Research study protocol

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. 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.

How to write a study protocol

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. 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.

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. 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.

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. 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).

It simply is a statement that the research will be conducted in accordance with regulations and hospital and irb policies. The irb is required to ensure that the proposed study is feasible and minimizes risk.

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. They create a setting for the ic objectives are statements of the research question(s).

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. 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.

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. 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?

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. Since the table provides a rapid reference for the timing of all study procedures, this table aids the investigative team maintain a compliant trial.

The same study can be described in several ways, and as complete a description of the study as possible should be provided. In addition, the investigators discuss the human subjects research ethics ational protocol:This second example is for an observational protocol.

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. 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 spirit 2013 statement: defining standard protocol items for clinical trials established criteria for items that should be in all clinical trial protocols. 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.

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. Ts of the protocol should go into as much detail about the research project as possible, to enable the review bodies to fully understand your new website is easier to navigate and find information.

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. 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.

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. 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?