![](bg4.png)
unique identification code that identifies the set of
the different types of related documents (technical
and administrative) collected during CIV process.
On the left side MEDIS provides two menus, the
upper one is dynamically created according to the
state of the notification. In this case it allows an
applicant to access the dossier as well as to reply to a
received request of further information (Riscontro).
The lower menu allows the applicant a) to access the
notification area (Area notifiche) where the user can
view its CIV proposals and/or make a new one, b) to
access the Organization area (Area Azienda) to view
and update information on the manufacturer and/or
authorized representative. On the right side, the
upper table shows the list of documents exchanged
during the CIV lifecycle, note that each document
type is linked to the attached documents (Documenti
allegati). In this case the notification identified by
the code i.5.i.m.2/6/2009 (meaning the 6
th
notification of pre-market CIV received in the year
2009) gathers all regulatory documents submitted
for the CIV approval. The lower table shows the list
of requests (Richiesta) and eventually the related
response (Riscontro) given by the applicant. In both
tables applicants can access the full text of the
document selected clicking on each item of the list.
4 CONCLUSIONS
MEDIS is a NCA’s information system developed to
support both CIV applicants to correctly submit trial
proposals and NCA to evaluate them as well as
monitor CIVs carried out at national level.
Moreover, MEDIS was designed on the basis of
HL7 v.3 methodology and standards in order to
make the system interoperable with other National
registries and in particular with the European
Databank on Medical Device (EUDAMED) that is
also developing an European system comprising
information on CIVs. At the moment the MEDIS
system has to be validated by real users in order to
test system performance and functionalities.
The role played by the content management
component has been described in this paper
considering it one of the main feature of NCA’s
information systems. The Dossier management has
the function of storing and retrieving documents and
data exchanged in the different phases of the CIV
lifecycle.
Moreover, clinical protocols describing CIV on
MDs as well as investigator’s brochures have been
analysed both in their structure and content
following the recommendation of Good Clinical
Practice (ISO, 2008) that guide applicants to
correctly write these technical documents. On the
basis of these features, our future intension is to
adopt HL7 CDA standard to further specify the
structure and semantic of CIV documents, taking
also into account BRIDG conceptual model
(Fridsma et al., 2007). This is in line with the
MEDIS design and development based on HL7 RIM
and it would further improve document exchange as
well as information retrieval of meaningful parts of
these documents.
ACKNOWLEDGEMENTS
This study was supported by the Italian Ministry of
Health through the MEDIS project (MdS-CNR
collaboration contract n° 1037/2007).
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