The Competency Assessment Template was created by the Training and Education Work Group to offer a clear and practical framework for staff tasked with writing competency assessments in clinical research. This template is particularly useful when there isn’t an existing document or framework available.

In addition to the generic Competency Assessment Template, we’ve also developed templates for specific activities, such as obtaining informed consent and safe sample processing.

• Streamlined all our competency documents into one easy to access toolkit – full list below!
• Developed a new Paediatric Informed Consent Competency Assessment Template.
• Added principals involved when seeking electronic consent.
• Reviewed all guidelines, led by expert CRF staff, making minor updates to formatting and improving clarity.

Generic Competency Assessment Template

Includes:

• Competency Assessment Template Guidelines
• Single Competency Assessment Form Template
• Multiple Competency Assessment Form Template

The single and multiple competency templates are generic blank templates that can be populated, utilised, and adapted for any relevant activity that required competency assessment.

The guidelines have recently been reviewed and updated to explain how to adapt the document for multiple assessments, select appropriate evidence and provide feedback.

Informed Consent Competency Assessments

Includes:

• Informed Consent Competency Assessment Guidelines
• Adult Informed Consent Competency Assessment Form Template
• Paediatric Informed Consent Competency Form Template

These templates provide a recommended structure to ensure that all staff undertaking the receiving of valid informed consent from research participants are adequately trained and equipped with the necessary skills. The templates may be adapted to meet local needs.

The update includes a new paediatric template (example below), and the guidelines now include the principals involved when seeking electronic consent.

Laboratory Competencies for Clinical Research Staff:

Includes:

• Safe Sample Processing within Research Laboratories (Word)
• Blank Laboratory Competency Assessment Tool (Word) – currently under review
• Pre-populated Laboratory Competency Assessment Tool (Word) – currently under review

The safe sample processing competency document is intended for clinical research delivery staff who are required to complete sample processing as a study role. It mirrors the training modules in the Network’s ‘Delivering Laboratory Skills Training to Clinical Research Staff Package’ covering: Legislation and Regulations, Risk Assessment, Safety in the Laboratory, Pre-analytics, Centrifuge Training, Pipetting, Tracking and Storage of Research Samples, Dangerous Goods Regulations.

You can download the full toolkit via the UKCRF Network Portal. If you don’t have access, simply complete the request access form at the bottom of the page.

We’re confident that this toolkit will make the process of developing competency assessments smoother and more efficient, supporting high-quality clinical research practices across the board.