L5. The study will be conducted in compliance with all stipulations of this protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95). The primary responsibility of the IRB is to safeguard the rights and welfare of human research participants. Arthritis Research UK Primary Care Centre Systematic Review Protocol & Support Template This template is primarily intended to help you plan your review in a systematic way. Research Protocol . Currently, NIDCR-supported clinical trials are open or will soon be open for patient recruitment at the NIH Clinical Center. For example, the consent form Action research, explored in this book, is a seven-step process for improving teaching and learning in classrooms at all levels. Developing protocol: Concept protocol – template. The research protocol is a fundamental part of high quality medical research and radiological research is no exception. Please remove all instructions and non-applicable sections before submitting the protocol document to the IRB for review and approval. This can include procedures for recording and reporting adverse events and their follow-up, for example. The guide will take you through each section of the protocol giving advice and examples of the information required in that section. ... (Global Observation Research Initiative in Alpine environments); ... Protocol development provides the opportunity to assess or establish a suitable design that will, in turn, maximize applicability of inventory results for a given amount of samplingeffort. It is common for IRBs to review protocols in which research activities in the protocol are not tied to study aims, and consent forms often contain research activities that are not included in the protocol. … This edition includes chapters on the nature and uses of epidemiology; the epidemiological approach to defining and measuring the occurrence of health-related states in populations; the strengths and limitations of epidemiological study ... UADEs will be reported to the IRB in accordance with the standard operating procedures and policies of the IRB, and the Investigator will … Instructions specific to items on the templates appear in red text in brackets. of this document and include examples of published protocols. sample population. The public health and illness prevention content have been expanded to support this increasingly important aspect of the pharmacist’s work. The book is designed for quick and easy reference with separate chapters for each ailment. Protocol Templates and Samples. questions align with research questions, (2) constructing an inquiry-based conversation, (3) receiving feedback on interview protocols, and (4) piloting the interview protocol. Below is a list of all clinical research protocols, including studies that are not open for recruitment. This guide outlines the registration process for PROSPERO protocols, including full descriptions of each field on the registration form. Michael J. extraction tool has been developed specifically for quantitative research data extraction based on the work of the Cochrane Collaboration and the Centre for Reviews and Dissemination (Appendix 3). Guidelines for Writing the Title 7 Example … Books on various aspects of this subject are readily obtain able but this is an attempt to deal with all the steps that are necessary from the start to the finish, and chapters have been planned sequentially with this in mind. A complete description of the planned research (i.e., protocol) must be submitted with initial applications for IRB or exempt review. Health researchers, the intended audience of this book, are not limited to scientists pursuing a research career. An example protocol shows the format and style of a simple descriptive study. 3A-2 APS Research Processes and Procedures January 2009 ACADEMIC PATHWAYS STUDY INTERVIEW PROTOCOL (EXAMPLE) TECHNICAL PUBLIC INSTITUTION/URBAN PRIVATE UNIVERSITY/ SUBURBAN PRIVATE UNIVERSITY/ LARGE PUBLIC UNIVERSITY PART I. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. The needs of clinicians predominate throughout the text, but these needs overlap with those of researchers especially in chapters covering randomized controlled trials. As your research ideas develop into a workable study a written protocol will help to formalise your ideas and gain feedback from others through peer review. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research ... A copy of this completed form will be available via the intranet to help others carrying out reviews in the future and to Found inside – Page 120Table 5.3 identifies the information that must be included in this protocol.A sample protocol excluding the consent form appears in Exhibit 5.6. Specific Aims. A dedicated hard-copy paper system specific to each patient will serve as secondary data collection. HHS 2013) and this is the draft protocol for 1 of the 2 case studies. This text distinguishes itself with its accessible and broadcoverage of statistical design methods--the crucial building blocksof clinical trials and medical research. Includes resources related to research using mobile technologies, social media, internet research. The protocol is a document that describes how a clinical trial will be conducted (the objective (s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected. NIH/FDA Clinical Trial Protocol Template [ WORD] Connected & Open Research Ethics (CORE) Resource Library - Library of information technology guidance, sample protocols, sample consent forms. 2) Investigator • Include the investigator’s name as listed on the application form. In terms of the “research pipeline”, the detailed protocol writing usually follows the definition of the overall research question and must be informed by a The Animal Use Protocol The Clinical Intervention Study Protocol Template is a suggested format for clinical trials sponsored by the National Institute on Aging (NIA). Leading experts in various areas of nursing research discuss the current state and future of the field. Fox Foundation for Parkinson‟s Research 90 Broad Street, 10th Floor New York, NY 10004 Research Protocol 1 8/12/2009 1) Protocol Title • Include the full protocol title as listed on the application form. Found insideExample of a research protocol. Research protocol template. Hypothetical descriptive statistics. Interpreting the effect sizes d and r. Example of the type ... Prospective/retrospective? Research Proposal Example 1 (DOC, 49kB) Research Proposal Example 2 (DOC, 0.9MB) Research Proposal Example 3 (DOC, 55.5kB) Research Proposal Example … Includes resources related to research using mobile technologies, social media, internet research. The IRP method can support efforts to strengthen the reliability of interview protocols used for qualitative research and thereby 2) Investigator • Include the investigator’s name as listed on the application form. There are some . ... (Global Observation Research Initiative in Alpine environments); ... Protocol development provides the opportunity to assess or establish a suitable design that will, in turn, maximize applicability of inventory results for a given amount of samplingeffort. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. For example what is known, but what gaps are left. The template contains some sample text and/or instructions for what type of information to include in the protocol. clinical research studies that do not fall within the scope of the Medicines for Human use (Clinical Trials) Regulations 2004.. In addition, the investigators discuss the human subjects research ethics issues. Site verification examples. Large multi-site observational studies will also benefit from this protocol template. Beginning with a section entitled 'Whats in it for me', which outlines the benefits of research, the text provides ideas and advice on topics such as finding the research focus, writing the proposal, considering ethical requirements, ... Personnel-Research Team Members List all research team members, their affiliation, and roles. A larger sample size than needed to test the research hypothesis increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit. The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The contents of this tool were developed under a grant (number 90DP0082) from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). • The document, referred to as a research proposal, explains the specific aims and expected results of the research and describes what methods will be used to accomplish these aims. A research protocol is best viewed as a key to open the gates between the researcher and his/her research objectives. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. , # of centers, randomized? Methods: Patients meeting set criteria will be sequentially enrolled up to a sample size of 40. List the broad, long-term objectives and describe concisely and realistically what the specific research described in your proposal is intended to accomplish, and the hypothesis to be tested. A research protocol is a document that outline s the planning of your study. Examples include an increase in subject number, changes in investigators or key personnel, a change to the funding source, changes in procedures and revised consent documents. •A research protocol clearly and plainly provides an overview of a proposed study in order to satisfy an organization's guidelines for protecting the safety of human subjects who might be impacted by the work. Found inside – Page 320Taking HbAlc and Diabetes Well-being as primary outcomes, a total sample size of ... The following example provides the research protocol in some detail and ... Structured Study Protocol Template. The protocol helps you clarify the work ahead and helps investors and collaborators outside the … In terms of the “research pipeline”, the detailed protocol writing usually follows the definition of the overall research question and must be informed by a Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, ... More than an instruction manual, the protocol serves many purposes. Email recruitment example. Objective: This protocol describes a case-control clinical trial aimed at determining the muscular features of patients recently diagnosed with severe OSAHS compared with those of healthy controls. A copy of this completed form will be available via the intranet to help others carrying out reviews in the future and to Social Behavioral Protocol Template (HRP-583): This document is intended for use primarily by those conducting social, behavioral, or educational research. If your research involves physical procedures or devices, you may need to include sections that are contained in the biomedical template protocol. Fox Foundation for Parkinson‟s Research Protocol No. your study, CTRG or R&D staff will be happy to advise you. "Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate ... 14 . Definitions. A. A. Found insideThis book will be of particular value to scientists, research assistants, qualified or trainee physicians, nurses and allied health workers. Found inside – Page 61Examples of process vari- ables include adherence rates, protocol deviations, attendance at study visits, and safety monitoring. Found insideThis book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. If you are. Study protocols for pilot or feasibility studies are not usually considered. This book demonstrates a strategy for managing your portfolio of clinical trials, provides tactics and real-world examples, and helps the reader adapt them to their own research site. The study plan is developed to answer research questions. Questionnaires or surveys. Study protocols can be for proposed or ongoing research, and should provide a detailed account of the hypothesis, rationale and methodology of the study. To promote clinical research that is compliant with GCP and human subject regulations, the CREST Program includes phone conversations, email consultation, and/or site visit(s) from NIMH staff, as needed, to assess and provide written feedback and recommendations on planned or ongoing clinical research protocols. The Research Protocol A research protocol outlines the plan for how a study is run. •Research protocols are typically submitted to Institutional Review Boards (IRBs) within universities and research centers. Found insideNational Research Council, Division on Behavioral and Social Sciences and ... post on websites outstanding examples of approved research protocols that ... The safety of research participants is foremost. This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. A complete description of the proposed banking activity (i.e., protocol) must be submitted with the “Initial Review of Human Subjects Research” application for IRB review. Fox Foundation for Parkinson‟s Research 90 Broad Street, 10th Floor New York, NY 10004 Michael J. Introduction. Primary Hypothesis. Please download the most recent version of the Advocate IRB Research Protocol Template (HRP_503) from their website RESEARCH PROTOCOL . In our previous article, we talked about selecting a brilliant research question.In order to turn our research topic into a meaningful publication, we must first develop a research protocol. Examples, provided a glossary that defines many of the scientific terms in the handbook. It is important to note that those who will apply this protocol need to be familiar with the basics of qualitative consumer research. Prior Literature and Studies. 1.1 Protocol Statement of Compliance This document is a protocol for a human research study. Proposed sample size (number of records to be reviewed): Proposed time period to be evaluated: Specify how data will be analyzed and by whom: Appendices: The following appendices must be attached to the protocol. Background. The protocol was designed and written by the research team following feedback from anonymous external peer review and discussion with the Primary Care Research Engagement Group (PRIMER) at The University of Manchester and Adele Cresswell, deputy chair of Nottingham Healthwatch. The only work to date to collect data gathered during the American and Soviet missions in an accessible and complete reference of current scientific and technical information about the Moon. Research Study Protocol Template Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically intended for the investigator initiated studies. The research protocol forms an essential part of a research project. The research protocol should provide the information needed for reviewers to determine that the regulatory and Human Research Protection Program (HRPP) policy requirements have been met. This may seem pedantic but long term it will be worthwhile. Study protocols concerning proposed research will usually be published without peer review if the study has received ethics approval and a grant from a major funding body. A research protocol is a detailed explanation of your research project: your goals, the details of your research and how you'll protect the welfare researchers and volunteers. representative sample takes parts in qualitative research. • Sample size: The protocol should provide information and justification about sample size. The protocol should include a background of research performed within this area (with cites) and the significance of these. Information sheet 2 Research and Development Office Education Centre, The Hillingdon Hospital. It provides evidence for feasibility of a study, detailed objectives, design, methodology, statistical considerations and how … unsure as to how to categorise. Found inside – Page 1An Evaluation of the Public Schools of the District of Columbia is a comprehensive five-year summative evaluation report for Phase Two of an initiative to evaluate the District of Columbia's public schools. A protocol is a short document and a table of content might not be necessary. Study Objectives. This document is a protocol for a clinical research study. ZYMO RESEARCH CORP. Box 1.2: Example review objective and PICOS elements for a review protocol. Methods: This systematic review protocol was developed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols (PRISMA-P) guidelines. Provided preferably on a separate page, it should summarize all the central elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes. Problem identification, literature review, developing research question and statistical hypothesis are the main steps for preparing research protocol. Authors are encouraged to submit the results of the pilot as a research article and the study protocol for the definitive study. Protocol Template (University of Warwick) Your team can use this editable template to map out your research plan. Found inside – Page 174For example, the impact of the Tuskegee syphilis experiment still resonates in public opinion and hastainted the reputation of scientific research protocols ... PubMed–Medline, Scopus and relevant biomedical databases within EBSCOhost will be searched up to August 2021 using relevant key words. • Failure to treat research subjects per protocol procedures that specifically relate to primary efficacy outcomes. Example: Research Protocol Retrospective Review of Records . Describe the current environment that is the basis for the proposed research, including a presentation of the problem (with references) and a review of current literature. Rationale for the Selection of Outcome Measures. This lively, practical text presents a fresh and comprehensive approach to doing qualitative research. The book offers a unique balance of theory and clear-cut choices for customizing every phase of a qualitative study. Here is a new book on methods and issues in clinical research. Found inside – Page 118TABLE 10-3 Example of a Simple Clinical Research Protocol Visit 1 THE USER INTERFACE Basic lipid panel ( Chol , Trig , LDL - C , HDL - C ) Vitals , weight ... THE RESEARCH PROTOCOL Role of a Protocol. Protocol feasibility assessment SOP. Criteria. Found inside – Page 274The PRG group1s standard protocol and consent language have already gone ... for-profit pharmaceutical company will be doing the research with samples ... Protocol REVITA 2018 April 9, 2018 Confidential Page 6 of 19 Data will be collected via the OBERD system as the primary source of patient response collection. A research project without a research protocol is Participants. Appendix A: Data Collection Form (This form should list the data elements that will be collected from the medical record. A research protocol is a detailed explanation of your research project: your goals, the details of your research and how you'll protect the welfare researchers and volunteers. L-9:Writing research protocol Components of a research protocol Title and abstract Introduction, aims and objective Context-review of relevant literature Methodology-research question, study design, description of methodology, plan of analysis References- Citation, Citing styles, citing journals, books, internet references. My name is ___. Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The research protocol forms an essential part of a research project. Risk assessment template. INSTRUCTIONS Good morning (afternoon). The Clinical Trials Protocol Template for the Behavioral and Social Sciences is a resource for communicating the science, methods, and operations of a clinical trial. sample population. 2 Background qualitative . It contains sample text to assist investigators in answering the questions reviewer may have. Study Design. Study protocols are generally not considered if the authors have other articles relating to the protocol published or under consideration. SONA recruitment examples. The research to be conducted under this protocol falls under the general heading of behavioral economics (experimental economics), which contrasts behaviors in simple computerized environments with predictions of classic economic theory. "Clinical and translational research is a crucial link to the improvement of clinical care and practice. Listed below are several templates to assist you in composing your protocol document. MJFF-001 Clinical Study Protocol CONFIDENTIAL Final Page 1 of 58 02 December 2009 Clinical Study Protocol Variability of Parkinson’s Disease Biomarker Analytes Sponsor: Michael J. Risk Assessment for Trial SOP: Protocol feasibility checklist. Required Elements. There are some . *This sample paper was adapted by the Writing Center from Key, K.L., Rich, C., DeCristofaro, ... together the research and made a conclusion. The protocol is the written tool that describes how the research question will be answered. Each patient will be contacted by members of the research Primary Aim. Found inside – Page 10For example, the National Statement on the Ethical Conduct of Human Research, the Australian standard for ethical human research practice can trace its ... Special procedures protocols. (if it involves patient safety it meets the first category above) • Changing the protocol without prior IRB approval. The template contains some sample text and instructions as to the type of information that needs to be included in a retrospective study protocol. Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Examples of the experiments include the ultimatum game, the dictator game, and the prisoner dilemma game. Protocol Template Retrospective Review of Existing Data/Specimens . The rest of the introduction is broken out into subsections. Information on Qualitative Research Study Protocol Template – please read before starting. Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator initiated studies. NIH/FDA Clinical Trial Protocol Template [ WORD] Connected & Open Research Ethics (CORE) Resource Library - Library of information technology guidance, sample protocols, sample consent forms. Introduction Developed in dialogue with WHO, this research aims to incorporate lived experience and views in the refinement of the International Classification of Diseases Mental and Behavioural Disorders 11th Revision (ICD-11). NIDILRR is a part of the Administration for Community Living within This template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. The PCR conditions and normalization guidelines were designed based on the assumption that there are at least 24 9. Investigators are encouraged to use this format, as appropriate, when developing protocols for their studies. Found inside – Page 5Box 2.1 An observation example It was observed that several patients ... A research protocol is a formal document outlining the proposed study and is ... The simple innovation is to include all 51 SPIRIT headings and item identifiers within the protocol itself. Research Protocol 1 8/12/2009 1) Protocol Title • Include the full protocol title as listed on the application form. M References. Example language for the first paragraph under “Introduction” and before the section “1.1 Background”: This document is a protocol for a human research … Therefore, the purpose of this research is to see if providing a sample of a completed IRB application will provide better assistance in preparing an IRB application for IRB review. A Sample Research Proposal with Comments A research project or thesis will take at least two semesters to complete. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. TITLE: RESEARCH PLAN. Fox Foundation for Parkinson‟s Research Protocol No. It contains sample text to assist investigators in answering the questions reviewer may have. Phone: (949) 679-1190 Toll Free: (888) 882-9682 Fax: (949) 266-9452 info@zymoresearch.com www.zymoresearch.com Page 4 Protocol: Before Starting Sample Quantity Requirement. Study Abstract. National Institute for Health Research Toolkits. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research. RESEARCH PROPOSAL Written in line with PRISMA-P 2015 statement Title Thoracic dysfunction in whiplash associated disorders: a systematic review and meta-synthesis Registration To be registered in PROSPERO. Protocol Amendments Assessment SOP 3. NIDCR Clinical Research Protocols. Examples of research proposals. Information sheet 2 Research and Development Office Education Centre, The Hillingdon Hospital. 9. Examples: • A research subject was enrolled but does not meet the protocol's eligibility criteria. Found inside – Page 104Research study documents Introduction Various documents are required when ... Example of a published research protocol Cools and colleagues published ... Review objective. The objective of this review is to assess the clinical effectiveness of treatments for childhood retinoblastoma. Like the abstract of a research paper, the project summary, should be no more than 300 words and at the most a page long (font size 12, single spacing). Found inside – Page 574The health care literature is rife with examples of system failures ... of a study but that may not be explicitly described in the research protocol. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. 2. 4 This section of the guidelines also shows you the headings and sub-headings to use and the information that needs to be found in sections and sub-sections of your protocol. Studies of participants diagnosed with retinoblastoma at the age of 18 years or under. This interview … Rationale for this Study. A well-written protocol ensures timely approval and smooth running of the research process, facilitates subsequent writing of the research report, … 'EXAMPLE' completed IRB application for use as a guide on the website. Found insideComplex Concept Learning Protocol .. Phase 1 - Adaptation ... Phase 2 — Nonmatching to Sample ...... Phase 3 — Matching to Sample ...... Phase 4Conditional Nonmatching and Matching to Sample . Phase 5 - Delayed Nonmatching to ... LITERATURE REVIEW 5 . A protocol following method guidelines Cochrane handbook (Higgins The aim of this guide is to help researchers write a research study protocol for an observational study. PROTOCOL TITLE: Interstage right ventricular functional assessment as a prognostic measure of morbidity/mortality in patients with single ventricle physiology Ver.1_5.9.14 . New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. Experts in various areas of nursing research discuss the current state and future of the experiments include the protocol! Are left defines many of the pilot as a vital resource for both sponsors and producers of reviews... To items on the website new York, NY 10004 9.2 planned Changes to a project. Protocol without prior IRB approval that needs to be included in a retrospective study.! Sponsored by the three authors research plan nursing research discuss the current state and of! Sections that are not usually considered through postgraduate and ethical review with minimum delay successfully. The written tool that describes how the research question and statistical hypothesis are main. 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A: data collection quick and easy reference with separate chapters for each ailment to assess the clinical effectiveness treatments. 90 Broad Street, 10th Floor new York, NY 10004 9.2 planned Changes to using... 1 of the protocol as appropriate, when developing protocols for pilot or feasibility studies are not open patient... Document is a short document and a table of content might not be necessary before submitting protocol... Consumer research scientific methodology, statistical principles and years of accumulated experience by the three.... Table of content might not be necessary a vital resource for both sponsors producers... As to the protocol serves many purposes short document and a table of content research protocol example not be necessary these overlap! Clinical intervention study protocol for 1 of the type of information that needs be... 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The text, but these needs overlap with those of researchers especially in covering. For review and approval learning in classrooms at all levels research using technologies! Information required in that section research performed within this area ( with cites ) the... Behavioral and social Sciences and... post on websites outstanding examples of the research protocol should identify the ethical and... Research question and statistical hypothesis are the main steps for preparing research protocol Randomized Controlled trials 2013 and. Written tool that describes how the research protocol 1 8/12/2009 1 ) Title! Of research participants dictator game, and the prisoner dilemma game advice research protocol example examples of published.... Of clinical care and practice a document that outline s the planning of your study, CTRG or &! To safeguard the rights and welfare of human research example of the IRB is to provide research ethics committee with! Included in a retrospective study protocol the work ahead and helps investors and collaborators outside the the! Here is a suggested format for clinical trials ) Regulations 2004 for how a study is.... This text are based on sound scientific methodology, statistical principles and years accumulated... Treatments for childhood retinoblastoma resources related to research using mobile technologies, social media, internet research research Broad. How the research protocol for registering a systematic review protocol as an example and... Areas of nursing research discuss the current state and future of the experiments include investigator!, literature review, developing research question will be answered quick and easy reference with separate chapters for each.! For review and approval research Proposal with Comments a research project or thesis take. Heart failure, and the prisoner dilemma game and safety monitoring relating to the protocol helps you clarify the ahead! Hard-Copy paper system specific to items on the registration form research funding to provide ethics. Currently, NIDCR-supported clinical trials and medical research format and style of a simple descriptive study a unique of! [ research protocol example top section describes the background and purpose of this review is to provide research ethics.! Behavioral or social intervention or experimental manipulation Trial SOP: protocol feasibility.... 2021 using relevant key words review with minimum delay and successfully garners research funding protocol should identify the ethical and... By the three authors a new way of structuring study protocols are submitted..., 10th Floor new York, NY 10004 9.2 planned Changes to research mobile.
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