Workstrategy

The main mission of the DB-ALM is to provide comprehensive method descriptions and related information in order to facilitate the assessment of the usefulness of a method/model for a defined purpose that includes their use within:

  1. decision making processes by the regulators in safety assessments
  2. by any end-user in topic area of biomedical sciences and toxicology

The information content of the DB-ALM originates principally from two main working approaches:

The DB-ALM operates in collaboration with international experts in the respective fields of science for the definition of the data sheets in addition to EURL ECVAM or other JRC services in-house expertise. The activities involve the selection, evaluation and final assessment of the information originally retrieved which is finally summarised, brought in a logical order and context in one comprehensive new document and is, therefore, ready-for-use. The initial focus has been given to in vitro techniques for toxicology assessments of chemicals and/or formulations, but is not restricted to it. All data sheets are reviewed by the DB-ALM staff before including them in the public DB-ALM version.

The major challenge for the DB-ALM consists in presenting scientific information that is available in different forms and levels of detail, completeness and plausibility with various focus and often with no relation among the single information pieces in a way that is most informative, readable and understandable by the non-experts in the field, providing an overall picture about its applications, scientific principle, eventual advantage and limitations, status of development and validation including who is working on it so far. Very rarely a single publication is linked to a factual protocol or exhaustive method description. Therefore these activities imply careful analyses and selection of the papers (medially one third of the initially selected articles is disregarded during the thematic review), bringing together that is missing and presenting it as one comprehensive standardised document that it therefore ready for immediate use. All are prepared in a way that allows to be processed by database allowing structured storage, management and subsequent easy retrieval.

Thematic approach

Particularly in the past, the main working approach for the DB-ALM, was the proactive thematic reviews. To best achieve the necessary quality for the information included in the DB-ALM, the strategy of working adopted for the definition of data sheets within a thematic approach can broadly be summarised as follows:

  1. Selection and in-depth evaluation of all relevant sources and articles.
  2. Definition of a provisional method/model list.
  3. Specific searches on each method/model by using biomedical online databases and related information sources.
  4. Definition of the relevant data sheets for the topic area investigated, such as the description of the methods, protocols, test results, evaluation and formal validation studies for the topic area in accordance with pre-determined criteria for data content and data evaluation.
  5. Consultation with domain experts (in-house specialist and/or external method developers).
  6. Online publication of finalised datasheets.

Project results

At the moment project results (original work) are mainly provided in the form of Protocols. In these cases step-by-step descriptions for methods are included to such a detail that allows their transfer to a laboratory without the need of additional information. The protocols are written up by the respective method user/owner according to DB-ALM standards for data content and reviewed by DB-ALM staff before their publication online. The indication of that contact person on the document is always included.

The establishment of a harmonised and user-friendly data retrieval system is guaranteed by using harmonised data-entry formats for each data sector, defined by the DB-ALM and made available to the experts.

The data entry formats are combined with criteria documents for their compilation to ensure the provision of standardised and adequately documented methods and their related information.

The information uptake, software development and/or refinements of the DB-ALM are decided based on regular working meetings with the respective experts and emerging customer needs in compliance with EURL ECVAM priorities. As a result, the content criteria, the database content and presentation of the information online are continually evolving.

As far as the collection, analysis, treatment and publication of information are concerned, the EURL ECVAM's activities mainly address the following points:

  1. The definition of the content criteria and their evolution in the light of specific needs of the topic area under study, needs of EURL ECVAM's evaluations and customers
  2. The setting of priorities for data collection activities based on the EURL ECVAM's priorities, regulatory needs or advances in science
  3. The organisation of the information into method/model and/or clusters of methods and their classifications
  4. The maintenance and further development of classification systems/controlled vocabularies
  5. The choice of external experts and
  6. The decision on the online publication of data sheets

The data sheets for methods and related data sectors are prepared by external and EURL ECVAM's experts (including DB-ALM staff in some cases). After submission, examination is performed for consistency with eventually overlapping/similar database content and for being in line with database requirements for data content, structure, retrieval procedures ensuring the use of the controlled vocabularies. Furthermore, quality control of the finalised data sheets is carried out by the DB-ALM staff before public access is allowed.

Last page update: April 2015
feedbacktutorial