Requests for data that are not already available in a secure data sharing platform will undergo a Due Diligence Assessment by the Data Holder. The primary purpose of the Due Diligence Assessment is for the Data Holder to provide the YODA Project with an assessment of its ability to make the data available to be shared externally, reviewing the Data Holder’s legal and regulatory considerations in order to determine if they have legal and ethical rights to make the data available to external investigators for scientific purposes. However, the Due Diligence Assessment will also include estimation of the resources that would be required to make the data available to external requestors, such as the time and effort required to de-identify data in compliance with current regional standards to protect patient privacy and prepare the necessary accompanying documentation, providing an understanding of the technical considerations for the release of older clinical trial data that do not exist in an easily shareable format. The rationale for collecting this information is to broadly inform the field with estimates of resources required by Data Holders to make data available.
The Due Diligence Assessment will also include determination as to whether other researchers, either internally employed by or externally affiliated with the Data Holder, are engaged in similar research studies. The rationale for making this determination is so that external requestors are made aware of similar ongoing research efforts (so that there are no misunderstandings about generation of research ideas), as well as to foster collaborations. Requests for data that are already listed as available on the YODA Project website will undergo a Due Diligence Assessment by the Data Holder for this purpose only.
Lastly, the Due Diligence Assessment assesses whether the proposed research can be reasonably addressed using the requested data, including whether the variables needed for the proposed analysis are included in the requested data and whether the research question can be addressed using summary-level data. Refer to YODA Project Data Release Policies and Procedures (Section 4) for further information.
The Due Diligence Assessment form being used by Johnson & Johnson can be reviewed here.