Detailed name Investigation or database title.
Sign or acronym Acronym or initials used to designate the database or investigation.
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Database authorisation number issued by the CNIL (French Commission for Data Protection). According to biomedical research law (Hurriez-Sérusclat Law), if the study or investigation is within the scope of interventional research i.e., which involves (or involved) diagnostic or therapeutic procedures or monitoring that is an additional or unusual procedure in relation to current care, the authorisation number and acquisition date issued by the CPP (Ethics Research Committee) should be specified.
Medical area Different medical areas covered in the database.
Pathology (details) Name(s) of pathology(ies) or health problem(s) that are identified in the database.
Health determinants Health determinants studied in the database.
Others (details) Aspect(s) (medical areas or health determinants) relevant to your database and are not in the above list.
Keywords Words or phrases that are specifically important for referencing and characterisation of the database or investigation. Keywords that improve database positioning and visibility.
Participation in projects, networks and consortia Participation or non-participation in consortia work and discussions, or projects (e.g. European projects, etc.)
Details Name of projects, networks and consortia concerned.
Others Other collaborations as part of the database.
Funding status Status of funding sources used to create the database, as well as those contributing to its maintenance and/or development.
Details Funding sources used to create the database, as well as those contributing to its maintenance and/or development.
Presence of scientific or steering committees Presence or absence of a committee responsible for ensuring the smooth running of the database (project follow-up, strategic choices, etc.).
Labelling and database evaluation Awarding a quality label to the database and evaluating the database (internal/external audit).
Scientific investigator Person(s) who are scientifically responsible for the database. This (these) person(s) agree to be contacted for any questions related to the database. In some cases, it is advisable to appoint an additional contact person.
Additional contact Advises an additional contact person.
Main features
Type of database Describe the type of database concerned. Administrative database: Relevant administrative healthcare database most often designed for management purposes. Register: A register is a continuous collection of individual data concerning one or more health events, aiming to comprehensively include a geographically defined population, for public health/research purposes Database after investigation: Cohort studies, case-control studies, cross-sectional studies (repeated or not repeated), longitudinal studies
Study databases (details) Cohort: A cohort consists of a set of subjects sharing a number of common characteristics that are monitored over time at an individual level to identify the occurrence of specific health events. A cohort study is based on following a pre-established protocol that involves the collection of information, as well as follow-up procedures for subjects (active or passive), so that the occurrence of specific health events may be identified without bias. Case-control study: Observational study where the characteristics and exposure of subjects with a defined pathology (the case) are compared with subjects free from the disease (the controls). Cross-sectional study: Observational study that describes that characteristics and exposure of a set of subjects collected at the time of recruitment. Longitudinal study: Observational study that describes that characteristics and exposure of set of subjects collected during successive contact with the healthcare system.
Database recruitment is carried out by an intermediary Origin of patient recruitment: Intermediary that recruited patients to database.
Base or register (detail) Base or register concerned
Database recruitment is is made on the basis of: Participant selection criteria: Identification criteria for participants in the database.
Database recruitment is carried out as part of an interventional study Interventional research corresponds to studies within the scope of biomedical research law (Hurriez-Sérusclat Law) i.e., which involves (or involved) diagnostic or therapeutic procedures or monitoring that is an additional or unusual procedure in relation to current care.
Details Level at which intervention takes place.
Additional information regarding sample selection. Sample selection procedures (sampling plan, means of selection and recruitment of subjects with the required inclusion criteria), or case selection and registration procedures. Example 1: A random selection is made from the electoral roll of subjects residing in Montpellier and its suburbs. 5,000 subjects were randomly drawn and contacted to participate in the study. Example 2: Cases are registered by correlating several identification sources (regional health insurance databases, discharge summaries for hospital stays [PMSI], etc.)
Main objective Main and/or secondary objectives linked to the database. If the database objectives are changed over time, the initial database objectives are first described, followed by future objectives.
Inclusion criteria Condition group that must be met for database inclusion.
Age Age groups of subjects relevant to the database.
Population covered This field indicates if the relevant database population consists of: - a population only defined geographically (inhabitants of a city, region, country, etc.) and not according to other characteristics: General populations, - only subjects with a defined disease: Sick subjects.
Pathology Indicates pathologies according to the ICD-10.
Gender If the relevant database population consists of subjects that are: - of male sex: Male, - of female sex: Female, - Other (transsexual, etc.): Both.
Geography area If the place of residence (or place of business, hospitalisation or birth) for individuals whose data are included in the database are distributed: - throughout several different countries: International - throughout the national territory: National (examples: throughout France, various regions, etc.) - at regional level: Regional (examples: throughout the PACA region, in all departments in Brittany except Morbihan, etc.) - at department level: Departmental (examples: throughout Gironde, in several Morbihan municipalities, etc.) - and limited to a city, well-defined canton, etc.: Local (examples: throughout Grenoble city, etc.)
French regions covered by the database Detail of the french regions covered by the database.
Detail of the geography area Place of residence (or place of work hospitalisation or birth) for individuals whose data are registered in the database.
Data collection
Date of first collection (YYYY or MM/YYYY) Date when information was first collected in the database, in YYYY or MM/YYYY format. Examples: 1968, 05/1981, 10/2010
Date of last collection (YYYY or MM/YYYY) Past or planned date for the final collection of information that is included (or eligible to be included) in the database, in YYYY or MM/YYYY format. This field should not be completed if there is no fixed final date for data collection (indefinite collection period). Similarly, this field should not be completed if the database is driven by a repeated cross-sectional investigation over time with no final date defined a priori. See "Data collection procedures" field.
Details of the number of individuals Details of the number of individuals included in the database (numeric value).
Database activity If data collection for the database: - is in progress: Collection of active data, - is completed: Completed data collection.
Type of data collected Type(s) of data registered in the database, given that: - administrative data usually correspond to people's identification data (such as civil status), but may cover a broader spectrum. Data are collected indirectly through administrative data sources or directly through database subjects; - biological data for biological examinations carried out specifically for the study, or following a treatment protocol whose results are included in the database; - clinical data related to medical observation. They are resulting from the observation of a person or possible symptom during medical examination. Data can be collected directly by medical staff following an ad-hoc medical examination carried out for the database, or extracts from medical records; - declarative data are data collected from individuals based on their responses to questionnaires. Individuals can complete the same questionnaires (handwritten or online self-administered questionnaires), or they can be interviewed for this questionnaire by another person according to different procedures (face to face, by email or phone);- Paraclinical data (excluding biology) are imaging, spirometry examinations, etc. that are performed.
Clinical data (detail) Type(s) of clinical data registered in the database.
Details of collected clinical data Details of clinical data registered in the database.
Declarative data (detail) Type(s) of declarative data registered in the database.
Details of collected declarative data Details of declarative data registered in the database.
Paraclinical data (detail) Details of paraclinical data registered in the database.
Biological data (detail) Details of biological data registered in the database.
Administrative data (detail) Details of administrative data registered in the database.
Cost data (detail) Detail of the cost data collected by the database.
Utility / preference data (detail) Detail of the utility and preference data collected by the database.
Presence of a biobank Presence or absence of a biobank, i.e., a collection of stored biological samples from the database.
Contents of biobank Type(s) of biological samples stored in the biobank.
Details of biobank content Details concerning the stored biobank biological samples from the database.
Health parameters studied Health parameters documented by the database.
Care consumption (detail) Types of consumed care documented by the database to assess this parameter.
Quality of life/perceived health (detail) Tools and methods used for quantifying database parameters for quality of life and perceived health.
Other (detail) Types of health events that are not categorized in the list and can be documented in the database.
Data collection method Method used and sources consulted for data collection. E.g., organisation of the collection, establishing a validation body, etc.
Classifications used Common or specific classification(s) used by the database regarding sociodemographic variables, main health variables and health determinants in particular. Example: International Classification of Diseases (currently ICD 10); MeSH, etc.
Quality procedure(s) used Details of collaborating methodology centre (e.g., epidemiology team, biostatistics team, CIC etc.) and the database management software.
Participant monitoring Introduction or non-introduction of monitoring to identify the possible occurrence of an event in an individual or population.
Details on monitoring of participants Individual monitoring details: duration, progress, etc. specific characteristics at each stage of data collection. It may be stated if there are specific aspects addressed in one or more monitoring phases. Example: Total monitoring period is 5 years. Subjects are seen at enrolment and at 4 years for a medical examination. They are contacted again every year to answer an invariant questionnaire (major health events that occurred since last contact, life style, etc.). A nutrition section is added to the questionnaire at three years. A blood sample is taken during the medical visit at 4 years.
Links to administrative sources Correlating the database with medical administrative data to monitor subjects and/or complete the database. Example: CépiDC, RNIPP, SNIRAM, etc.
Linked administrative sources (detail) Medical administrative databases used as sources. Examples: CéPIDC, SNIIRAM, etc.
Promotion and access
List of publications related to the database File or link to publications from the database (links to HAL-Inserm and PubMed are recommended).
Other information Other elements related to database promotion.
Dedicated website Address or website dedicated to the database or investigation and/or allows a browser to access the site by connecting to it directly. Example: https://pandora.vjf.inserm.fr/public/
Presence of document that lists variables and coding procedures Presence or absence of coding dictionary to allow familiarisation of variables and coding procedures.
Terms of data access (charter for data provision, format of data, availability delay) Complete or partial access to data in the database for external teams that wish to carry out analyses from this data. If access to data from the database is not defined and if future access to this data is possible, the field shall state: "access to the database is currently being defined".

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