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Table 6 Different scenarios for communication between Data Holder and Researcher

From: EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers

Communication between data holder and researcher


How to implement / alternatives

Consequences if not possible

While researcher is putting together the research proposal

Researcher fully understanding which data have been collected, study design etc.

Possibility for Researchers to raise questions directly regarding data collected on the data sharing company sites.

Higher number of research proposals needing to be rejected or resubmitted following initial review.

During research to clarify understanding of study’s SAP, dataset specifications

Enable the Researcher to understand data and the analysis already conducted.

Ensure complete documentation is provided by data holder to eliminate this as much as possible

Lack of knowledge of data collected potentially leading to inappropriate analysis.

Sharing the completed analysis, interpretation and proposed publications

Sponsor is aware prior to publication of any difference in interpretation of results

Sponsor requests to be informed up front of publication. The alternative is to take a risk and deal with receiving information in parallel to it being in public domain

Differing results based on analyses of anonymized data could lead to different interpretation and raise either justifiable or unnecessary concerns in scientific and public domains