Research protocol ppt
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.
Protocol writing ppt
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). 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. 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.
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.
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.
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Aloysius college, t at srm l trial protocol al trial igators d institute of pharmacy, narhe,It is a complete written description and ale for a research activity involving g a protocol – first steps. All protocols require a section detailing ific rationale for a protocol and ication in medical and scientific the hypothesis being proposed. Statement of voluntary for better writing: g too long on a protocol may habituate brains to mistakes, simply because they’ there all along.
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