Biological Samples in Clinical Trials

Flashcards about Biological Samples in Clinical Trials.

Why are laboratory/scientific components critical to clinical trial design and execution?

They ensure success from planning to sample analysis.

In the clinical study/trial context, what are examples of sample management activities?

Sample plan, collection, shipping, analysis and storage.

What is 'sample utility'?

Maximizing sample value through integrity, data protection, and proper handling.

What aspects should be considered for sample utility?

Sample integrity, Sample traceability, and Health and safety considerations

Name some considerations for sample collection and processing.

Appropriate facilities, expertise/training, and clear protocols.

What are important steps in sample shipping and receipt?

Receipt logs, temperature records, reconciliation with manifest, and safe handling (e.g., of dry ice).

Describe sample traceability.

Clear instructions, user-friendly strategy, and appropriate technology (databases, barcodes).

Give an example of points for sample QC.

Collection at clinical site, onsite processing and short term storage, shipment to a central lab.

Name the three essential infrastructural supports for Sample Storage/Biobank.

Physical requirements, Monitoring Requirements and Sample and Data management systems.

What are some examples of sample analysis in clinical trials?

Standard blood work, disease biomarkers, therapy monitoring, and genetic testing.

What standard covers quality control and quality assurance measures in medical laboratories?

ISO15189

Name two key elements that have to be recorded in an auditable fashion related to sample management.

Sample chain of custody and Sample cold chain management

Give an example of how quality control is maintained in a lab.

Intra-lab quality control, inter batch qc, inter-lab information sharing, and reference testing.

Name aspects of an overall lab quality system.

SOPs, training/proficiency testing, document management, and internal audits.