PROTOCOL OF I.B.AHC - BIOBANK AND CLINICAL REGISTRY FOR ALTERNATING
The current protocol of I.B.AHC - Biobank and Clinical Registry for Alternating Hemiplegia consists of the following steps:
- Enrolment of the patients, their parents and their treating physicians
A.I.S.EA Onlus collects the consent forms from the participating patients, from
their parents and from their treating physicians, for the processing of their
data (Italian National Law 30.06.2003 Nr 196).
A CID is assigned by A.I.S.EA Onlus and notified to each participant. Only A.I.S.EA
Onlus can communicate personally with the participants.
- Collection of the Clinical Data and the Blood Samples
The treating physicians receive from A.I.S.EA Onlus an account (username and
password) to login to the I.B.AHC on-line Clinical Registry and enter the clinical data of their patients.
With the collaboration of the
physicians, also the blood drawings are organized and the samples, labelled by the CIDs, are sent to the
I.B.AHC Biological Bank.
A.I.S.EA Onlus updates the list of the available CIDs on the public portal of
I.B.AHC: in this way, the patients can easily check their presence in the
Biobank and in the Clinical Registry.
- Validation of the Diagnosis
At least once a year, A.I.S.EA Onlus organizes a video-session
for the diagnosis validation, during which new suspected AHC cases are presented by their
treating physicians and
discussed together by the Scientific Committee of the association and by all the physicians participating to I.B.AHC.
If the diagnosis is confirmed, the patient CID is validated and its data and
biological samples are made available for the usage (next step).
- Usage of I.B.AHC
Any research group, treating physician and health-care professionals can apply
to request the use of the
clinical data and/or the biological samples kept in I.B.AHC for diagnostic
screenings, data analysis, training, clinical studies and genetic
research, by filling the Usage Request Form and sending it to
the Responsible of the BioBank or to the Data Managers of the Clinical Registry.
The request is evaluated by the Scientific Committee of the association,
within the following thirty days.
A Material and Data Transfer Agreement (MDTA),
based on the evaluation comments and proposed by A.I.S.EA Onlus, must be signed
by the applicant, before accessing I.B.AHC.