Data integrity around sample management is a team effort, meaning all site staff, CRAs and Lab Personnel involved in sample management, must ensure that their samples are collected, processed, stored, shipped, received and analysed according to standardised principles – Good Clinical Laboratory Practice (GCLP) , Good Clinical Practice (GCP) and processes – outlined in the Study Protocol and Lab Manuals – as well as document all these according to Good Documentation Practices and the ALCOA++ principles.
With our immersive and engaging online course in Sample Management, TASK Research Academy will take you on a unique journey, giving you the opportunity to discover, explore and develop competence in sample management and its various stages in a clinical trial, from the pre-analytical stage (preparation, collection to shipment) all the way to its post-analytical stage, as well as performing critical oversight, as conducted in-house as well as by the CRA/monitor. Advocated by years of industry experience and developed by industry subject matter experts, this course will equip you with the knowledge and skills needed for quality sample management in a clinical trial. The course will also introduce you to all the various role players involved and what their responsibilities are toward ensuring the maintenance of sample integrity throughout its lifecycle.
The ultimate purpose of a clinical trial is to establish whether a treatment or intervention (such as a drug, vaccine, device, or procedure) is safe and effective in its purpose, for human use. The data, generated from a trial, helps regulatory authorities, healthcare providers, and researchers make evidence-based decisions about whether the intervention should be approved, how it should be used, and what its benefits and risks are.
The data is generated from collected samples of participants of the trial. Biological samples are not considered as endpoints in a clinical trial. However, these samples (such as blood, sputum, tissue, or urine) are critical to measuring endpoints, especially in trials that rely on biomarkers, pharmacokinetics (PK), or pharmacodynamics (PD) data.
If the samples are used to measure the primary endpoints, it is even more critical that they are handled correctly as failing to meet primary endpoints can make regulatory approval and scientific validation more difficult.
As such, the collection, handling, processing, storing, transporting, receipt and analysis of biological samples is key to the integrity of the data generated in a clinical trial.
