Scientific Thinking Area

Click on a number to see the correponding competency definition, or scroll down this page. Suggested abilities of staff who demonstrate that competency are taken from real-life examples of clinical research job descriptions.

1- Design & planning of research

Competency definition: The individual has enough knowledge of a specific area linked to health, either with a background in fundamental or social sciences. This knowledge enables them to understand the purpose, concept and topic of a study. They have an appropriate education or experience in health sciences dependant on their role, which they are able to apply daily to perform their research job appropriately (e.g. to provide clinical care or deliver the intervention to participants, to set clinical research questions or to analyse quantitative and qualitative data). They maintain their understanding and knowledge of new advancements in their specific field by engaging with the professional community, i.e. by attending conferences or seminars and by reading relevant articles.

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Competency Definition: The individual has an understanding of the different types of research methods and study designs, the different sources of data (primary and secondary), and they recognise when each might be used. In particular, they are aware of methods that are being used in the study they are working in. They are also well aware of the processes within a clinical trial or research project and of how they differ from practice.

Expert: Following conduction of a comprehensive literature review, the individual recognises the gaps in current knowledge and can suggest a suitable and practicable research question. They are able to turn the question into a feasible and appropriate trial design, adopting appropriate randomisation and blinding procedures. They suggest appropriate measures to answer the research question (primary and secondary outcomes, endpoints, etc.). They have a deep understanding of statistics as they relate to research design, including issues of validity, reliability and power calculations. They can suggest adaptations to the design or make appropriate allowances depending on the risk and setting of the trial, thus facilitating the research without inhibiting the validity of the results.

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Competency Definition: The individual understands the different elements of a research protocol. They can write and/or review a protocol which operationalises the chosen research design appropriately for the disease and the setting in question.

Developing the protocol (which may be a pre-clinical, exploratory or clinical study) requires writing skills, combined with the ability to use theoretical knowledge of research methods and scientific concepts. The protocol development spans from drafting to approval, via review and then continuous updating.

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Competency Definition: The individual understands therequirements of different funding sources, and can write an effective grant application which ensures maximum chances of success. Budget and resource requirements are planned thoughtfully and accurately. Attracting the necessary funding requires the individual to identify sources for funding, and to understand the current interests of donor agencies and global health stakeholders. Based on that information, the individual is able to plan a relevant study which will be attractive to the grant call, to evaluate study costs and necessary supplies, and to write effectively and in a persuasive manner.

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2- Protocol operationalization

Competency Definition: The individual has sufficient understanding of the protocol and research processes to make plans for, and write documents to support the conduct of the study. They can contribute to or independently write the informed consent forms or other trial documents, as required for their role. They can design appropriate and pragmatic plans in relation to their role within the trial; for example how to project-manage the whole trial procedure, how to design the consent process and participant flow, etc.

Developing plans and documents to support the study requires good writing skills together with a comprehensive knowledge and understanding of the study protocol, the constraints within which the study will be run (e.g. low-resource or particular cultural setting, infectious disease requiring constraining protection measures), with the ability to translate this high-level document into practical and reproducible operations.

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Competency Definition: The individual has sufficient understanding of the protocol, of the practicalities of its execution and of the risks associated to the study to design a quality management system and risk-mitigation strategies. They develop a quality assurance plan in accordance with Good Clinical Practice guidelines in order to deliver the best-quality science and study. They understand how to take account of pre-study assessments (feasibility, risk and site assessment) to develop study-specific quality management plans. The QMS should include plans for audits at different sites and contractor organisations, if applicable.

The individual also understands the structure and requirements that SOPs must fulfil, and know how to write detailed, clear and pragmatic guidelines that will enable replicable performance of study activities between individuals, between sites, etc., thus enabling consistent execution of the QMS plan. Developing SOPs to operationalize study plans requires good writing skills together with detailed knowledge of the requirements of the organisation within which the individual is working and the standards it requires. 

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Competency Definition: The individual has sufficient understanding of the study and of data management constraints to suggest practical means for data capture and to write documents to collect study data. In particular, they design a suitable Case Report Form (CRF) and/or questionnaires, taking account of the outcomes to measure, of the study endpoints, etc. They also develop plans for the overall data management process, including methods for reporting and monitoring the safety data. They must ensure the CRF and planned data management system (DMS) will enable acquisition of appropriate and high quality data in order to answer the research question.

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3- Interpretation of study results

The individual can extract and analyse quantitative data using appropriate software, applying their knowledge of biostatistics, trial design and medicine to draw valid conclusions from the data and outline limitations. The analysis stage may involve some modifications of the data (e.g. creating graphs, calculating rates) to clearly present results. The individual is able to perform statistical monitoring and interim analyses if required, including to validate the data.

Data may also be qualitative, in which case the individual uses different software if necessary, and applies different knowledge related to social sciences methods to perform the analysis and draw accurate conclusions.

Data analysis and interpretation requires analytical thinking and IT skills of the relevant software.

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The individual is aware of the importance of reporting the results of research, and of the various dissemination formats available for different audiences. They can clearly communicate results in writing and speaking, in a manner suitable for the audience. They take appropriate steps to feed results back to the local community, and are able to prepare lay summaries for research participants and the public. They are able to submit an abstract for a conference, and subsequently prepare a suitable poster or oral presentation (or assist others to do so). They understand the component parts of a scientific publication or final report, and can draft, coordinate and write one confidently.

Language and communication skills are of primary importance to disseminate findings, as is the ability to synthesise complex information to explain to others. The task may require coordination and managerial skills when the first author or leader is expected to collect contributions from various parties in their team.

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