Recommendation	Rationale
Develop and make available knowledge about your RWD source.	Accurate interpretation of RWE requires a detailed understanding of each RWD source. Ideally, a representative of each data partner may be part of the study team, but this is not always possible. In addition to overall descriptive statistics, meta‐data should be made available such as how information was captured, by whom, and in which populations, etc., as well as listing any known biases or exclusions. For examples of relevant meta‐data, see https://catalogues.ema.europa.eu
Adopt streamlined data access approval processes and harmonize requirements for study protocols across RWD sources.	Pharmacovigilance operates under short timelines and, depending on the signal, may need access to multiple sources of RWD to support signal management, either separately or in a network study. The greater the efforts and longer the waiting times to secure approvals, the less likely it is that RWD will influence decision‐making during signal management.
Consider data access approval for overarching study designs/master protocols for pharmacovigilance use cases.	When pharmacovigilance signals are detected, they need to be assessed with minimal delays. Pharmacovigilance is on the lookout for the unexpected and can generally not be restricted to a small set of drug‐outcome pairs of interest. Overarching study designs/master protocols may use prespecified (and benchmarked) reproducible analytical workflows but include broad sets of drug‐outcome pairs of potential interest.
Map datasets (and maintain mappings) to the broadly used Common Data Models, including their standard vocabularies	Up‐front mapping of data to a Common Data Model (or to multiple CDMs) including standard vocabularies enables execution of reproducible analytical workflows within the restricted time frames required to support pharmacovigilance signal management, and the inclusion of the RWD source in network studies.
Develop capability and infrastructure to execute reproducible analytical workflows in support of major signal management use cases	To enable timely generation of RWE in support of the signal management use cases.
Consider embedding data collection in support of pharmacovigilance and pharmacoepidemiological analyses within existing or new health data systems	Targeted collection of more detailed data would enable RWD analyses that can better support signal management and also execution of active surveillance/registry collection within existing health data systems. This may include capturing information on brand names, lack of efficacy or exacerbation of other conditions, indications for treatment, differential diagnoses, or explicitly confirmed treatment/outcome start dates to reduce the risk of misclassification.