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.

Abilities

  • Design overall operational plan for the study, e.g. project management plan

  • Design participant flow process, with visit schedules, appropriate documentation and time-points for sample taking, etc.

  • Design study processes related to ethics, such as community sensitisation plans, participant information leaflets, recruitment strategies and informed consent form

  • Design practical communication plans to circulate information within trial staff and to key stakeholders, e.g. participants groups

  • Coordinate/Contribute to the writing of study documents, such as information leaflets for participants

Related competencies

Similar tasks: Developing a protocol; Developing the QMS and SOPs; Developing the CRF and DMS; Initiating study; Project management

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

 

 

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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. 

Abilities

  • Develop quality management systems for the whole study, and for specific sites, laboratories or pharmacies, where appropriate

  • Develop and write procedures for quality assurance, e.g. how to track participants’ information and check the accuracy of collected data without breaking confidentiality rules

  • Develop and write procedures to control compliance to protocol and SOPs on a daily basis and throughout the study

  • Design risk management and safety plans, e.g. adverse event reporting systems, safety management plans, etc.

  • Coordinate/Contribute to the writing or drafting of SOPs

  • Write SOPs that are both GCP and regulations compliant

  • Develop guidelines to ensure study procedures will be consistently applied and adhered to

  • Plan and translate the quality management system into pragmatic SOPs

Related competencies

Similar tasks: Developing a protocol; Developing study plans and documents; Developing the CRF and DMS; Risk and safety management; Determining liability and insurance needs; Working as per the QMS; Controlling quality of research; Initiating study; Project management
Knowledge base: Good Clinical (and other) Practice; Governance and organisational context; Research regulations

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

 

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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.

Abilities

  • Coordinate/Contribute to the writing of CRFs or source documentation forms

  • Develop health questionnaires

  • Design a data management plan for the study

  • Contribute to quality management systems for the study as they apply to data processes, such as monitoring of safety data and checking database requirements

  • Investigate potential data management systems for the study

Related competencies

Similar tasks: Developing a protocol; Developing study plans and documents; Developing the QMS and SOPs; Controlling quality of research; Creating and maintaining a database; Data management

Knowledge base: Health-related knowledge; Research methodology

Required skills: Language and communication skills (writing); Computer and IT skills

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