clinical trial risk management plan template

% V46nI6"d83OEP|1 (>/ %PDF-1.4 % Clinical trials are big projects. It would be expected that the sponsor undertakes a continual review of the risk assessment, which is particularly important when new information becomes available. Risk management needs to begin at the moment of the trial's conception. Before we get started on how to design this plan, the relevant documentation deserves a brief mention. The MHRA GCP Inspectorate has set up a collaborative group to produce example documentation relating to the risk-adapted approach. For example, ensuring the requirements for specific aspects of monitoring identified in the risk assessment are subsequently captured in the trial monitoring plan (or other trial procedure). { Risk management concepts can be extracted from the ISO 14971: Risk Management for Medical Devices and ICH Q9: Quality Risk Management. H0si_IZ]XnoV{Rq@ '%{sI1lTz^``}- i`D$I3!BYUBYteF- I. Examples of SAEs include death, life-threatening complications, or anything leading to immediate hospitalization, physical disability, or congenital abnormalities. In the second year of the study, some anomalies were discovered through remote monitoring at Site B. This is the recommended starting point for identification, prompted by reviewing the annual BIMO findings posted by the FDA or other regulatory agencies for clinical sponsors, sites, and IRBs. Download Data and Safety Monitoring Plan Template - Word. EMA Reflection Paper, Reflection paper on risk based quality management in clinical trials, November 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500155491.pdf, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm261409.htm. SharePoint Server, available in Standard or Enterprise versions, can be developed as either. Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. The listed steps are repeated regularly throughout the entire project; however, it is important to note that an event may occur that initiates the evaluation process outside of a regularly scheduled risk session. 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. Use this free template to develop your own clinical study document tracking log. Pharmaceutical and Biotech You can take it in your own time. No-code required. To help us improve GOV.UK, wed like to know more about your visit today. Additional steps that are required throughout the process include communication of risks and documentation activities. 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. Organize, manage, and review content production. Download Clinical Trial Communication Plan Template - Word. Support The risk assessment should be kept in the trial master file (TMF), but it is important that the sponsor and, where appropriate, site staff are aware of the content of the risk assessment. If you are not sure if you qualify, then first read, MyRBQM Academy | RBQM Essentials White Belt Course, Process Flowcharts for Adaptive Monitoring in Clinical Trials, The rationale of application of RBQM for the clinical study, Risk assessment and categorization tool (RACT), Data archiving and provision of final materials to the sponsor. This Clinical Data Management Plan (CDMP) template may be employed for studies using an Electronic Data Capture System (EDC), unless another template has been . the blood sampling, consent), but also some adaptation from traditional GCP (e.g. Henok Negussie, Thomas Addissie, Adamu Addissie, Gail Davey, TREAD (The Research Ethics Application Database), Worldwide Antimalarial Resistance Network (WWARN), East African Consortium for Clinical Research, Webinar on community engagement in clinical research involving pregnant women, Free Webinar: Science, technology and innovation for upskilling knowledge-based economies in Africa, Open Public Consultation on Strengthened cooperation against vaccine preventable diseases, https://globalhealthtrials.tghn.org/community/training-events/, https://globalhealthtrainingcentre.tghn.org/webinars/, https://globalhealthtrials.tghn.org/elearning, PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts, 5 ways statistics can fool youTips for practicing clinicians, How to prepare for a job interview and predict the questions youll be asked, Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia, Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control. It should be noted that information contained in the risk assessment may prove useful in completing the application form for approvals, particularly for the REC application. Typical participants in the risk management joint efforts are: To fully support the learning organization concept, the risk management process requires an effective communication and consultation of the results and related learnings. For the best experience, we recommend using a modern web browser such as Google Chrome, Mozilla Firefox or Microsoft Edge. financial) and also the potential type (A, B, C). January 29, 2015 Starting by finding the cause of each risk, youll then be able to work out how to address it and whether or how critically it really needs to be addressed. 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. This list can assist in creating discussions of topics that would apply to a specific trial. endstream endobj 845 0 obj <>stream xref The relevant personnel undertaking the risk assessment would typically include a medic with understanding of the therapeutic area and the therapeutic use of the proposed investigational medicinal products (IMP) (for example Medical Monitor or Chief Investigator); a pharmacist/toxicologist/pharmacologist who has a detailed understanding of the IMP (this is particularly important for potential type B and C trials); a statistician with relevant experience of medical statistics and a person with an appropriate level of understanding of applicable regulatory, legal and GCP requirements (e.g. endstream endobj 831 0 obj <> endobj 832 0 obj <> endobj 833 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]>> endobj 834 0 obj <> endobj 835 0 obj <> endobj 836 0 obj <> endobj 837 0 obj [/ICCBased 854 0 R] endobj 838 0 obj <> endobj 839 0 obj <> endobj 840 0 obj <> endobj 841 0 obj <> endobj 842 0 obj <>stream XyfK|1IsCD,IoykSMJ ? Please ensure that you read and adapt them carefully for your own setting, and that you reference Global Health Trials and The Global Health Network when you use them. It is recommended that the risk assessment, (it may also be known as a risk management plan), should not repeat information covered elsewhere, for example information that is in the protocol, patient information sheet, SmPC, investigators brochure; as this makes the document lengthy and cross referencing is more useful. Does the investigational product have any safety concerns? Register now. 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. To mitigate this risk, the traditional approach is to ensure personnel involved are educated and trained appropriately. Administrators select a level (or type) of risk assessment in the Type field when they create an assessment template. HtUMo0W( k9E Deliver results faster with Smartsheet Gov. Exclusion criteria specify the characteristics that disqualify participants from taking part in the research. Clinical research can result in complications for the participants and trigger an adverse or severe adverse event. A clinical Risk Management Plan sets out how risks will be managed in a clinical trial. 0000003367 00000 n This example explores a clinical study that includes a primary endpoint that is a non-standard of care test. This shows some adaptations from traditional GCP in terms of AE recording, but remains in compliance with the legislation. Regardless of the platform you use, you should have full project management functionality, such as planning and reporting modules, as well as the ability to track participant contact information, deadlines, and milestones. Example 2, Training of Clinical Research Sites with Varying Experience. 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. The following risk assessment has been developed on a trial with IMP status of Type A by working with the trial research fellow on behalf of the co-sponsors, which are the Liverpool Womens NHS Foundation Trust and the University of Liverpool. 0000001382 00000 n The sponsor has to track and evaluate where more mitigation activities would be required. An early risk assessment will also identify the study management requirements, which can assist in the planning and resourcing aspects of the trial (e.g. When possible, use templates to ensure consistency and best practices. Download Clinical Study Document Tracking Log. The trial is co-sponsored by the University of Edinburgh and NHS Lothian. 0000013348 00000 n In 2016, ICH published a document that represents a new formal standard of risk-based approaches to clinical trials. Risk management in clinical trials is an ever-changing and improving process thats all the more critical with the increases in trial complexity and reductions in R&D budgets. The risk assessment identifies some vulnerabilities, though not rated as high (e.g. Test any planning tools or software before the trials start. If the risk assessment is reviewed and it is not updated, the sponsor should document that the review has taken place. This means taking a tour to determine whether the site has the capabilities to meet the sponsors goals. 0000005488 00000 n endobj MHRA would like to thank the research fellow and the trial sponsors for their assistance and support given to the collaborative group and for sharing their documentation. This portion of the process will depend on the type of project that is being examined and its parameters. 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. As clinical trials become more complex, new risks emerge, and the essential nature of risk management is emphasized and put to the test. As such, this would be part of the overall risk assessment. A need for supplementary guidance on the . ISO14155: Clinical investigation of medical devices for human subjects Good clinical practice, 2011. http://www.iso.org/iso/catalogue_detail?csnumber=45557. 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). 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