Documentation in EQIPD - Revision history

Antonbespalov at 08:49, 6 May 2021

2021-05-06T08:49:39Z

Antonbespalov at 08:46, 6 May 2021

2021-05-06T08:46:38Z

Bjoerngerlach at 09:27, 26 March 2021

2021-03-26T09:27:57Z

ChristophEmmerich at 13:10, 24 March 2021

2021-03-24T13:10:52Z

ChristophEmmerich at 13:06, 24 March 2021

2021-03-24T13:06:00Z

Bjoerngerlach at 14:45, 8 March 2021

2021-03-08T14:45:17Z

Bjoerngerlach at 10:28, 8 March 2021

2021-03-08T10:28:57Z

Bjoerngerlach at 07:44, 12 February 2021

2021-02-12T07:44:51Z

Bjoerngerlach at 15:24, 11 February 2021

2021-02-11T15:24:01Z

Bjoerngerlach at 15:22, 11 February 2021

2021-02-11T15:22:03Z

@@ Line 38: / Line 38: @@
 |All activities must comply with relevant legislation and policies
 |[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]
-|No
+|(Yes)
-|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.
+|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues. For research units conducting studies using laboratory animals, there must be either a full accreditation by AAALAC (or equivalent) or a standalone description of animal care and use program according to [https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf the EQIPD checklist]
 |-
 |5

@@ Line 39: / Line 39: @@
 |[[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

@@ Line 120: / Line 120: @@
 |[[4.1.2 Self assessment|4.1.2]]
 |No
-|Evidence for such approach is provided indirectly by the information described in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template] that is completed at regular intervals (as a minimum, annually).
+|Evidence for such approach is provided indirectly by the information described in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EXjMqJ74JcpLh9x8_UN7EmkBzgAcgODVOTKlDWnAPnIpvw?e=tYih6H Self assessment template] that is completed at regular intervals (as a minimum, annually).
 |-
 |'''Sustainability'''

@@ Line 108: / Line 108: @@
 |[[4.1.1 Risk assessment|4.1.1]]
 |No
-|Study (experimental) plans are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study protocol]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].
+|Study protocols are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study protocol]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].
 |-
 |16

@@ Line 77: / Line 77: @@
 |[[2.1.4 Purpose of research|2.1.4]]
 |No
-|This requirement is most optimally met by providing corresponding information in the study (experimental) plan, see [[2.1.1 Study (experimental) plan]].
+|This requirement is most optimally met by providing corresponding information in the study protocol, see [[2.1.1 Study protocol]].
 |-
 |11
@@ Line 89: / Line 89: @@
 |[[3.5.2 Protocols for methods and assays|3.5.2]]
 |No
-|Methods can be described in either standalone protocols or be part of study (experimental) plans. ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
+|Methods can be described in either standalone protocols or be part of study protocol. ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
 |-
 |13
@@ Line 108: / Line 108: @@
 |[[4.1.1 Risk assessment|4.1.1]]
 |No
-|Study (experimental) plans are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study (experimental) plan]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].
+|Study (experimental) plans are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study protocol]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].
 |-
 |16

@@ Line 130: / Line 130: @@
 |}
-Research units working with animals are required to look into the Toolbox section [[3.4.1 Animal characteristics, care and use]] and might need to document animal care and use processes using the following template  - [https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf 3.4.1 Animal care and use.docx]
+Research units working with animals must fill out the [https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf Animal care and use form] unless they are AAALAC certified. Additional information in Toolbox section [[3.4.1 Animal characteristics, care and use]].
 Additional information about expectations can be found in [https://paasp.sharepoint.com/:b:/s/EQIPD/EWXf1VnZ8ytNr2jl97dGnV0BDJCfEFnO-TH_R71BegJCiQ?e=xcdG5f this] pdf document.
 Back to the [[EQIPD Quality System]] or [[Core Requirements]].

@@ Line 1: / Line 1: @@
 EQIPD Quality System is lean and does not require excessive documentation.
-The following table describes the documentation required to address the EQIPD core requirements.
+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.
@@ Line 130: / Line 130: @@
 |}
 Back to the [[EQIPD Quality System]] or [[Core Requirements]].

@@ Line 52: / Line 52: @@
 |[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]
 |Yes
-|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
+|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 |-
 |7
@@ Line 58: / Line 58: @@
 |[[3.1.3 Data security|3.1.3]]
 |Yes
-|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
+|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 |-
 |8
@@ Line 64: / Line 64: @@
 |[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]
 |Yes
-|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
+|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 |-
 |9

@@ Line 51: / Line 51: @@
 |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
+|Yes
 |Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
 |-
@@ Line 57: / Line 57: @@
 |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]]
 |Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
 |-
@@ Line 62: / Line 63: @@
 |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]]
 |Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.
 |-