Table 3.

Summary of sponsors’ perceptions.

Regulatory	Legal	Technological	Organizational
Investigators still assessing many reports causally related and sponsors may agree with their assessment. A desire to not go against the investigators’ causality assessment as they feel they are at point of care and understand the patient better than the sponsor. Fear that underreporting may lead to regulatory repercussions, such as inspections or audits. Lack of global harmonization on reporting rules.	Impact on the marketplace of a perception of underreporting events. Perception of concern if during a legal challenge cases were marked as related by investigators but not many by sponsors (i.e. may be interpreted as the sponsor “hiding” events).	More popular safety systems can route reports based on reporting rules to recognize the different regulatory requirements in different countries Sponsor companies may be “masking” the real issue of submitting reports that do not adhere to the final rule by trying to make the process easier with electronic portals.	Fully complying with the final rule requires cultural and infrastructural changes that are difficult and time-consuming to implement. Key personnel may not fully understand the nuances of the final rule.