CaNIOS Registry

Introduction

CaNIOS National Registry is a web based database hosting all CaNIOS data under one roof. The datasets we collect are Demographics, Medication Information, ACR Criteria, SF36 version 1, SLEDAI 2K, SLAM and SLICC measurements. The ideal is to populate and combine data from different centers to describe SLE in Canadian population, increase the power of medical research, and exchange valuable clinical information between doctors and researchers.

Technology

We use cutting edge Information Technology to host and exchange data through the Internet. The hosting software company has expertise in Health Industry practice. It has built several disease registry/reporting systems and databases for health professional associations. The data hosted or exchanged on the CaNIOS National Registry are encrypted by using Secure Socket Layer (SSL). The web based database is very flexible, allowing a CaNIOS Data Administrator to incorporate all data without changing their data format. All centres will be able to upload and download their own data after the basic database structure is set by the Data Administrator. Data exchange online is possible after all privacy agreements are signed. Designated window will be opened for a period of time the centres who sign the agreements. The system will be set up so there will be three types of users working on the database: Administrator, PI and Research Assistants. Each user will have different privileges on the database that will be assigned to a research centre.

Access to the National Registry web site

Access to the CaNIOS National Registry is strictly restricted to registered CaNIOS members on the National Registry web site. Some basic training is needed to get data transfer up and down the server. Here is the the link to the CaNIOS National Registry.

Data Access

The CaNIOS Data Access Sub-Committee is the arbiter between CaNIOS centres and CaNIOS management centre. It responds to requests for data from CaNIOS researchers. It will gather and record any primary project information, data access information, and correspondence information. The goal of this sub-committee is to make sure the data is safe, confidential and properly used.

Process

The process for data access will follow the steps on the Data Access Flowchart described here:

A CaNIOS Investigator (requestor who has signed the Confidentiality Agreement and Letter of Intent) will submit the Data Request Form. This form includes information of: which centres information is required, the variables required (not necessary are the specific variable name), who of his team will have access to the dataset, estimated time of completion of examination of dataset and also the copy of Research Ethnics Board Approval. This request will be made through CaNIOS Data Administrator (DA). The DA is then responsible for sending out the report to the members of the committee requesting a review and decision. If needed a conference call will be scheduled. If needed, the DA will contact the requestor for clarifications, further explanations, Although this is not to be a scientific validity review. The committee’s recommendations are submitted to the CaNIOS Executive for review. The final decision will be given by the Data Access Sub-committee and CaNIOS Executive Board. The decision will be passed on to the DA. The DA will contact the center who owns the data for permission to use their data by the requestor. A copy of the Request Form will accompany the e-mail along with the comments from both committees. There will be a 2-week delay for response. If no response is received then the assumption will be willingness to have the centre’s cohort data shared with requestor. The DA will gather the dataset from CaNIOS National Database or assign the requester the right to download data from Internet. Requestor will perform the analyses wished and return the dataset to the DA in specified time limit. Also to return to the DA the SAS files with dataset information. The DA will store in file named by Investigator and study.

Things are recorded in Data Communication Sub-Committee

a) Each request will be assigned a unique number and the information on the request form will also be recorded in an Access Database.
b) Dates: sub-committee was e-mailed request; final response and recommendation; executive committee was e-mailed; subcommittee recommendation; executive final recommendation; recommendations returned to requestor; request sent to listed participating centres
c) Answer of each centres and date sent to investigator
d) Date dataset sent to requestor
e) Date dataset and analyses files returned to the DA.
f) A quarterly report submitted to the executive and sub-committee.

Data user’s responsibility

a) The Data user (DU) will be the only user of the data unless written authorization has been received from the Data Access Sub-Committee in CaNIOS. DU will not use the data for any purpose other than for statistical reporting and analysis.
b) DU will keep the data in a secure the place or media to which DU have sole access.
c) DU will not present/publish data in which an individual can be identified.
d) Within 6 months of receipt of data from CaNIOS, all source data and intermediate data should be destroyed or returned to the Data Access Sub-Committee.
e) The Data Access Sub-Committee should be acknowledged the reports or papers prior to publication or public release, which result from the use of the data.
f) DU may not sell, rent, lease, or transfer the data to any one else. DU will not copy the data or any part of it for use by anyone else, nor may DU transfer or convert the data to any other medium for use by anyone else. DU may not develop or derive for sale or distribution any product in machine-readable form that incorporates or uses any substantial part of these data.