Robust research design and management to ensure the integrity, reliability, and validity of the research
Inspirational framework 'Research Design and Management' for PhD candidates
Added valueof theresearch stage
Objective of the inspirational framework
Achievementsand training opportunities
Best practices by PhD candidates
Expectations
Objective of the inspirational framework
Objective
- To provide inspiration on how to approach the 'Research Design and Management' stage during the PhD trajectory
- To clarify the minimal expectations regarding good research design andresearch data management in PhD research
- To guide the members of the doctoral advisory committee and project counselortowards their coaching opportunities for the various research stages
Added value of the research stage 'Research Design and Management'
Added value
- To implement a structured approach and transparency
- To ensure validity and enhance reliabilitiy
- To minimize bias and reduce errors
- To take into account ethical considerations
- To optimize efficient use of resources
Expectations
- To master skills and methods associated with the research domain
- To manage your research data (cfr. RDM at Ghent University and KCGG )
- To be familiar with the principles of integrity, ethics, and law
- To be familiar with the Framework for Good Research Practice
- To apply these skills for the general method section of the PhD dissertation (if applicable)
Expectations
Take a look!
PhD candidates enrolled from AY 2020-2021 onward must submit a Data Management Plan (DMP) within six months after their enrolment. They are expected to keep their DMP up to date during the trajectory. Prior to the public defence, the PhD candidate must submit the final version of the DMP.
Achievements and training opportunities
Ethical Committeeapplication
Protocol or technical paper
Studypre-registration
DataManagement Plan
Pilot study /preliminary data collection
Achievements
Optimizing of the research method and training in the method used
Power analysis
Ensuring reproducibility and replicability
Data-analysis plan
Grant applications
Training opportunities
Please note that it is not mandatory to implement all of the above components within the ‘Research Design and Management’ phase of your PhD, as this largely depends on your research domain and question(s)!
Best practices by PhD candidates
Babette Demeester is a doctoral researcher at the Department of Public Health and Primary Care. Her research team developed the ‘KickAsh!-intervention’, which actively engages adolescents experiencing societal vulnerability and their youth workers to prevent smoking in sport and recreational settings. In preparation for the intervention study, she designed and documented the protocol in a protocol paper. The paper provided a solid foundation for the intervention study through a comprehensive literature review at the start of her PhD. As a result, she encountered fewer issues during the pilot testing for the intervention study. The protocol paper also helped her strengthen the Ethics Committee application, Data Management Plan and Clinical Trial pre-registration, and vice versa. Babette published the protocol smoothly as a 'Study Design Article' in the Scandinavian Journal of Public Health, marking her first publication as a lead author in her PhD.
Best practices
Take a look!
Please note that writing a protocol paper is not always feasible — either due to the nature of the research domain or because the project is part of a larger whole. In such cases, alternative approaches like conducting a literature review and/or a pilot study can serve as good starting points to substantiate the 'Research Design and Management' phase of your PhD.
Best practices by PhD candidates
Tine Vanhaverbeke is a doctoral researcher at the Department of Internal Medicine and Pediatrics. Her research focuses on erosive hand osteoarthritis, examining, among others, the safety and quality of synovial tissue biopsies as well as the efficacy of pharmacological treatments such as Denosumab and Alendronate in these patients.
Best practices
Tine recognizes that administrative procedures during the Research Design and Management phase were key to high-quality and efficient research during her PhD. Given the involvement of patient populations and invasive methods, Ethical Approval was essential to secure safety and benefits of both biopsies and medications. Ethical Committee applications were prepared in close collaboration with pharmaceutical companies, whose input also supported the development of the protocol and final papers. As part of the Ethical Committee application, she established a biobank to enable accurate data collection and storage, which in turn facilitated the retrieval of biopsy samples afterwards. Pre-registration of her protocol and Statistical Analysis Plan (SAP) on EudraCT and ClinicalTrials.gov promoted early planning and transparency, and improved publication quality through feedback. Take a look at the EudraCT registration of one of her studies and get inspired:
Take a look!
The collaboration with several key stakeholders - such as pharmaceutical companies, study nurses, and lab staff - together with relevant training courses (e.g., Doctoral School Project Management, DMPonline) and Good Clinical Practice (GCP) certification, further strengthened her Research Design and Management skills throughout her PhD.
Acknowledgements and references
AcknowledgementsSpecial thanks to Anne Magherman and Valery Labarque for the outline of the inspirational frameworks. Many thanks to Team Open Science at the Ghent University - especially Laura Standaert - for providing a solid content-related foundation for the development of this inspirational framework. Sincere gratitude to drs. Babette Demeester and drs. Tine Vanhaverbeke for sharing their experiences on research design and management and the added value of a study protocol paper.ReferencesNature masterclasses Orpheus Best Practice Handbook 2024 Open Science , Research Tips , Doctoral School of Ghent University
Acknowledgementsand references
A data management plan (DMP) is a document specifying how research data will be handled both during and after the research project, ensuring that research data are: - High-qualitative - Secure - Sustainable - (to the extent possible) Accessible and reusable Take a look at Research Data Management (RDM) and Open Science at Ghent University! Important: PhD candidates enrolled from AY 2020-2021 onward must submit a DMP within six months after their enrolment. They are expected to keep their DMP up to date and to submit a final version prior to the public defence. Click here for more information on what your DMP should include and how to submit it.
Helps in clearly documenting the research process, making your research more feasible and your final data high-qualitative, secure, sustainable and (to the extent possible) accessible and reusable. Take a look at Open Science at the Ghent University!
Optimize your research method based on pilot data and/or feedback: - Check your technique and the protocols- Check your tools - Check your materials - Consider other potential sources of error
Achieve mastery in conducting experiments by rigorous training and practice!
A data-anaylysis plan is a description of how you want to process, analyse and interpret your data to answer your study research question. This helps to make the analysis transparent and reproducible, and can form the basis for writing your research paper. Take a look at the Nature Masterclasses Platform and the Research Tips website of the Ghent University, or follow the hands-on courses of the Biostatistics Unit to support this stage of your research!
Reduces bias and errors by applying methods such as randomization, blinding, or peer review of your research design.
Helps in making your findings more trustworthy and replicable.
Ensuring reproducibility (others can get the same results using your data and analysis techniques) and replicability (others can repeat your study based on a sufficiently detailed description of your materials and methods) in research is crucial for scientific integrity and transparency.- Ensure transparent reporting in your research (cfr., study pre-registration, data management plan, data-analysis plan) - Test the reproducibility of your own experiments (as part of a pilot study or a seperate research paper in your PhD)
Protocol paper: dedicated paper focusing on the overall method or protocol.Technical paper: paper that answers a concise question (often a short report), reflecting a succinct review of a specific topic, historical perspective, or application of a specific (statistical) procedure. Important: In case of a protocol or technical paper, a manuscript with original research data is also required when submitting the PhD for defence. This manuscript must be accepted/published or submitted for publication to fulfill the faculty minimum criteria.
Address ethical considerations by ensuring ethical committee approval and informed consent. Take a look at the ethics decision tree of the Ghent University!
For concrete grant writing tools, take a look at: Doctoral School offer Nature Masterclasses Platform The Health, Innovation and Research Institute (HIRUZ) of the Ghent University Hospital
Explore the Doctoral School offer and the training opportunities of the Faculty Research Training Program on 'research design and management' Module: Integrity, ethics and law- Medical Device Regulation- Clinical Trial Regulation- ... Module: Biostatistics Module: Research Data Management (RDM)Want to learn more about RDM? Follow a training, request an info session, or attend an event organized by Ghent University’s data stewards and curators .
Helps in planning timelines, budgets, and data collection and analysis effectively, avoiding delays or overspending.
Power analysis helps researchers design studies with an adequate sample size to ensure meaningful and reliable study results. Reduces the risk of false negatives Increases the chance of finding statistically meaningful effects Helps in planning ethical research by avoiding unnecessarily large samples. Where to perform? G*Power, SPSS, R, Python,... Take a look at the hands-on courses of the Biostatistics Unit to broaden your knowledge and skills!
Preparing and submitting an ethics committee application is a mandatory part of conducting research (except for some specific cases). It can add significant value to both the research itself and the PhD candidate's own professional development by Promoting transparency and understanding of ethical standards Enhancing a robust and ethically sound study design Increasing independence and professional skills, accountability and ownership of the project. Use the ethics decision tree at the Ghent University intranet to verify the applicable regulations and the appropriate ethics committee for your submission.
Study pre-registration is increasingly valued in research because it enhances transparency, credibility, and rigor in scientific findings. Take a look at: Open Sciene at Ghent University Open Science Framework (OSF) and > registered reports Clinical trial registrations (e.g., ClinicalTrials.eu , ClinicalTrials.gov ) Systematic review protocol registrations (e.g., PROSPERO, The Campbell Collaboration, The Cochrane Collaboration) Important: Make sure to register your study in time (e.g., before participant enrollment). Many journals now require pre-registration before they will consider your study for publication. However, pre-registration is not mandatory for all types of research — for example, in the case of exploratory studies.
It is important to run preliminary experiments to - Check/refine your design- Identify unexpected factors that influence your experiment - Seek feedback - Provide proof-of-concept of your experiment - Share your experimental design - ... Take a look at the Nature Masterclasses Platform with concrete tips to manage this research stage!
Inspirational framework 'Research Design and Management'
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Transcript
Robust research design and management to ensure the integrity, reliability, and validity of the research
Inspirational framework 'Research Design and Management' for PhD candidates
Added valueof theresearch stage
Objective of the inspirational framework
Achievementsand training opportunities
Best practices by PhD candidates
Expectations
Objective of the inspirational framework
Objective
Added value of the research stage 'Research Design and Management'
Added value
Expectations
Expectations
Take a look!
PhD candidates enrolled from AY 2020-2021 onward must submit a Data Management Plan (DMP) within six months after their enrolment. They are expected to keep their DMP up to date during the trajectory. Prior to the public defence, the PhD candidate must submit the final version of the DMP.
Achievements and training opportunities
Ethical Committeeapplication
Protocol or technical paper
Studypre-registration
DataManagement Plan
Pilot study /preliminary data collection
Achievements
Optimizing of the research method and training in the method used
Power analysis
Ensuring reproducibility and replicability
Data-analysis plan
Grant applications
Training opportunities
Please note that it is not mandatory to implement all of the above components within the ‘Research Design and Management’ phase of your PhD, as this largely depends on your research domain and question(s)!
Best practices by PhD candidates
Babette Demeester is a doctoral researcher at the Department of Public Health and Primary Care. Her research team developed the ‘KickAsh!-intervention’, which actively engages adolescents experiencing societal vulnerability and their youth workers to prevent smoking in sport and recreational settings. In preparation for the intervention study, she designed and documented the protocol in a protocol paper. The paper provided a solid foundation for the intervention study through a comprehensive literature review at the start of her PhD. As a result, she encountered fewer issues during the pilot testing for the intervention study. The protocol paper also helped her strengthen the Ethics Committee application, Data Management Plan and Clinical Trial pre-registration, and vice versa. Babette published the protocol smoothly as a 'Study Design Article' in the Scandinavian Journal of Public Health, marking her first publication as a lead author in her PhD.
Best practices
Take a look!
Please note that writing a protocol paper is not always feasible — either due to the nature of the research domain or because the project is part of a larger whole. In such cases, alternative approaches like conducting a literature review and/or a pilot study can serve as good starting points to substantiate the 'Research Design and Management' phase of your PhD.
Best practices by PhD candidates
Tine Vanhaverbeke is a doctoral researcher at the Department of Internal Medicine and Pediatrics. Her research focuses on erosive hand osteoarthritis, examining, among others, the safety and quality of synovial tissue biopsies as well as the efficacy of pharmacological treatments such as Denosumab and Alendronate in these patients.
Best practices
Tine recognizes that administrative procedures during the Research Design and Management phase were key to high-quality and efficient research during her PhD. Given the involvement of patient populations and invasive methods, Ethical Approval was essential to secure safety and benefits of both biopsies and medications. Ethical Committee applications were prepared in close collaboration with pharmaceutical companies, whose input also supported the development of the protocol and final papers. As part of the Ethical Committee application, she established a biobank to enable accurate data collection and storage, which in turn facilitated the retrieval of biopsy samples afterwards. Pre-registration of her protocol and Statistical Analysis Plan (SAP) on EudraCT and ClinicalTrials.gov promoted early planning and transparency, and improved publication quality through feedback. Take a look at the EudraCT registration of one of her studies and get inspired:
Take a look!
The collaboration with several key stakeholders - such as pharmaceutical companies, study nurses, and lab staff - together with relevant training courses (e.g., Doctoral School Project Management, DMPonline) and Good Clinical Practice (GCP) certification, further strengthened her Research Design and Management skills throughout her PhD.
Acknowledgements and references
AcknowledgementsSpecial thanks to Anne Magherman and Valery Labarque for the outline of the inspirational frameworks. Many thanks to Team Open Science at the Ghent University - especially Laura Standaert - for providing a solid content-related foundation for the development of this inspirational framework. Sincere gratitude to drs. Babette Demeester and drs. Tine Vanhaverbeke for sharing their experiences on research design and management and the added value of a study protocol paper.ReferencesNature masterclasses Orpheus Best Practice Handbook 2024 Open Science , Research Tips , Doctoral School of Ghent University
Acknowledgementsand references
A data management plan (DMP) is a document specifying how research data will be handled both during and after the research project, ensuring that research data are: - High-qualitative - Secure - Sustainable - (to the extent possible) Accessible and reusable Take a look at Research Data Management (RDM) and Open Science at Ghent University! Important: PhD candidates enrolled from AY 2020-2021 onward must submit a DMP within six months after their enrolment. They are expected to keep their DMP up to date and to submit a final version prior to the public defence. Click here for more information on what your DMP should include and how to submit it.
Helps in clearly documenting the research process, making your research more feasible and your final data high-qualitative, secure, sustainable and (to the extent possible) accessible and reusable. Take a look at Open Science at the Ghent University!
Optimize your research method based on pilot data and/or feedback: - Check your technique and the protocols- Check your tools - Check your materials - Consider other potential sources of error Achieve mastery in conducting experiments by rigorous training and practice!
A data-anaylysis plan is a description of how you want to process, analyse and interpret your data to answer your study research question. This helps to make the analysis transparent and reproducible, and can form the basis for writing your research paper. Take a look at the Nature Masterclasses Platform and the Research Tips website of the Ghent University, or follow the hands-on courses of the Biostatistics Unit to support this stage of your research!
Reduces bias and errors by applying methods such as randomization, blinding, or peer review of your research design.
Helps in making your findings more trustworthy and replicable.
Ensuring reproducibility (others can get the same results using your data and analysis techniques) and replicability (others can repeat your study based on a sufficiently detailed description of your materials and methods) in research is crucial for scientific integrity and transparency.- Ensure transparent reporting in your research (cfr., study pre-registration, data management plan, data-analysis plan) - Test the reproducibility of your own experiments (as part of a pilot study or a seperate research paper in your PhD)
Protocol paper: dedicated paper focusing on the overall method or protocol.Technical paper: paper that answers a concise question (often a short report), reflecting a succinct review of a specific topic, historical perspective, or application of a specific (statistical) procedure. Important: In case of a protocol or technical paper, a manuscript with original research data is also required when submitting the PhD for defence. This manuscript must be accepted/published or submitted for publication to fulfill the faculty minimum criteria.
Address ethical considerations by ensuring ethical committee approval and informed consent. Take a look at the ethics decision tree of the Ghent University!
For concrete grant writing tools, take a look at: Doctoral School offer Nature Masterclasses Platform The Health, Innovation and Research Institute (HIRUZ) of the Ghent University Hospital
Explore the Doctoral School offer and the training opportunities of the Faculty Research Training Program on 'research design and management' Module: Integrity, ethics and law- Medical Device Regulation- Clinical Trial Regulation- ... Module: Biostatistics Module: Research Data Management (RDM)Want to learn more about RDM? Follow a training, request an info session, or attend an event organized by Ghent University’s data stewards and curators .
Helps in planning timelines, budgets, and data collection and analysis effectively, avoiding delays or overspending.
Power analysis helps researchers design studies with an adequate sample size to ensure meaningful and reliable study results. Reduces the risk of false negatives Increases the chance of finding statistically meaningful effects Helps in planning ethical research by avoiding unnecessarily large samples. Where to perform? G*Power, SPSS, R, Python,... Take a look at the hands-on courses of the Biostatistics Unit to broaden your knowledge and skills!
Preparing and submitting an ethics committee application is a mandatory part of conducting research (except for some specific cases). It can add significant value to both the research itself and the PhD candidate's own professional development by Promoting transparency and understanding of ethical standards Enhancing a robust and ethically sound study design Increasing independence and professional skills, accountability and ownership of the project. Use the ethics decision tree at the Ghent University intranet to verify the applicable regulations and the appropriate ethics committee for your submission.
Study pre-registration is increasingly valued in research because it enhances transparency, credibility, and rigor in scientific findings. Take a look at: Open Sciene at Ghent University Open Science Framework (OSF) and > registered reports Clinical trial registrations (e.g., ClinicalTrials.eu , ClinicalTrials.gov ) Systematic review protocol registrations (e.g., PROSPERO, The Campbell Collaboration, The Cochrane Collaboration) Important: Make sure to register your study in time (e.g., before participant enrollment). Many journals now require pre-registration before they will consider your study for publication. However, pre-registration is not mandatory for all types of research — for example, in the case of exploratory studies.
It is important to run preliminary experiments to - Check/refine your design- Identify unexpected factors that influence your experiment - Seek feedback - Provide proof-of-concept of your experiment - Share your experimental design - ... Take a look at the Nature Masterclasses Platform with concrete tips to manage this research stage!