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Table 3 Items to be considered for a standardized description of databases/registries

From: A methodological framework for drug development in rare diseases

Items Examples
Type of database Registry
Objectives Include extensive information on all forms of a given rare disease grouped within several main categories
Database conception Team composed of clinicians and databank professionals
Recruitment sources Nationwide recruited patients
Inclusion/exclusion criteria Number of variables collected per patient at each visit
Follow-up characteristics: Number of follow-up visits per year for each patient
Main results Launch date
Total number of patients
Median duration of follow-up
Number of centers
Database perpetuation Specific contacts with the coordinating team through e-mail, phone calls and local visits, periodic meetings with all affiliated centers.
Technical aspects Use of a secured Internet protocol into a safe database through a web interface and specification of the characteristics of the available export formats
Ergonomic aspects Rolling menus and data entry forms accessible to unskilled users
Cross-linking of registries In order to share and compare data with other similar registries in other nations
Quality control A data manager/technical team should be in charge of quality control, monitoring for data coherence, absence of duplicates, and transfer of data
Organization/management rules A charter describes general rules relating to organization and rules governing access to data
Data sharing Rules for sharing: for cross-centre studies, the respective centers must agree explicitly to share its anonymous data with other centers
Confidentiality of patient records All subjects receive a unique study-identification code, which anonymizes the records. Only the registry's main investigators know the code and are able to link an individual report to an individual patient
Ethical considerations Informed consent characteristics
Funding sources, competing interests To be extensively specified