E-BOOK
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E-BOOK
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THE STRATEGIC APPROACH: CRAFTING USER-CENTRIC KITS
EXAMPLE SCENARIO: LAMINATED REFERENCE SHEET FOR QUICK GUIDANCE To facilitate swift and accurate execution, a laminated reference sheet with helpful descriptions can be provided. This allows study nurses to quickly verify the correct order of blood drawing for various primary tubes (such as serum tubes without coagulants, followed by EDTA tubes) and follow pre-analytical sample handling steps like mixing, incubation and centrifugation.
A pivotal strategy in mitigating the challenges of oncology clinical trials lies in the careful design of sample collection kits. The principle is simple: The kits should make the process as seamless as possible for the site staff. This means that each patient’s visit should be neatly encapsulated within a dedicated kit. EXAMPLE SCENARIO: STREAMLINED KIT FOR MULTI-TIME BLOOD DRAW Imagine a patient visit that necessitates blood drawing prior to administration and then at 30 minutes, two hours, and four hours post-administration. In this scenario, a well-structured kit is essential. Each patient’s visit should be encapsulated within a dedicated kit. This kit box should be meticulously packed so that upon opening, the materials (including gloves, butterfly pipettes and labels) required for each specific blood-drawing time point are readily accessible. For instance, the pre-dose kit should be conveniently positioned on top of the others, containing all the essential items for pre-dose blood collection. As the layers unfold, the subsequent kits for the 30-minute, two-hour, and four-hour post-dose time points seamlessly reveal themselves. the kit box should be organized so that the necessary materials are easily accessible.
Whether the visit requires pre-dose blood drawing or multiple post-dose time points, the kit box should be organized so that the necessary materials are easily accessible.
COLORS THAT SIMPLIFY COMPLEXITY
For trials that demand serum, EDTA plasma, and citrate plasma, complexity peaks. Enter color-coded cryovials – a brilliant yet simple solution. These cryovials, each adorned with a specific colored top, are paired with preprinted cryovial labels in corresponding colors. This visual coding ensures that even in the midst of complexity, sample handling remains straightforward. EXAMPLE SCENARIO: COLOR-CODED CRYOVIALS FOR COMPLEX TRIALS For example, serum samples could be designated for cryovials with white tops, EDTA plasma with red tops, and citrate plasma with blue tops. The cryovial labels, mirroring the colors, would come with essential information preprinted: details about the study, visit, time point, materials and analytes to be tested.The same color-coding would then be applied throughout the entire study.
GUIDING WITH CLARITY: INSTRUCTIONS AND QUICK REFERENCES
Clear and concise sample collection instructions are central to this process. The laboratory manual should be designed to be easily understood and followed, acknowledging the time constraints faced by study nurses. A quick-reference sheet offers helpful descriptions that guide study nurses just before sample collection.
It helps them ensure the correct order of blood drawing for various primary tubes and follow essential pre-analytical sample handling steps. This addition not only streamlines the process but also minimizes the chances of errors.
CONCLUSION
The impact of thoughtful kit design
When navigating the complex landscape of sample collection, never underestimate the power of thoughtful kit design. The culmination of these strategic design elements results in meticulously crafted study-specific kits. These kits encompass all necessary materials, organize time-point kits in a logical sequence, and are accompanied by user-friendly lab manuals,
laminated reference sheets and color-coded cryovials with corresponding labels. The benefits ripple across the entire process, as accurate blood collection and pre-analytics becomes the norm. The results obtained from these samples are dependable, patient safety is enhanced and the value of the clinical trial is bolstered.
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