IMPACT OBSERVATORY is an international study, a tool to assess, inform, and contribute to ongoing changes of research due to sharing and reuse of research data.

Opening of research data is expected to have positive scientific, ethical, health, and economic impact thus contributing to efficiency and integrity of research. More specifically, the reanalysis of clinical trial (CT) data enables critical evaluation of performed trials and it would speed the knowledge creation. It is expected that opening of data from research on aging would have the same effect.

The IMPACT Observatory Objective is to assess the impact on research of opening of clinical trial and other research data. This project is expected to contribute to the opening of research data and refining observatory methods to assess and inform the process. The overall goal of the project is to establish the Observatory as a methodology for assessing the impact on research of the ongoing transition of data sharing, especially changes of barriers, gaps and opportunities.

Methodology: Observatories or natural experiments are empirical studies assessing the impact of one or more interventions that are not controlled by the researcher to inform the process and indicate trends.

Impact Observatory consists of three major interrelated tasks

The first task is to further a development of the IMPACT (IMProve Access to Clinical Trial data) Observatory we started in 2014. The Observatory has been assessing the CT data sharing dynamics, and its impact on research. Preliminary findings of the Observatory indicate that although there are many barriers preventing full sharing of CT data, its evolution is encouraging. Numerous players, including regulators, journals, publishers, public funders, researchers, academia, consumers, and the pharmaceutical industry lead CT data sharing initiatives.

The second task is to explore the feasibility of expanding the observatory to aging research by defining the field, identifying key players, and adapting the IMPACT Observatory methods to this interdisciplinary research area.

The third task is to develop a rich dissemination strategy and a website to attract key players to provide and use the information on data sharing in their respective fields.

Note about the acronym: IMPACT Observatory started as a project of the: IMProving Access to Clinical Trial data- IMPACT Initiative. In 2016 as we are expanding the Observatory to other research fields, starting with the interdisciplinary field of aging, the term the IMPACT became the acronym for IMProving ACcess To research data.

More information about the IMPACT Observatory can be found on  



Dr Karmela Krleza-Jeric about the chapter on e-tools for clinical trial transparency.

Dr Karmela Krleza-Jeric and colleagues published a chapter on clinical trials transparency e-tools in the 3rd edition of  Clinical Research Informatics published by Springer Nature. Throughout 25 chapters written by a number of scientists each with a specific expertise, this textbook aims at presenting the intersection between clinical research and information science, provides definitions, and numerous e-tools.  Editors of this book, Rachel Richesson, James Andrews, and Kate Fultz-Hollis expressed a belief that the content of this new edition will support the research training and infrastructure development needed to improve the efficiency and impact of clinical and translational research.


Cochrane & Global Evidence Synthesis Initiative (GESI) organized two webinars on access to clinical trial data:  on 27th February

and 27th March 2019.

In these webinars Drs Karmela Krleza-Jeric and Khaled ElEmam discussed a dynamics of the opening of clinical trial data, IMPACT Observatory, and the management of privacy of study participants. 


The study and some of its preliminary results are presented in:; DOI:10.11613/BM.2016.035

Krleza-Jeric K. Clinical Trial Registries, Results Databases, and Research Data Repositories. In: Richesson RL, Andrews JE, editors. Clinical Research Informatics. Second Edition. Springer International; 2019. p. 453–80.