98:, 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. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment. Since 1996, clinical trials conducted are widely expected to conform to and report the information called for in the
87:(SOP) governing general practices required by the laboratory. A protocol may also reference applicable laws and regulations that are applicable to the procedures described. Formal protocols typically require approval by one or more individuals—including for example a laboratory directory, study director, and/or independent ethics committee—before they are implemented for general use. Clearly defined protocols are also required by research funded by the
47:. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias.
123:: Procedural information may include not only safety procedures but also procedures for avoiding contamination, calibration of equipment, equipment testing, documentation, and all other relevant issues. These procedural protocols can be used by skeptics to invalidate any claimed results if flaws are found.
129:: Equipment testing and documentation includes all necessary specifications, calibrations, operating ranges, etc. Environmental factors such as temperature, humidity, barometric pressure, and other factors can often have effects on results. Documenting these factors should be a part of any good procedure.
113:: Safety precautions are a valuable addition to a protocol, and can range from requiring goggles to provisions for containment of microbes, environmental hazards, toxic substances, and volatile solvents. Procedural contingencies in the event of an accident may be included in a protocol or in a referenced
220:
An experimenter may have latitude defining procedures for blinding and controls but may be required to justify those choices if the results are published or submitted to a regulatory agency. When it is known during the experiment which data was negative there are often reasons to rationalize why that
204:
A protocol may require blinding to avoid bias. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. A good clinical protocol ensures that
74:
Various fields of science, such as environmental science and clinical research, require the coordinated, standardized work of many participants. Additionally, any associated laboratory testing and experiment must be done in a way that is both ethically sound and results can be replicated by others
212:
if they deduce or otherwise obtain information that has been masked to them. Unblinding that occurs before the conclusion of a study is a source of experimental error, as the bias that was eliminated by blinding is re-introduced. Unblinding is common in blind experiments, and must be measured and
65:
Finally, in the field of social science, a protocol may also refer to a "descriptive record" of observed events or a "sequence of behavior" of one or more organisms, recorded during or immediately after an activity (e.g., how an infant reacts to certain stimuli or how gorillas behave in natural
135:: A protocol may specify reporting requirements. Reporting requirements would include all elements of the experiments design and protocols and any environmental factors or mechanical limitations that might affect the validity of the results.
141:: Protocols for methods that produce numerical results generally include detailed formulas for calculation of results. A formula may also be included for preparation of reagents and other solutions required for the work. Methods of
102:
Statement, which provides a framework for designing and reporting protocols. Though tailored to health and medicine, ideas in the CONSORT statement are broadly applicable to other fields where experimental research is used.
195:
Best practice recommends publishing the protocol of the review before initiating it to reduce the risk of unplanned research duplication and to enable transparency, and consistency between methodology and protocol.
66:
habitat) to better identify "consistent patterns and cause-effect relationships." These protocols may take the form of hand-written journals or electronically documented media, including video and audio capture.
43:
of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through
1018:
Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn (October 2014). "The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications".
75:
using the same methods and equipment. As such, rigorous and vetted testing and experimental protocols are required. In fact, such predefined protocols are an essential component of
163:
used is representative. For instance political polls are best when restricted to likely voters and this is one of the reasons why web polls cannot be considered scientific. The
167:
is another important concept and can lead to biased data simply due to an unlikely event. A sample size of 10, i.e., polling 10 people, will seldom give valid polling results.
879:
PRISMA-P Group; Moher, David; Shamseer, Larissa; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A (1 January 2015).
155:
is common to all measurements. These errors can be absolute errors from limitations of the equipment or propagation errors from approximate numbers used in calculations.
50:
Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g.,
755:. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 9 November 2016. pp. 34–37
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is the most common and sometimes the hardest bias to quantify. Statisticians often go to great lengths to ensure that the
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NCCIH requires that study investigators submit a final protocol document for all funded clinical projects.
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recommend that all studies assess and report unblinding. In practice, very few studies assess unblinding.
939:
681:
300:
39:. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful
1082:
881:"Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement"
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62:
gears at a facility) are consistent to a specific standard, encouraging safe use and accurate results.
83:(GCP) regulations. Protocols written for use by a specific laboratory may incorporate or reference
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59:
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231:
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80:
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440:
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UNDP/World Bank/WHO Special
Programme for Research and Training in Tropical Diseases (2001).
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Ethics and
Experiments: Problems and Solutions for Social Scientists and Policy Professionals
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367:
241:
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151:: Many protocols include provisions for avoiding bias in the interpretation of results.
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830:"Evidence of Experimental Bias in the Life Sciences: Why We Need Blind Data Recording"
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721:"Handbook for good clinical research practice (GCP): Guidance for implementation"
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40:
746:"Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)"
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data shouldn't be included. Positive data are rarely rationalized the same way.
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blinding is as effective as possible within ethical and practical constrains.
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National center for
Complementary and Integrative Health (24 July 2018).
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44:
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Design and
Analysis of Experiments: Introduction to Experimental Design
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often require the blinding of patients and researchers as well as a
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Procedural method for the design and implementation of an experiment
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are concepts used to quantify the likely relevance of a given
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Holman, L.; Head, M.L.; Lanfear, R.; Jennions, M.D. (2015).
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1017:
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Consumer
Behaviour: Perspectives, Findings and Explanations
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612:
Metatheory in Social
Science: Pluralisms and Subjectivities
208:
During the course of an experiment, a participant becomes
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581:. Atlantic Publishers and Distributors. p. 164.
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490:"Recommended practices for calibration laboratories"
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may be included to guide interpretation of the data.
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821:
691:. World Health Organization. pp. 16–18, 29–33
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547:. Educational Technology Publications. p. 3.
372:. Vol. 1. John Wiley & Sons. p. 11.
58:at a calibration laboratory, and manufacturing of
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615:. University of Chicago Press. pp. 61–62.
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682:"Chapter 2: Good Laboratory Practice Training"
488:National Research Council Canada (June 2003).
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466:American Society for Microbiology (2016).
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689:Handbook: Good laboratory practice (GLP)
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366:Hinkelmann, K.; Kempthorne, O. (1994).
35:in the design and implementation of an
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512:"Automotive Protocols & Standards"
652:. Palgrave Macmillan. pp. 71–2.
306:Royal Commission on Animal Magnetism
199:
13:
719:World Health Organization (2005).
14:
1094:
776:"NCCIH Clinical Research Toolbox"
578:Dictionary of the Social Sciences
1020:Journal of Clinical Epidemiology
979:
948:Encyclopedia of Research Design
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1032:10.1016/j.jclinepi.2014.05.007
106:Protocols will often address:
31:is most commonly a predefined
1:
411:. CRC Press. pp. 12–13.
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89:National Institutes of Health
85:standard operating procedures
70:Experiment and study protocol
56:certified reference materials
847:10.1371/journal.pbio.1002190
445:. Routledge. p. PT382.
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938:Salkind, N.J., ed. (2010).
301:Randomized controlled trial
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139:calculations and statistics
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956:10.4135/9781412961288.n471
646:O'Shaughnessy, J. (2012).
54:at a hospital, testing of
541:Thiagarajan, S. (1980).
77:Good Laboratory Practice
277:Paradigm (experimental)
232:Adaptive clinical trial
575:Reading, H.F. (1996).
510:Nash, T. (July 2005).
468:"Laboratory Protocols"
439:Desposato, S. (2015).
336:Statistical population
81:Good Clinical Practice
1068:Design of experiments
898:10.1186/2046-4053-4-1
726:. WHO. pp. 27–34
405:Selwyn, M.R. (1996).
242:Design of experiments
237:Blocking (statistics)
988:"Double-Blind Study"
940:"Triple-Blind Study"
609:Fiske, D.W. (1986).
291:Nucleic acid methods
282:Propagation of error
215:Reporting guidelines
143:statistical analysis
311:Sample (statistics)
272:Observational error
153:Approximation error
944:Trible-Blind Study
885:Systematic Reviews
331:Standard deviation
326:Scientific control
169:Standard deviation
1083:Scientific method
1026:(10): 1059–1069.
544:Protocol Packages
267:Medical guideline
257:Estimation theory
200:Blinded protocols
33:procedural method
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45:peer review
41:replication
1062:Categories
1005:2021-08-10
992:StatPearls
622:0226251926
588:8171566057
554:0877781516
418:0849394619
379:0471551783
353:References
252:Estimation
213:reported.
121:procedures
79:(GLP) and
37:experiment
1040:1878-5921
907:2046-4053
801:"History"
759:6 October
730:6 October
695:6 October
210:unblinded
133:reporting
1078:Research
1048:24973822
1000:31536248
971:23 March
950:. Sage.
925:25554246
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866:26154287
810:23 March
782:23 March
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495:22 March
473:22 March
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225:See also
173:variance
29:protocol
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179:. The
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111:safety
778:. NIH
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516:Motor
94:In a
1044:PMID
1036:ISSN
996:PMID
973:2019
960:ISBN
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761:2023
732:2023
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387:2019
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289:and
183:and
171:and
149:bias
23:and
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115:SOP
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