Clinical study documents are stored in the centres where the research is done. The archiving systems are reasonably sure and reliable.
The law regarding the storage of documents is not always clear. In most cases, the institutions do not carry out the storage of a clinical study’s administrative documents.
The storage of the above documents is a great burden for the institution (large quantities, long period of conservation, need for a specific procedure).
The loss of clinical and administrative documents by the investigator / institution, may have considerable consequences for the sponsor especially regarding the following aspects: market, regulatory system and property.
The cost of an appropriate Long Term Archiving service (LTA) is very small compared to the global cost of a clinical study and it is insignificant compared to the damage caused by data loss.
From the sponsor’s point of view an LTA Service should be seen as
In general the LTA service protects the parties involved in a clinical study (institution, patients, sponsor, investigators).
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