Checklist for study protocols - Revision history

Bosmana fem at 18:38, 10 April 2023

2023-04-10T18:38:30Z

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	#* Clearance will be sought from an ethical committee		#* Clearance will be sought from an ethical committee

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	'''FEM PAGE CONTRIBUTORS 2007'''		'''FEM PAGE CONTRIBUTORS 2007'''
	;Contributor		;Contributor

Bosmana fem: /* FEM PAGE CONTRIBUTORS 2007 */

2023-04-10T18:38:01Z

FEM PAGE CONTRIBUTORS 2007

← Older revision		Revision as of 18:38, 10 April 2023
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	==FEM PAGE CONTRIBUTORS 2007==		<div style="display: inline-block; width: 25%; vertical-align: top; border: 2px solid #000; background-color: #d7effc; padding: 10px; margin: 5px;">
			'''FEM PAGE CONTRIBUTORS 2007'''
	;Contributor		;Contributor
	:yvan.hutin		:yvan.hutin
			</div>

	[[Category:Writing a Study Protocol]]		[[Category:Writing a Study Protocol]]

Bosmana fem at 22:18, 29 March 2023

2023-03-29T22:18:55Z

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			==FEM PAGE CONTRIBUTORS 2007==
			;Contributor
			:yvan.hutin


	[[Category:Writing a Study Protocol]]		[[Category:Writing a Study Protocol]]

Bosmana fem at 22:18, 29 March 2023

2023-03-29T22:18:01Z

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			10-point checklist for self or peer assessment:

			# Rationale of the study
			#* The topic is of documented local public health importance (i.e., high burden, intervention available, local awareness)
			#* The introduction logically introduces a need for new information through a research question
			#* The information generated by the study will allow more effective prevention and control
			#* The introduction section is short (i.e., does not exceed 20% of the document)
			# Study objectives
			#* The objectives are focused
			#* The objectives leave aside the expected benefit (referred to in the introduction or a specific paragraph at the end)
			#* The objectives are clear
			#* The objectives make use of one verb each
			#* The objectives are clearly about measurement (i.e., "estimate") or hypothesis testing (i.e., "determine", "identify")
			# Study population
			#* Clear, precise time, place and person inclusion and / or exclusion criteria define the study population
			#* The study population is relevant to answer the research question
			#* The study population is defined independently from the sampling methods that will be used to approach it
			# Study design
			#* The study design will allow addressing the study objectives to bring an answer to the proposed research question
			# Operational definitions
			#* The operational definitions are clear, precise and explicit
			#* The operational definitions are based upon (1) standardized internationally accepted criteria or (2) explained rationale
			# Study sample
			#* The sample will allow statistical inference (i.e., representative of the population, avoiding convenience/ purposive methods)
			#* The parameters used for the sample size calculation are explicit and justified
			#* The sample is of a size that is sufficient to generate the statistical power needed
			# Data collection
			#* The protocol specifies the broad categories of information elements that will be collected
			#* The protocol specifies who will collect the data
			#* The protocol specifies how the data will be collected (i.e., tool, data collection method)
			#* The data collection instruments are provided in the appendix
			# Analysis plan
			#* The protocol outlines the how the data analysis will address each of the study objectives
			#* Appropriate dummy tables in the appendix documents the planned data analysis procedure
			# Quality assurance
			#* The protocol was peer reviewed
			#* Quality assurance measures are planned for data collection (e.g., pilot-testing, back-translation) and data analysis
			#* The potential bias that could affect the study are raised and discussed
			# Human subject protection
			#* Potential risks are listed with a plan to minimize them (including confidentiality)
			#* Potential benefits are identified with a plan to maximize them
			#* The appendix contains a form to collect informed consent from study participants
			#* Clearance will be sought from an ethical committee



	[[Category:Writing a Study Protocol]]		[[Category:Writing a Study Protocol]]

Bosmana fem: Created page with " Category:Writing a Study Protocol"

2023-03-22T22:46:52Z

Created page with " Category:Writing a Study Protocol"

New page

[[Category:Writing a Study Protocol]]