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

Table 2 Typical End to End Process for requesting Patient Level Data (PLD)

Step	Considerations
1. Develop PLD research proposal	What studies have been conducted?
	Who is the Data Holder?
	Do they have a data access policy and is this study available?
	Could access to the CSR help inform the research proposal development?
	Does the Data Holder have a specific template for the research proposal?
2. Submission and review of research proposal	Who will review it? Independent review panel or within the Data Holder organisation?
	Data Holder’s expectations for sharing data
	Researcher’s expectations for accessing data
3. Dataset preparation for external sharing	How will the data be shared? (open, secure system or other?)
	Data Sharing Agreement review and sign-off
	Data de-identification principles
4. Analysis	Data package contents
4. Analysis	Opportunities to ask questions
5. Reporting / Publication	Data Holder’s expectations regarding publication of the results.
	Referencing the data source
	Any commitments to share the results/manuscript prior to publication?

ISSN: 1471-2288