Real World Evidence (RWE) 101 – Compliance Maps

RWE 101 – Compliance Maps

In the context of multi-country Real-World Evidence (RWE) studies, “Regulatory Compliance Maps” are essentially a detailed representation of the diverse regulatory requirements specific to each participating country.
RWE studies involve the analysis of data derived from a number of different sources outside of typical clinical trials, such as electronic health records (EHRs), medical claims and billing data, patient registries, and patient-generated data. Different countries have varied regulations regarding the use and sharing of such data, including the handling of patient privacy, data security, and informed consent among others.
To navigate through this complex landscape, regulatory compliance maps are created for several purposes:
[1] Understanding the Regulation: These maps help in identifying the specific regulatory requirements in each country. They define how to handle, process, store, and share patient data.
[2] Comparison: They also provide a comparative view of the regulatory landscape across different countries. This comparison allows companies to understand the relative complexity of conducting RWE studies in different regions.
[3] Planning: Based on these compliance maps, companies can strategise and design their RWE studies to ensure they meet all regulatory requirements. This might involve altering the study design or selecting specific data collection tools in different regions.
[4] Risk Mitigation: By understanding the specific regulations in each region, companies can take proactive steps to minimize risks associated with non-compliance, which might lead to legal repercussions or reputational damage.
[5] Collaboration: These maps also facilitate better communication and cooperation with local authorities, including IRBs/RECs, as they demonstrate the company’s understanding and respect for local regulations.
Creating and maintaining regulatory compliance maps can be a complex task due to the evolving nature of regulations, the diversity of data sources, and the need for expertise in different jurisdictional laws. However, it is an essential part of conducting efficient and ethical multi-country RWE studies.

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