View source for Documentation in EQIPD

EQIPD Quality System is lean and does not require excessive documentation.

The following table describes the documentation required to address the EQIPD core requirements.

In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.

{| class="wikitable"
|rowspan="2"|'''Categories'''	 
|rowspan="2"|'''No'''
|rowspan="2"|'''Core Requirement'''
|rowspan="2"|'''Toolbox reference'''
|colspan="2"|'''Implementation of the Core Requirements'''
|-
|'''Stand-alone document'''
|'''EQIPD expectations'''
|-
|rowspan="2"|'''Research team'''	
|1
|Process owner must be identified for the Quality System
|[[1.5.2.3 Process owner|1.5.2.3]]
|No
|Process Owner should act and be recognized as such by the research unit members. 
|-
|2
|Communication process must be in place
|[[1.2 Scope|1.2]]
|Yes
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.
|-
|rowspan="3"|'''Quality culture'''
|3
|The research unit must have defined quality objectives	
|[[1.1 Mission|1.1]]
|Yes
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.
|-
|4
|All activities must comply with relevant legislation and policies
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]
|No
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.
|-
|5
|The research unit must have a procedure to act upon concerns of potential misconduct
|[[4.2.3 Responsible conduct of research|4.2.3]]
|No
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.
|-
|rowspan="4"|'''Data integrity'''
|6
|Generation, handling and changes to data records must be documented
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]
|rowspan="3"|Yes
|Can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.
|-
|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 Data security|3.1.3]]
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.
|-
|8
|Reported research outcomes must be traceable to experimental data
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.
|-
|9
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome
|[[2.4 Reporting|2.4]]
|No
|This information could for example be found in presentation as reference to the original experiments
|-
|rowspan="5"|'''Research processes'''
|10
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim
|[[2.1.4 Purpose of research|2.1.4]]
|No
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]
|-
|11
|All personnel involved in research must have adequate training and competence to perform assigned tasks
|[[3.2.1 General guidance on training|3.2.1]]
|No
|Participation in training could be hold available with the training records
|-
|12
|Protocols for experimental methods must be available
|[[3.5.2 Protocols for methods and assays|3.5.2]]
|No
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
|-
|13
|Adequate handling and storage of samples and materials must be ensured
|[[3.3.3 Management of research materials and reagents|3.3.3]]
|No
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol
|-
|14
|Research equipment and tools must be suitable for intended use and ensure data integrity
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]
|No
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances
|-
|rowspan="3"|'''Continuous performance'''
|15
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
|[[4.1.1 Risk assessment|4.1.1]]
|No
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]
|-
|16
|Critical incidents and errors during study conduct must be analyzed and appropriately managed
|[[4.2.2 Error and incident management|4.2.2]]
|No
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level
|-
|17
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues
|[[4.1.2 Self assessment|4.1.2]]
|Yes
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]
|-
|'''Sustainability'''
|18
|Resources for sustaining the EQIPD Quality System must be available
|[[1.5.5 Sustainability|1.5.5]]
|No
|No documentation needed
|}


Back to the [[EQIPD Quality System]] or [[Core Requirements]].