Research study protocol
And ch policy ended format for a research 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). 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. It should stand on its own, and not refer the reader to points in the project ol title, protocol identifying number (if any), and and address of the sponsor/ and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of (s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the ale & background rationale specifies the reasons for conducting the research in light of current knowledge. It is the equivalent to the introduction in a research paper and it puts the proposal in context. It should answer the question of why and what: why the research needs to be done and what will be its relevance. They create a setting for the ic objectives are statements of the research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). After statement of the primary objective, secondary objectives may be scientific integrity of the study and the credibility of the study data depend substantially on the study design and methodology. The design of the study should include information on the type of study, the research population or the sampling frame, and who can take part (e. The same study can be described in several ways, and as complete a description of the study as possible should be provided. For example, a study may be described as being a basic science research, epidemiologic or social science research, it may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc. The link below provides more information on how to describe a research methodology section is the most important part of the protocol. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly entions should be described in detail, including a description of the drug/device/vaccine that is being tested. Interventions could also be in the realm of social sciences for example providing training or information to groups of ures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant's environment, etc. Must also be the case of a randomized controlled trial additional information on the process of randomization and blinding, description of stopping rules for individuals, for part of the study or entire study, the procedures and conditions for breaking the codes etc.
How to write a study protocol
Graphic outline of the study design and procedures using a flow diagram must be provided. 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. It is useful to remember that even administering a research questionnaire can have adverse effects on research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow u, especially for adverse events, even after data collection for the research study is management and statistical protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification. The statistical methods proposed to be used for the analysis of data should be clearly outlined, including reasons for the sample size selected, power of the study, level of significance to be used, procedures for accounting for any missing or spurious data etc. For projects involving qualitative approaches, specify in sufficient detail how the data will be protocol should describe the quality control and quality assurance system for the conduct of the study, including gcp, follow up by clinical monitors, dsmb, data management ed outcomes of the protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health ination of results and publication protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, on of the protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be section should discuss the difficulties that the investigators anticipate in successfully completing their projects within the time frame stipulated and the funding requested. It should also offer possible solutions to deal with these section should describe the role and responsibility of each member of the protocol should have a description of ethical considerations relating to the study. It should also describe how the investigator(s) plan to obtain informed consent from the research participants (the informed consent process). Consent approved version of the protocol must have copies of informed consent forms (icf), both in english and the local language in which they are going to be administered. If the research involves more than one group of individuals, for example healthcare users and healthcare providers, a separate specifically tailored informed consent form must be included for each group. For guidance on how to write an informed consent form, click mmes and region of the south-east asia eastern mediterranean western pacific up for who invited you to join this research protocol pal investigator:Institutional affiliations:I. List the broad, long-term objectives and describe concisely and realistically what the research is intended to accomplish and the hypotheses to be ctive/retrospective? Assessment of te how investigator will ensure that the study:Has sufficient access to the study sufficient time to conduct and complete the adequate qualified staff members to conduct the ty is adequate to conduct the has been adequately trained on the protocol and their specific research related e a description of the study procedures (as they relate to the subject). Be sure to include (as applicable):Plans for number and estimated length of each study ures and/or interventions that will be performed for each visit (a chart may be helpful).
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A drug study, include instructions for administering drugs, handling instructions, and storage and disposal biological samples, explain how the samples will be collected, as well as storage, testing, and disposal behavioral studies, identify the instruments being used and who will be administering the instrument (including their a survey study, include who created the survey, whether survey has been standardized, how survey will be distributed and returned, and how confidentiality will be chart review, indicate whether or not the materials will be obtained prospectively, or if the materials will come from previously existing specimens, records, or data. Explain what information will be used to identify potential human subjects for inclusion in research. If requesting waiver or alteration of consent, explain why it is needed to complete the study. Justify any costs that the subject will incur as a result of participating in the study. The use of benefits to offset the burden due to participation in the research should be incremental and not based on study completion. Preparation for study submission ยป -center protocols:The irb does not accept a chop-specific protocol for multi-center research studies. When the pi at chop is responsible for the overall protocol, it should be written in a site-neutral way so that it can be implemented at all of the other sites. For scientific reasons, all sites conducting a given study must use essentially the same protocol. Permitting substantial variation in what happens to subjects at different sites introduces bias and risks rendering the study results uninterpretable. The protocol provides the scientific basis for the proposed research; it defines the study objectives, the population to be studied, the procedures to be followed, the evaluations to be performed and the plan for analysis; and lastly, it discusses the administrative aspects of the study such as safety management and regulatory first step in writing a protocol is to decide on the appropriate study design to address the research question. The irb has four protocol templates including one for each of the following types of design:Descriptive research;. The general advice is applicable to the other protocol ines for writing (standard protocol items: recommendations for interventional trials): spirit is an initiative to create a checklist for protocols that complements the consort requirements for trial reporting. The spirit 2013 statement: defining standard protocol items for clinical trials established criteria for items that should be in all clinical trial protocols. A companion document, spirit 2013 explanation and elaboration: guidance for protocols of clinical trials provides a more extensive discussion of each of the items on the spirit there are differences between a clinical trial and an observational trial, there is considerable overlap with many protocol items. Both the spirit statement and the spirit 2012 explanation and elaborationserve as valuable references to aid protocol ptive protocol:An example protocol shows the format and style of a simple descriptive study.
The protocol is succinct but still manages to convey clear objectives, an overview of the study design, inclusion/exclusion criteria, data to be abstracted and analysis plan. In addition, the investigators discuss the human subjects research ethics ational protocol:This second example is for an observational protocol. The details of each of the study procedures are in section 5, where a short paragraph describes each procedure. The analysis plan is complete and the sample size calculations are provided in enough detail that they could be ention protocol synopsis is a 1 - 3(4) page outline of the study in miniature. It enables investigators, study coordinators, irb reviewers and regulatory personnel and auditors to quickly acquaint themselves with the study. Table listing the study procedures and the timing of procedures helps provide a summary for investigative team members and for reviewers. Since the table provides a rapid reference for the timing of all study procedures, this table aids the investigative team maintain a compliant trial. List of study abbreviations can aid consistency and improve n 1: background information and background and rationale should be no more than 3 - 5 pages. Information about the study intervention, summary of the non-clinical data and clinical data, and a review of the literature are all part of this section. If the study involves the administration of a drug or biologic, a justification of the dosage and dosing interval should be provided. This statement is not a review of the ethical issues raised by the study design. It simply is a statement that the research will be conducted in accordance with regulations and hospital and irb policies. The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data are research ethics committees behaving unethically? Some suggestions for improving performance and n 2: study study objectives (or aims) should be broken down into primary and secondary objectives.
The objectives need to be specific to the intervention - for a drug, they should specify the dosage level, route, frequency and duration of administration and in a defined population - "does the study drug reduce blood pressure when administered twice a day as an oral liquid, at a dose of 50 mg, in children age 6 - 12 years who have moderate hypertension". Secondary objectives may be exploratory or hypothesis generating and the study may not be powered to achieve these objective has a corresponding endpoint and a corresponding analysis plan. Some protocols include a table that maps each objective to its endpoint and corresponding analysis ives for a pk study:Objectives for a clinical trial:Objectives and endpoints in a n 3: study l schema of study design:This section provides a brief overview of the entire study design including various phases of the study (if more than one). The details are provided later in this ization and blinding:Should be discussed as an overview including how randomization schedules are generated, who executes the schedule, how the schedule is concealed and the study blinding procedures. Duration, enrollment, number of sites:Describes the burden on subjects (duration of their participation) and should also address study feasibility. Research that is not feasible is not s who will take part in the research. The risks and benefits of the study depend on who the participants are and the enrollment criteria also must be constructed to ensure an equitable selection of there are any situations where there might be flexibility in the enrollment criteria, this should be stated explicitly in this section. Enrolled of subjects that do not otherwise meet one or more of the enrollment criteria constitutes a major protocol deviation that will need to be reported promptly to the n 4: study section is a visit schedule which is visit-by-visit listing of all the procedures that will take place at each visit. Blood draws for a pk study) then the timing of each of these should be section on unscheduled visits may be applicable when patients are anticipated to require rescue therapy or might need interim care due to chronic examples for the study visits to the right and below come from different clinical itant medications: should list all medications that are permitted or explicitly forbidden during awal from study: since subjects are permitted to change their minds withdraw from participation from a research study at any time, the procedures that will be followed to provide for an orderly transition from the research to routine care should be outlined. For studies without an intervention this section may not be applicable but subjects may not be able to abruptly discontinue some medications and a plan needs to be in place to manage this 3 and subsequent visits:Section 5: study measures and study measurements should provide the detailed descriptions for how each measurement will be made including. Section on unscheduled visits may be applicable when patients are anticipated to require rescue therapy or might need interim care due to chronic examples for the study measures to the right and below come from different clinical logical or other measurement scales that will be used should be described. Those that are not on the list should be included in the appendix or uploaded into is not necessary to include a copy of the case report form if all of the study measurements are listed in this section of the protocol. The protocol template also includes an alternative table format that may be easier for certain measurements such as laboratory logical instruments:Section 6: statistical endpoints or outcomes translate the study objectives into explicit statements that describe the comparisons to be each endpoint or outcome, the trial protocol should define four components:The specific measurement variable, which corresponds to the data collected directly from trial participants (eg, beck depression inventory score, all cause mortality);. Method of aggregation, which refers to the summary measure format for each study group (eg, mean, proportion with score > 2); specific measurement time point of interest for the objective is to determine the efficacy of drug a compared to placebo for the treatment of hypertension, the study endpoint might be the change in the mean (method of aggregation) systolic blood pressure (measurement variable) for drug a compared to placebo between visit 1 and visit 4 (participant analysis metric and time point of interest). When a power calculation is performed the protocol should include the following:The primary endpoint (outcome);.
Values assumed for the outcome in each study group (eg, proportion with event, or mean and standard deviation);. Usually at least 80%); calculated sample size per group - both assuming no loss of data and, if relevant, after any inflation for anticipated missing data modified from spirit 2012 explanation and elaboration: guidance for protocols of clinical studies, such as exploratory studies, studies of rare diseases or pharmacokinetic trials may have a sample size that is based on more pragmatic criteria rather than a power less of whether or not there is a formal power calculation, the sample size section should provide sufficient information to explain the why the study is proposing to enroll the specified number of subjects and not more or fewer. The number of subjects needs to be sufficient to enable the study to achieve its objectives without being any larger than necessary. The irb is required to ensure that the proposed study is feasible and minimizes risk. A study that is not large enough to achieve the stated objectives is not considered scientifically valid. A study that is larger than necessary exposes more subjects to risk and inconvenience than required to achieve the scientific e sample size section:Analysis plan provides the specific plan for how each component of the analysis will be performed. The irb will not approve collection of extraneous data without a plan for how it will be uate analytic plans are the most frequent shortcoming of investigator-initiated research. Statistical consultation should be sought prior to submission of the protocol not after completion of the study. The analysis of observational research study designs is usually more complex than for clinical trials. A plan is need to deal with all of the sources of bias and for confounding the study will have an interim analysis, then the stopping rules for safety and benefit should be much detail should there be in the statistical analysis plan? Once created, the sap should be cited in the methods, submitted along with the manuscript for review, and potentially made available as an online appendix to a published thomas and peterson's paper in jama 2012 the value of statistical analysis plans in observational research defining high-quality research from the e of analysis plan for primary endpoint:Example stopping rule:Section 7: study drug (or study intervention for non-pharmacologic trials). Section should include the details regarding the packaging, dosing, storage and accountability of study medications or other interventions. For studies that will test a device or diagnostic test, the information regarding the device or the test might be best placed at this point in the protocol, particularly if the device or diagnostic is being studied under an ide, hde or ption of non-pharmacologic interventions:protocols (and clinical trial reports) frequently omit key descriptions of the study intervention. Enough detail should be present in the protocol to allow another investigator to replicate the study without consulting the it clear where the intervention will be delivered? 2 adverse event the study procedures are not greater than minimal risk, saes are not expected.
If any unanticipated problems related to the research involving risks to subjects or others happen (including saes) these will be reported to the irb in accordance with chop irb sop 408: unanticipated problems involving risks to subjects. Aes that are not serious but that are notable and could involve risks to subjects will be summarized in narrative or other format and submitted to the irb at the time of continuing r than minimal risk safety management:a generic safety plan for greater then minimal risk research is included in the protocol templates. A thorough discussion of reporting requirements for unanticipated problems involving risks to subjects and others, including serious adverse events is available on the irb webpage on reportable l risk safety management:when a study is limited to procedures that are not greater than minimal risk, the safety management section of the protocol may be n 9: study section enumerates the procedures that will be used to run the research study. Sufficient detail is required to ensure that the research plan will produce valid ent assignment: the consort reporting standards require that the details of randomization and blinding be reported. These elements must therefore be in the protocol in sufficient detail to assure that the trial results will be unbiased. If the study is not a randomized trial, it may still be appropriate to include the details for how measurements, tests or radiological images will be blinded prior to ization sequence generation and concealment procedures:Data collection and management:care in data management is a requirement to assure valid study results. Sloppy data handling will add variability to the study assessments and will affect the outcome of the tory and ethical considerations:this section should identify the areas of risk to human subjects and address how the study will minimize those risks and maximize the potential benefits to ed consent and assent: the protocol should provide sufficient information regarding will obtain consent, what information will be transferred (consent form, verbal script, video presentation, booklet, etc. The steps that will be taken to assure comprehension (informed consent and not just consent) and lack of coercion should also be s: the informed consent section should also outline and provide a justification for all of the waivers (if any) that apply to the research. If hipaa applies to the research then there should be an explanation of each requested waiver, alteration or partial waiver with a justification for each. It is insufficient to simply reiterate the regulations when justifying a waiver request; the justification needs to explain why the research satisfies the conditions for each monitoring plan: should address how those in charge of the management for the study will assess the evolving study progress including adverse events and data quality. Provided that the study intervention(s) and monitoring procedures are of reasonably low risk, early phase trials might have a plan as simple as having the investigator review all of the adverse event reports as they occur. To subjects: if subjects or parents/guardians are to be paid for the inconvenience of participating in the study, the amount of payment(s) must be stated in the protocol. Subjects not completing the study, for matters of choice (subject or investigator), may be paid on a pro rata basis. Subjects that are forced to discontinue due to an adverse experience, should be compensated the entire n 10: publication declaration of helsinki - ethical principles for medical research involving human ch registration and publication and dissemination of results. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. Reports of research not in accordance with the principles of this declaration should not be accepted for ch that will not be published does not contribute to generalizable knowledge. This violates the first of emanuel's requirements for what makes clinical research ethical - namely that the research have social (and scientific value). Generally this should include no more than 10 - 20 key references that demonstrate a thorough review of the literature and provide support for the methodology, dosage choice, measurement techniques, investigator's brochure or the grant application generally provide extensive reference material that need not be repeated in the protocol.