Throughout the development of the Policy and Procedures to Guide External Investigator Access to Clinical Trial Data, the YODA Project aimed to support its core principles. Many issues and ideas arose throughout the development process that required careful consideration by the YODA Project on how to move forward. The YODA Project spent the past few months determining how best to handle the following questions and situations:

• How to fulfill a data request when the requested data were generated many years ago and are not in shareable data files? Much clinical trial data generated prior to 1990 may only be available in paper formats and not readily accessible.
• There will be requests for data that cannot legally or ethically be filled. For instance, data requests for which the privacy and confidentiality of research participants and their data cannot be protected or the clinical trial informed consent does not allow the sharing of de-identified data for public health research or educational purposes cannot be filled. Additionally, data requests for a compound that has been obtained from or has been developed in collaboration with an external partner will require agreement on data sharing from all involved partners before a request can be approved.
• How much time and effort is required for appropriate data de-identification as per current regional standards to protect patient privacy as well as preparation of the necessary accompanying documentation before the data are made available?

The YODA Project implemented a staged approach to data access to better understand the time, effort and data formats necessary to release clinical trial data. This data release pilot project included a Due Diligence Assessment by Janssen Pharmaceuticals to assess the following:

• Its ability to make the data available to be shared externally, including 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 informed consent documentation from clinical trials of interest to ensure that the rights and privacy of research participants are upheld
• The time and effort required for appropriate data de-identification as per current regional standards to protect patient privacy as well as preparation of the necessary accompanying documentation

The results of this pilot project have helped to inform and improve the YODA Project data release process.