Difference between revisions of "Core Requirements"

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|​​Data integrity
 
|​​Data integrity
 
|6
 
|6
Generation, handling and changes to data records must be documented ​2.3.1​
+
|Generation, handling and changes to data records must be documented
7 Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs ​3.1.3
+
|​2.3.1​
8
+
|7
Reported research outcomes must be traceable to experimental data ​3.1.2.1
+
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs
9
+
|3.1.3
Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​
+
|8
​2.4
+
|Reported research outcomes must be traceable to experimental data
​ ​
+
|3.1.2.1
​​​Research processes ​ ​ ​ ​ 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim ​2.1.4
+
|9
11
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|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​
All personnel involved in research must have adequate training and competence to perform assigned tasks ​3.2.1
+
​|2.4
12 Protocols for experimental methods must be available ​3.5.2
+
|​​​Research processes
13 Adequate handling and storage of samples and materials must be ensured ​3.3.3
+
|10
14 Research equipment and tools must be suitable for intended use and ensure data integrity ​3.3.2​
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|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim
​ ​
+
|​2.1.4
​Continuous performance ​ ​ 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
+
|11
4.1.1​​
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|All personnel involved in research must have adequate training and competence to perform assigned tasks
16
+
|3.2.1
Critical incidents and errors during study conduct must be analyzed and appropriately managed ​4.2.2
+
|12
17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​
+
|Protocols for experimental methods must be available
​4.1.2
+
|3.5.2
​ ​
+
|13
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available
+
|Adequate handling and storage of samples and materials must be ensured
​1.5.5​​
+
|3.3.3
 +
|14
 +
|Research equipment and tools must be suitable for intended use and ensure data integrity
 +
|3.3.2
 +
|Continuous performance
 +
|15
 +
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
 +
|4.1.1
 +
|16
 +
|Critical incidents and errors during study conduct must be analyzed and appropriately managed
 +
|4.2.2
 +
|17
 +
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​
 +
​|4.1.2
 +
|Sustainability
 +
|18
 +
|Resources for sustaining the EQIPD Quality System must be available
 +
​|1.5.5​​
 
|}
 
|}
  
 
Back to the [[EQIPD Framework]]​.​​​​
 
Back to the [[EQIPD Framework]]​.​​​​

Revision as of 07:38, 4 September 2020

Categories​​​ No Item ​Toolbox item
Research team ​ 1 Process owner must be identified for the Quality System 1.5.2.3​
2 Communication process must be in place 1.2
Quality culture ​

​|3

The research unit must have defined quality objectives ​ 1.1
4 All activities must comply with relevant legislation and policies 1.4.2
5 The research unit must have a procedure to act upon concerns of potential misconduct 4.2.3​
​​Data integrity 6 Generation, handling and changes to data records must be documented ​2.3.1​ 7 Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs 3.1.3 8 Reported research outcomes must be traceable to experimental data 3.1.2.1 9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​

​|2.4

​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim ​2.1.4 11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 12 Protocols for experimental methods must be available 3.5.2 13 Adequate handling and storage of samples and materials must be ensured 3.3.3 14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 Continuous performance 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1 16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​

​|4.1.2

Sustainability 18 Resources for sustaining the EQIPD Quality System must be available

​|1.5.5​​

Back to the EQIPD Framework​.​​​​