Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. The following advice is adapted from both lectures and our work with students as we guide them through both writing dynamic interview protocols and conducting interviews. All Rights Reserved. Listed below are the traditional elements of a protocol. Audit Objectives for Cutoff for Sales Transactions. Withdrawal 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. Thus, a protocol or a synopsis forms an integral part of a research project or a thesis. The Investigator's Brochure or the Grant application generally provide extensive reference material that need not be repeated in the protocol. Protocol summary: Give a concise overview of the project. The background and rationale should be no more than 3 - 5 pages. How to Write Protocols that Work •Step 1: Figure out a good way to do the research process the protocol will detail. This implies that the SAP should delineate populations (exclusion criteria); end points; descriptive objectives; testable hypotheses; modifications or derivations of standard variables; statistical methods, including handling of missing data, correlated data, bias, and confounding; subgroups; interactions; and sensitivity analysis. Writing the research protocol 5.1 Introduction After proper and complete planning of the study, the plan should be written down. general elements of the study protocol will be similar. Procedures are the steps required to complete a task, such as first checking to ensure the customer's name and point of contact are correctly entered in your sales database before accepting product or service orders. This statement is not a review of the ethical issues raised by the study design. Subjects not completing the study, for matters of choice (subject or investigator), may be paid on a pro rata basis. It is insufficient to merely list the tests to be used without including a discussion of exactly what comparisons will be performed. Evaluation of the Puataunofo Programme. Analysis Plan provides the specific plan for how each component of the analysis will be performed. Procedures are essential for making your business as efficient as possible. A study that is not large enough to achieve the stated objectives is not considered scientifically valid. F) Statistical Analysis. M References. If the client’s continues the drug on subsequent visits, the nurse must reorder the drug based on the nurse protocol. L5. Introduction. Another form of protocol in this instance may include briefing the company president on high-value sales. All rights reserved. Introduction. the values assumed for the outcome in each study group (eg, proportion with event, or mean and standard deviation); the calculated sample size per group - both assuming no loss of data and, if relevant, after any inflation for anticipated missing data modified from. Waivers: The Informed consent section should also outline and provide a justification for all of the waivers (if any) that apply to the research. While the SAP should be finalized prior to data analysis, authors may make changes to the analytic plan in response to subsequent findings. Each objective has a corresponding endpoint and a corresponding analysis plan. Write a Protocol. Remember, this is a document that’s supposed to break down all aspects of the work to be done, so it’s important that no detail is open to misinterpretation. E) Methods. Chalmers I, et al. Writing policies and procedures can be a long, involved process. Remember, this is a document that’s supposed to break down all aspects of the work to be done, so it’s important that no detail is open to misinterpretation. Secondary objectives may be exploratory or hypothesis generating and the study may not be powered to achieve these objectives. BMJ 2013. ), when the consent process will occur, where it will occur and how (in person, by telephone, etc.). Rationale for the Selection of Outcome Measures. Continually refining protocol can ensure that you are sustaining the quality of performance that will benefit your company's business reputation and its bottom line. demographics, comorbidities; … The section on unscheduled visits may be applicable when patients are anticipated to require rescue therapy or might need interim care due to chronic illness. This section should include the details regarding the packaging, dosing, storage and accountability of study medications or other interventions. This violates the first of Emanuel's requirements for what makes clinical research ethical - namely that the research have social (and scientific value). These include waivers of consent and assent, waivers of documentation of consent and waivers of parental permission. It is important to think of a protocol (may it be wet or dry lab-based, biology or chemistry-focused, simple or advanced) as a brief, modular and self-contained scientific publication. Writing Successful Interview Protocols . Descriptive studies are limited to summaries of the data (means, medians, standard deviations, etc.) Prior Literature and Studies. The objectives are usually written as bullet points. How and what data will be collected (i.e. For example, if blood pressure will be measured, it is important to state the subject"s condition (resting for at least 5 minutes), position (seated), arm (left) and technique (mercury sphygmomanometer).. 35. This section is mandatory and key for every study, regardless of design. 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. The checklist is intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should consider How to Write a Chemistry Lab Report. 9. This section enumerates the procedures that will be used to run the research study. The consent form by itself does not address the circumstances under which consent will be obtained. This second example is for an observational protocol. Describes the burden on subjects (duration of their participation) and should also address study feasibility. Regardless 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. Project summary The summary should be concise, and should summarize all the elements of the protocol. Observational Research (cohort, case-control and cross-sectional studies); Intervention Studies (clinical trials); and. Princeton University's Outdoor Action Program defines protocol as what is "proper and correct in official dealings," or a "set of rules governing the communication or transfer of data." For example, your sales transactions may require verifying customer information, checking stock for the requested products or the availability of service staff, scheduling delivery, creating and transmitting an invoice, and confirming receipt of the product with a post-sale communication, via email or telephone call. 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". Is the procedure (including the sequencing of the technique) of the intervention sufficiently clear to allow replication? Psychosocial hazards in work environments and effective approaches for managing them. Clinical research is either experimental or observational. Transparency for clinical trials - the TEST Act. ❡ 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. After writing, your documents should be reviewed, validated, and approved. The first step in writing a protocol is to decide on the appropriate study design to address the research question. Primary Hypothesis. The endpoints in the IRB's protocol templates are located in the analysis section. The IRB must review both the amount and method of payment to subjects to insure that neither presents an undue influence on the trial subjects. The protocol template also includes an alternative table format that may be easier for certain measurements such as laboratory tests. B) Aims. Every employer needs a firm set of ground rules to ensure that people are treated fairly. Review the flowcharts that you have created with the process owners for accuracy. But because these documents impact everyone at work every day, it’s important to get it right. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. 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 interpretation. A Standard Operating Procedure (SOP) is, on the other hand, the documentation of the process. Documentation of the written drug order by the RN shall include the following components: Not all elements are applicable to every protocol, but taken together, they describe a clinical research study. The full title should be concise, but it should also provide readers with an accurate summary of the study, including the study design, drug product to be tes… 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 IND. The plans for publication should be provided as a statement of the investigators assurance that the results will be made public and shared. That way, the overall structure/messaging of the first protocol can be pulled directly into the second protocol and the team can focus on one document at a time. 9. © 2020 Children's Hospital of Philadelphia. Inadequate analytic plans are the most frequent shortcoming of investigator-initiated research. Is the description of the intervention complete? DATA COLLECTION. The inclusion and exclusion (enrollment) criteria define the population that will be participating. Documenting procedures is critical for several reasons, one of which is to ensure consistency in service delivery. The general advice is applicable to the other protocol templates. 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 review. Study Objectives. Enough detail should be present in the protocol to allow another investigator to replicate the study without consulting the investigator. BMJ 2013, SOP 408: Unanticipated Problems Involving Risks to Subjects, Emanuel's requirements for what makes clinical research ethical. All trials must be registered and the results published, Decullier E et al. Secondary Aim. To help you work out when and what to write and make writing and reviewing easier. Some suggestions for improving performance and accountability, SPIRIT 2012 explanation and elaboration: guidance for protocols of clinical trials, The Value of Statistical Analysis Plans in Observational Research Defining High-Quality Research From the Start, Hoffman et al. Note that the procedures in Section 4 are simply bullet points and these match the Table of Procedures. The length of the research protocol will be … A. The details of the execution of randomization and blinding procedures should be included in the Statistical Analysis Section (Section 9). Since the table provides a rapid reference for the timing of all study procedures, this table aids the investigative team maintain a compliant trial. For example, the military hierarchy system dictates protocol for addressing various officer ranks, such as a lower-rank military service member is required to salute a high-ranking officer. Payments 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. Create a flowchart that depicts the input to the process, the work steps, and the output. A badly written protocol can contribute substantially to approval times especially for investigator-initiated studies. In the health care industry, formal protocol is described as a best practice or the recommended course of action for delivering specific types of care. Are the physical or informational materials used adequately described (and available)? Greater than Minimal Risk Safety Management:A generic safety plan for greater then minimal risk research is included in the protocol templates. 1. Preparing to write your procedures Decide on a platform. "For scientific reasons, all sites conducting a given study must use essentially the same protocol. 1. Employees would wear whatever they want to work, and behave according to their own rules. D) Hypothesis. Is the schedule (interval, frequency, duration, or timing) of the intervention clear? The IRB will not approve collection of extraneous data without a plan for how it will be used. For each endpoint or outcome, the trial protocol should define four components: If 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). Rationale for the Selection of Outcome Measures. Write a Protocol. the specific measurement time point of interest for analysis. Writing effective healthcare policies and procedures for healthcare organizations is a daunting task. Conduct the interviews and document the results. Purpose of the Study Protocol. Ruth Mayhew has been writing since the mid-1980s, and she has been an HR subject matter expert since 1995. This section is not in the Observational Template since there aren't any interventions. Determine the types of exposure risk to the identified hazards that each step could present. SPIRIT (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. Practices, on the other hand, are probably more akin to protocol because a practice is something that you customarily do to carry out a task. 8.2 Adverse Event Reporting Subjects that are forced to discontinue due to an adverse experience, should be compensated the entire amount. Don’t talk or yell past your immediate neighbor. Since the study procedures are not greater than minimal risk, SAEs are not expected. A study that is larger than necessary exposes more subjects to risk and inconvenience than required to achieve the scientific aims. Many universities have made it mandatory for the postgraduate degree student to prepare a thesis as a part of their postgraduate training. The number of subjects needs to be sufficient to enable the study to achieve its objectives without being any larger than necessary. From Thomas and Peterson's paper in JAMA 2012 The Value of Statistical Analysis Plans in Observational Research Defining High-Quality Research From the Start. L5. Research that is not feasible is not approvable. A needs assessment is the first step in protocol development. It enables investigators, study coordinators, IRB reviewers and regulatory personnel and auditors to quickly acquaint themselves with the study. Study Procedures. 9. A compliance statement is included in the template. Primary Hypothesis. 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. For example, if you are developing protocol for handling sales transactions that exceed, say, $1 million, review the basic steps for all sales transactions. The SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials established criteria for items that should be in all clinical trial protocols. It requires a great deal of time, effort, and attention to detail. Properly written protocols help to ensure that nuclear medicine procedures are performed in a standardized, reproducible manner so that patients receive high-quality care. Worker Exposure Survey. Get up, stretch your legs, burn some calories … Every research study should have a protocol, and the protocol should be written. Write a set of interview questions. Developing either or both first requires understanding their differences, as well as knowing the definition of other P words, such as policies and practices. Most companies favor a progressive model, which allows the employer to tailor the penalty according to the circumstances. Study Endpoints or Outcomes translate the study objectives into explicit statements that describe the comparisons to be made. 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 issues. Discipline protocols are the employer's road map for dealing with employees who break the rules. The study objectives (or aims) should be broken down into primary and secondary objectives. 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, etc. 2. The Analysis Plan provides a justification for the data that will be collected. Sometimes students think one issue will be easier to research than another, professors prefer certain projects, or they are doing group work and get talked into something that Poor description of non-pharmacologic interventions. An example given is an employee who expresses interest in teaching. This is usually not the case. All parties should adhere to accepted guidelines for ethical reporting. Writing a clinical research protocol is a complex and time consuming process. Project … Outterson K. Clinical trial transparency - antidote to weaker off-label-promotion rules? Sample Size and Power: All studies require a justification for the chosen sample size. of the writing of the protocol to reflect more closely the sense of the study. Even if it is not required, writing a protocol is a good idea because it will help you to organize your thoughts and ensure that you do not overlook any components of the experiment. 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. Even before the protocol is written, the study team must frame and refine their research question, and then determine the protocol’s level of pragmatic constraints. Regulatory 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 subjects. If there are any situations where there might be flexibility in the enrollment criteria, this should be stated explicitly in this section. The steps that will be taken to assure comprehension (informed consent and not just consent) and lack of coercion should also be addressed. Defines who will take part in the research. Writing of the research protocol should precede application for ethical and regulatory approval; and the final protocol will be required by ethical committees and research and upfront development departments. The IRB is required to ensure that the proposed study is feasible and minimizes risk. 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. In addition, your protocol might include client-focused practices that are not necessarily steps in the sales process, such as adding the client to an internal list of valued customers, assigning the most senior representative to handle that customer's calls or the sales manager writing a personal note to the customer to show appreciation for the business. Most of the work happens before you ever begin to write. 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. Understanding these terms will simplify the development of protocol and procedures for your organization. Mann H. Research ethics committees and public dissemination of clinical trial results. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Creating good policies takes time and effort, but you can increase your chances for success by remembering a few basics. Observational studies are often more complex than randomized controlled trials because it is often quite challenging to adjust for all of the sources of bias and confounding. Research Registration and Publication and Dissemination of Results. Avoid the use of acronyms. from Are research ethics committees behaving unethically? As part of the procedure, make teaching part of their job, but give them ownership over making it work. Special procedures protocols. Rationale for this Study. It 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. These changes to methods, hypotheses, or both should be noted in the SAP to capture when and why components were modified during analysis. The examples for the Study Measures to the right and below come from different clinical trials. 8.1 Clinical Adverse Events •Find the news articles yourself •Observe the phenomena you want others to observe for you •Step 2: Re-do the process, writing down … Procedures may need updating based on technology that supports your company transactions or staffing changes and assignment of duties. After writing, your documents should be reviewed, validated, and approved. The RN shall write the drug order in accordance with the nurse protocol and based on a client assessment each time the drug is ordered. While the intent of an SOW is to give an overall description of a project, the key to writing one is to keep it clear and precise.

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