1- Oversight

Competency Definition: The individual can plan the practical aspects of starting the study based on the protocol, including conducting early feasibility and risk assessment. They prepare study teams, including setting up and managing oversight committees, and negotiate start dates and milestones with all parties. They conduct site selection activities, and understand the needs of the chosen sites to address before study start, for example recognising the need for specific training or equipment. They run launch meeting and site initiation meetings, and ensure that the sites have the relevant information and documentation, such as the investigator’s brochure (IB) and site specific information (SSI). Individuals managing study initiation should have a good knowledge of the planned study operations so as to be able to execute them appropriately from start, and a thorough understanding of the protocol.

Abilities

  • Review protocols and conduct feasibility planning, risk assessments

  • Recruit study teams, Quality Control teams, and oversight committees such as steering committee

  • Plan and coordinate study initiation process (initial requirements in infrastructure and facilities, supplies, staff, training, etc.), in particular laboratory and pharmacy start-up activities

  • Conduct site and investigator selection: identify, visit and recruit suitable sites, identifying training and technical assistance needs

  • Test, document and pilot risk and mitigation strategies, such as code breaking procedure in emergencies (piloting)

Related competencies

Similar tasks: Developing a protocol; Developing study plans and documents; Developing the QMS and SOPs; Working as per the QMS; Securing and maintaining approvals; Securing and maintaining contracts; Project management; Human resources; Overseeing essential documents; Logistics and facilities management; Engaging with the community

Required skills: Strategic leadership; Interpersonal skills (negotiation); Organisational skills

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Competency Definition:  The individual is able to perform study close-out activities such as site close-out visits, and reconciliation of study supplies at the end of the study. They write and coordinate relevant notifications (e.g. to institutions, regulatory authorities). They have an understanding of the requirements of the sponsor, regulatory bodies, GCP and any other applicable standards for archive of trial data and documents, and make relevant arrangements. They arrange for database lock at an appropriate time-point. Performing study closure requires good knowledge of the relevant guidelines and good project management and reporting skills.

Abilities

  • Perform study close out visits at sites, and audit as required

  • Plan and coordinate data and source document archive for specified time period

  • Maintain study documents archive inventory, and make arrangements for (selected) access to files after close-out

  • Ensure unused trial supplies are accounted for, and appropriate disposal of trial materials once research is completed

  • Send notifications of closures: inform and submit relevant reports to official bodies (regulatory authorities, EC, etc.) and to other people involved with the study (investigators, institution, trial subjects, etc.)

  • Ensure and oversee close-out activities in case of premature termination of trial

Related competencies

Similar tasks: Disseminating study findings; Controlling quality of research (monitoring); Securing and maintaining approvals; Project management; Reporting; Overseeing essential documents; Data management

Knowledge base: Research regulations; Good Clinical (or other) Practice

Required skills: Organisational skills

 

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Competency Definition: The individual manages the study implementation and oversees the conduct of all activities from initiation to completion of the research project. They keep oversight of the project timeline, financing, human resources, other resources and logistics, in particular at and between groups and sites. They coordinate the relevant processes and teams, using project management tools if required.

Project management demands organisational and time management skills, and the ability to prioritise conflicting needs in order to successfully coordinate the activities of different parties (laboratories, research sites, etc.) involved in a clinical study.

Abilities

  • Oversee study and site management, including managing multiple sites/laboratories and ensuring consistency

  • Oversee specified processes within the trial, e.g. recruitment, monitoring, follow-up

  • Plan work schedules and timelines, review associated reports

  • Coordinate or manage teams or CROs

  • Understand how to use project management processes and tools

Related competencies

Similar tasks: Developing study plans and documents; Developing the QMS and SOPs; Working as per the QMS; Controlling quality of research; Securing or maintaining contracts; Initiating study; Closing study; Tracking study progress; Liaising or acting as a link; Human resources; Supervising or mentoring; Logistics and facilities management; Finances management

Required skills: Strategic leadership; Cognitive skills (problem-solving); Interpersonal skills; Organisational skills

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Competency Definition: The individual understands the project scope, milestones, budgets and timelines and can appropriately track the progress of these against the original planned target. They review status reports from other members of the team in relation to meeting these milestones, and can analyse the progress sufficiently to anticipate problems in advance. 

Tracking study progress requires good project oversight and managerial skills, along with good attention to detail and record-keeping, as the individual must constantly keep an eye on others’ activities, on goals and targets and ensure they are met.

Abilities

  • Tracking; Progress; Milestones; Deadlines; Timely; Objectives/goals/targets

  • Understand project scope, milestones, budgets, timelines; track these appropriately

  • Track progress of study, using tracking tools or software if appropriate, and measures progress against planned objectives and targets

  • Use progress tracking to anticipate potential issues, so initiative can be taken for resolution

  • Ensure timeliness of reporting relevant milestones

  • Review status reports from other team members in relation to milestones

Related competencies

Similar tasks: Working as per the QMS; Controlling quality of research; Closing study; Project management

Required skills: Cognitive skills; Organisational skills; Record-keeping

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