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.

Abilities
  • Have sufficient scientific knowledge for their role, e.g. understanding of medical terminology or HIV issues if the role warrants it

  • Maintain up-to-date understanding in their area of expertise, e.g. pharmacology (pharmacodynamics and pharmacokinetics), epidemiology

  • Be an expert or solid reference on health sciences for the team

  • Contribute medical input into study designs and protocol

Related competencies

Tasks based on this knowledge: Developing a protocol; Analysing data; Disseminating research findings; Providing clinical care; Ensuring appropriate use of IMPs; Handling biomedical products; Performing laboratory assays

Similar knowledge: Research methodology

Required skills: Cognitive skills; Work ethic 

back to complete 'Scientific Thinking' area 

 

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.

Abilities

  • Understand the importance of and how to access, critique and synthesize literature appropriately

  • Be aware of/understand the elements (statistical, epidemiological and operational) of clinical and translational study design; and different stages of clinical trials

Expert
  • Design an appropriate clinical trial, including: select a design for the research question, define outcome measures and endpoints, perform power calculations, design a randomisation and blinding system, etc.

  • Develop cost effective risk-based strategies to run clinical research studies effectively in low-resource settings

Related competencies

Tasks based on this knowledge: Developing a protocol; Developing study plans and documents; Developing the CRF and DMS; Analysing data; Initiating study

Similar knowledge: Health-related knowledge 

back to complete 'Scientific Thinking' area 

 

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.

Abilities

  • Be aware of the different elements that must be covered in a research protocol, including the specific requirements (e.g. regulatory, ethical) linked to the study type and/or setting

  • Draft an appropriate protocol

  • Contribute to relevant sections of a protocol

  • Coordinate protocol writing and review; track inconsistencies, errors or omissions

Related competencies

Similar tasks: Attracting funding; Developing study plans and documents; Developing the QMS and SOPs; Developing the CRF and DMS

Knowledge base: Health-related knowledge; Research methodology; Ethics and human subject protection; Good Clinical (or other) Practice; Research regulations

Required skills: Language and communication skills (writing); Organisational skills (planning)

back to complete 'Scientific Thinking' area 

 

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.

Abilities

  • Have an understanding of major funding bodies, and that application requirements vary from one to another

  • Understand the component parts of a grant application process

  • Plan costings and resources for a grant application

  • Independently write or contribute to grant application

  • Seek to address funders’ interests by developing original grants

Related competencies

Similar tasks: Developing a protocol; Securing or maintaining contracts; Logistics and facilities management; Finances management

Required skills: Strategic leadership; Language and communication skills (writing)

 

back to complete 'Scientific Thinking' area