Protocol Title - ITHS



<Protocol Title>Principal investigator:Co-Investigators:Research team and contact Information:Study site:Protocol Version/Date: <Version #, dated mm/dd/yy><< The ITHS basic protocol is meant to be a document to explain key features of study purpose, study design, study population, procedures, timeline, and participant safety in order to ensure that your study is conducted in a safe and reproducible manner on the UW Clinical Research Center. The template provided here is the minimum amount of information required and is not reflective of a complete study protocol that may be required by a study Sponsor, IRB or regulatory agency. If you already have a protocol document that contains the basic elements described in the following pages you may submit that in lieu of completing this template. Alternatively you can find a complete protocol template at: . The length of a protocol will depend on the complexity of the study. Please contact the ITHS Research Coordinator Core (RCC) at rccore@uw.edu if you would like assistance with developing a complete protocol. If you have questions or need assistance in completing this basic template please contact the RSB core at rsbcore@uw.edu.>> Contents TOC \o "1-2" \h \z \u Research Synopsis PAGEREF _Toc326326543 \h 3Background and Significance PAGEREF _Toc326326544 \h 4Objectives PAGEREF _Toc326326545 \h 4Primary Objective PAGEREF _Toc326326546 \h 4Secondary Objectives PAGEREF _Toc326326547 \h 4Study Design and Methodology PAGEREF _Toc326326548 \h 4Study Population PAGEREF _Toc326326549 \h 4Sample Size PAGEREF _Toc326326550 \h 4Inclusion /Exclusion Criteria PAGEREF _Toc326326551 \h 4Study Duration, Timeline, and Procedures PAGEREF _Toc326326552 \h 5Informed Consent Process PAGEREF _Toc326326553 \h 5Risk to Participants PAGEREF _Toc326326554 \h 6References PAGEREF _Toc326326555 \h 6Research Synopsis<<The synopsis should provide a brief, one page summary of the information that is detailed later in your protocol. It gives a quick, helpful snapshot of your study for anyone needing to reference it, especially for protocols that are lengthy.>> Study Title: <Enter the full title>Study Population: <Summarize inclusion/exclusion criteria. Include a brief description of the population such as health status, gender, age, etc.>Study Design: <Present an overview of the study design for example, retrospective chart review, data or specimen collection etc.>Sample Size: <Include total number of participants for the study including other sites.>Study Duration: <Length of time from enrollment of first subject to completion of data analysisPrimary Objective: <Include primary objective and outcome measures.>Secondary Objective(s): <Include secondary objective and outcome measures.>Background and SignificanceGive a 2-3 paragraph summary of existing knowledge relevant to your research question. This may be similar to the “background and purpose” section for your IRB application.Objectives Primary Objective <Include the details of your primary objective (which is your main purpose of performing this study and should be focused on one question), outcome measures, and method by which outcomes will be determined. Sample text: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis.>Secondary Objectives <Include secondary objectives which can be dependent or independent of the primary objective, outcome measures, and method by which secondary outcomes will be determined. Sample text: To assess patients overall change in symptoms and return to daily activities after 2 weeks of antibiotic treatment.To evaluate management and treatment factors as potential predictors of outcome.>Study Design and Methodology<Include the description of study type, for example prospective data or specimen collection, retrospective, or observational, survey, or questionnaire. Sample text: This is a cross-sectional study to evaluate prevalence of xx in the general population.….>Study PopulationSample Size <Provide total number of participants to be enrolled at all sites and indicate any per site enrollment targets or caps, if applicable. Inclusion /Exclusion Criteria <What are the criteria for including or excluding any particular population? >Study Duration, Timeline, and Procedures<Briefly state the stages of your study, for example:Stage 1, Participant recruitment ----4-6 monthsStage 2, Participant follow up ----8-12 monthsStage 3, Data analysis, presentation and publication ----6-12 monthsInclude a projected start date.Provide the total length of time and include an approximate end date of the study.Include length of time participants will be followed Provide Table of Procedures: Procedures to be done in each study visit including examination, questionnaire, laboratory evaluation, medication administration and dosing, and the study schedule in the form of a flow chart or table.Example: Follow-Up Schedule: WeekScreen Enroll1234Signed Consent FormXAssessment of Eligibility CriteriaXXReview of Medical HistoryXXReview of Concomitant Medications XXXXXXStudy InterventionXXStudy questionnaireXXXXXLabs: CBC, Chem 7, LFTXXXXX Include a list of all laboratory evaluations, if applicable.>Informed Consent Process<Insert sample text.Please outline your process for conducting informed consent. Include information about any alternate methods that may be used like conducting consent by phone. Some sample language is provided below which you can use or modify to fit the nature of your study.>“Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and continuing throughout the individual’s study participation. Extensive discussion of risks and possible benefits of participation in this study will be provided to the participants and their families. Consent forms describing in detail the study procedures and risks are given to the participant and written documentation of informed consent is required prior to enrolling in the study. Consent forms will be IRB approved and the participant will be asked to read and review the document. Upon reviewing the document, the investigator will explain the research study to the participant and answer any questions that may arise. The participants will sign the informed consent document prior to being enrolled in the study. The participants will have the opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. The participants may withdraw consent at any time throughout the course of the study. A copy of the informed consent document will be given to the participants for their records. The rights and welfare of the participants will be protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to participate in this study.”Risk to Participants<Describe in detail any physical, psychological, social, legal, economic or any other risks to participants that are reasonably foreseen (i.e. were observed in previous studies or as outlined in the study drug package insert, investigator’s brochure or device manual)for all study procedures being conducted, including administration of study drug or use of an investigational device. This does not need to be an exhaustive list of all possible risks but it should include those risks that will be included in the consent form.>References<List all the references used in the background section at the end of the protocol.> ................
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