Difference between revisions of "2.1.1 Study protocol"

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(B. Guidance & Expectations)
 
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== ​​​​​​​​​​​​​A. Background & Definitions ==
 
== ​​​​​​​​​​​​​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).  
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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]].  
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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]].  
  
  
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It is strongly recommended that, for every study (experiment), there is a study plan prepared prior to the study being conducted.  
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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.
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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.
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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:
 
This template is provided as a general guidance and serves only as an example:
 
# Title of the study
 
# Title of the study
 
# Study hypothesis
 
# Study hypothesis
# [[Purpose of research]] (see section 2.1.4 for comments and further guidance)
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# [[2.1.4 Purpose of research]]
 
## ​Indicate whether the research is undertaken with the intention to inform a formal knowledge claim  
 
## ​Indicate whether the research is undertaken with the intention to inform a formal knowledge claim  
 
# Choice of experimental model(s) or method(s)
 
# Choice of experimental model(s) or method(s)
## Describe how and why specific models and/or methods were chosen (e.g. based on [[Appraisal of literature and systematic reviews]] - see section 2.1.3 for comments and further guidance).
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## Describe how and why specific models and/or methods were chosen (e.g. based on [[2.1.3 Appraisal of literature and systematic reviews]]
 
## If animal subjects are involved, justify why alternative are not suitable; as well as the selection of species, strain, age, and sex (if applicable)  
 
## If animal subjects are involved, justify why alternative are not suitable; as well as the selection of species, strain, age, and sex (if applicable)  
 
# Choice of controls
 
# Choice of controls
## Describe the controls (negative, positive, shams), why and how these were chosen (e.g. based on [[Appraisal of literature and systematic reviews]] - see section 2.1.3 for comments and further guidance).
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## Describe the controls (negative, positive, shams), why and how these were chosen (e.g. based on [[2.1.3 Appraisal of literature and systematic reviews]]
 
## If a positive control is included, indicate explicitly how the study outcome will be interpreted if positive control fails.
 
## If a positive control is included, indicate explicitly how the study outcome will be interpreted if positive control fails.
 
# Measures against risks of bias
 
# Measures against risks of bias
## Randomization (if selected, a [[Randomisation]] protocol must be available - see section 2.1.8 for comments and further guidance)
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## [[2.1.8 Randomisation]] (if selected, a randomisation protocol must be available)
## Blinding (if selected, a [[Blinding]] protocol must be available - see section 2.1.7 for comments and further guidance)
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## [[2.1.7 Blinding]] (if selected, a blinding protocol must be available)
 
## If randomization and/or blinding are not applied, please describe the reasons as well as any other measures to control the risks of bias that will be applied.
 
## If randomization and/or blinding are not applied, please describe the reasons as well as any other measures to control the risks of bias that will be applied.
 
# Sample size
 
# Sample size
 
## Describe methods used to estimate the sample size (such as power analysis).
 
## Describe methods used to estimate the sample size (such as power analysis).
## For definitions and guidance on [[Sample size and power analysis]] - see section 2.1.6 for comments and further guidance.
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## For definitions and guidance see section [[2.1.6 Sample size and power analysis]]
 
## Specify the primary outcome measure that was used to determine the sample size (see [[ARRIVE Essential - Outcome measures]])
 
## Specify the primary outcome measure that was used to determine the sample size (see [[ARRIVE Essential - Outcome measures]])
 
## The sample size is the number of experimental units per group (for definition of experimental unit – see [[ARRIVE Essential - Study design]])
 
## The sample size is the number of experimental units per group (for definition of experimental unit – see [[ARRIVE Essential - Study design]])
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## For definitions and guidance on sample size estimation and power analysis, please follow the link.
 
## For definitions and guidance on sample size estimation and power analysis, please follow the link.
 
# Inclusion and exclusion criteria
 
# Inclusion and exclusion criteria
## Indicate any [[Inclusion and exclusion criteria]] to be applied (for further information - see section 2.1.9 for comments and further guidance)
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## Indicate any [[2.1.9 Inclusion and exclusion criteria]] to be applied
 
# Animal resources, reagents and materials
 
# 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. if you chose to use section 3.3.3 of the Dossier for [[Management of research materials and reagents]])
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## 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]]
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##If animals are used, provide sufficient details expected for reporting ([[ARRIVE 2.0]])
 
# Study design overview
 
# 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).
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## 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).
##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 [[Protocols for methods and assays]])11.
 
 
# Experimental procedures
 
# 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 [[Protocols for methods and assays]])
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## 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]])
 
## If experimental methods are not described in separate documents, follow [[ARRIVE 2.0]] Recommended Set suggestions (items 14-17 here as well as guidance provided here)
 
## If experimental methods are not described in separate documents, follow [[ARRIVE 2.0]] Recommended Set suggestions (items 14-17 here as well as guidance provided here)
 
## If more than one method or procedure is used, describe sequence or experimental workflow
 
## If more than one method or procedure is used, describe sequence or experimental workflow
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### Why (provide rationale for procedures)
 
### Why (provide rationale for procedures)
 
# Data analysis
 
# 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]]​)
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## 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]])
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## 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]])
 
## Describe any methods used to assess whether the data met the assumptions of the statistical approach ([[ARRIVE Essential - Statistical methods]])
 
# Amendments
 
# Amendments
## Describe what was changed in the original study plan, why, when and by whom
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## 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
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## 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
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## Amendments may be saved as documents separate from the original study protocol
 
# References
 
# References
 
## If necessary, include references
 
## If necessary, include references
 
# Preregistration
 
# Preregistration
## ​EQIPD strongly recommends to pre-register study (experimental) plans (more information – [[Preregistration]])
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## ​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
 
## If pre-registered, please indicate the platform used, registration link and other relevant reference information
  
  
 
'''RISK ASSESSMENT'''
 
'''RISK ASSESSMENT'''
 
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* 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 plan 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 ==
 
== C. Resources ==
 
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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]
 
 
Template to create a study plan based on the above guidance - 2.1.1 Study plan.docx, 2.1.1 Study plan with macro.docm
 
  
 
Experimental design tools:
 
Experimental design tools:
* MANILA (Matched Animal Analysis): link to the original article (here) and the tool (here)
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* MANILA (Matched Animal Analysis): link to the original article ([https://www.nature.com/articles/srep30723]) and the tool ([https://biomedportal.utu.fi/utu-apps/Rvivo/])
* NC3Rs’ Experimental Design Assistant - www.eda.nc3rs.org.uk
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* NC3Rs’ Experimental Design Assistant [https://www.nc3rs.org.uk/experimental-design-assistant-eda]
 
 
 
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back to toolbox
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back to [[Toolbox]]
  
 
Next item: [[2.1.2 Unique study ID]]​
 
Next item: [[2.1.2 Unique study ID]]​

Latest revision as of 12:24, 20 October 2021

​​​​​​​​​​​​​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).

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.


B. Guidance & Expectations

It is strongly recommended that, for every study (experiment), there is a study protocol prepared prior to the study being conducted.

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 protocol.

This template is provided as a general guidance and serves only as an example:

  1. Title of the study
  2. Study hypothesis
  3. 2.1.4 Purpose of research
    1. ​Indicate whether the research is undertaken with the intention to inform a formal knowledge claim
  4. Choice of experimental model(s) or method(s)
    1. Describe how and why specific models and/or methods were chosen (e.g. based on 2.1.3 Appraisal of literature and systematic reviews
    2. If animal subjects are involved, justify why alternative are not suitable; as well as the selection of species, strain, age, and sex (if applicable)
  5. Choice of controls
    1. Describe the controls (negative, positive, shams), why and how these were chosen (e.g. based on 2.1.3 Appraisal of literature and systematic reviews
    2. If a positive control is included, indicate explicitly how the study outcome will be interpreted if positive control fails.
  6. Measures against risks of bias
    1. 2.1.8 Randomisation (if selected, a randomisation protocol must be available)
    2. 2.1.7 Blinding (if selected, a blinding protocol must be available)
    3. If randomization and/or blinding are not applied, please describe the reasons as well as any other measures to control the risks of bias that will be applied.
  7. Sample size
    1. Describe methods used to estimate the sample size (such as power analysis).
    2. For definitions and guidance see section 2.1.6 Sample size and power analysis
    3. Specify the primary outcome measure that was used to determine the sample size (see ARRIVE Essential - Outcome measures)
    4. The sample size is the number of experimental units per group (for definition of experimental unit – see ARRIVE Essential - Study design)
    5. Specify the exact number of experimental units allocated to each group, and the total number in each experiment.
    6. For definitions and guidance on sample size estimation and power analysis, please follow the link.
  8. Inclusion and exclusion criteria
    1. Indicate any 2.1.9 Inclusion and exclusion criteria to be applied
  9. Animal resources, reagents and materials
    1. 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)
    2. If animals are used, provide sufficient details expected for reporting (ARRIVE 2.0)
  10. Study design overview
    1. 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).
  11. Experimental procedures
    1. 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)
    2. If experimental methods are not described in separate documents, follow ARRIVE 2.0 Recommended Set suggestions (items 14-17 here as well as guidance provided here)
    3. If more than one method or procedure is used, describe sequence or experimental workflow
    4. For each experimental group, including controls, describe the procedures in enough detail to allow others to replicate them, including (more guidance - ARRIVE Essential - Experimental procedures)
      1. What was done, how it was done and what was used
      2. When and how often
      3. Where (including detail of any acclimation periods)
      4. Why (provide rationale for procedures)
  12. Data analysis
    1. Describe the processing of raw data (for definition of raw data – see section 2.3.1 Generation, recording, handling and archiving of raw data​)
    2. Describe statistical method(s) to be applied for each analysis (2.3.3 Statistical analysis)
    3. Describe any methods used to assess whether the data met the assumptions of the statistical approach (ARRIVE Essential - Statistical methods)
  13. Amendments
    1. Describe what was changed in the original study protocol, why, when and by whom
    2. When amending the study protocol, please make sure not to over-write the original version
    3. Amendments may be saved as documents separate from the original study protocol
  14. References
    1. If necessary, include references
  15. Preregistration
    1. ​EQIPD strongly recommends to pre-register study protocol (more information – 2.1.11 Preregistration)
    2. If pre-registered, please indicate the platform used, registration link and other relevant reference information


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

Template to create a study protocol based on the above guidance - 2.1.1 Study protocol.docx, 2.1.1 Study protocol with macro.docm

Experimental design tools:

  • MANILA (Matched Animal Analysis): link to the original article ([1]) and the tool ([2])
  • NC3Rs’ Experimental Design Assistant [3]


back to Toolbox

Next item: 2.1.2 Unique study ID