2.1.1 Study protocol - Revision history

Sara.Neyt at 10:24, 16 June 2025

2025-06-16T10:24:02Z

Anton.bespalov: /* A. Background & Definitions */

2025-06-02T10:58:07Z

‎A. Background & Definitions

Bjoerngerlach at 10:37, 22 January 2025

2025-01-22T10:37:18Z

Bjoerngerlach: /* B. Guidance & Expectations */

2021-10-20T12:24:13Z

‎B. Guidance & Expectations

Bjoerngerlach: /* C. Resources */

2021-03-25T15:39:14Z

‎C. Resources

ChristophEmmerich at 12:55, 24 March 2021

2021-03-24T12:55:27Z

Bjoerngerlach: Bjoerngerlach moved page 2.1.1 Study (experimental) plan to 2.1.1 Study protocol: A consensus meeting by EQIPD WP5/6 members decided on the change of "Study plan" to "Study protocol".

2021-03-23T20:06:07Z

Bjoerngerlach moved page 2.1.1 Study (experimental) plan to 2.1.1 Study protocol: A consensus meeting by EQIPD WP5/6 members decided on the change of "Study plan" to "Study protocol".

ChristophEmmerich at 19:45, 23 March 2021

2021-03-23T19:45:56Z

Bjoerngerlach at 16:48, 5 September 2020

2020-09-05T16:48:51Z

Bjoerngerlach at 16:47, 5 September 2020

2020-09-05T16:47:15Z

@@ Line 35: / Line 35: @@
 ## The sample size is the number of experimental units per group (for definition of experimental unit – see [[ARRIVE Essential - Study design]])
 ## Specify the exact number of experimental units allocated to each group, and the total number in each experiment.
 # Inclusion and exclusion criteria
 ## Indicate any [[2.1.9 Inclusion and exclusion criteria]] to be applied

@@ Line 1: / Line 1: @@
 == A. Background & Definitions ==
-Within the EQIPD Quality System and the Toolbox, the term "study protocol" refers to a document that is used to describe and summarize information related to a specific study (experiment).
+The term "study protocol" refers to a document that describes and summarizes information related to a specific study (experiment).
 == B. Guidance & Expectations ==

@@ Line 69: / Line 69: @@
 '''RISK ASSESSMENT'''
-* If study protocol references to other protocols or dociuments (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?
+* If study protocol references to other protocols or documents (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?
 == C. Resources ==

@@ Line 44: / Line 44: @@
 # Study design overview
 ## For complex study designs, include a visual representation that more easily interpreted than a text description (e.g. a timeline diagram, table or flow chart – e.g. using an Experimental Design Assistant).
 # Experimental procedures
 ## Include a detailed description of methods and experimental procedures and/or provide references to separate document(s) with the relevant information (e.g. if you chose to use section 3.5.2 of the Dossier for storing [[3.5.2 Protocols for methods and assays]])
@@ Line 71: / Line 70: @@
 '''RISK ASSESSMENT'''
 * If study protocol references to other protocols or dociuments (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?
 == C. Resources ==

@@ Line 74: / Line 74: @@
 == C. Resources ==
-Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/Ecmg1s58CM1Nssq_Wv3-Ei8BfcCMqxgQcRzesGy9a5gdRg?e=Nc8dHL 2.1.1 Study protocol.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/ETydIHKmJ1ZEt6EC87dtn9AB9RP3u29lxF0Omb-Ugesh1Q?e=dAnKJg 2.1.1 Study protocol with macro.docm]
+Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=b6nxpH 2.1.1 Study protocol.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/EXmh9e3w78ZLqPjOd1WNdaQBpt4FZ0mTctaQCRTM8NisMw?e=1wrV2o 2.1.1 Study protocol with macro.docm]
 Experimental design tools:

← Older revision	Revision as of 20:06, 23 March 2021
(No difference)

@@ Line 1: / Line 1: @@
 == A. Background & Definitions ==
-Within the EQIPD Quality System and the Toolbox, the term "Study plan" refers to a document that is used to describe and summarize information related to a specific study (experiment).
+Within the EQIPD Quality System and the Toolbox, the term "study protocol" refers to a document that is used to describe and summarize information related to a specific study (experiment).
-A single study plan may contain references to one or more research methods and assays.  For protocols for specific research protocols and assays, please refer to item [[3.5.2 Protocols for methods and assays]].
+A single study protocol may contain references to one or more research methods and assays.  For protocols for specific research protocols and assays, please refer to item [[3.5.2 Protocols for methods and assays]].
@@ Line 9: / Line 9: @@
-It is strongly recommended that, for every study (experiment), there is a study plan prepared prior to the study being conducted.
+It is strongly recommended that, for every study (experiment), there is a study protocol prepared prior to the study being conducted.
-Each study plan should identify author(s), date when it was created and a unique ID of the study that it describes.
+Each study protocol should identify author(s), date when it was created and a unique ID of the study that it describes.
-EQIPD has developed a template (please see below) that outlines the suggested structure and content of a Study Plan.
+EQIPD has developed a template (please see below) that outlines the suggested structure and content of a study protocol.
 This template is provided as a general guidance and serves only as an example:
@@ Line 59: / Line 59: @@
 ## Describe any methods used to assess whether the data met the assumptions of the statistical approach ([[ARRIVE Essential - Statistical methods]])
 # Amendments
-## Describe what was changed in the original study plan, why, when and by whom
+## Describe what was changed in the original study protocol, why, when and by whom
-## When amending the study plan, please make sure not to over-write the original version
+## When amending the study protocol, please make sure not to over-write the original version
-## Amendments may be saved as documents separate from the original study plan
+## Amendments may be saved as documents separate from the original study protocol
 # References
 ## If necessary, include references
 # Preregistration
-## EQIPD strongly recommends to pre-register study (experimental) plans (more information – [[2.1.11 Preregistration]])
+## EQIPD strongly recommends to pre-register study protocol (more information – [[2.1.11 Preregistration]])
 ## If pre-registered, please indicate the platform used, registration link and other relevant reference information
 '''RISK ASSESSMENT'''
-* If study plan references to other protocols or dociuments (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?
+* If study protocol references to other protocols or dociuments (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?
 == C. Resources ==
-Template to create a study plan based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/Ecmg1s58CM1Nssq_Wv3-Ei8BfcCMqxgQcRzesGy9a5gdRg?e=Nc8dHL 2.1.1 Study plan.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/ETydIHKmJ1ZEt6EC87dtn9AB9RP3u29lxF0Omb-Ugesh1Q?e=dAnKJg 2.1.1 Study plan with macro.docm]
+Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/Ecmg1s58CM1Nssq_Wv3-Ei8BfcCMqxgQcRzesGy9a5gdRg?e=Nc8dHL 2.1.1 Study plan.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/ETydIHKmJ1ZEt6EC87dtn9AB9RP3u29lxF0Omb-Ugesh1Q?e=dAnKJg 2.1.1 Study plan with macro.docm]
 Experimental design tools:

@@ Line 41: / Line 41: @@
 # Animal resources, reagents and materials
 ## Include a detailed description of reagents and materials and/or provide references to separate document(s) with the relevant information (e.g. use the description in [[3.3.3 Management of research materials and reagents]] to add information to your Dossier)
-##If animals are used, provide sufficient details expected for reporting ([[ARRIVE 2.0]]
+##If animals are used, provide sufficient details expected for reporting ([[ARRIVE 2.0]])
 # Study design overview
 ## For complex study designs, include a visual representation that more easily interpreted than a text description (e.g. a timeline diagram, table or flow chart – e.g. using an Experimental Design Assistant).

@@ Line 56: / Line 56: @@
 # Data analysis
 ## Describe the processing of raw data (for definition of raw data – see section [[2.3.1 Generation, recording, handling and archiving of raw data]])
-## Describe statistical method(s) to be applied for each analysis ([[Statistical analysis]])
+## Describe statistical method(s) to be applied for each analysis ([[2.3.3 Statistical analysis]])
 ## Describe any methods used to assess whether the data met the assumptions of the statistical approach ([[ARRIVE Essential - Statistical methods]])
 # Amendments