Research nurse role in managing clinical samples to maintain transparency and sample integrity

Posted on Jul 14, 2011 by Kelly Gleason in Lab Skills, Research

The Experimental Cancer Medicine Centre (ECMC) Research Nurse Steering Committee was established to support nurses, including research nurses, working in early phase and translational clinical research. As the group has developed it has increased the training and educational support offered to research nurses. It has worked with our clinical laboratory partners and quality analysis teams in areas where there is an overlap in training needs.

By working together, the ECMC Network Group’s remit is to address areas of unmet need, in specific training for research staff in these roles. The sample handling document provides generalised information for junior levels of nursing and laboratory staff and to those new to skills of sample collection and handling. It is understood that the document provides general guidance only on some key regulations and that an element of responsibility is required by the user.

The document aims to explain what needs to be done and when. Also, it explains the importance of both research nurse and laboratory staff roles, in the sample collection and handling process. It provides staff with the general overview detail, a checklist, flowchart and regulatory appendices. The document will be regularly reviewed and updated and it highlights to the research nurse or laboratory staff that the way in which every sample is…

collected, handled, labelled, prepared, processed and transported

And how a sample is…

coded, recorded, data logged, stored and subsequently analysed

…ultimately has a direct impact on the overall success of the study.

The document includes references of institutional, regulatory and custodial arrangements for sample collection, plus the recording, monitoring and storage of samples to meet the requirements of good clinical practice (GCP). The identity, quality and integrity of the sample for its given lifetime must be assured by all parties involved in the sample process.

In general, the statutory responsibility rests with the employing authority to protect staff from any occupational hazards that they may be exposed to in the course of their duties. For example, signs and emergency lighting showing where fire exits are and the use of yellow warning cones when floors are wet and slippery. However, sample handling and processing may expose the handler to a multitude of different risks that may be very specific to a particular type of study, or process; most are minor, although some may pose a more significant risk. These risks can range from biohazards when handling blood, serum or plasma, to radiation risks when assisting in specific techniques using radioactive markers, or gamma radiation used in research investigating sentinel node biopsies. It is important to check that risk assessments are undertaken, the required safety measures are honoured and that any training required has been undertaken by any persons involved in the sample management process.

Please refer to the document as a general guide. It is provided as a tool to promote and encourage further exploration and more detailed investigation by the user through accessing the references and web links provided later within the document.

www.ecmcnetwork.org.uk/prod_consump/groups/cr_common/@ecm/@gen/documents/generalcontent/cr_070921.pdf

We hope the document is helpful, please let us know!

The Experimental Cancer Medicine Centre (ECMC) Early Phase and Translational Research Nurse Network Group

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