This protocol template is a tool to facilitate the development of a research study protocol.
In the natural sciences a protocol is a predefined written procedural method in the design and implementation of experiments. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Formal protocols are the general rule in fields of applied science, such as environmental and medical studies that require the coordinated, standardized work of many participants. Such predefined protocols are an essential component of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. Definition-Clinical Research Protocols (protocols) are research studies conducted by NIH staff. The protocol may test something for a specified condition or purpose, e.g., a drug or medical device, or may review previous studies or record the history of a disease or condition. Staff on a protocol consist of a Principal Investigator (PI), possibly a Co-Principal Investigator (Co-PI), one or several Associate Investigators (AI), a Medical Advisory Investigator (MAI), and a Research Contact (RC). There may also be consultants to the protocol, e.g., statistical or scientific consultants. Manufacturing protocols are required by current good manufacturing practice (cGMP) for manufacture of foods, pharmaceuticals, and medical devices. In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. Formal protocols are the general rule in fields of applied science, such as environmental and medical studies that require the coordinated, standardized work of many participants. Such predefined protocols are an essential component of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. Do not confuse a research protocol with a research proposal. A proposal is meant to persuade your instructor, peers, or a grant-making committee, while a research protocol is meant to detail a study's methodology in straightforward fashion to satisfy an entity's human subjects requirements. Function. A research protocol clearly and plainly provides an overview of a proposed study in order to satisfy an organization's guidelines for protecting the safety of human subjects who might be impacted by the work. INTRODUCTION. The Protocol is the primary reference document for the conduct of the study and provides detailed, written documentation that sets out the conduct of the study. It is written before the study starts – a well thought out protocol will make the completion of the study approval application forms easier.  The term protocol is defined as a complete written description of, and scientific rationale for, a research activity involving human subjects. In the context of this manual, protocol means both the written description of the research activity and the activity itself. The CC supports approximately 950 active protocols for intramural (i.e., on-site) research. 1 The Protocol Title is the name of the study. 2  It should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. 3  Brevity with specificity is the key, and comprehensiveness definitely comes in second. 1 Study Protocol Template (Chart Reviews) Instructions: This protocol template is a tool to facilitate the development of a study protocol specifically designed for the investigator initiated studies. It contains sample text to assist investigators in answering the questions reviewers may have.  This manual describes the steps necessary to design a good clinical protocol; defines the review process needed to ensure scientific validity, ethical merit, and other hallmarks of good research; and outlines the process of managing a study using the protocol and other research tools. 1 The Protocol Title is the name of the study. 2  It should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. 3  Brevity with specificity is the key, and comprehensiveness definitely comes in second. 1 Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator initiated studies. It contains sample text to assist investigators in answering the questions reviewer may have. 
https://en.wikipedia.org/wiki/Clinical_trial_protocol http://www.niehs.nih.gov/about/od/ethics/protocols/index.cfm https://en.wikipedia.org/wiki/Clinical_trial_protocol http://www.ehow.com/facts_5916663_define-research-protocol.html http://www.adhb.govt.nz/ResearchOffice/Research-Resources/Study%20Protocol%20guide%20%20final%20vs%207%20Oct%2009.doc http://www.medtran.ru/eng/trials/protomechanics/ch1.htm http://health.usf.edu/NR/rdonlyres/90EA1301-F79A-4235-B038-883060288F2E/0/protocoltemplateChartReviews081108sa.pdf http://www.medtran.ru/eng/trials/protomechanics/ch1.htm http://health.usf.edu/NR/rdonlyres/1399E404-ACD1-46B0-A3B5-5C5BB5F16B71/0/protocoltemplateCTrials081108sa.pdf
research study protocol meaning