4.1.1 Risk assessment - Revision history

Leonardo.restivo at 08:14, 16 September 2026

2026-09-16T08:14:25Z

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			{{Preamble
			\| aliases =
			* risk assessment
			* identifying risks
			* risks to data quality
			* risk
			\| answers =
			* What is risk assessment in EQIPD?
			* How do I identify risks to my research data?
			* What counts as harm in the EQIPD risk framework?
			* Which core requirement covers risk assessment?
			}}

	== A. Background & Definitions ==		== A. Background & Definitions ==
	This item refers to one of the [[Core Requirements]] (Core Requirement 15 - "Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data") and is, therefore, considered as essential.		This item refers to one of the [[Core Requirements]] (Core Requirement 15 - "Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data") and is, therefore, considered as essential.

Bjoerngerlach: /* A. Background & Definitions */

2021-10-20T12:36:35Z

A. Background & Definitions

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	For any research unit using EQIPD Quality System, there are three main areas of risk assessment:		For any research unit using EQIPD Quality System, there are three main areas of risk assessment:
	* alterations from strongly recommended practices (i.e. situations when EQIPD language included „should“ and the research unit provided a declaration on why it does not or cannot apply to them)		* alterations from strongly recommended practices (i.e. situations when EQIPD language included „should“ and the research unit provided a declaration on why it does not or cannot apply to them)
	* key / support processes that are inherently associated with risks endangering the validity of results (e.g. risk of unblinding; emergency access to blinding codes; see also [[Plausibility check]])		* key / support processes that are inherently associated with risks endangering the validity of results (e.g. risk of unblinding; emergency access to blinding codes; see also [[2.1.10 Plausibility check]])
	* changes in the environment of the research unit (new hires / key people leaving; facility changes, etc.)		* changes in the environment of the research unit (new hires / key people leaving; facility changes, etc.)


	== B. Guidance & Expectations ==		== B. Guidance & Expectations ==

ChristophEmmerich at 13:15, 18 October 2021

2021-10-18T13:15:49Z

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	== A. Background & Definitions ==		== A. Background & Definitions ==
	This item refers to one of the [[Core Requirements]] (Core Requirement 15 - "Risk assessment must be performed to identify factors affecting the generation, processing and reporting of ~~reserach~~ data") and is, therefore, considered as essential.		This item refers to one of the [[Core Requirements]] (Core Requirement 15 - "Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data") and is, therefore, considered as essential.

	Risk is the combination of the probability of occurrence of harm, and the severity of that harm. In the context of EQIPD Quality System, harm is defined as research data not being fit for purpose, research data being biased and/or inadequate data integrity.		Risk is the combination of the probability of occurrence of harm, and the severity of that harm. In the context of EQIPD Quality System, harm is defined as research data not being fit for purpose, research data being biased and/or inadequate data integrity.

Bjoerngerlach: /* B. Guidance & Expectations */

2021-10-18T07:14:59Z

B. Guidance & Expectations

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	\|}		\|}

	Optionally, risk assessment can be conducted more often by the process owner or a dedicated ~~personon~~ on a broader level than what is suggested above. When doing so, the following questions can be used for guidance:		Optionally, risk assessment can be conducted more often by the process owner or a dedicated person on a broader level than what is suggested above. When doing so, the following questions can be used for guidance:
	* What can go wrong and have a negative impact on the research data or unit?		* What can go wrong and have a negative impact on the research data or unit?
	* How likely is it to happen?		* How likely is it to happen?
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	'''DO NOT FORGET'''		'''DO NOT FORGET'''
	* To justify acceptance of risk based on both probability and severity of harm		* To justify acceptance of risk based on both probability and severity of harm


	== C. Resources ==		== C. Resources ==

ChristophEmmerich at 13:04, 24 March 2021

2021-03-24T13:04:40Z

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	\|Team member with the primary responsibility over design and execution of a particular study		\|Team member with the primary responsibility over design and execution of a particular study
	\|For each planned / conducted study		\|For each planned / conducted study
	\|Yes, as part of a [[2.1.1 Study ~~(experimental) plan~~]] that should have a dedicated section or box for risk assessment summary		\|Yes, as part of a [[2.1.1 Study protocol]] that should have a dedicated section or box for risk assessment summary
	\|Certain Toolbox items are marked with a warning sign and a "please do not forget" text in order to suggest processes that may require attention		\|Certain Toolbox items are marked with a warning sign and a "please do not forget" text in order to suggest processes that may require attention
	\|-		\|-

B.gerlach at 20:01, 5 September 2020

2020-09-05T20:01:09Z

B.gerlach at 20:00, 5 September 2020

2020-09-05T20:00:49Z

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	EQIPD expects risk assessment to be conducted at three levels:		EQIPD expects risk assessment to be conducted at three levels:
	{\| class="wikitable"		{\| class="wikitable"
	\|		! scope="col"\|
	! scope="col"\|'''By whom'''		! scope="col"\|'''By whom'''
	! scope="col"\|'''When / how often'''		! scope="col"\|'''When / how often'''

B.gerlach at 20:00, 5 September 2020

2020-09-05T20:00:34Z

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	{\| class="wikitable"		{\| class="wikitable"
	\|		\|
	\|'''By whom'''		! scope="col"\|'''By whom'''
	\|'''When / how often'''		! scope="col"\|'''When / how often'''
	\|'''To be documented?'''		! scope="col"\|'''To be documented?'''
	\|'''Use of EQIPD tools'''		! scope="col"\|'''Use of EQIPD tools'''
	\|-		\|-
	\|'''Alterations from strongly recommended practices'''		\|'''Alterations from strongly recommended practices'''

Bjoerngerlach at 18:55, 5 September 2020

2020-09-05T18:55:54Z

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	== B. Guidance & Expectations ==		== B. Guidance & Expectations ==

	~~NOT COMPLETED: TABLE MSSING HERE:~~

	EQIPD expects risk assessment to be conducted at three levels:		EQIPD expects risk assessment to be conducted at three levels:
	{\| class="wikitable"		{\| class="wikitable"

Bjoerngerlach at 18:55, 5 September 2020

2020-09-05T18:55:33Z

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	'''DO NOT FORGET'''		'''DO NOT FORGET'''
	To justify acceptance of risk based on both probability and severity of harm		* To justify acceptance of risk based on both probability and severity of harm

← Older revision		Revision as of 20:00, 5 September 2020
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	EQIPD expects risk assessment to be conducted at three levels:		EQIPD expects risk assessment to be conducted at three levels:
	{\| class="wikitable"		{\| class="wikitable"
	\|		! scope="col"\|
	! scope="col"\|'''By whom'''		! scope="col"\|'''By whom'''
	! scope="col"\|'''When / how often'''		! scope="col"\|'''When / how often'''

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	! scope="col"\|'''Use of EQIPD tools'''		! scope="col"\|'''Use of EQIPD tools'''
	\|-		\|-
	\|'''Alterations from strongly recommended practices'''		! scope="col"\|'''Alterations from strongly recommended practices'''
	\|Process Owner		\|Process Owner
	\|At least as part of [[4.1.2 Self assessment]]		\|At least as part of [[4.1.2 Self assessment]]
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	\|If EQIPD Planning Tool is used, alterations from the recommended practices can be marked or highlighted in the corresponding Risk Assessment column in the Action Plan.		\|If EQIPD Planning Tool is used, alterations from the recommended practices can be marked or highlighted in the corresponding Risk Assessment column in the Action Plan.
	\|-		\|-
	\|'''Inherent risks of key / support processes'''		! scope="col"\|'''Inherent risks of key / support processes'''
	\|Team member with the primary responsibility over design and execution of a particular study		\|Team member with the primary responsibility over design and execution of a particular study
	\|For each planned / conducted study		\|For each planned / conducted study
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	\|Certain Toolbox items are marked with a warning sign and a "please do not forget" text in order to suggest processes that may require attention		\|Certain Toolbox items are marked with a warning sign and a "please do not forget" text in order to suggest processes that may require attention
	\|-		\|-
	\|'''Changes in the environment'''		! scope="col"\|'''Changes in the environment'''
	\|Process Owner (alone or with the team)		\|Process Owner (alone or with the team)
	\|Ad hoc		\|Ad hoc

4.1.1 Risk assessment - Revision history

Leonardo.restivo at 08:14, 16 September 2026

Bjoerngerlach: /* ​​​​​​​​​​​​​​​​​​​​​A. Background & Definitions​ */

ChristophEmmerich at 13:15, 18 October 2021

Bjoerngerlach: /* B. Guidance & Expectations */

ChristophEmmerich at 13:04, 24 March 2021

B.gerlach at 20:01, 5 September 2020

B.gerlach at 20:00, 5 September 2020

B.gerlach at 20:00, 5 September 2020

Bjoerngerlach at 18:55, 5 September 2020

Bjoerngerlach at 18:55, 5 September 2020

Bjoerngerlach: /* A. Background & Definitions */