What happens in reality and which consequences arise

Clinical documents
(clinical notes)

With regard to the current Italian jurisprudence, the clinical notes are a “public act” drawn-up by a public official authorised to grant official validity.

DL n° 1409 del 30-09-63 regarding public archives
Public document destruction is possible following a fixed time period from initial archiving, this period will be fixed depending on document typology.

Circular letter of the Ministry of Health 19-12-86
Medical records and related reports, must be conserved for an nlimited period of time, because they represent an official act to guarantee the certainty of a right and a documentary source of research. At the beginning the documents are to be conserved in a normal archive and after 40 years in a separate subdivision of the archive.

Administrative Documents

Public Acts
Some of the acts are drawn-up by a public official (e.g research contracts), all of them must be considered “public acts”.
They are regulated by the rules regarding public archives. They represent a small part of the administrative documentation related to a clinical study.

Private Acts
Part of the documents are private, even if used in a public context (protocol, Investigators’ Brochure safety communications, laboratory data, scientific correspondence). 

Since this acts are not subject to the laws regarding public archives, their archiving must be agreed in the contract.
 
Private acts represent a large part of the administrative documentation.

Undefined Allocation
Other documents have a more uncertain allocation, such as completed CRFs, Ethics ommittee act and signed Informed Consent forms.