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

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