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Table 6 Different scenarios for communication between Data Holder and Researcher
| Communication between data holder and researcher | Purpose | 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 |
