STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH

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1 STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH Version 1.0 Version date Effective date Number of pages 9 pages Review date November 2018 Author NNUH UEA Joint Research Office Approved by Lisa Chalkley Role Research Services Manager Signature Lisa Chalkley Date Authorised by Prof Alastair Forbes Role Chief of Research and Innovation Signature Prof Alastair Forbes Date SOP 725 v1.0 Effective date: Date to be entered once authorised Page 1 of 9

2 It is the responsibility of all users of this SOP to ensure that the correct version is being used. All staff should regularly check the NNUH R&D website for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use. The definitive versions of all Joint NNUH/UEA health care research SOPs appear online. If you are reading this in printed form please check that the version number and effective date is the most recent one as shown on the NNUH R&D website. TABLE OF CONTENTS 1 ABBREVIATIONS 3 2 INTRODUCTION 3 3 SCOPE 4 4 DEFINITIONS 4 5 RESPONSIBILITY 4 6 PROCEDURE Capacity, Capability and Risk Assessment Acceptable Limits Which Assessment is required? Completing the Capacity, Capability and Risk Assessment Tool Capacity, Capability and Risk Review 7 7 REFERENCES 7 8 RELATED DOCUMENTS 7 9 LIST OF APPENDICES 7 Appendix 1: Flow chart of Responsibilities 8 Appendix 2: Change Control, Revision and Review Sheet 9 SOP 725 v1.0 Effective date: Date to be entered once authorised Page 2 of 9

3 1 ABBREVIATIONS AE CI CMD CTIMP ecrf EDC EU GCP ICH-GCP IMP ISO MHRA MP MTD NHS NNUH PI R&D ReDA RF SDV SmPC SOP SUSAR TMF UK Adverse Event Chief Investigator Clinical Investigation of Medical Device Clinical Trial of Investigational Medicinal Product Electronic Case Report Form Electronic Data Capture European Union Good Clinical Practice International Conference on Harmonisation Guidelines for Good Clinical Practice Investigational Medicinal Product International Organization for Standardization Medicines and Healthcare products Regulatory Agency Monitoring Plan Maximum Tolerated Dose National Health Service Norfolk and Norwich University Hospitals Principal Investigator Research and Development Research Database Application Research Facilitator Source Data Verification Summary of Product Characteristics Standard Operating Procedure Suspected Unexpected Serious Adverse Reaction Trial Master File United Kingdom 2 INTRODUCTION Where the Trust is acting as a potential study site, a capacity, capability and risk assessment will be conducted to assess the Trust s capacity and capability to deliver on a study, in line with the HRA approval process, and to identify potential hazards and assess the likelihood of those hazards occurring and resulting in harm. Follow-up actions will be dependent on the outcome of the assessment. The Medicines for Human Use (Clinical Trials) Regulations 2004 allow for riskadapted approaches to the management of clinical trials of investigational SOP 725 v1.0 Effective date: Date to be entered once authorised Page 3 of 9

4 medicinal products (CTIMPs). Norfolk and Norwich University Hospitals NHS Trust (NNUH) has adopted the risk-adaptive approach for the management of all studies it hosts, including CTIMPs, clinical investigations of medical devices and all other research. 3 SCOPE This SOP applies to all healthcare research hosted by NNUH, regardless of who the study sponsor is, which falls within the scope of the Research Governance Framework (2nd edition 2005). Where additional legislation applies - for example the Medicines for Human Use (Clinical Trials) Regulations 2004 (and amendments) or the Medical Devices Regulations required procedures will be indicated. External sponsors may require use of their own SOPs and this will be specified in site agreements. It is the responsibility of the local PI to ensure that study-specific SOPs can be operated without conflict with this SOP and in accordance with all organisational polices related to research. 4 DEFINITIONS Low Risk Likelihood Medium Risk Likelihood High Risk Likelihood Likely to be safe or without problem. Documentation and relevant experience / training in place. Concern of a possible effect on safety and/or possible problem arising, but evidence presented to address possible safety issues / problems. Majority of essential documentation and training in place with evidence of a plan to acquire missing documentation / training in place. Issues identified regarding safety and/or problems arising, with no evidence presented to address safety issues / problems. Essential Documentation missing with no plan in place for acquiring documents. Evidence of relevant experience and/or training not demonstrated, or documented, with no plan in place to acquire necessary training / experience. 5 RESPONSIBILITY Host (fulfilled by the Research and Development (R&D) department on behalf of NNUH) The Research Facilitator (RF) will facilitate completion of the Capacity, Capability and Risk Assessment Tool and schedule attendees for the capacity, SOP 725 v1.0 Effective date: Date to be entered once authorised Page 4 of 9

5 capability and risk assessment meeting, as required. The RF will discuss any concerns they have regarding the outcome of the meeting with the study team and, when necessary the study Sponsor, to see if they can be resolved. If issues cannot be resolved and study team wishes to go ahead with the study the RF should discuss their concerns with the Research Services Manager (RSM) or Research Governance Coordinator (RGC) so an appropriate course of action can be decided. Principal Investigator (PI) To meet with RF for an initial review of capacity, capability and risk and to complete any required follow-up actions. 6 PROCEDURES 6.1 Capacity, Capability and Risk Assessment The assessment is based on the Trust s capacity and capability to deliver on a study, identifying the potential hazards associated with the trial and an assessment of the likelihood of those hazards occurring and resulting in harm. Appropriate management/mitigation strategies should then be identified and implemented to bring any harm identified to within an acceptable limit. The assessment should be undertaken prior to the capacity and capability assessment deadline for studies the Trust will potentially be hosting Acceptable Limits If any section is rated high risk, after mitigating factors have been taken into account, NNUH will not host the study. The decision to host a study rated high risk will be re-evaluated by the RSM or RGC once it has been demonstrated by the PI and / or study Sponsor that appropriate mitigating factors has been implemented to reduce the likelihood of risk to at least a medium risk level. 6.2 Which Assessment is required? If it is unclear whether NNUH is the potential study Sponsor or Host the RF should discuss with the RSM prior to conducting the assessment. If NNUH is the potential Sponsor for a study please refer to SOP_720 Risk Assessment of Trials Sponsored by NNUH or UEA. If it is unclear what type of research is being undertaken (i.e. is it a clinical trial?) the RF or CI/PI should seek to confirm this by contacting the study Sponsor. The RF will co-ordinate the capacity, capability and risk assessment process (see 6.3 and Appendix 1 for guidance). 6.3 Completing the Capacity, Capability and Risk Assessment Tool The NNUH Capacity, Capability and Risk Assessment Tool has been created as a result of the HRA Approval process, and in line with HRA guidelines for assessing capacity and capability of hosting a study. SOP 725 v1.0 Effective date: Date to be entered once authorised Page 5 of 9

6 The NNUH Capacity, Capability and Risk Assessment Tool is a working document which can be updated by the RF for the duration of the capacity and capability assessment period. Prior to the capacity and capability assessment deadline the RF will meet with the PI, and if possible members of the study team, to conduct the initial capacity, capability and risk assessment and discuss and document any issues that may have arisen as a result of the initial assessment meeting. It may be possible for the RF to complete parts of the NNUH Capacity, Capability and Risk Assessment Tool prior to the meeting based on the study information available to them already (e.g. Protocol). After the initial meeting the NNUH Capacity, Capability and Risk Assessment Tool should be ed to the PI for them to review what has been entered so far, and to give them an opportunity to comment, and update, if they have any post-meeting information. In the a reasonable timeline within which the PI should respond should be given. Any concerns that arise from the initial capacity, capability and risk assessment meeting should be discussed with the study team, and when necessary the study Sponsor, to see if they can be resolved. If issues cannot be resolved, and the study team wishes to go ahead with the study, the RF should discuss the concerns with the RSM or RGC so an appropriate course of action can be decided. The initial level of risk entered can be amended throughout the duration of the capacity and capability assessment period if follow-up action(s) reduce(s) the risk(s) initially identified. The table of risk at the end of the tool should only be completed with the final level of risk recorded for each section. Any actions resulting from the capacity, capability and risk assessment meeting should be entered into the table at the end of the tool; completion of the actions can take place after Capacity and Capability and Risk Assessment Tool has been finalised. If the RF is satisfied with the outcome, once the Capacity and Capability and Risk Assessment Tool has been finalised, the document should be saved electronically in the projects shared folder on the shared drive and documented in ReDA. If the RF has concerns regarding the final outcome of the capacity, capability and risk assessment that were not satisfied during the capacity and capability assessment period, the RF should inform the RSM or RGC to make them aware of these concerns. The RSM or RGC will decide the next steps. The Capacity and Capability and Risk Assessment Tool should be saved electronically in the projects shared folder on the shared drive and documented in ReDA. 6.4 Capacity, Capability and Risk Assessment Review The Capacity, Capability and Risk assessment may be reviewed at any time during the study taking into account new knowledge and experience, and may SOP 725 v1.0 Effective date: Date to be entered once authorised Page 6 of 9

7 include reconsiderations for the acceptable limit of risks. This may occur as a result of any of the following (this list is not exhaustive): i. Monitoring findings; ii. Audit or inspection outcome; iii. Safety review; iv. Serious breach or non-compliance; v. Change to protocol, resources, personnel, facilities or external service providers. The capacity, capability and risk assessment review will be completed as per 6.3. It may not be necessary to revise all sections of the Capacity Capability and Risk Assessment Tool, or convene all original members of the meeting. The RF and / or RSM or RGC and the PI will agree which sections will be revised and who should attend the review meeting. 7 REFERENCES ICH Harmonised Tripartite Guideline Quality Risk Management Q9: Current Step 4 version, 9 November 2005 MRC/DH/MHRA Joint Project Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products: version 10 October 2011 The Medicines for Human Use (Clinical Trials) Regulations 2004 Medical Devices Regulations 2002 The MHRA Good Clinical Practice Guide 2012 Research Governance Framework (2nd edition 2005). 8 RELATED DOCUMENTS Capacity, Capability and Risk Assessment Tool SOP_720 Risk Assessment of Trials Sponsored by the NNUH and UEA 9 LIST OF APPENDICES Appendix 1: Flow chart of Responsibilities Appendix 2: Change Control, Revision and Review Sheet SOP 725 v1.0 Effective date: Date to be entered once authorised Page 7 of 9

8 Appendix 1: Flow chart of Responsibilities HOSTED All studies Research Facilitator wil work with PI to complete feasibility and Risak Assessment of trials Hosted by the NNUH - Capacity, Capability and Risk assessment of Trials Hosted bythe NNUH SOP to be follwed - Capacity, Capability and Risk assessemnt tool to be completed - The RF will feed back any concerns they have regarding the outcome of the meeting to the study Sponsor, the Research Services Manager and the Research Governance Coordinator so they can decide appropriate course of action Does the outcome of the outcome of the feasibility & risk assessment raise any concerns? Yes No If the Research Facilitator has concerns regarding the final outcome of the capacity, capability and risk assessment that were not satisfied during the capacity and capability assessment period, the Research Facilitator should inform the Research Service Manager or Research Governance Co-ordinator to make them aware of their concerns. The RSM/RGC will decide next steps. The Capacity and Capability and Risk Assessment Tool should be saved electronically in the projects shared folder on the shared drive and documented in ReDA. If the Research Facilitator is satisfied with the outcome, once the Capacity and Capability and Risk Assessment Tool has been finalised the document should be saved electronically in the projects shared folder on the shared drive and documented in ReDA. SOP 725 v1.0 Effective date: Date to be entered once authorised Page 8 of 9

9 Appendix 2: Change Control, Revision and Review Sheet CHANGE CONTROL, REVISION AND REVIEW SHEET: SOP 001 Version No Change Date Reason for Change Reviewer : Designation : Signature and Date: Reviewer : Designation : Signature and Date: SOP 725 v1.0 Effective date: Date to be entered once authorised Page 9 of 9