Clinical trials documentation storage

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

Systems audits in archiving should verify that SOPs and procedures are in place for timely archiving and adequate retrieval of clinical documents. This involves, for example, a dedicated facility/ area for long-term storage with adequate access controls and environmental protection (e.g. against loss, flood, vermin or fire). A dedicated person (and a backup) must be responsible for the management and operation of the archive. Documents provided to the archive must be indexed to ensure retrieva-bility. A reasonable timeframe should be specified for documentation to be moved into the archive after trial termination. 

Labeling, retrieval, and storage of samples should be regulated in detail, just as sample flow. Equipment should be maintained and calibrated regularly the personnel operating them should be trained properly. Note that these not just have to be performed adequately, but have to be documented in detail. Clinical work should typically be performed according to GCP an international ethical and scientific quality standard. Its main objective is to ensure that the data and reported results are credible and accurate, and that the rights of trial subjects are adequately protected. 

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