This cheatsheet provides a quick reference guide for clinical trial coordinators involved in laboratory processing. It covers essential steps, best practices, and troubleshooting tips to ensure efficient and compliant sample handling. Remember to always adhere to the specific protocol requirements of each individual study.
Essential Pre-Processing Steps
Before any sample handling begins, ensure you have:
- Verified Patient Identity: Double-check the patient's identification against the study protocol and lab requisition form. Any discrepancies must be immediately reported to the principal investigator (PI).
- Reviewed Protocol Requirements: Familiarize yourself with the specific requirements for specimen collection, handling, processing, and storage as outlined in the study protocol. This includes timing, temperature requirements, and acceptable tubes/containers.
- Prepared Necessary Materials: Gather all required supplies, including appropriate tubes, labels, ice packs, transport containers, and any necessary processing equipment. Ensure everything is appropriately labelled and within its expiration date.
- Reviewed Chain of Custody (COC) Procedures: Understand and strictly adhere to all COC procedures to maintain sample integrity and traceability. Document all handling steps accurately on the COC form.
Sample Processing Techniques
The specific processing techniques will vary widely depending on the type of sample (blood, urine, tissue, etc.) and the study's objectives. However, some common steps include:
- Centrifugation: Properly balance the centrifuge before operation and adhere to the specified speed and duration. Note the type of centrifuge used, RPM, and time in your documentation.
- Aliquoting: Accurately aliquot samples into appropriate containers, ensuring proper labeling and volume. Avoid cross-contamination at all costs.
- Sample Storage: Immediately store processed samples according to the protocol's instructions. This often involves specific temperature requirements (e.g., -80°C freezer). Record the storage location and date.
- Specimen Integrity Checks: Throughout the process, regularly assess sample integrity. Look for signs of hemolysis, clotting, or contamination. Any abnormalities must be documented and may require additional action.
Troubleshooting Common Issues
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Hemolysis: This occurs when red blood cells break down, releasing hemoglobin into the plasma. Causes include improper venipuncture technique, vigorous shaking of the sample, or freezing/thawing. Document the extent of hemolysis and consider the impact on the study results. Sometimes samples may be unusable due to severe hemolysis.
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Clot Formation: This is common in blood samples if the anticoagulant isn't adequate or is improperly mixed. If a clot forms, the sample may need to be re-collected or processed differently, depending on the protocol.
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Sample Leakage: Ensure tubes are properly capped and sealed to prevent leakage. Leakage can compromise sample integrity and pose a biohazard risk.
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Temperature Excursions: Maintain the cold chain at all times. Temperature excursions outside the specified range can invalidate the sample. Immediately report any temperature excursions.
What are the common mistakes in clinical trial lab processing?
Common mistakes include improper labeling, inadequate mixing of anticoagulants, incorrect centrifugation parameters, improper storage temperatures, and insufficient documentation. Following the study protocol meticulously and adhering to good laboratory practices (GLPs) are crucial for minimizing these errors.
How do I ensure the chain of custody is maintained during lab processing?
Maintain a detailed chain of custody (COC) record for each sample. This involves meticulously documenting every step in the handling process, including who handled the sample, when, and where it was stored. Each transfer of the sample must be recorded on the COC form with appropriate signatures. This ensures traceability and integrity.
What are the critical aspects of proper sample handling in clinical trials?
Critical aspects include accurate sample identification, timely processing, adherence to temperature requirements, prevention of contamination, proper documentation (including COC), and immediate reporting of any abnormalities.
How do I handle a sample that is damaged or compromised?
Report any damaged or compromised samples immediately to the PI. Document the nature of the damage and any suspected cause. Depending on the study protocol, the sample may need to be re-collected or the incident documented as a deviation.
This cheatsheet serves as a guide only. Always refer to the specific study protocol and Good Clinical Practice (GCP) guidelines for detailed procedures and requirements. Regular training and competency assessments are essential for maintaining high standards in clinical trial lab processing.
