EQIPD for Core Facilities - Revision history

Bjoerngerlach at 12:39, 15 April 2021

2021-04-15T12:39:35Z

ChristophEmmerich at 12:48, 24 March 2021

2021-03-24T12:48:26Z

Bjoerngerlach: /* Review and Reporting */

2021-03-17T13:41:31Z

‎Review and Reporting

Bjoerngerlach: /* Review and Reporting */

2021-03-17T13:40:08Z

‎Review and Reporting

Bjoerngerlach: /* Analysis of Experimental Data */

2021-03-17T13:38:46Z

‎Analysis of Experimental Data

Bjoerngerlach: /* Rigor in Study Design */

2021-03-17T13:37:35Z

‎Rigor in Study Design

Bjoerngerlach: /* Experimental Record */

2021-03-17T13:36:46Z

‎Experimental Record

Bjoerngerlach: /* Experimental Record */

2021-03-17T13:35:49Z

‎Experimental Record

Bjoerngerlach: /* Background */

2021-03-17T13:34:42Z

‎Background

Bjoerngerlach at 13:25, 17 March 2021

2021-03-17T13:25:52Z

← Older revision		Revision as of 12:39, 15 April 2021
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	** Unique IDs for facilities		** Unique IDs for facilities
	* Any external presentation/publication whether oral or in writing should include a statement of conflict of interest.		* Any external presentation/publication whether oral or in writing should include a statement of conflict of interest.
		+
		+	=Resources=
		+	Documents for download:
		+	* [https://paasp.sharepoint.com/:x:/s/EQIPD/EUxUx_BKVYpCrkQYDYSTPCEB09ETCcXrMs4iRfV70ydtUw?e=JkR2BF NEED for CF here]
		+	* [https://paasp.sharepoint.com/:w:/s/EQIPD/EaT-fuKHT8pFt7s1NHokYxAB3Nt5RHx7SUZO7VIeU0cEPQ?e=Kknac8 Guidance for CF users created by EQIPD working group]

@@ Line 50: / Line 50: @@
 * All raw and any processed data must be retrievable and traceable, directly or by reference. No raw data should be erased.
 * An experimental record must describe any significant changes and deviations from the original study protocol.
-** User must report/document if study execution is not in accordance with study (experimental) plan and deviations such as changes to study hypothesis, design or analysis must be documented (including the rationale for the changes).
+** User must report/document if study execution is not in accordance with study protocol and deviations such as changes to study hypothesis, design or analysis must be documented (including the rationale for the changes).
 ** Examples of significant changes: Changes in the doses, experimental conditions and groups, sample size, methods of analysis, etc.
 ** Any change or deviation from a protocol approved by animal welfare authority would be significant and requires documentation in the experimental record.
@@ Line 59: / Line 59: @@
 ==Rigor in Study Design==
 * For every study, there should be a study protocol prepared prior to the study being conducted.
-** Please see a definition of the study plan above.
+** Please see a definition of the study protocol above.
 ** Study protocols involving more than one experiment should include a dedicated section explaining the sequence and relationships between different experimental operations or procedures.
 * The study protocol '''must''' include:
@@ Line 71: / Line 71: @@
 ** Study design overview for complex studies
 ** Detailed description of experimental procedure(s) (or references to standalone descriptions if available)
-* The plan '''should''' include:
+* The protocol '''should''' include:
 ** Statement whether study is exploratory or knowledge-claiming
 ** Statement about choice of experimental methods

@@ Line 104: / Line 104: @@
 * Any external presentation/publication whether oral or in writing should give credit to the CF where the work was performed.
 ** Identify all contributing researchers and reference unique identifiers for the experimental records
-** encourage the use of an unique identifier for reseachers (ORCID)
+** encourage the use of an unique identifier for reseachers ([https://orcid.org ORCID])
 ** Unique IDs for facilities
 * Any external presentation/publication whether oral or in writing should include a statement of conflict of interest.

@@ Line 99: / Line 99: @@
 ** the location of the data must be identifiable for all data records, e.g. reference with the permanent identifier.
 ** Reporting must include for each analysis the exact number of biological units for each condition
-* Experimental records should be reviewed by a CF for completeness and accuracy and it is advised to document this review
+* Experimental records should be reviewed by a member of the CF for completeness and accuracy and it is advised to document this review
 ** Users should give CF staff the possibility to review data for analysis and reporting
 * Report should always provide summaries of all related data, processes, and conclusions, and include justification for excluding any relevant experimental records or individual data points from the summary analyses.

@@ Line 86: / Line 86: @@
 ** It is very important to define responsbility
 ** CF should be in the position/have the possibility to check this or run occasional audits
 ==Data Storage and Traceability==

@@ Line 77: / Line 77: @@
 ** Description of raw data analysis
 ** use versioning (or have a section for amendments)
-* It is advisable to:
+* It is '''advisable''' to:
 ** Include references to relevant literature
 ** Conduct risk assessment
 ** Preregister the study protocol
 ==Analysis of Experimental Data==

@@ Line 56: / Line 56: @@
 * An experimental record must provide an explanation and justification for exclusion of any data points from analysis.
 ** Critical incidents (any unexpected or unplanned events) and errors must be recorded and made part of the experimental record.
 ==Rigor in Study Design==

@@ Line 39: / Line 39: @@
 ==Experimental Record==
-* Unique study identifiers must be used and defined by the future owner of the raw data for each experiment.  Unless this is the CF, the owner of the raw data should communicate the unique study ID to the  CF.	** Best practices should be communicated by the CF during training or by providing a reference to EQIPD Toolbox (e.g. date_User inititals_experiment).
+* Unique study identifiers must be used and defined by the future owner of the raw data for each experiment.  Unless this is the CF, the owner of the raw data should communicate the unique study ID to the  CF.
 ** CF and PI may generate separate study IDs but there must be a way established to communicate, to connect separate IDs and to enable traceability.
 ** For EQIPD, it should be clear who is in charge of generating and storing the Unique Study Identifiers.

@@ Line 1: / Line 1: @@
 =Background=
-Recommendations outlined in this document has been developed by a task force of members and stakeholders of the EQIPD consortium, the largest private-public partnership completely dedicated to improving data quality in preclinical research.
+Recommendations outlined in this document has been developed by a task force of members and stakeholders of the [https://quality-preclinical-data.eu/ EQIPD consortium], the largest private-public partnership completely dedicated to improving data quality in preclinical research.
 These recommendations are intended to improve the robustness, reliability, traceability and integrity of the data obtained from the research activities supported by academic core facilities.  They aim to:
-improve communication between core facilities and the users of the services and infrastructure provided by the core facilities,
+* improve communication between core facilities and their users of the services and infrastructure provided by the core facilities,
-minimize bias and errors in the collection, reporting or representation of such information, and
+* minimize bias and errors in the collection, reporting or representation of such information, and
-create reliable scientific and supporting evidence in resulting publications, presentations, reports, patents and other types of research output.
+* create reliable scientific and supporting evidence in resulting publications, presentations, reports, patents and other types of research output.
 The experimental record and its thorough description is the ultimate source of information and documentation regarding the experiment.  Therefore, the contents of the experimental record must be accurate and thorough enough to be fully traceable to permit the reproduction of the work conducted. The experimental record is the official data record for each experiment and the most important primary source of data.  It is expected that the practices outlined in this document will be applied to experimental planning, record-keeping procedures and reporting, to the fullest extent possible.
 Recognizing the diversity of environments and settings in which core facilities operate, the current recommendations can be used in two modes - “Training service” and “EQIPD service”.
 It is expected that core facilities and their users discuss both types of services, any ambiguities or conflicts regarding the recommended practices, and ensure alignment and understanding prior to the start of the experiments.
@@ Line 15: / Line 19: @@
 ===EQIPD Service===
-# Core Facility implements those aspects of EQIPD recommendations that do not depend on the users and that enable support of EQIPD-compliant research (items with "CF" in Column B below).
+# Core Facility implements those aspects of EQIPD recommendations that do not depend on the users and that enable support of EQIPD-compliant research.
-# Core facility provides the users with the information about research practices recommended by EQIPD (items with "yes" in Column C below) and offers to support in conducting EQIPD-compliant research.
+# Core facility provides the users with the information about research practices recommended by EQIPD and offers to support in conducting EQIPD-compliant research.
 # If the user accepts the offer (and, as necessary, provides required resources), Core Facility:
-## together with the user (""PI""), identifies the best solution to implement specific recommendations (items marked with ""shared"" in Column B below). Shared responsibility over implementation means ""joint decision, knowledge and transparency"" and may still require certain recommendations fully implemented at the Core Facility while others - fully implemented on the user's side.
+## together with the user (and supervisor/PI if necessary), identifies the best solution to implement specific recommendations. Shared responsibility over implementation means ""joint decision, knowledge and transparency"" and may still require certain recommendations fully implemented at the Core Facility while others - fully implemented on the user's side.
-## assumes responsibility over spot checks (requires acceptance by the PI if certain recommendations are implemented on the user's side)
+## assumes responsibility over spot checks (requires acceptance by the user if certain recommendations are implemented on the user's side).
 ## confirms to the user that the study was conducted as ""EQIPD compliant"" or not (e.g. to be stated in the report or in a publication)"
 # If the user does not accept the offer, no changes in the routine practice and the studies remain to be not compliant with EQIPD recommendations.
 =Proposed statements=

← Older revision		Revision as of 13:25, 17 March 2021
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	# If the user does not accept the offer, no changes in the routine practice and the studies remain to be not compliant with EQIPD recommendations.		# If the user does not accept the offer, no changes in the routine practice and the studies remain to be not compliant with EQIPD recommendations.

−	~~=Glossary=~~
−	~~Must vs should~~
−
−	Experiment is an operation or procedure carried out under controlled conditions in order to discover an unknown effect, law, characteristic of an object, subject or substance, to test or establish a hypothesis, or to illustrate a known law (based on definition in the Merriam-Webster’s dictionary).
−
−	Study is one or more experiments, which may also be referred to as tests or trials, that are described in one study protocol, address the same research question(s) or objective(s), share key resources, and are part of one experimental record.
−
−	~~EQIPD uses the terms:~~
−	~~study protocol to refer to a description of the design of a study. Design of individual studies is described in separate study protocols.~~
−	~~experimental procedure when referring to description of specific procedures, operations, or methods.~~
−
−	~~Experimental Record~~
−
−	~~Raw data~~
−
−	~~Processed data~~
−
−	~~Data traceability~~
−
−	Reviewer: An individual at your organization or outside who preferably did not perform the experiment but who may have been involved in the design of it as a supervisor or team member. The reviewer should check the experimental record for completeness and scientific rigor.