This cheatsheet provides a quick reference guide for clinical trial coordinators involved in laboratory processing. It covers key aspects to ensure smooth, efficient, and compliant sample handling and processing. Remember, specific procedures will vary based on the trial protocol and laboratory's Standard Operating Procedures (SOPs). Always refer to the official protocol and SOPs for detailed instructions.
Key Considerations Before Sample Collection
- Protocol Adherence: Strictly follow the protocol's specifications for sample collection timing, methods (e.g., venipuncture, urine collection), and volumes. Any deviation must be documented and justified.
- Patient Identification: Verify patient identity using two independent identifiers (e.g., name and date of birth) before and during sample collection. Double-check all information against the case report form (CRF).
- Specimen Labeling: Accurately label each specimen with the patient's unique identifier, date and time of collection, sample type, and collector's initials. Use permanent, waterproof markers.
- Chain of Custody: Maintain a complete and unbroken chain of custody for all samples. Document every step of the process, including transfer between personnel and locations. Use secure, tamper-evident containers and shipping materials.
- Sample Integrity: Ensure proper handling and storage to prevent sample degradation. This includes using appropriate temperature-controlled containers and minimizing exposure to light.
- Pre-analytical Variables: Recognize factors that can affect sample results (e.g., hemolysis, lipemia, improper collection technique). Document any observations that could compromise the sample quality.
Sample Processing: Key Steps
- Centrifugation: Follow specific protocol instructions for centrifugation speed, time, and temperature. This is critical for separating serum or plasma from cells.
- Aliquoting: Divide samples into appropriate aliquots for storage and analysis. Clearly label each aliquot with the same information as the original sample, plus the aliquot number.
- Storage: Store samples at the specified temperature (e.g., -80°C, -20°C, 4°C) according to the protocol. Utilize appropriate freezer storage systems to maintain temperature integrity.
- Sample Tracking and Management: Use a robust system for tracking samples throughout the entire process. This could involve a laboratory information management system (LIMS) or a manual log.
- Quality Control: Include appropriate quality control samples (e.g., positive and negative controls) in each batch to monitor the accuracy and reliability of the laboratory procedures.
Troubleshooting Common Issues
H2: What are the most common errors in clinical trial lab processing?
Common errors include incorrect labeling, inadequate chain of custody documentation, improper sample handling leading to degradation, and failure to adhere to protocol specifications for centrifugation and storage. These errors can significantly impact the validity and reliability of the study results.
H2: How do I handle a missing or damaged sample?
Immediately report any missing or damaged sample to the study investigator and the laboratory. Document the incident thoroughly, including the date, time, sample identification, and any potential causes. Follow the protocol's guidelines for handling such events, which might involve repeating the sample collection or conducting a deviation report.
H2: What are the critical steps to ensure sample integrity during transportation?
Use appropriate temperature-controlled shipping containers (e.g., dry ice, gel packs) to maintain the sample's integrity during transportation. Accurately document the temperature throughout transport and upon arrival at the laboratory. Utilize secure packaging to prevent breakage and leakage. Follow all relevant regulations for transporting biological specimens.
H2: How do I deal with discrepancies between the collected sample and the CRF?
Thoroughly investigate any discrepancies between the collected sample and the CRF. Verify patient identity and check the labelling against the CRF. If the discrepancy is confirmed, report the event to the study investigator and document it appropriately. Follow protocol guidelines for handling such discrepancies, possibly involving a correction or amendment to the CRF.
Conclusion
This cheatsheet provides a general overview; always refer to your study protocol and the laboratory's SOPs for detailed instructions and specific requirements. Accuracy and adherence to procedures are paramount to ensure the quality and integrity of clinical trial data. Continuous training and adherence to best practices are essential for all coordinators involved in laboratory processing.
