. Studies not in the early phase of roll out can still expect to see early improvement to set up times as the HRA supports further improvement and efficiency across current systems. Updated: 8 January 2015 Page 4 of 13

5 2.8 Would it be correct to say that HRA Approval is REC and R&D approval rolled into one? (06/06/2014) Updated This is true to an extent; those issues that can be looked at once for a study will be brought together into an assessment and an independent ethical review. However, a number of critical aspects of local R&D activity have to remain outside of HRA Approval i.e. working with the sponsor to ensure that the site is suitable for a study and putting the arrangements in place to set-up and oversee delivery. 2.9 Will HRA Approval satisfy the REC requirements for NHS Management Permission to be in place? (06/06/2014) Updated Under current arrangements, the favourable ethical opinion is conditional on obtaining NHS Permission at sites. The ethics committee is required to consider the suitability of the investigator and supporting staff and the quality of the facilities for the trial. This consideration is called site-specific assessment, for NHS sites this is delegated to the NHS, and is the reason why currently NHS permission is a condition of the favourable ethical opinion. When HRA Approval is implemented, the act of an NHS organisation confirming that it will participate in the research provides the evidence that the NHS organisation hosting the research considers that the local investigator and facilities are appropriate. As now, there will be discussions about site selection and feasibility that include checking that there is a suitable investigator and that the site has the facilities to conduct the study. The next step will involve putting the arrangements in place to deliver the study How will the HRA ensure there truly is efficiency and that all duplicate assessment and requests for information will be taken out? (06/06/2014) Updated HRA Approval will be based on one application package validated once by the HRA. The HRA will manage and maintain the project document set, including any amendments, maintain a list of proposed sites and notify sites of the HRA Approval status, including other regulatory approvals. The HRA Approval will incorporate assessments currently undertaken in study-wide review and the multiple local R&D reviews and includes the independent Research Ethics Committee opinion. This will reduce the complexity of the approvals process for non-commercial and industry research significantly. Site permissions will be replaced by decisions to deliver the approved study, based on local capacity and capability. The HRA will take accountability for the assessment and approval of the study, including accepting responsibility for regulatory inspection findings relating to HRA Approval. This will remove the perceived need of individual NHS organisations to review all aspects of the study to suit their local interpretations of legal compliance. Once a study is submitted for HRA Approval, it will be validated and local sites notified so that local capacity and capability can be assessed and arranged and site initiation dates can be agreed. One of the ways that the HRA will measure success is the timelines for review, particularly in the achievement of target timelines set at validation. Updated: 8 January 2015 Page 5 of 13

6 2.11 Will HRA Approval be compatible with the changes required to implement the new EU clinical trials regulations? (06/06/2014) Updated Yes, HRA Approval will provide a foundation for the implementation of the new European Clinical Trials Regulation in 2016 / 2017 and the HRA will continue to work the MHRA and with colleagues in the Devolved Administrations to support a UK-wide framework for review. This will provide UK readiness for the regulatory changes and provide reassurance to Industry that the UK is ready to adopt the changes and that they can plan to place trials in the UK with confidence How will the implementation of HRA Approval be coordinated with the changes in NIHR CRN? (06/06/2014) Updated The HRA is working closely with the NIHR CRN to ensure that timelines for implementation are compatible with network activities. NIHR CRN will continue to have the lead role for supporting delivery of research within the NIHR CRN portfolio. Removing duplication of effort currently seen in local approvals will enable a greater focus for the NIHR CRN on delivery. 3 HRA Approval process 3.1 What will applicants need to do differently to work with HRA Approval? (06/06/2014) Updated Applicants will need to be ready to submit a complete application package to the HRA ready for proceeding through the whole approvals process. Although currently there is very little difference between the REC and R&D forms on IRAS many applicants apply for REC review well before they are ready to set up sites, resulting in protocol amendments when practical details of conducting the study are developed after REC approval. Applicants will also need to ensure they are better prepared at application. The HRA will implement more robust validation process to avoid accepting applications that are not ready for review. In return, the overall elapsed time to get all sites set up will be shorter and more predictable. 3.2 What will a valid application look like? (07/10/2014) A valid application for HRA Approval will look similar to the current REC and R&D applications. A form will be submitted electronically in IRAS alongside a checklist of documents required for the assessment and REC review. We will be working with stakeholders to develop the form and checklist over the coming months. There is separate work underway to consider the information requirements at site level. 3.3 How and when will an application be validated? (08/01/2015) New An application will be validated in very much the same way as current REC applications are. Once it has been submitted electronically in IRAS, we will work to a Standard Operating Procedure (SOP) around validation and give a response within a specified number of days. Validation will be carried out by HRA staff. Updated: 8 January 2015 Page 6 of 13

7 3.4 Does a submission for HRA Approval also cover applications to all required regulators (e.g. the MHRA)? (07/10/2014) Not in the short term. HRA Approval will provide a single approval for research in the NHS in England that will incorporate assessments by staff alongside the independent Research Ethics Committee opinion. Although the assessment will confirm that all regulatory approvals are in place, separate submission via IRAS will still be required to the MHRA where their review is required. Over time, we plan to include other regulatory applications within the application for HRA Approval but this will be after the initial implementation. When the new EU Clinical Trials Regulations are introduced, in 2016/2017, a single application for clinical trials will be required, so HRA Approval provides a first step in preparing for the Regulation. We will work with colleagues in the Devolved Administrations to support a UK-wide framework for review of clinical trials. 3.5 Will HRA Approval cover non-portfolio research? (08/01/2015) New Yes, HRA Approval will provide a single approval system for all research for the whole NHS in England. Therefore, it will apply to non-portfolio research as well as NIHR CRN portfolio research. 3.6 How does HRA Approval work for English sites if the study has been reviewed by a REC in Scotland, Wales or Northern Ireland? (07/10/2014) HRA Approval will be used for all studies in England, including both NIHR portfolio and non-portfolio studies. Studies that receive a Research Ethics Committee opinion in a Devolved Administration, but which intend to use NHS sites and/or Participant Identification Centres (PICs) in England, will still require HRA Approval. We are working with the Devolved Administrations to ensure that we have efficient systems for UK-wide working. 3.7 How does HRA Approval work for sites in Scotland, Wales or Northern Ireland? (07/10/2014) We are in the process of working with the Devolved Administrations of these countries to ensure compatibility and effective communication where studies have research sites across the UK. We will be building on the existing compatible arrangements, which mean that assurances provided by one country are accepted across the other countries in the UK. The details of the arrangements are not yet in place but are included in plans. 3.8 Will HRA Approval cover non-nhs sites in England? (07/10/2014) Our ambition is for HRA Approval to be implemented for research in England involving NHS organisations and NHS care (i.e. including NHS care delivered through other providers) by the end of It will be rolled out gradually but we do not have a set timetable. When HRA Approval is running successfully for research within the NHS, we will put plans together for other care related settings. In the meantime, we are undertaking separate work to address some of the complexities being faced by specific settings such as care homes and hospices. 3.9 How will HRA Approval work if a study is sponsored outside of the UK? (07/10/2014) HRA Approval will be required for all studies within the NHS in England, no matter who the sponsor is or where they are based. Updated: 8 January 2015 Page 7 of 13

8 3.10 Will the HRA maintain a document store for NHS organisations hosting research to access? (08/01/2015) New Documents submitted to the HRA will be stored in our database for use during the REC review and assessment. We are still working on what the arrangements will be for NHS organisations to be provided with the necessary assurances and information with regard to study documents. As currently, it will remain a sponsor responsibility to ensure that the local study team is provided with the approved documents for study delivery; this was never a function of NIHR CSP As a researcher, I welcome the consistency of review that HRA Approval promises. What happens if some sites continue to ask for additional information or prevent me from making an SSI submission? What should I do? (07/10/2014) If researchers have any concerns they should in the first instance discuss these with their local research management team at the site. If there is no resolution researchers will be able to address concerns directly to the HRA through the queries line hra.queries@nhs.net Does HRA Approval comply with the new EU clinical trials regulations? (07/10/2014) HRA Approval will ensure that the UK is well placed to meet the requirements of the new EU Clinical Trials Regulations. Many details of the Regulations are yet to be finalised but key components are greater integration of decision making by the Member State (MHRA in the UK) and Research Ethics Committee (REC), EU-wide harmonisation of the competent authority decision and setting specific timeframes for the overall process. These components are in line with our aim to streamline the regulation of research. We will work with the MHRA in developing HRA Approval to ensure that it is compliant with the new Regulations What happens if the HRA make a mistake in their Approval? If a sponsor or site is inspected by MHRA who will be blamed if the site accepted HRA Approval without checking it? (07/10/2014) The MHRA will inspect a sponsor or research site proportionately against relevant information and against the Standard Operating Procedures in place. Sponsors and sites must ensure that processes and procedures are updated to reflect the fact that the organisation is using the assessment provided within HRA Approval. The HRA, in issuing HRA Approval, are confirming certain arrangements are in place to allow a study to commence. We will work with the MHRA (and other regulators) to ensure that HRA Approval is compliant with their respective regulations. In relation to a regulatory inspection, we will accept responsibility for any findings in relation to the HRA Approval itself What safeguards will be in place to ensure researchers do not start studies once HRA Approval has been issued, without first having obtained local agreement to do so? (08/01/2015) New While HRA Approval will be the single approval for research in the NHS in England, there is still the requirement for researchers to engage with sites and for sites to confirm that they have all the arrangements in place in order to participate in the study. Guidance will be provided on the format in which sites confirm they have all the arrangements in place. Updated: 8 January 2015 Page 8 of 13

9 4 HRA assessment 4.1 How will the HRA alleviate current delays with contracting at individual sites? (06/06/2014) Updated Universities and NHS sponsors report significant resource investment in contract negotiation with individual sites. The HRA assessment will include confirmation of compliance with standard template agreements. This will mean that for applicants complying with the national standards there will be no delay to wait for local negotiation. The HRA will collaborate with Academic Health Science Networks and Clinical Research Networks to facilitate agreement where non-compliance is identified. The HRA will not negotiate contracts, site agreements or costs for individual studies. However, HRA validation will require that certain standards are met in the provision of information relating to costing and local resource requirements, as well as in the use of template agreements. The HRA is revising the model non-commercial agreement (mnca) to ensure that an agreed template is available to meet the sponsor-site arrangements for most studies. The revised mnca will be published for comment by early In January 2015, the HRA will also take on responsibility for the full suite of template agreements, including for reviewing the model commercial agreement and for developing new templates where required. The template agreements will ensure that the division of responsibilities between sponsor and site are clear. Work is ongoing to refine the HRA assessment service offering around costing and contracts. 4.2 Will HRA Approval cover IRMER and ARSAC issues? (06/06/2014) Updated HRA Approval will include a single medical exposure review building on the current system for lead reviewers in IRAS. The HRA is working with the radiation professions and with ARSAC to revise guidance, create a coordinated process and simplify ARSAC arrangements. The first phase of the clinical support assurance for medical exposure is being finalised and the project was initiated at a workshop with our Experimental Cancer Medicine Centre (ECMC) partners in December Will HRA Approval guarantee compliance with Data Protection legislation? (06/06/2014) Updated Currently individual NHS organisations and their staff interpret the requirements of data protection legislation and information governance codes of practice in different ways. This results in unacceptable levels of variation in requirements on researchers. We are undertaking work with information governance professionals to ensure that there are clear agreed standards and guidance against which the assessment will be undertaken and the relevant assurance provided to NHS organisations in which the research is taking place. The HRA will be working with information governance professionals to ensure that research sites will be able to accept that HRA Approval covers data protection compliance and therefore will not need to ask further questions. The HRA recognises the importance of NHS organisations maintaining awareness of the use of patient identifiable information. Updated: 8 January 2015 Page 9 of 13

10 5 Amendments 5.1 If a study is amended in any way during the HRA Approval process, how will sites be made aware of the changes in order to assess if feasibility needs to be reconsidered? (07/10/2014) The HRA will work with Investigators and sponsors to improve the quality of applications before they are submitted for HRA Approval, minimising the need for amendments during the HRA Approval process. Currently applicants are not allowed to make significant changes to a submitted application before the REC has issued an initial opinion; this is will also be the case under the HRA Approval process. After the initial HRA Approval has been issued, amendments will be reviewed and affected sites notified. 5.2 Will the HRA review and categorise amendments and reissue an updated HRA Approval? (07/10/2014) Yes, we will review and categorise amendments using the UK-wide amendments process, however the exact process is yet to be defined. Once categorised, we will issue notice to the sponsor and research sites as appropriate. As an interim measure, we are currently establishing a process for reviewing amendments for non-csp studies. This process involves categorisation of the amendment, so that only sites that are affected need to be notified to consider the implications. 6 R&D functions 6.1 What will be the role for NHS R&D offices once HRA Approval is implemented and how can they be ready for HRA Approval? (07/10/2014) The document Research support functions following HRA Approval implementation describes the functions that R&D offices in England might undertake in order to support research delivery in their organisation. R&D offices are encouraged to use this document to review and revise their systems to ensure they are ready for HRA Approval. Through their Study Support Service, the NIHR Clinical Research Network (NIHR CRN) already provides resources for many of these functions for studies that are part of the NIHR CRN Portfolio. We will work in partnership with the NIHR CRN as they define and communicate the local activities that will complement HRA Approval, specifically the tasks funded and performed by the NIHR CRN and those that will be supported by the NHS. HRA has also seconded regional Change Leads to support NHS organisations in preparing for the implementation of HRA Approval. The Change Leads and their contact addresses are available on the HRA website. In addition, we are working with the NIHR Champions for Research Support and CRN RM&G Leads to facilitate local discussions around HRA Approval. Updated: 8 January 2015 Page 10 of 13

11 6.2 How will this affect the roles of NHS R&D staff and research governance staff in networks? (06/06/2014) Updated The HRA s plans have been developed to support the efficient approval of research. The HRA has secured funding through the business planning process to implement this new service. This will not affect the overall national funding allocation provided to NIHR Clinical Research Network (CRN) for services in The new arrangements will allow research funding through the NIHR CRN to be devoted to supporting and delivering research. HRA Approval will allow CRN funded staff to focus on research delivery and management. Similarly, the new service will be of value to Trusts in enabling resources for research to be focussed on the successful set up, recruitment and delivery of health research. The functions which NHS based R&D staff can deliver to support research delivery are described in Research support functions following HRA Approval implementation. Although some of the activities currently involved in local NHS Permission will no longer be required once HRA Approval is implemented, these activities are only a small part of what CRN and R&D staff currently do. Many R&D and CRN staff are focussed on supporting researchers in assessing site capacity and capability, negotiating arrangements with local staff and overseeing the set up and delivery of studies. In addition, staff may undertake sponsor activities, manage funding for grants, support costs and infrastructure, develop researcher capacity through training and professional development, encourage and enable patient and public involvement and engagement in research, and support the development and implementation of innovation. Freed from the requirements of NHS permission, local staff will be able to devote more time to these vital activities. Further information around how these activities are supported through NIHR CRN can be found at R&D staff currently deliver training on research regulation. Will this training still be needed? (07/10/2014) Yes, local research staff will still require training on regulations and other aspects of research. It is expected that research sites will ensure that their staff have access to appropriate training, which can be delivered by a range of providers. 6.4 What RM&G funding will NHS organisations receive through the NIHR Clinical Research Network? (07/10/2014) Through their Study Support Service, the NIHR Clinical Research Network (NIHR CRN) already provides resources for delivery of studies that are part of the NIHR CRN Portfolio. We will work in partnership with the NIHR CRN as they define and communicate the local activities that will complement HRA Approval, specifically the tasks funded and performed by the NIHR CRN and those that will be conducted by the NHS. If NHS organisations have questions or concerns, they should direct them to their LCRN Chief Operating Officer in the first instance. Contact details are available on the Clinical Research Network website. 6.5 How will research sites and participant identification centres know that they have been listed on an application for HRA Approval? Currently sites are informed through CSP for NIHR CRN Portfolio studies. (07/10/2014) Once HRA Approval has been implemented, CSP will no longer be required. Local research management teams will continue to be made aware of all forthcoming research studies involving their organisation. The exact mechanisms to support this are yet to be finalised. As now, the responsibility Updated: 8 January 2015 Page 11 of 13

12 for working with sites to undertake feasibility assessments and open studies will remain with sponsors, or their delegated representatives. 6.6 How will Site-Specific Information (SSI) submissions work with HRA Approval? How will SSI submissions work for Primary Care sites? (07/10/2014) We are still developing the processes for provision of site-specific information. We are working with the Primary Care Working Group of the NHS R&D Forum to ensure that HRA Approval also supports primary care based research. 6.7 Will NHS sites still need to give permission for a study to begin at their site? (07/10/2014) Updated No, sites will not have a formal NHS permission process. Research sites will work with sponsors to assess, arrange and confirm local capacity and capability to undertake a study. Once HRA Approval has been issued, research sites will be able to confirm with the sponsor their readiness to recruit and open the study. 6.8 Will there be guidance on what NHS organisations should issue instead of NHS permission letters? (08/01/2015) New Yes, guidance will be provided. NHS sites in England will no longer issue a letter of permission or confirmation. Instead, we envisage that signing of the sponsor/site agreement signals that all study arrangements are in place and recruitment or study activities can begin. Standard template site agreements are currently being developed and/or revised to facilitate this Because implementation of HRA Approval is phased by study type, there will be a period where NHS organisations will still be required to issue NHS permission for studies not yet incorporated into HRA Approval. NHS organisations will therefore need to operate to different office processes (or SOPs) for different study types. We will communicate clearly about this at each stage of implementation. 6.9 Are NHS organisations expected to amend their SOPs to reflect HRA Approval? (08/01/2015) New Yes. In preparation for the implementation of HRA Approval, we advise Trusts to have interim office processes or Standard Operating Procedures (SOPs), or addendums to existing office processes or SOPs in order to reflect the phased approach to HRA Approval implementation and be clear which studies still require NHS permission. These will need to be kept under review as implementation progresses. Once HRA Approval has been fully implemented, all offices processes or SOPs should be updated to reflect the new way of working. In NHS organisations where research SOPs have to be signed off by a Board; we advise that there is discussion about how processes are documented and adhered to during the implementation period before a final version can be signed off. Updated: 8 January 2015 Page 12 of 13

13 7 Staffing 7.1 Who will undertake the HRA assessment? What training will they have? Where will they be based? (07/10/2014) Updated Operational staff will be employed by the HRA to undertake HRA assessment and the recruitment process for the first of these staff has begun. All staff employed will have an agreed job description and will be required to possess key competencies and experience. The assessment will be supported by assurances about pharmacy and radiation provided by lead professional reviewers in the NHS. It is envisaged that staff will be based within HRA Centres (currently: Bristol, Jarrow, London, Manchester, and Nottingham). For HRA Approval, a suite of Standard Operating Procedures (SOPs) and guidance documents will be produced. All HRA staff involved in assessment will be trained in these SOPs, and their performance will be measured against defined standards. 7.2 Who are the staff in the HRA Approval Programme Team? (07/10/2014) Details of staff appointments to the HRA Approval Programme Team that are developing the new processes can be found in the Vacancies and Appointments section of the HRA website. 8 IT systems 8.1 Will changes be made to IRAS? (07/10/2014) Yes, IRAS will be developed to support HRA Approval. Changes will also be made to support the needs of other IRAS partners, including changes needed to accommodate the new EU Clinical Trials Regulation. 8.2 Will implementation require changes to other current systems that IRAS interfaces with? (06/06/2014) Updated To begin implementing HRA Approval, no technical system changes will be required for the systems of IRAS partners, including NIHR CRN. NIHR CRN systems, including NIHR CSP Module, will not need to change whilst the early phases of HRA Approval are being rolled out. HRA is continuing to work closely with the NIHR CRN over the arrangements to ensure that the significant improvements in performance are maintained and that studies continue to be set up promptly and delivery of studies continues efficiently. Once HRA Approval is fully established, the NIHR CSP system will no longer be required. Updated: 8 January 2015 Page 13 of 13