4.1.1 Risk assessment - Revision history

Bjoerngerlach: /* A. Background & Definitions */

2021-10-20T12:36:35Z

‎A. Background & Definitions

ChristophEmmerich at 13:15, 18 October 2021

2021-10-18T13:15:49Z

Bjoerngerlach: /* B. Guidance & Expectations */

2021-10-18T07:14:59Z

‎B. Guidance & Expectations

ChristophEmmerich at 13:04, 24 March 2021

2021-03-24T13:04:40Z

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

B.gerlach at 20:00, 5 September 2020

2020-09-05T20:00:34Z

Bjoerngerlach at 18:55, 5 September 2020

2020-09-05T18:55:54Z

Bjoerngerlach at 18:55, 5 September 2020

2020-09-05T18:55:33Z

Bjoerngerlach at 18:54, 5 September 2020

2020-09-05T18:54:56Z

@@ Line 8: / Line 8: @@
 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)
-* 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.)
 == B. Guidance & Expectations ==

@@ Line 1: / Line 1: @@
 == 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.

@@ Line 41: / Line 41: @@
 |}
-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?
 * How likely is it to happen?
@@ Line 52: / Line 52: @@
 '''DO NOT FORGET'''
 * To justify acceptance of risk based on both probability and severity of harm
 == C. Resources ==

@@ Line 31: / Line 31: @@
 |Team member with the primary responsibility over design and execution of a particular 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
 |-

@@ Line 21: / Line 21: @@
 ! scope="col"|'''Use of EQIPD tools'''
 |-
-|'''Alterations from strongly recommended practices'''
+! scope="col"|'''Alterations from strongly recommended practices'''
 |Process Owner
 |At least as part of [[4.1.2 Self assessment]]
@@ Line 28: / Line 28: @@
 |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
 |For each planned / conducted study
@@ Line 34: / Line 34: @@
 |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)
 |Ad hoc

@@ Line 15: / Line 15: @@
 EQIPD expects risk assessment to be conducted at three levels:
 {| class="wikitable"
+! scope="col"|
 ! scope="col"|'''By whom'''
 ! scope="col"|'''When / how often'''

← Older revision		Revision as of 18:55, 5 September 2020
Line 54:		Line 54:

	'''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

@@ Line 26: / Line 26: @@
 |'''Alterations from strongly recommended practices'''
 |Process Owner
-|At least as part of [[Self assessment]]
+|At least as part of [[4.1.2 Self assessment]]
 (Process Owner may decide to conduct assessments more frequently)
-|Yes, as part of a [[Self assessment]] protocol
+|Yes, as part of a [[4.1.2 Self assessment]] protocol
 |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.
 |-
@@ Line 34: / Line 34: @@
 |Team member with the primary responsibility over design and execution of a particular study
 |For each planned / conducted study
-|Yes, as part of a [[Study (experimental) plan]] that should have a dedicated section or box for risk assessment summary
+|Yes, as part of a [[2.1.1 Study (experimental) plan]] 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
 |-
@@ Line 40: / Line 40: @@
 |Process Owner (alone or with the team)
 |Ad hoc
-|Optional (to be decided by the Process Owner - see below for a template, can be easily done with Planning Tool Version 2.1.1)
+|Optional (to be decided by the Process Owner - see below for a template, can be easily done with Planning Tool current version[https://paasp.sharepoint.com/:u:/s/EQIPD/Eaq198yQK_xAvr24inTL1PoBDL6N7qanY62awbTLTHNN-Q?e=5DyhXi])
 |Corresponding Toolbox items may be consulted for any specific guidance or references to useful resources; If EQIPD Planning Tool is used, new solutions and changes to existing solutions can be recorded
 |}
@@ Line 68: / Line 68: @@
 * EMA [https://www.ema.europa.eu/en/ich-q9-quality-risk-management]
-Template for optional risk assessment - 4.1.1 Risk Management.docx
+Template for optional risk assessment - [https://paasp.sharepoint.com/:w:/s/EQIPD/EfSJLIZdbOFOlKneuiRrf5MBeTug7VsZoWHsETvI3pY_mg?e=GXBsdk 4.1.1 Risk Management.docx]

4.1.1 Risk assessment - Revision history

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 at 18:54, 5 September 2020

Bjoerngerlach: /* A. Background & Definitions */