Research Operations Area (2)

2- Clinical & laboratory operations

Competency Definition: Clinical care relates to the theoretical knowledge of medicine and the ability to apply it during the research process, for example assessing clinical history, taking relevant measurements and samples, and providing appropriate and safe care and treatment. The individual may be involved in care in different ways: as a performer (conduct participants’ visits), as a coordinator (oversee or lead the clinical team) or as a controller (review participants’ medical records). The individual understands the differences between research and standard clinical care, and has a good understanding of the clinical field of study. The individual may also carry out data collection tasks that involve direct interaction with participants, such as administering health questionnaires or taking samples and measurements. They also deliver the intervention, monitor the participant for toxicity of the intervention, control adherence to treatment and provide emergency care in case of Adverse Event (AE).

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Competency Definition: The individual demonstrates an understanding of pharmacology and of the appropriate use of drugs, including investigational medical products (IMPs). They have knowledge of drug toxicity, pharmacokinetics and pharmacodynamics issues, and know how those should influence the clinical research process and participants’ clinical management. They apply their pharmacology knowledge to the IMP, ensuring safe use and dispensing of the IMP and of any appropriate comparators within the trial. They have a thorough knowledge of Good Manufacturing and Pharmacy Practices, and understand how to ensure the drug contains the appropriate active compound, especially in settings where counterfeit drugs occur frequently. They may assist in study design and implementation by providing pharmacological advice on the IMP and the comparators (placebos) to be used.

The individual also understands the importance of pharmacovigilance, both throughout and beyond the study lifecycle, and suggests steps to continually monitor drug effects in both situations.

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Competency Definition: Biomedical products may be participants’ biological samples (e.g. blood, tissues) as well as drugs or other medical devices used for treatment, and this competency relates to the ability to source, track and process these products safely and carefully within the trial environment. 

The individual has a good understanding of the requirements for storage, handling and tracking of the relevant biomedical products. They develop systems to handle these products appropriately, ensuring correct labelling and storage temperatures are maintained and documented. They ensure that they have the correct and completed paperwork for any samples taken and received.
Handling biomedical products require logistical skills (e.g. inventory and ordering of drug supplies, dealing with export/import permits) as well as technical knowledge (e.g. conditions for transport and storage, processing and reconstitution on receipt if applicable). Within the context of clinical trials, it also requires record-keeping skills as products need to be tracked, e.g. to identify participants from which a sample was taken or to ensure the drug labelling is made according to the code in blinded trials.

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Competency Definition: The individual uses lab equipment to conduct routine diagnostics for the trial, and can interpret and document the results appropriately. Performing laboratory operations requires scientific background knowledge (e.g. to interpret biological tests) and record-keeping skills.

Expert: The individual is also able to plan and set up new procedures and techniques within a laboratory.

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