Planning for sample availability to support future research begins with obtaining the proper patient consent prior to sample collection. In addition, irrespective of sample type, source or the assay being performed by the researcher, it is essential that the unique information associated with each sample be determined prior to collection and documented at time of collection. Research protocols should be explicit regarding consent, collection and processing requirements (i.e., consent form, collection process, centrifuge time, defined temperature requirements and the manner in which the specimen should be processed and shipped). Providing sites with a specific sample management section within their investigator manual can help improve compliance of site processes and reduce the impact of pre-analytical variables on sample integrity prior to laboratory processing.
- Secure facilities and redundant measures to ensure specimens are kept in compliant conditions at all times when in storage
- Expert staff that has been trained specifically in sample storage and transportation
- Unique sample bar-coding and chain of custody-tracking to support regulatory audits
- Storage technologies capable of monitoring and reporting sample temperature variations and manage inventory that are US FDA 21 CFR Part 11 compliant
- Business continuity plans and redundant systems to protect sample integrity during emergencies
Filed Under: Drug Discovery