Chiari Malformation Project Database CM1 D

Orfeo Mazzella | CM1D database 1


The involvement of the patient on the part of the scientific community and the of The involvement of the patient on the part of the scientific community and the of voluntary associations in the collection and sharing of online data is as follows:voluntary associations in the collection and sharing of online data is as follows:

for the promotion of health and for the study of it’s natural evolution

Quality of Life

for the improvement of auditing “ clinical risk”

for the distribution and common usage of scientific knowledge

to supply a scientific base for the comprehension and the study of health

to establish a universal language to describe health and it’s conditions in order

to improve communication between diverse users: medical staff, researchers,

political exponents and the population

to render possible a comparison between data collection worldwide

to supply a systematic coding scheme for in house healthcare IT systems

IntroductionIntroduction


The collection of data adheres to all privacy normsThe collection of data adheres to all privacy norms

www.garanteprivacy.it/garante/navig/jsp/index.jspwww.garanteprivacy.it/garante/navig/jsp/index.jsp


Data according to SISMEC and CEAS recommendationsData according to SISMEC and CEAS recommendations

www.sismec.infowww.sismec.info

Recommendations of good practice in the research of epidemiology Recommendations of good practice in the research of epidemiology and clinical environmentand clinical environment


The publication of means of mass media must come The publication of means of mass media must come about only after the results have been revealed in an about only after the results have been revealed in an appropriate scientific contest and, possibly, through appropriate scientific contest and, possibly, through divulging the sourcedivulging the source

RecommendationsRecommendations

(According to clinical environment - SISMEC)


The collection of patient data: Quality of lifeThe collection of patient data: Quality of life


The collection of data adheres to the principlesThe collection of data adheres to the principles

GPC (Guideline for Good Clinical Practice)

Principals of ethics of the Helsinky declaration


The sharing and availability of data allows to “audit” thus allowingThe sharing and availability of data allows to “audit” thus allowing

a guarantee that the patient receives the best possible treatment

clinical practice improvement

the work to improve generally

an optimal supply of resources

this service becomes an opportunity for training and up - to - date research

Data sharingData sharing


Why collect the data?Why collect the data?

The systematic compilation of data and of information is a fundamental element in healthcare. The world of healthcare is in charge of organizing this data in a systematic and trustworthy fashion, so that a decision maker put in such a situation of having to look at all relevant material available can readily use the necessary data at hand

The same goes for the patient end – user who is also guaranteed a more trusting rapport with his doctor if the data can be efficiently found at hand


Registry, archive or database?Registry, archive or database?


A database, or data bank, is a structured collection of records or filing system that is stored in a computer system. The structure is achieved by organizing the data according to a database model. It can be accessed (for data inputting, research, management and data maintenance) via system software

Definition of a databaseDefinition of a database

The database is a gathering of information, of data which is then subdivided into a logic order into tables to be then split up into fields


1.51 Source DataAll information in original records and certified copies of

original records of clinical findings, observations, or other activities in a clinical trial necessary for it’s reconstruction and evaluation. Source data are contained in source documents (original records or certified copies)

Definition of data sourceDefinition of data source

European Medicines Agency July 2002 Guideline for Good Clinical Practice


1.52 Documents Source Original documents, data, and records (e.g., hospital

records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

Definition of document sourceDefinition of document source

European Medicines Agency July 2002 Guideline for Good Clinical Practice


NORD (National Organization Rare Disorders)

ORDR (Office Rare Disease Research)

SRDD (Swedish Rare Disease Database)

ORPHANET

CNMR (Centro Nazionale Malattie Rare)

Generic database for rare illnesses on internetGeneric database for rare illnesses on internet


NORDNORD www.rarediseases.orgwww.rarediseases.org


ORDRORDR www.rarediseases.info.nih.govwww.rarediseases.info.nih.gov


SRDDSRDD www.socialstyrelsen.se/en/rarediseaseswww.socialstyrelsen.se/en/rarediseases


ORPHANET ORPHANET www.orpha.netwww.orpha.net


CNMR CNMR www.iss.it/cnmrwww.iss.it/cnmr


ORCID (Orthopaedic Rare Conditions Internet database)

RBDD (Rare Bleeding Disorder Database)

GDMCC (Genetic Disorder Mucociliary Consortium)

EN-RBD (European Network Rare Bleeding Database)

ESID (European Society for Immunodeficiensies Database)

CM1D (Chiari Malformation 1 Database)

Specific database for rare illnesses on internetSpecific database for rare illnesses on internet


ORCIDORCID Orthopaedic Rare Conditions Database


RBDDRBDD Rare Bleeding Disorder Database


EN-RBDEN-RBD European Network Rare Bleeding Database


ESIDESID European Society for Immunodeficiencies


CM1D CM1D Chiari Malformation 1 Database

http://aismac.unior.ithttp://aismac.unior.it


What is the database used for?What is the database used for?

Mainly to observe the natural history of pathologies

For observational studies

To promote the knowledge and sharing new discoveries on MC1 e SM

To reunite distributed data with countries out of reach


What info to is required?What info to is required?

Info related to the quality of life

Info from the patient records according to the present consensus

The patient’s outcome


Is the data input anonymous?Is the data input anonymous?

Yes, it is anonymous and scrambled

anonymoususer


Who inserts the data?Who inserts the data?

The doctors

The patients

Onto the records of the health care centre


Is the data constantly updated?Is the data constantly updated?

Yes, on the basis of a yearly follow- up


How is the data collected?How is the data collected?

Via a programme on a remote Italian server


Where is the server that hosts the database?Where is the server that hosts the database?


Do you need to install a program on the PC to access?Do you need to install a program on the PC to access?


Is it possible to share the found data on a network?Is it possible to share the found data on a network?

Yes, it is

You can do this simultaneously between multiple users


From where is the data accessible?From where is the data accessible?

Wherever you are

Anywhere in the world via the internet connecting you to the project page


Are there any otherways of accessing the data?Are there any otherways of accessing the data?

Yes, every user has his own personal password for access


Is there a way of controlling the data’s safety against fraud?Is there a way of controlling the data’s safety against fraud?

Yes, for example you cannot duplicate any data entered


Is it possible to add X rays to the database?Is it possible to add X rays to the database?

Yes, in addition to the DICOM data the X ray would automatically be erased afterwards ensuring privacy by using a program especially for this purpose


Is the information of the patient’s privacy safe?Is the information of the patient’s privacy safe?

Yes, the patient is identified in the database through a number generated at random


How do you surf the database?How do you surf the database?

Through some cards linked to eachother


Who owns the data?Who owns the data?

The patients who have authorised this in written format (art.26 D.lgs 196/2003)

An authorised person is named who guarantees safety of the data (art. 28 D.lgs 196/2003)


Can the data be used to carry out a study?Can the data be used to carry out a study?

Yes, in an anonymous way


http://aismac.unior.ithttp://aismac.unior.it


CM1D CM1D Chiari Malformation 1 DatebaseChiari Malformation 1 Datebase




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PartnershipPartnership


Thank you for your kind attentionThank you for your kind attention


http://aismac.unior.it

[email protected]

Date post:	26-May-2015
Category:	Health & Medicine
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Chiari Malformation Project Database CM1 D

Health & Medicine