Data terminology

What is data sharing?

Data sharing is the practice of making research data available to other investigators.

What is data standardization?

Data standardization is the critical process of bringing data into a common format that allows for collaborative research, large-scale analytics, and sharing of sophisticated tools and methodologies.

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What is data harmonization?

Data harmonization involves transferring data from a source system, often a proprietary one, to a common data representation, such as OHDSI’s OMOP CDM. This process can vary in complexity depending on how the source data is structured, how the information is coded (or not coded), language, volume of data, and other factors.

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What does ETL stand for?

ETL is short for extract, transform & load. Three database functions that are combined into one tool to pull data out of one database and place it into another database.

  • Extract is the process of reading data from a database. In this stage, the data is collected, often from multiple and different types of sources.
  • Transform is the process of converting the extracted data from its previous form into the form it needs to be in so that it can be placed into another database. Transformation occurs by using rules or lookup tables or by combining the data with other data.
  • Load is the process of writing the data into the target database. The ETL process is often used in data warehousing.
What do the FAIR principles stand for?

The FAIR Data Principles are a set of guiding principles in order to make data “findable”, “accessible”, “interoperable” and ”reusable”.

What is the GDPR?

The General Data Protection Regulation (EU) 2016/679 is a regulation in EU law on data protection and privacy in the European Union (EU) and the European Economic Area (EEA). It also addresses the transfer of personal data outside the EU and EEA areas. The GDPR aims primarily to give control to individuals over their personal data and to simplify the regulatory environment for international business by unifying the regulation within the EU. Superseding the Data Protection Directive 95/46/EC, the regulation contains provisions and requirements related to the processing of personal data of individuals (formally called data subjects in the GDPR) who reside in the EEA, and applies to any enterprise—regardless of its location and the data subjects' citizenship or residence—that is processing the personal information of data subjects inside the EEA.

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What is OHDSI?

Observational Health Data Sciences & Informatics is a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics. All their solutions are open-source.

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What is the OMOP CDM?

OMOP stand for the Observational Medical Outcomes Partnership. The OMOP Common Data Model (CDM) allows for the systematic analysis of disparate observational databases. The concept behind this approach is to transform data contained within those databases into a common format (data model) as well as a common representation (terminologies, vocabularies, coding schemes), and then perform systematic analyses using a library of standard analytic routines that have been written based on the common format.

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Regulatory terminology

What is the difference between Regulatory agencies, HTA bodies and payers?

All of these play key roles in enabling people to access new drugs. This includes approving and assessing the quality, safety and efficacy of medicines (regulators); reviewing the clinical and in some cases, the cost effectiveness of medicines compared with standard practice (HTA bodies); and funding access to health care and support for people with neurodegenerative disorders (payers).

What are Regulatory agencies?

Regulatory agencies are responsible for the assessment and authorisation of medicines. Before a medicine can be marketed and made available to patients, medicine developers must submit an application for marketing authorisation to the relevant regulatory authority. The regulator will then assess the quality, efficacy and safety of the medicine and determine if the benefits of the medicine outweigh its risks in the group of patients for whom the medicine is intended. In the EU there are four main routes for a medicine to receive a marketing authorisation:

  • Centralised procedure: The centralised procedure is compulsory for certain types of medicines and optional for others. Approval of medicines through this procedure enables medicine developers to market a medicine throughout the EU as well as Iceland, Lichtenstein and Norway. Applications authorised through this procedure are granted by the European Medicines Agency (EMA).
  • National procedure: Authorisations through this procedure are granted by national regulatory authorities and limit the marketing of medicines to the country in which authorisation is granted.
  • Mutual Recognition procedure: Through this procedure, if a medicine developer has marketing authorisation for a medicine in 1 or more EU country, they can apply for this authorisation to be recognised in other EU countries.
  • Decentralised procedure: This procedure allows medicine developers to apply for a marketing authorisation of a new medicine in more than one EU country at the same time. The initial assessment is undertaken by one EU country (the Reference member state) and then submitted to other EU countries (the Concerned members states) for validation and approval.
What does accelerated assessment mean?

The European Medicines Agency offers an accelerated assessment process with shorter assessment times for drugs that meet certain criteria, such as those that are a major interest for public health or aimed at addressing unmet medical needs. The assessment time for marketing authorisation is reduced from 210 days to 150 days or less.

What is a conditional marketing authorisation?

Conditional marketing authorisation enables earlier access to medicines which fulfill an unmet medical need but for which less comprehensive clinical data is available. To receive a conditional marketing authorisation, the benefit of the medicine being immediately available should outweigh any risks associated with the lack of availability of data. As part of the conditional approval, medicine developers will have specific obligations to gather more comprehensive data, for example through ongoing or new studies.

What is the Innovation Task Force (ITF)?

The European Medicines Agency’s Innovation Task Force (ITF) provides an opportunity for academics, researchers, and small to medium sized enterprises (SMEs) to enter informal discussions with European Medicines Agency staff and scientific committee members about their research activities. Discussions can focus on scientific, legal and regulatory aspects relating to the development of new medicines or new scientific approaches that might be used during drug development or approval (e.g. biomarkers, modelling and simulation, or novel clinical trial methodology), and to identify other more formal regulatory procedures that might be appropriate.

What is the Qualification of Novel Methodologies (QoNM) procedure?

The Qualification of Novel Methodologies (QoNM) procedure is a type of scientific advice offered by the European Medicines Agency which is available to pharmaceutical companies, research consortia, networks, or public-private partnerships. The QoNM allows for a regulatory assessment of methods and tools that are intended to be used in drug development (e.g. new biomarkers, disease models, etc) and results in either:

  • A ‘qualification opinion’ on the acceptability of a proposed new method/tool, based on the assessment of protocols, study reports and supportive data.
  • ‘Qualification Advice’ on draft protocols and development plans relating to a proposed method/tool, based on the evaluation of scientific rationale and preliminary data.

Qualification advice/opinion is taken into consideration during the Marketing Authorisation Application.

What is meant by the term Scientific Advice in a regulatory context?

Scientific Advice enables medicine developers to ask questions about their evidence development plans and clinical trial designs to support marketing authorisation applications and Health Technology Assessment submissions for new medicines. Several regulatory agencies and Health Technology Assessment bodies provide scientific advice, including the European Medicines Agency, national regulatory agencies, and Health Technology Assessment bodies.