LCRN Guidance Suite. V1.1 July Document Ref No: D04. Page 1 of 18

Transcription

1 LCRN Guidance Suite Provision of good practice in assessing, arranging and confirming local capacity and capability for Participating Organisations delivering CRN Portfolio studies V1.1 July 2016 Document Ref No: D04 Page 1 of 18

2 Document Control This document is issued and updated by the national Clinical Research Network (CRN) Coordinating Centre (CC) and forms part of the Local Clinical Research Network (LCRN) Guidance Suite a group of documents provided to support LCRN delivery against the CRN Performance and Operating Framework. Readers should ensure that the latest version is being viewed. Document Information Document Title Document Ref No. Principles of good practice in assessing, arranging and confirming local capacity and capability for participating organisations delivering CRN Portfolio studies D04 Version V1.1 Supersedes Function N/a Performance and Operating Framework: Section 6 Research Delivery Effective Date March 2016 Audience LCRN Partner Organisations Participating Organisation Staff delivering NIHR CRN Portfolio Studies LCRN Staff Category Expectation Purpose For guidance National standard with local flexibility This document sets out the framework The support an LCRN provides to its Participating Organisations across all care settings to help them meet their responsibilities for assessing, arranging and confirming local capacity and capability as required for NIHR CRN Portfolio studies. The general lines of responsibility and accountability between the Participating Organisation and the LCRN for assessing, arranging and confirming local capacity and capability related activities. The principles of good practice in assessing, arranging and confirming local capacity and capability to an agreed standard for CRN Portfolio studies. Page 2 of 18

3 Contents 1. Introduction 4 2. Provisions of CRN support 4 3. Responsibilities and Accountability 5 4. Provision of good practice in assessing, arranging and confirming local capacity and capability for Participating Organisations delivering CRN Portfolio studies Framework for local capacity & capability 8 6. Associated workflow data set for participating organisations Key contact Abbreviations and Glossary 17 Page 3 of 18

4 1. Introduction HRA approval provides one approval for research studies for the NHS in England. It combines a single assessment of governance and legal compliance with the independent REC opinion (if required). For Participating Organisations, this provides the means to confidently assess, arrange and confirm local capacity and capability for their involvement in a study to Sponsors. While the Participating Organisation has overall responsibility for study set up (capacity and capability assessment) and confirmation of study participation, the Local CRN or a contracted research office may undertake these set-up activities on their behalf as agreed by the local parties. Organisational activities, distinct from the role of the Sponsor or Lead CRN, are defined in the HRA document assessment, arrangement and confirmation of local capacity and capability and are aligned with research support functions and the companion primary care R&D office local support functions developed by the R&D forum Primary Care Working Group. The HRA in conjunction with the Devolved Administrations will develop and maintain a UK-wide policy framework for the management and conduct of health and social care research. The CRN is committed to providing support for CRN portfolio studies with a view to increasing access to research, and to improving the experience of Sponsors, Researchers and Participating Organisations. The CRN has therefore produced this document, in conjunction with the HRA and the R&D Forum, to support its participating partner organisations consistently deliver their assessment, arrangement and confirmation of local capability and capacity activities for CRN studies in accordance with the framework outlined by HRA approval. 2. Provisions of CRN Support The LCRN is responsible for supporting partner organisations with activities relating to assessing, arranging and confirming local capacity and capability participating in a CRN Portfolio study. The LCRN may support its partner organisations to participate in CRN Portfolio studies in the following ways: Ensuring appropriate and/or complementary support for the activities and roles to assess, arrange and confirm local capacity and capability is provided to Participating Organisations through the local models determined suitable for such support provision e.g. CCG/consortium providing support for Primary Care settings. Enabling support provision through effective management of the allocation provided through the annual LCRN Funding Allocation model (specifically via the project based services component). Working collaboratively with the Participating Organisation to help address local support needs. Escalating any shared needs or issues identified relating to assessing, arranging and confirming local capacity and capability to the Lead CRN as required to support study wide resolution and avoiding duplication of effort at all times. Providing a Framework of good practice principles, contained herein, to support consistency in delivery of assessing, arranging and confirming local capacity and capability for CRN Portfolio studies. NB: These principles are not prescriptive but have been developed to provide a mechanism through which a consistent approach can be achieved Page 4 of 18

5 to improve the Researcher, participation organisation and Sponsor experience for CRN Portfolio studies. 3. Responsibilities and Accountability Participating Organisations are: Required to work collaboratively with the LCRN to establish how the LCRN support available may be best used to consistently deliver the principles and framework described in this document. Ultimately responsible for providing confirmation of capacity and capability for all studies in a consistent and timely manner through defined operational processes which: 1) are developed in conjunction with the LCRN 2) are consistent with HRA guidance 3) ensure involvement of relevant Multi-Disciplinary Team and Support Department contributing to the delivery of the study as required 4) include any amendments requiring Participating Organisation review as determined under the UK wide categorisation of amendments 5) clearly document respective roles and responsibilities for all parties involved in the assessing, arranging and confirming of local capacity and capability activities. Accountable for their performance for delivering these activities. Where activities have been contracted to another provider (or combination of providers) such as an LCRN, R&D office, CCG or Consortium team (particularly relevant in primary care), contracts should reflect the expectations of the Participating Organisation for performance and monitoring for those providers. Responsible for the proper and transparent management of any funds it receives from the LCRN to support activities for assessing, arranging and confirming capability and capacity, which may include relevant distribution to any contracted provider where applicable (e.g. CCG or R&D office supporting primary care). This excludes use of these funds for unrelated activity e.g. sponsorship activity or governance activity provided by the HRA. Required to collect and report associated data points described in this document. The LCRN is Responsible to support Participating Organisations with activities relating to or complementing assessing, arranging and confirming local capacity and capability for CRN Portfolio studies. Accountable for their LCRN funding allocation and appropriate application in support of assessing, arranging and confirming local capacity and capability activities. Monitoring the delivery and consistency of assessing, arranging and confirming capability and capacity through the review of associated data points and metrics. Responsible for delivery of any assessing, arranging and confirming capability and capacity activities provided to any Participating Organisation as agreed between them. Page 5 of 18

6 4. Principles of good practice for assessing, arranging and confirming local capacity and capability for CRN Portfolio studies. Participating Organisations The activities below should be undertaken by Participating Organisation staff (which includes their representative Research Office staff), or LCRN funded staff in accordance with the approach agreed between the parties. It is expected that the allocation of the individual activities is clearly defined and documented. This is intended to avoid duplication by providing a clear and simple process for the sponsor and local study delivery team. 1. Use the information provided by the Sponsor to put in place all necessary arrangements for the site to support study delivery to time and target ensuring research management and delivery teams work closely together and all service support requirements are met. 2. Take a pragmatic and tailored approach to site set-up considering relevant aspects as outlined in this framework, rather than performing a tick box exercise, aligning with HRA guidance in HRA Initial Assessment and HRA Approval letters as well as the latest HRA documents available on the HRA website: Assessing, Arranging and Confirming Capacity and Capability and as applicable guidance for NHS Organisations. Participating Organisations are to take assurance from the HRA that studies have been reviewed in line with the HRA assessment criteria and standards. 3. Engage with the LCRN as early as possible to mitigate set-up issues upfront and access/share study wide lessons learned. 4. Have clear arrangements in place for communicating with Sponsors, the LCRN and other relevant parties. NB: it should be made explicit to the Sponsor at all times whom the principal point of contact is for that Participating Organisation to avoid duplication of effort. 5. Provide and utilise a consistent, generic point of contact/ address for the research management staff for the Sponsor and Researchers publicised via the contact details for NHS Organisations on the NHS R&D Forum website and copy the LCRN generic address (also on the NHS R&D Forum website) on initial study correspondence to ensure Local CRN are aware of the study to provide any necessary CRN support. Promote/redirect to central R&D address when individual NHS staff are approached directly by Sponsors. 6. Wherever possible: a. Acknowledge receipt of information to Sponsors within 3 working days b. Agree a study set up and delivery timetable (noted in the HRA document assessment, arrangement and confirmation of local capacity and capability) using the Statement of Activities or relevant Agreement as outlined in the HRA Initial Assessment and/or HRA Approval letters, including for example estimated dates for Study initiation Visits, training by the Sponsor or delivery of supplies. c. Document in writing where possible if the Participating Organisation decides not wish to participate following discussion with the Sponsor. A decision not to participate due to being unable to put in place the necessary capacity and capability to deliver the study (e.g. suitable participants are unlikely to be recruited, equipment not available at Participating Organisation) should initially be discussed with the Sponsor to explore potential resolution of any issues (e.g. protocol amendment) Page 6 of 18

7 d. Issue any objection to participation clearly to the Sponsor in writing within the HRA specified timeline for studies in which the HRA has advised that confirmation of capacity and capability is not required (stated on the Initial Assessment letter) e. Use the IRAS reference number as a consistent identifier in all correspondence and records to identify the study. f. Escalate queries as necessary to the Sponsor, LCRN (who may escalate to Lead CRN as required) or HRA as relevant. NB: Templates may be provided by the HRA (e.g. template for confirmation of capacity and capability) or CRN to support this for use where suitable. 7. Use the Local Portfolio Management System (LPMS) for all studies, including those not requiring local confirmation of capacity and capability, to: a. Record and quality check all relevant workflow dates and confirm outcome status as described, which will form part of the LPMS minimum data set (once defined by the CRN CC) for all studies. This information may be required to support CRN evaluate audit of compliance with this guidance document. b. Collect additional data points as required locally for continuous improvement of processes and/or identification of barriers to rapid set-up such as understanding what departments/resources are leading to delay in issuing capacity decision. c. Where possible, log, control and manage documents provided by the Sponsor in line with Participating Organisation processes including those to enable local capacity and capability activities to be undertaken by any sub-contracted providers (e.g. to enable conduct of any sub-contracted of activities to support a General Practice). 8. Where appropriate establish or amend Local Standard Operating Procedures, guidance or work instructions to reflect the of good practice principles and framework within this document for example: a. The authorised institutional representative(s) to issue confirmation through the Statement of Activities or relevant Agreement as outlined in the HRA Initial Assessment and HRA Approval letters. b. Arrangements for working with partner organisations (e.g. University or Clinical Trial Unit) when undertaking research involving NHS patients to clearly define roles relating to local capacity and capability. c. Local training requirements, refresher training or use of national training modules to support the required staff competency to assess capacity and capability and put any necessary arrangements in place. d. Evidence of due diligence when confirming agreement ready to participate, which might include documented appropriate discussions, local SOPs/Guidance/work instructions, site Agreement, delegation log or completed Statement of Activity e. The specific role of the LCRN where applicable i.e. if providing support for primary care sites to assess, arrange and confirm local capacity and capability to deliver the study. 9. Work towards an initial target timeline of 40 calendar days from Date Participating Organisation selected to Date Participating Organisation confirmed as described. Timeline proposed will be refined during testing of these principles, potentially resulting in a range of timelines for different study types. 10. For any amendments determined by the HRA to require Participating Organisation review, ensure all relevant people at site are able to review in order for the Participating Organisation to communicate any change in needs to the LCRN where additional or reduced support is required as a result of the amendment. Page 7 of 18

8 5. Framework for local capacity and capability The following framework provides an outline of activities that should be considered for during assessing, arranging and confirming of local capability and capacity as appropriate, by Participating Organisation staff or those acting on their behalf. The work should be undertaken quickly and effectively in a way that is proportionate to the type of the study, involvement of the site, the scale of the study and the risks involved. The NIHR Framework for Research Support Services provides tools to support such an approach. CONSIDERATIONS SUITABILITY OF LOCAL RESEARCH DELIVERY TEAM Investigator considerations: The Initial Assessment and HRA Approval letters will confirm if a Principal Investigator (PI), a Local Collaborator or neither is required at a Participating Organisation. Where a PI is required, the Participating Organisation has identified a suitable investigator. Suitable defined as a named investigator taking into account his/her professional qualification, knowledge of research field, expertise in the procedures involved, previous research experience, training in research methods (including informed consent), training in Good Clinical Practice (if applicable), PI oversight training and ability to take clinical responsibility for local research team. The Statement of Activity indicates whether a PI has been identified or identification is required. Clinical Research staff considerations: Clinical research staff are available within all departments involved to set-up and deliver this study with appropriate specialist personnel (e.g. sub-specialist physicians/technicians/physical therapists) and/or administrative staff, who are appropriately qualified and trained to undertake their study related task(s) at the Participating Organisation. A sub-investigator and deputies have been identified where applicable. The PI and research team understand the requirement to document appropriately delegated duties, study training and competence e.g. via a Delegation of Duties Log or training log. Up-to-date CVs and documented evidence of training have provided for the Site File. Study Management considerations: The management of study delivery within the Participating Organisation will be appropriately conducted by the Investigator and the research delivery team in conjunction with the research management team Study Follow-up considerations: The clinical research staff or Participating Organisation have the capacity to follow all procedures in the protocol which includes support study follow up as required Conflict of interest considerations: Any possible conflict of interest for Participating Organisation staff, e.g. personal involvement with the sponsor or funder, has been declared by the Investigator or Participating Organisation research team member, and the Investigator or research team member s employer is aware of this Supervision considerations: Appropriate local clinical or management supervision will be provided as required to ensure the research team and other relevant staff are suitably resourced and trained to comply with: Good Clinical Practice acceptable to the Sponsor (e.g. NIHR GCP training) or other relevant standards are applicable to the study Page 8 of 18

9 type. Note GCP training is not required for all types of research. the research procedures set out in the protocol and other supporting information such as study manuals, procedures(especially those not classed as standard skills for all clinical staff) study specific equipment study specific Case Report Forms (CRFs) including ecrfs as applicable the requirements for reporting to the sponsor on progress and pharmacovigilance the monitoring arrangements expected by the sponsor the arrangements reviewed by the REC for identifying and approaching potential participants the arrangements reviewed by the REC for seeking consent in particular where the study involves adults unable to consent for themselves, participants under the age of 16 or emergency research the arrangements for handling of Investigational Medicinal Product (IMP) the arrangements for security, storage and archiving of trial material, e.g. documents and samples Health and safety training requirements at the Participating Organisation Obtaining consent in accordance with the study protocol/investigational plan while considering the needs of participants who may not adequately understand verbal explanations or information written in English as necessary Training considerations: The Participating Organisation can accommodate training format required by the Sponsor e.g. online, face to face or routine briefings within the specified time frame required by the Sponsor. Where an initiation visit has been arranged, the PI and relevant staff are able to attend. Human Resources considerations: Any employer human resource requirements should be in place to ensure that staff only undertake study specific activities that are appropriate to the job and competencies of the individual, including provision of appropriate supervision as required. This should be in line with the information provided by HRA Initial Assessment letter or HRA Approval letter and be in place within the specified time frame required by the Sponsor. This many include arrangements to issue letters of access or an honorary contract where participants will be seen by non-nhs Organisation employees. Any Research Passport has been validated by the employing organisation for the relevant staff member as described in the HR Good Practice resource pack* Available guidance: The NIHR website currently provides guidance for Research Passport and Streamlined Human Resources Arrangements through the Research in the NHS: Human Resource (HR) Good Practice Resource Pack. Responsibility for this guidance has transferred to the HRA and it will in due course be updated. The package sets out guidance and good practice standards, underpinned by standard documentation, so that individual NHS bodies can be confident that the process used to carry out criminal record and other checks on external researchers undertaking activities at the NHS organisation is in line with NHS Employment Check Standards. Responsibilities: Assurances on compliance with the HR Good Practice Resource Pack should be undertaken at a local level. Research Page 9 of 18

10 Passports are validated by the first NHS organisation the researcher approaches. For studies applying for HRA Approval, the Initial Assessment and HRA Approval letters will provide details regarding the need for Letters of Access and/or Honorary Research Contracts. It will also confirm what pre-engagement checks should or should not be requested, in line with the HRA Good Practice Resource Pack and the HRA assessment criteria and standards. However the HRA will not be validating Research Passports, where one is required. The sponsor should identify a Lead NHS organisation in England to validate the Research Passport where one is required and put in place the necessary local HR arrangements in line with the initial assessment letter, HRA assessment criteria and standards and HRA Good Practice Resource Pack as part of supporting participating NHS Organisations in arranging capacity and capability. Discussions between the Local CRN and their partner Organisations will determine the support required from the LCRN for activities relating to or complementing local capacity and capability decisions. This includes activities around validating Research Passports in line with the HR Good Practice Resource Pack recommendations for pre-engagement checks, and information provided in the initial assessment letter. CONSIDERATIONS FOR ADEQUACY OF LOCAL FACILITIES INCLUDING SUPPORT DEPARTMENTS Clinical pathway considerations: The Participating Organisation offers a clinical pathway for the condition being studied or excess treatment costs will support a new pathway within the timeframe specified by the Sponsor to enable participation in research involving novel care pathways. Any impact of the study on the local pathway is considered for staff, participants and Participating Organisation patients. This includes ascertaining standard of care pathway for the patient at the site. Recruitment target considerations: Based on the projected study timelines there are sufficient numbers of potential participants meeting the inclusion/exclusion criteria when taking into account any competing trials currently open or planned to open at the Participating Organisation to minimise the potential for inadequate patient recruitment or non-completion of research. The recruitment target has been assessed reliably (such as using patient databases, screening of clinic lists or previous study recruitment data) and consideration has been given to recruitment mechanisms such as advertising and increasing patient populations through use of Participant Identification Centres (PICs) as appropriate for study. The recruitment target reflects considerations for patient willingness to participate in line with the patient s standard of care treatment options. Space considerations: Adequacy of space to recruit participants into the study along with the necessary clinical space to perform clinical trials assessments and procedures, taking into account day-case, inpatient stays, access to support services such as imaging/radiotherapy as applicable. Adequacy of secure space for storage of equipment and site files as relevant. Internal arrangements considerations: Internal arrangements with the relevant department/directorate/practice are agreed and in place as required for that Participating Organisation which includes suitable arrangements for peripheral clinics/access when study involves NHS patients external to the Participating Organisation (e.g. another NHS Organisation) occupational health and safety such as those arising from the location of the research procedures (e.g. where lone worker arrangements need to be put in place in line with relevant policies and costed appropriately) Page 10 of 18

11 Suitability considerations: Suitability of Participating Organisation facilities including; adequacy of facilities for any novel procedures or for procedures not part of existing clinical activity; availability and access to resources, facilities, equipment and storage considering impact on current levels of use for non-research activities; and considering Sponsor quality expectations. This could include calibration, arranging loans of equipment from the Sponsor. Impact of study on workload considerations: Supporting services or departments have the ability to manage additional workload such as additional processes (additional to standard of care), unfamiliar processes, intensive procedures, resource, equipment, facilities, and/or long term retention/archiving requirements (study records, worksheets) including consideration of any impact on delivery of non-research service activities Support considerations to meet the: Pathology requirements (where applicable) for the study taking into account sample processing and testing; sample storage; postage/collection; archived material (retrieval/testing); CRF completion; out of hours/emergency contacts; transfer of relevant material Different research settings (e.g. a prison) or vulnerable participant populations requirements for Researchers conducting studies in these research settings And once implemented support considerations to meet the: Pharmacy requirements (where applicable) outlined in the HRA Pharmacy Technical Review for the study taking into account drug/placebo dispensing is under the relevant blinding conditions; prescribing; drug supply; drug storage and dispensing; equipment; CRF completion; out of hours/emergency contacts. Imaging/radiological requirements (where applicable) for the study taking into account that the study has been reviewed by the HRA Radiation Assurance process prior to application for HRA Approval, the ARSAC application; RECIST reporting; radioneucleotide techniques; medical physicist input; data reporting/saving; independent assessments CRF completion; out of hours/emergency contacts Agreements considerations: The HRA Initial Assessment and HRA Approval letters will confirm which agreements the sponsor will use between the sponsor and the site. Use of appropriate agreements including any sub-contractor or service level agreements (including GP agreement, GP information sheet or equipment/loan agreements) to detail allocation of relevant responsibilities and rights for services obtained in support of the study (e.g. X-rays; CT or MRI scans; echocardiograms) from Any Qualified Provider. Any prior Participating Organisation contracts with the Sponsor which are related to the study e.g. Confidentiality disclosure agreements or Letters of Intent should be sufficiently superseded or do not create conflict with the study contract terms. Financial arrangements and management considerations: The financial arrangements applicable to the Participating Organisation are adequately described, agreed and documented between the parties. This may include agreement of CRN provided support (including for studies involving independent contractors) or the use of NHS employees and/or NHS facilities e.g. laboratories or x-ray or post-study treatment not included in NICE guidelines or a local prescribing policy. Arrangements for excess treatment costs are agreed with appropriate Page 11 of 18

12 provider organisations (i.e. managed within tariff or offset against cost savings from other studies) before approaching commissioners commissioning bodies and are documented as per local requirements. Equipment considerations: Appropriate arrangements for receiving, storing and, where applicable, servicing, maintaining and PAT testing goods including loaned or gifted equipment and where applicable segregation of trial-use only equipment. Where equipment is loaned, the contract documents the responsibilities in relation to breakages, maintenance and calibration. Information Technology considerations: Appropriate arrangements for any study requirements such as online CRF completion, access to relevant databases, IVRS account set-up, use of encrypted USB sticks, electronic record storage (including original destruction process) as applicable. NOTE: The RSS Planning Tool could support this assessment. CONSIDERATIONS FOR LOCAL ARRANGEMENTS TO SUPPORT RESEARCH PARTICIPANTS Participant safety considerations: Potential impact on patient safety is minimised by the Participating Organisation through implementation of suitable management plans and safeguards (e.g. the effects of additional treatments or changes in treatment; the effects of additional invasive procedures or exposures) which includes appropriate mechanisms in place for identifying and reporting safety concerns/incidents including those reported by other healthcare professionals who are made aware of the participant s involvement in the study or during out of hours, if relevant. Emergency procedures considerations: Emergency procedures that may be necessary can be conducted at the Participating Organisation in accordance with the protocol (e.g. to protect the participant in the event of a life-threatening incident or adverse event) Back-up/Support considerations: Backup/support arrangements that may be necessary can be conducted at the Participating Organisation in accordance with the HRA approved arrangements (e.g. to support a participant or research staff when discussing upsetting/embarrassing topics or news; sensitivity to a participant s confidentiality/data security; notification of other health or social care staff with an interest in the participant s care) Participant comfort considerations: Consider requirements for participant comfort such as transfers across site, duration of visits or time of visits to site, entertainment, bed / chair availability, refreshments and their related expenses. Local contact information considerations: Where applicable to the study type that the participant is clear about the local arrangements for the study e.g. name of Participating Organisation (including Any Qualified Providers), address and telephone number (usually included in the letterhead of the Participating Organisation), contact details of the local investigator(s), and if applicable, other members of the research team, e.g. research nurses, Emergency contact information, if appropriate, contact information for complaints and, where appropriate, independent advisors. Some studies are managed centrally and local contact points will not be applicable. Local communication consideration: As relevant for the local population, consider arrangements (with appropriate cost coverage as Page 12 of 18

13 required) to provide support for participant communication needs, for example signing for deaf patients or translation of local documentation. CONSIDERATIONS FOR COMPLIANCE OF PARTICIPATING ORGANISATION HRA guidance considerations: The HRA Approved protocol and any guidance provided in the HRA Approval letter are adhered to. This includes, but is not limited to, any patient consent, Information Governance, Human Tissue Act, and Mental Capacity Act arrangements. Practicalities considerations: Compliance to deliver practical aspects of the protocol related to these required could include local policies/processes for: accessing personal identifiable information anonymisation or pseudonymisation of personal identifiable information set out in the protocol, if relevant storage of data during the study and any post study archiving arrangements identifying personal or professional legal representatives where the study involves adults unable to consent for themselves complying with the requirements for initial and on-going assessment of capacity including arrangements for adults who may become incapacitated during the course of the research and/or research involving emergency treatment. identifying personal or nominated consultees or legal representatives separate from the research team Information Governance considerations: All research delivery staff and research management staff for the study have had the appropriate Information Governance training as per Participating Organisation standard practice in relation to provision of NHS services Fraud and misconduct considerations: Local systems are in place for dealing with fraud and misconduct CTIMP considerations (where applicable): the research can be carried out in accordance with Good Clinical Practice (GCP) or equivalent as appropriate (Good Pharmacovigilance Practice GPP) and the MHRA CTA authorisation Radiation considerations (where applicable): The Ionising Radiation (Medical Exposure) Regulations 2000 and the Medicines (Administration of Radioactive Substances) Regulations 1978 requirements are met Transparency considerations: Local communication processes in place to ensure compliance with transparency requirements for research Page 13 of 18

14 6. Associated workflow data set for participating organisations Start-up data points intended for collection via LPMS as part of the Minimum Data Set. The complete data set is available on the NIHR website under the Faster, Easier Clinical Research section. Data Point Definition Context Date Site Invited Date Site Selected HRA Approval Date Date Site Confirmed by Date on the Sponsor received by the site providing the protocol in the version to be submitted for regulatory review Date on the Sponsor received by the site providing the minimum defined documents to enable site to commence arrangement and/or confirmation of local capacity and capability as applicable representing that the site has been selected to take part in the study. Date of HRA Approval for study as per HRA Approval Letter Date of the first contract signature of all the A clear record from the sponsor's perspective of the date that engagement with a site started. This must be sent to the l generic R&D address and the Local CRN (for NIHR CRN Portfolio studies) as listed on the R&D Forum website at a minimum and may take place before or after the site has been listed in Part C of the IRAS Form and e-submitted to the HRA. Start of assessing capacity and capability. The date of the provides formal written communication at a discrete time point of the joint decision between the Sponsor and the site that the site will undertake assessment, arrangement and/or confirmation of its capability and capacity to deliver the Sponsor's study as applicable. Start of arranging capacity and capability. This must be sent to the generic R&D address and Local CRN (for NIHR CRN Portfolio studies) as listed on the R&D Forum website at a minimum. This can only be provided after the IRAS Form has been e- submitted to the HRA. The can only be sent after the 'Initial Assessment' letter has been released by the HRA to the Sponsor. The minimum local document set that the site would need to start this process is as described by the latest HRA guidance on the HRA website. Versions should be as submitted to HRA unless the activity is taking place after HRA Approval in which case the documents should be the versions as approved by HRA, and in this case the package should include the HRA Approval letter. Site confirmation cannot take place prior to HRA Approval. Provision of this date enables robust data collection. The date represents the date when the Sponsor regards that all arrangements and Page 14 of 18

15 Sponsor Date Site Confirmed Non- Confirmation Status Date Site ready to start organisations involved (i.e. sponsor, site, 3rd party) or Date on the received from Sponsor providing the final statement of activity ready for final agreement. Date of the last contract signature of all the organisations involved (i.e. sponsor, site, 3rd party) or date of final written agreement of statement of activity (as applicable) Record reason for nonconfirmation of a site to start the study Date that the site is ready to start (i.e. recruit study participants, provide data or tissue) defined by all other requirements to start, additional to contract signature and/or Statement of Activity agreement, are satisfied negotiations for the study with that site to be complete and that the site will take part in the study, and is documented by the Sponsor providing the complete agreement or Statement of Activity. End of arranging and start of confirming capacity and capability. This demonstrates (i) the Sponsor is satisfied all site capacity and capability has been agreed in principle and arrangements have been put in place (ii) study finances agreed (iii) site agreement fully drafted prior to execution or statement of activity fully drafted and costs agreed by the site prior to final agreement by all parties (iv) HRA approval has been given. Where an agreement is not required, the Statement of Activity must be sent to the generic R&D address (as listed on the R&D Forum website) at a minimum. The recorded date is the date of fully executed site contract (as evidenced by the signature date box within the contract) or date statement of activity accepted by both the site and sponsor (evidenced by formal written communication of this agreement). This confirms all capacity and capability has been put in place in preparation to start and that all parties confirm their agreement with terms of these arrangements. If the site agreement is the only item required, then the last signature would be used as the date to confirm. All requirements from the site must be completed prior to exchange of contract eg staff in post, honorary research contracts issued. Status selected as either a) Sponsor declined site confirmation b) Site confirmed no capacity and capability (declined to participate) Depending on the type and nature of study there could be one or several factors that inform this date. The date recorded is the date that the sponsor confirms that all activities required by the sponsor have been satisfied or a date by which these will be satisfied i.e. site initiation completed, site file in place, IMP shipped to site as applicable. All requirements from the site must be completed prior to exchange of contract e.g. staff in post, honorary research contracts issued. Page 15 of 18

16 Continuous Improvement The CRN will apply the continuous improvement process of Plan, Do, Study, Act (PDSA) to maintain the effectiveness of this guidance. Please provide any feedback on this guidance to the Study Support Service Help Centre at 7. Key contact Laura Bousfield Study Start-Up Manager Fairbairn House Clarendon Road Leeds LS2 9PH Tel: Page 16 of 18

17 8. Abbreviations Term Any qualified Provider CRN LCRN NIHR CCG CI CPMS CRF/eCRF CTIMP GCP GPP HRA LPMS Participating Organisation Partner Organisation PIC R&D REC Site Definition For the purpose of this document the term Any Qualified Provider applied to any organisation providing services on behalf of the NHS and therefore may provide these services to research Clinical Research Network Local Clinical Research Network National Institute for Health Research Clinical Commissioning Group Chief Investigator Central Portfolio Management System Case Report Form/electronic Case Report Form Clinical Trial Investigational Medicinal Product Good Clinical Practice Good Pharmacovigilance Practice Health Research Authority Local Portfolio Management System For the purpose of this document the term Participating Organisation is an organisation at a study level and includes an NHS organisation, General Practice, Tertiary Centre, Independent Provider, Any qualified Provider or Participant Identification Centre (PIC) as appropriate Meaning and organisation party to a written LCRN agreement Participant Identification Centre Research & Development Research Ethics committee The location which research activities are taking place for the study. Page 17 of 18

18 Fairbairn House Clarendon Road Leeds LS2 9PH Tel: Web.