3- Regulations & Governance

Competency Definition: Trial staff should understand the relevant submissions required (trial registry, regulatory, ethics, and any others such as national or local requirements), and contribute to or write the submissions. The individual coordinates and maintains the required submissions and provides appropriate updates, for example in the case of protocol amendments or for annual reporting purposes. Those in charge of maintaining approvals must be aware of the regulations that apply to trials and know how to submit applications to regulatory bodies. Reviewing authorities should ensure submission dossiers are complete and should provide an appropriate and timely review of those dossiers. They must keep written records of their decisions and respond clearly to investigators regarding those decisions.

Abilities

  • Understand application process for ethical/regulatory approvals

  • Coordinate/write submission for ethics or regulatory approval 

  • Submit to trial registry

  • Submit protocol amendments to relevant authorities

  • Understand the importance of maintaining ongoing approval throughout study and the requirements for this, e.g. annual reports

  • Understand other relevant approvals, e.g. local R&D department, marketing applications, local health authority permissions required

Reviewing authorities:

  • Provide timely review and approval of relevant documents, e.g. approval of protocol or protocol amendments

  • Ensure that the right submission dossier documents or associated queries have been promptly sent

Related competencies

Tasks based on this knowledge: Similar tasks: Determining liability and insure needs; Securing and maintaining contracts; Reporting; Liaising or acting as a link; Overseeing essential documents

Knowledge base: Research regulations

Required skills: Language and communication skills (writing); Record-keeping

 

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Competency Definition: The individual understands the importance of, and manages, binding agreements and contracts. These could be with individuals or with sites or subcontractors. The individual ensures that all the relevant contracts are agreed and that they are signed, stored, and updated appropriately. Securing contracts require good negotiation skills and a thorough understanding of responsibilities and liability within the clinical trial team. The individual should also be able to assess vendors and/or suppliers based on their claimed qualifications, experience, accreditation, etc. Contracts should define the distribution of roles, responsibilities and accountability within the contractors, and define the governance processes that apply.

Sponsor specific: Sponsors should consider legacy after trial closure (e.g. issues relating to access to drug for a wider public, including participants outside the trial).

Abilities

  • Manage contracts, including (but not limited to): investigator contracts, sponsor/site agreement, site agreements, agreement with CRO or subcontractors, data access and transfer agreements in compliance with confidentiality requirements, compensation in the event of harm

  • Manage contracts, ensure they are signed appropriately, track deadlines for renewal and ensure timely update, etc.

  • Read and review contracts to ensure they are comprehensive

  • Ensure contract and documentation of specified responsibilities that are subcontracted (e.g. to a CRO)

Related competencies

Tasks based on this knowledge: Determining liability and insurance needs; Securing or maintaining approvals; Initiating study; Liaising or acting as a link; Overseeing essential documents

Knowledge base: Governance and organisational context; Research regulations

Required skills: Interpersonal skills (negotiation); Record-keeping 

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Competency Definition: The individual has an understanding of the roles and responsibilities of staff within relevant organisations, both in terms of practical application to their day-to-day role and of governance. The individual understands the roles and responsibilities of organisations involved in the trial (e.g. sponsor, regulatory authorities, contract research organisation, other sites), how organisations relate to groups involved in a trial, and understand how their own site/group fits into this framework. They understand their own roles and responsibilities and how their job fits into the overall research project, who they must report to, and when delegations are required. They also understand where the research study fits within the wider scientific aims of their organisation and what plans should be put in place for the future distribution of the product would it be proven safe and effective. They ensure that others in the team understand their own roles and responsibilities, and work within this remit. 

Abilities

  • Be aware of the structure, roles and functions of regulatory and ethics review boards, sponsor, institutional and other organisations relevant to their research project (e.g. CRO)Understand the roles and responsibilities of key personnel within the research project, and how their own role fits in with this

  • Consistently work within own role; adhere to the roles/responsibilities documents

  • Contribute to the development of governance systems and documentation within the organisation

  • Specialist setting: Understand how roles and responsibilities might differ in academia or not-for-profit research as opposed to industry

Related competencies

Tasks and skills using this knowledge: Determining liability and insurance needs; Securing or maintaining approvals; Securing or maintaining contracts; Human resources; Liaising or acting as a link; Strategic leadership

Similar knowledge: Research regulations

 

 

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Competency Definition: The individual has an understanding of the relevant guidelines relevant to their work, whether local policies, international guidelines or regulatory authorities requirements; and applies them to their work. They report appropriately, especially in the case of breach of abidance, and work with the authorities when required such as during audits. They understand fraud and misconduct during research and seek to address them. All staff should consistently abide by regulations, and some hold particular responsibility to check that the study meets regulatory requirements, local policies, and applicable international guidelines.

Abilities

  • Understand the processes and phases necessary for approval of a drug or other investigational medical product (diagnostic, device, gene therapy, etc.) through the different stages in a trial

  • Keep up-to-date with relevant international, national, and local laws, policies and guidelines relating to clinical research (including ethical ones)

  • Understand the laws relating to the use of animals in research, if applicable

  • Be responsible for the study meeting regulatory requirements, local policies, and applicable international guidelines

  • Have an understanding of fraud and misconduct in clinical research and raises concerns appropriately

  • Ensure compliance with relevant guidelines, e.g. database, labelling, reporting of AEs and SUSARS, protocol amendments, etc.

  • Work with regulatory authorities, e.g. during audits or when submitting reports
    Expert:

  • Review and assess clinical trial regulatory documents

Related competencies

Tasks using this knowledge: Developing study plans and documents; Controlling quality of research; Securing or maintaining approvals; Securing or maintaining contracts

Similar knowledge: Governance & organisational context

 

 

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