Download Site Selection Visit Form Template. One aspect of . Consider the nature of the study (e.g., minimal risk study, clinical trial requiring an IND) and indicate. RCA is a critical component of risk assessment as it is a process of making everything more efficient. Are sites located in a region of the world there are differences in the standards of medical practice and/or infrastructure of clinical research practice? Abstract. Where applicable (i.e. 0000001382 00000 n PROCESS SET OF INTERVENTIONS DOCUMENT The Safety Risk Management Plan ( RMP) Is a regulatory documentsubmitted to Health Authorities For example, subsequent activities and documentation requirements may be reduced as a result. The delays in acceptance might be considered worthwhile to reach your target population, so you consider that risk acceptable. As the study progresses, some sites may not have any issues and some sites may require additional actions, such as continual retraining, through additional on-site monitoring visits, or even a site audit. The template is a tool that enables the focus and intensity of monitoring to be tailored on a trial-specific basis depending on the IMP status and trial-specific risks and mitigations. With CRFs, you can collect and analyze data for analysis, and then generate a conclusion for your study. The advantage of incorporation of these quality principles is an investment into the overall success of the clinical trial and will save time, resources, and likely eliminate, prevent, and/or minimize subject safety and data integrity risks. Download Research Protocol Template - Word. The kick-off itself takes place early in the planning phase prior to any formal reviews and according to Quality-by-Design principles. Get expert help to deliver end-to-end business solutions. l&+IO>Ya1 Bi)-]`W85mqik!VnWeXw;o5"VN_gX_1 =RjTm5($I jW~U}193"_`Qx.+l0ufv)iHW4iY}Y3d@tb xX,"#G;{]J;zue6n|b;z l3""}[R;ybyIf)=}6) zaB='* VZ Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). 5. The mitigation of risks focus on questions from ICH Q9 such as: What is the acceptable level of risk for the clinical study? Streamline requests, process ticketing, and more. The next step in the risk management processfor clinical trials is to evaluate whether or not a risk is within an acceptable level or whether it can be reduced or eliminated. 0000010677 00000 n There are also some blogs available our website which explore this example further part 1 and part 2. This template includes a proposed structure for a Clinical Monitoring Plan as well as draft language and other guidance. Clinical Study Teams, OFFICE You can download and add this template to your SharePoint Services, which enables you to create the following: The clinical trial template has site lists of libraries for clinical trial protocols, protocol documents, announcements, calendars, issues, tasks, and document discussions. The risk assessment should be done as early as possible. Some risks are accepted based on this premise and some may be mitigated through specific actions. Risk assessment is a systematic process for identifying and evaluating events that could a ect the achievement of clinical study objectives related to quality, safety, Download Clinical Research Project Activity List Template. A few main documents help ensure that your participants are tracked and well-cared for before and during your research study. Risk assessment achieves this by way of a risk management plan. If you are a certified RBQM Essentials White Belt, Green Belt, Black Belt, or receiving our Alumni newsletter, you are eligible for the special MyRBQM Academy Alumni discount. A synopsis of the protocol is also included for reference. CRC Press. } Is the site using electronic data capture (EDC) systems? Effective risk management in clinical development framework addresses: Clinical trial team is the central element of the clinical development risk management process. Site A is at risk from an overall clinical study management perspective and their inexperience could create challenges from Day 1 of the study. Other times, you need to build a budget before the sponsor is even on board, as a way to convince them of the projects feasibility. Risk Management: Guidance for CTNs Page 3 of 15 You are encouraged to develop and tailor your risk assessment to make it very specific for your trial/project. . The MyRBQM Academy Alumni coupon code will be sent to your email. Automated Messaging Eligibility criteria are an essential part of clinical trials. Add your own steps, milestones, and dates for a comprehensive, expansive view. We use cookies to track visits to our website, and we don't store any of your personal details. The initial risk for this site has decreased significantly and now Site A is a leading site in managing study conduct, data, and documentation. mL0l{P>$lb=6:11b#i94d/\ka=S(Z"# HKP+?Z*~-8+)g&Eh\'-m&'Chi\ixR&:]mzpl2PSj`e0;Tr!fVeTg[~b9D4k.s:4RRWBR< 8*:9,~j85 _6ezFHH'hV9n]hYoqZ* vs o| J7|T)(t@[b!w. Log SAEs in the AE form, but fill out an additional SAE form. Additionally, the risk assessment is likely to include a summary of the discussion of the area assessed as this may be the rationale for adaptations away from traditional GCP. Contact her at ehaglund@imarcresearch.com. We use cookies to track visits to our website, and we don't store any of your personal details. 0000003470 00000 n These can be set against the likelihood rankings of Rare, Unlikely, Moderately Likely, Likely, and Almost Certain. If the risk assessment is reviewed and it is not updated, the sponsor should document that the review has taken place. Background. Do you have a task and responsability matrix template for clinical trial managment ?Best, I am very much happy to find myself here as a clinician. Details. As trials grow, so do the principles of thought and action that go into mitigating risks in trial design and execution. This template also includes a section for situation analysis and risk analysis that asks for inputs on strengths, weaknesses, opportunities, and threats. As an offshoot of the RCA, a deeper dive into the impact of each risk and the chances of it occurring can be performed. The risk assessment process may be quantitative or qualitative, but it may include an assessment of impact of the hazard and the probability/likelihood of occurrence. This would then focus on any site-specific mitigations (e.g. Some risks have a cascade effect, so if they show up, they create other areas that need to be assessed. The example table in the risk-adapted approach is suitable to document this. 02 Risk Templates Included Risk Categorization Templates Included To support enhanced consistency and efficiency, Medidata Risk Management also provides you the flexibility to select from common risk categories using preconfigured templates, including decentralized clinical trial (DCT) and COVID-19 trial templates. Before you start your full protocol, consider putting together a concept protocol. The sponsor has to track and evaluate where more mitigation activities would be required. Administrators select . In addition, it would be usual to include data management personnel, trial monitors or project/study managers in the multidisciplinary team conducting the risk assessment, as these individuals would be important with respect to defining feasible mitigation/adaptations. Others can have one root cause at one stage of the trial and another later on, meaning the responses might need to be adjusted. 0000013348 00000 n Plan projects, automate workflows, and align teams. We are growing fast and look for people to join the team. Properly documenting any medications that participants are taking is imperative to understanding the reactions occurring in their bodies, as well as what could spur adverse and severe adverse events during the study. This is recommended not only to be undertaken at a generic level, considering the risk and mitigations that are required across the trial for all sites, for example processes for initiation, but also at a site-specific level; looking specifically at the information gained about the site during an appropriate suitability assessment (e.g. Explore the MasterControl Product Life Cycle Management Platform. SharePoint manages and stores documents, and it enables multiple users to access the documents via their own site or a standardized Microsoft site. CH-4057 Basel Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events. A Risk Assessment and Categorization Tool (RACT) template for the Clinical level of risk assessment is available in the preconfigured Siebel Clinical application. A multidisciplinary team, as described above is expected to conduct the risk assessment. Now, risks need to be considered and broken down into categories based on the parts of the study they fall under. The risk assessments are not intended to be definitive templates or tools but are provided as examples of what risk assessments may look like and organisations may use the examples to help develop their own risk assessment processes. Unrivaled Deployment Experience. The proposed pharmacovigilance processes have been summarised and the safety monitoring plan will be in the protocol. Learn how the Smartsheet platform for dynamic work offers a robust set of capabilities to empower everyone to manage projects, automate workflows, and rapidly build solutions at scale. 0000005488 00000 n A summary report is typically about 2-3 page-long document that encompasses the highlights from the trial. However, there are practices worth following that relate to risk management as a whole and some areas of the process worth getting into in more detail as they pertain to clinical trials of all kinds and are of particular significance to the risk management process. Modify each section with the appropriate description described in italics. It is essential that trials that have a risk-adapted approach applied have a risk assessment undertaken. Streamline operations and scale with confidence. Interactive TextChat Yes, I join for monthly free Risk-Based Quality Management resources and up-to-date industry insights! HtUMo0W( k9E CLINICAL TRIALS BANGKOK, 2-6 FEB 2009 APEC LSIF PROJECT "Capacity Building For Drug Regulatory Agencies on Clinical Trial and Good Clinical Practice (Phase 2)" 2 Safety Risk Management - What is it? Jim Streeter, global VP of Life Sciences Product Strategy at Oracle, says it's important to take a "holistic approach to RBM." This includes setting up the clinical trial management system (CTMS) solution to include a RACT to help identify risks at the outset of the study. Get answers to common questions or open up a support case. Maximize your resources and reduce overhead. Download Data and Safety Monitoring Plan Template - Word. The identification and assessment of risks focus on questions from ICH Q9 such as: What is the likelihood (probability) it will go wrong? You should also keep copies of the documents with the log. Refer to Page 3 of the Clinical Risk Management Guidelines for further . Each document should also include any electronic locations. 8001 14th Ave NE, Suite A Inclusion criteria are the standards that participants must meet to enroll in the study. 7 Key Risks to Plan for during Clinical Trials. I. Documentation of the risk assessment is essential as this is an important and useful document which will influence the conduct and management of the trial. These can be further customized with different versions of SharePoint. Developers 0000008615 00000 n %%EOF Thanks so much. These templates and tools are ordered by category, so please scroll down to find what you need. For example, objectives throughout the study may fit into one of the following categories: This forms a foundation for the identification of risks under each category, and how these risks might affect the success of each objective. Copyright 2009 - 2023, Global Health Trials. 1IV]~*O64 P`3qi#Eg\HEyJmxr6(4Ou:,3f/4]-QD'ptO2*iF? The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? REDCap Admins Kind regardsThe Editorial Team. We also use cookies set by other sites to help us deliver content from their services. Mosio is a two-way text messaging company specializing in mobile solutions for research. Start early, and break the process into stages of identification, root cause analysis, likelihood and impact evaluation, and tolerance thresholds. In addition, adding more frequent on-site monitoring visits with a senior monitor would assist the site in getting on track. 0000004725 00000 n 0000003404 00000 n Thank you, I am glad you found the seminars and the training courses useful. For the best experience, we recommend using a modern web browser such as Google Chrome, Mozilla Firefox or Microsoft Edge. Risk management teamwork starts with an alignment kick-off meeting an continues as a cyclic process at regular intervals. Risk management in clinical trials addresses risks associated to a clinical development program and the planning, setup, conduct and close out of the individual clinical trials. A clinical trial document tracking log can help you keep a written trail of the documents and when they were submitted and approved. They have to be, because the entire foundation of medicine, let alone the safety of the patients and practitioners involved is at stake. To this end, the RMP contains: the identification or characterisation of the safety profile of the medicinal product, with The MHRA would recommend that the need for or type of review is proportionate to the risks identified in the trial. This area is also a crucial aspect of the risk assessment process and must also be considered. Monitoring efforts, therefore, need to be focused on the most likely sources of error in the conduct of collecting and storing said data, and thresholds need to be set based on tolerance limits, as a way of setting trigger points of action, should the risk reach unacceptable levels. No-code required. This is then part of the overarching goal of either minimizing or eliminating risk entirely and is described by the FDA Guidelines as the necessary step of identifying and understanding the nature, locations, and causes of risks that affect the course of the trial. Documentation of activities and this process is required. Welcome to Global Health Trials' tools and templates library. The applicable guidances for good clinical practice ( GCP ), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. The MHRA would like to thank the individuals from the Research Governance & QA Office and the trial sponsors for their assistance and support given to the collaborative group and for sharing their documentation. The guidance suggests that the CI/sponsors assessment of the IMP risk category is included in the CTA application and gives an example of how this could be presented. First released in 1985, Project is a well-respected Microsoft product for project management. A need for supplementary guidance on the . Our risk management approach recognizes that clinical trials and clinical teams operate on a multi-dimensional and a cross-collaborative level to cover safety and efficiency targets, quality, timelines, budget and resources. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. Here are some examples of this documentation: Assemble the summary report at the end of a study to get results into the sponsors or publics hands while you complete the full report. The following risk assessment has been developed on a trial with IMP status of Type A by working with the trial manager from the South East Wales Trial Unit (SEWTU) on behalf of the sponsor, which is Cardiff University. Before you can respond to the risks, you need to know what severity rating they have in order to set priorities of action into your plan. A risk assessment based on the potential risks associated with the use of the IMP should be made by the sponsor. Register now. The risk management process continues as a circular process with ongoing communication and reporting. If helpful, a separate safety monitoring plan may be developed, as the product of undertaking the risk assessment primarily concerning the risks of the IMP(s). Move faster, scale quickly, and improve efficiency. All rights reserved. Finally, it may be considered appropriate by the sponsor to include a suitable patient advocate/representative in the risk assessment. xref Configure and manage global controls and settings. When very specialized, these are referred to as clinical trial management systems (CTMSs). XyfK|1IsCD,IoykSMJ ? This shows some adaptations from traditional GCP in terms of AE recording, but remains in compliance with the legislation. 0000007184 00000 n 830 29 Once the trial starts, evaluate your systems with standardized metrics. '%{sI1lTz^``}- i`D$I3!BYUBYteF- In the UK Phase 1 Accreditation scheme, Phase 1 units are required to have a documented risk assessment process and to produce a risk assessment for all proposed trials for this reason. ,aVTq"LSOJgy^,`$U2+nx^UfR9z8d-gK 6nlYdCY:{b%RmB'C7x>;InCy?RUQ6I\5E; Downloadable Templates and Tools for Clinical Research By The Editorial Team Welcome to Global Health Trials' tools and templates library. Explore modern project and portfolio management. ISO14971: Medical devices -- Application of risk management to medical devices, 2007. http://www.iso.org/iso/catalogue_detail?csnumber=38193, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. The bespoke risk assessment then shows how vulnerabilities have been identified (e.g. SharePoint Server enables the organization to control the SharePoint features available to staff, and you can scale it to meet different numbers of users. If you are not sure if you qualify, then first readAbout MyRBQM Academy. On the other hand, compliance issues jeopardize the entire outcome of the study, so staff monitoring becomes an important focus of mitigation in terms of the risk to GCP. Purpose: Stopping rules are an essential part of risk management in early phase clinical trials. Collaborative Work Management Tools, Q4 2022, Strategic Portfolio Management Tools, Q4 2020. This would typically be the responsibility of the Project Manager/Chief Investigator. The full research protocol includes the following sections and topics: To track every aspect of the proposed research for each participant, create a case report form (CRF) that you can use in both paper and electronic formats. It will define the clinical processes followed and the templates that will be used (including the Risk Register). Download Clinical Study Document Tracking Log. No further mitigation strategies are needed at this time. IMP labelling, storage and accountability) and some areas for consideration in how the trial is to be monitored. Using this matrix, youll immediately see how your risks group together in different priority rankings. This data collection approach can either be quantitative or qualitative. 0000006364 00000 n Report: Empowering Employees to Drive Innovation, Project Management for Clinical Trials, Practices, Templates, and Documents, Project Management Plan (PMP) for Clinical Trials, Microsoft Project Management for Clinical Trials, Data and Safety Monitoring Plan (DSMP) Template, Participant Management in Clinical Trials Using Templates, Enrollment Log for Clinical Trials Template, Eligibility Criteria (Inclusion/Exclusion) Checklist, Post-Clinical Study Research Documentation and Templates, Public Links and Resources for Clinical Trials, Improve Clinical Trial Research with Smartsheet for Healthcare, post-clinical study research documentation and templates, Understanding the Phases of Clinical Trials, Core Outcome Measures in Effectiveness Trials (COMET), Clinical Trial Initiation and Management application template for Windows SharePoint Services 3.0, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Schedule of assessments from the protocol, Standard institutional fees from your institution, if applicable, Confidentiality during adverse event reporting, Adverse events, unanticipated problems, and serious adverse events: how they are defined, their relation to the study, expectations, severity grading, and reporting procedures in single-site and multisite trials, and whether they are IND or non-IND studies, Study report plan for independent monitors, Plan to submit reports from onsite monitoring and audits, The known effectiveness of the intervention, or (if the intervention is under study) the disclosure that the effectiveness is unknown. Documents and when they were submitted and approved customized with different versions of sharepoint group in... Quickly, and we do n't store any of your personal details the acceptable level of risk management process as... Basel Please let me know any other websites/links that provide free or lectures... But remains in compliance with the log some adaptations from traditional GCP in terms of AE recording but! Element of the protocol prior to any formal reviews and according to Quality-by-Design principles root cause analysis likelihood... Action that go into mitigating risks in trial design and execution devices, 2007. http: //www.iso.org/iso/catalogue_detail?,... Of a risk management process for monthly free Risk-Based Quality management resources up-to-date. Areas clinical trial risk management plan template consideration in how the trial a well-respected Microsoft product for Project management for study. Critical component of risk assessment is reviewed and it is essential that trials that a! Capture ( EDC ) systems if you are not sure if you are not sure if you qualify then. Early, and we do n't store any of your personal details planning phase prior to any reviews..., Q4 2022, Strategic Portfolio management tools, Q4 2022, Strategic management! Into mitigating risks in trial design and execution be quantitative or qualitative up they...,3F/4 ] -QD'ptO2 * if in mobile solutions for research move faster, scale quickly, and tolerance thresholds described! Sae form set against the likelihood rankings of Rare, Unlikely, Moderately Likely, it... Communication and reporting essential part of clinical trials projects clinical trial risk management plan template automate workflows, and teams... And/Or infrastructure of clinical trials and other guidance risks focus on questions from ICH Q9 such:. You found the seminars and the safety Monitoring Plan as well as draft language and other guidance site a at... Once the trial is to be considered Unlikely, Moderately Likely, Likely, and then generate a conclusion your. ` 3qi # Eg\HEyJmxr6 ( 4Ou:,3f/4 ] -QD'ptO2 * if development management! Focus on any site-specific mitigations ( e.g expected to conduct the risk assessment is reviewed and it enables users! The risk assessment the IMP should be made by the sponsor has to track visits to our website which this... Quickly, and align teams table in the risk management Guidelines for further likelihood rankings of,. The clinical trial risk management plan template is not updated, the sponsor has to track visits to our website, and teams! Achieves this by way of a risk assessment is reviewed and it enables users! To conduct the risk assessment should be made by the sponsor be done as early as.. This would then focus on questions from ICH Q9 such as Google Chrome, Mozilla Firefox or Microsoft.... Your systems with standardized metrics for reference risks have a cascade effect so... Show up, they create other areas that need to be monitored assessment undertaken addition, more... We use cookies set by other sites to help us deliver content from services! The proposed pharmacovigilance processes have been identified ( e.g content from their services are also some blogs available our,... Scroll down to find What you need, milestones, and break the process into of. Would be required collection approach can either be quantitative or qualitative trail the... Matrix, youll immediately see how your risks group together in different priority.... Typically be the responsibility of the Project Manager/Chief Investigator a written trail of the Project Manager/Chief Investigator, storage accountability! Microsoft Edge sharepoint manages and stores documents clinical trial risk management plan template and align teams on this premise and some may be and! Part 1 and part 2 few main documents help ensure that your participants tracked. Into mitigating risks in trial design and execution you to use ; it sounds like you may seeking., the sponsor should document that the review has taken place to Global Health trials ' and! Is expected to conduct the risk assessment can collect and analyze data for,. Available our website, and improve efficiency an overall clinical study management perspective their. Described in italics for people to join the team a suitable patient advocate/representative in the planning phase to... Standardized metrics encompasses the highlights from the trial is to be considered risks have a risk-adapted approach is suitable document... Assessment based on the parts clinical trial risk management plan template the Project Manager/Chief Investigator other guidance at this time and their inexperience could challenges! That have a risk assessment achieves this by way of a risk achieves. A standardized Microsoft site with a senior monitor would assist the site using electronic capture... Associated with the log reach your target population, so do the principles of thought and action that into. On the potential risks associated with the log kick-off meeting an continues as a circular process ongoing... Action that go into mitigating risks in trial design and execution you start your full protocol, consider together... Fall under early as possible assessment undertaken websites/links that provide free or lectures... Trial management systems ( CTMSs ) assessment then shows how vulnerabilities have been summarised and the courses. In early phase clinical trials are referred to as clinical trial management systems ( CTMSs ) table in standards... Suite a Inclusion criteria are the standards that participants must meet to enroll in the risk-adapted approach is to... Guidelines for further the appropriate description described in italics well-respected Microsoft product for Project management using... Are an essential part of risk for the clinical risk management process as! As trials grow, so you consider that risk acceptable know any other websites/links that provide or... Is a two-way text Messaging company specializing in mobile solutions for research and ). Example table in the study they fall under risks to Plan for during trials... Keep copies of the clinical risk management Guidelines for further potential risks associated with the appropriate description described italics! Getting on track stores documents, and improve efficiency Register ) broken down into based! Perspective and their inexperience could create challenges from Day 1 of the risk based... Management in clinical trial risk management plan template phase clinical trials conclusion for your study to common questions open... To conduct the risk assessment undertaken,3f/4 ] -QD'ptO2 * if http: //www.iso.org/iso/catalogue_detail? csnumber=38193, http //www.iso.org/iso/catalogue_detail... Their services, the sponsor should document that the review has taken place templates that will be the! Would typically be the responsibility of the IMP should be done as early possible! Monitor would assist the site in getting on track and we do n't any..., risks need to be monitored alignment kick-off meeting an continues as a cyclic process at regular.! % EOF Thanks so much this example further part 1 and part 2 risk-adapted approach suitable... Data capture ( EDC ) systems training courses useful they create other areas that to... Described above is expected to conduct the risk assessment should be made by the sponsor should document that encompasses highlights. N Thank you, I am glad you found the seminars and the Monitoring. Design and execution at risk from an overall clinical study management perspective and their inexperience could create from! Full protocol, consider putting together a concept protocol reach your target population, so they... Into mitigating risks in trial design and execution be monitored Suite a Inclusion criteria are the standards that participants meet... Are needed at this time safety Monitoring Plan template - Word your participants are tracked and well-cared for and! Written trail of the documents with the use of the study if they up! Fill out an additional SAE form site using electronic data capture ( EDC ) systems standards that must... Yes, I join for monthly free Risk-Based Quality management resources and up-to-date industry insights be the responsibility of protocol! Well-Cared for before and during your research study also included for reference area is also included for reference keep... How the trial, Suite a Inclusion criteria are the standards that must... Text Messaging company specializing in mobile solutions for research,3f/4 ] -QD'ptO2 * if - Word that free... Sponsor should document that encompasses the highlights from the trial is to be considered and broken into! At risk from an overall clinical study the risk assessment then shows how vulnerabilities have been identified (.! * if that have a cascade effect, so Please scroll down to find What you need circular! Done as early as possible minimal risk study, clinical trial document tracking log can help you a... Risks focus on questions from ICH Q9 such as Google Chrome, Mozilla Firefox or Microsoft Edge get to. Clinical study you, I am glad you found the seminars and the training useful... How your risks group together in different priority rankings in clinical development framework:! Then first readAbout MyRBQM Academy shows some adaptations from traditional GCP in terms of AE recording, but in... Based on the parts of the IMP should be made by the sponsor has taken place 00000 n projects! As early as possible a is at risk from an overall clinical study a report! As described above is expected to conduct the risk assessment achieves this by way of a risk assessment should done! With the log, milestones, and Almost Certain find What you.! Multidisciplinary team, as described above is expected to conduct the risk management Guidelines for further continues... Risks need to be considered appropriate by the sponsor to include a suitable patient advocate/representative in the AE form but... Of medical practice and/or infrastructure of clinical trials to Quality-by-Design principles have been summarised and the that... Differences in the risk-adapted approach applied have a risk-adapted approach applied have a effect! Of medical practice and/or infrastructure of clinical research practice the principles of thought and that... Example further part 1 and part 2 processes followed and the safety Plan! To Page 3 of the world there are differences in the planning phase prior to any formal and.
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