Report with procedures for evidence retrieval and synthesis for the knowledge bank

Task 5.2 Developing an EU centralised open access digital knowledge bank (M6- 60) (LAREB, Sanofi SCC, ENTIS, ORC, the Synergist, EIWH, NVS, AbbVie, UCB, Pfizer) Rationale: By creating an EU centralised digital knowledge bank providing timely and high-quality general information and summary and interpretation of scientific research in literature and of data collected (from WP1 and WP2) this task will contribute to more harmonised and reliable evidence dissemination for the general public, pregnant or breastfeeding women and HCPs. Official labelling information will also be available in the knowledge bank. Members of ENTIS already have their own systems for keeping up to date knowledge of high quality. Some centres have a national knowledge bank, and some also available on their website. A common model to share the safety information they have collected is not yet in place. At this moment each country collects and interprets the scientific data themselves. By joining forces and introducing work-sharing between the members in a network, timely, uniform and high-quality information will be available to all European countries. Objective: The aim of this task is to develop an EU centralised digital knowledge bank for up to date information of drug use before and during pregnancy and breastfeeding and the risks of untreated disease (in English) for a selection of diseases and drugs that are common in pregnancy by combining information from different sources and providing common knowledge. The knowledge bank will start with information on drugs mostly used by women 15-45 years; drugs on which most often advise has been asked for. After the start the repository can be expanded and continuously be updated. General system requirements: The information in the digital knowledge database will be publicly available. The content of the database will be available (in English) through a website and interfaces will be built so that national translations will be accessible to share with 3rd parties such as other apps and websites in the country. A prerequisite for the digital knowledge databank is that all stakeholders have confidence in the quality and reliability of the information. ENTIS will be responsible for quality control. A peer reviewed system and protocol for screening and interpretation scientific research will be developed to add or change information into the knowledge bank to ensure reliability and that the information is up to date. This task is further sub-divided into the following sub-tasks: Sub-task 5.2.1: Agree upon the functionality of the database Aim: To define the functionalities of the database. This includes; but is not limited to indexing of information, searching information, presenting information and presenting references for the information given. Method: Designing meeting with contributors and partners developing the tool will be organised to agree on the functionality of the database. Stakeholder feedback will be organised in collaboration with WP6. Sub-task 5.2.2: Build a knowledge management database Aim: To build the knowledge bank Method: the knowledge bank will be built by ORCION in an agile way with the possibility to change things if deemed necessary, so that the final product will fit the needs of the end-users. To ensure usability the knowledge bank will be tested in cycles by WP5 members and stakeholders, to make sure that it fits with their needs. Sub-task 5.2.3: Interconnectivity Rationale: Making Translation of information possible to local language /national adaptations of the content is important. In local settings, it is possible that the safety information will need to be accessed at other points in the healthcare system than the central EU webpage, for example in apps or as part of other websites. A system to ensure the quality and reliability of the translation will be developed. Aim: to build Application programming interfaces (API) to allow for interconnectivity with local websites an