National HIV Nurses Association

Identifies and reports on an abnormality and have an understanding on the protocol and department requirements to manage toxicities

Reports on any missing tests not undertaken in accordance with the protocol

Checks and confirms appropriate kits are available to undertake study visits. Ensures all tests are carried out in accordance with the protocol

Identifies when tests need repeating in accordance with the protocol

Plans a patient’s follow up in accordance with protocol and treatment guidelines

Collates and interprets the results and reports them to the doctor stating actions to be taken in accordance with the protocol

Plans and implements individual patient follow-up to ensure appropriate management

Evaluates and reports >grade 4 toxicities as per protocol and implements serious adverse event (SAEs) reporting in accordance with guidelines

Evaluates the effectiveness of tools to ensure that clinical trial investigations are reported in line with the study protocol

Undertake and monitor teaching to ensure study team aware of reporting requirements

Reviews policies and procedures in line with departmental and study requirements

Plans the patient’s visits to ensure that the samples are taken in a timely manner

Ensures all samples are obtained and processed in accordance with protocol, local policy and laboratory manuals

Undertakes the processing of blood samples in accordance with the protocol and laboratory manual

Follows the specific protocol requirements regarding the timing, sequence and processing of samples

Documents all results in accordance with protocol and in line with sponsor-specific requirements

Undertakes and delivers training to ensure all staff members are aware of guidelines

Ensures equipment used is calibrated and monitored in accordance with local and sponsor requirements

Designs standard operating procedures to ensure samples are taken and processed in accordance with protocol and laboratory manuals

Undertakes health and safety assessments to ensure all staff are trained and safe to handle and process of samples

Designs and evaluates training programmes in clinical trial guidelines

Undertakes a risk assessment on laboratory area

Evaluates the outcomes of individual procedures and investigations/interventions as a whole to determine the success of the approaches adopted and any further action required

Designs and evaluates quality control systems to monitor the collection, processing and storage of samples

Demonstrates an understanding of the importance of accurate data collection in relation to Good Clinical Practice (GCP) guidelines [1]

Uses appropriate tools and techniques to collect data

Understands the principles of the Data Protection Act [2]

Identifies and understands what constitutes a source document

Collects data accurately and systematically in a patient’s notes in accordance with the protocol

Identifies different types of data, data collection processes and verification issues during studies

Demonstrates an understanding of the role of the clinical research associate

Identifies appropriate tools to assist in the identifying of patients for clinical trials

Develops and implements tools to assist in data collection

Demonstrates an understanding of the importance of auditing within clinical trials

Demonstrates a comprehensive understanding of the data collection process and the consequences on practice

Identifies areas of concern in regard to misconduct and fraud and acts appropriately within GCP guidelines and the Research Governance framework [3]

Applies quality assurance methods to ensure data integrity

Designs methods for data capture

Designs and maintains databases to capture activity data

Complies with ICH GCP in the archiving and storage for study related documentation [4]

Designs training programmes to train and support staff to in relation to audits and inspections

Has a full knowledge of study set-up related documentation

Demonstrates effective management in the of the co-ordination of a programme of studies

Identifies key resources that are required in order to conduct a study

Demonstrates the effective reporting for adverse and serious adverse events

Maintains databases of study activity

Takes appropriate action in the event of: protocol deviation; serious adverse events; participant withdrawal

Demonstrates an understanding of the process to obtain research ethics approval

Fully understands the regulatory aspects of clinical research

Demonstrates an understanding of the elements of informed consent

Assess the patient’s suitability to enter a clinical trial in liaison with the research team

Designs tools for the assessment of resource requirements and implications of all clinical research projects

Initiates and implements risk assessments in accordance with local policies and study protocol

Produces detailed costings and resource utilisation information. Leads in the implementation of the national, European and ICH guidelines for the management of research studies

Advises, supervises and manages others in the co-ordination of studies

Implements the documentation for research ethics approval

Reviews and implements the regulatory approval documents and required R&D approvals

Undertakes feasibility assessments in accordance with sponsor requirements

Designs and evaluates training packages and audit tools for all elements of informed consent