Real World Evidence (RWE) 101 – Audits

RWE 101 – Audits

A quality assurance auditor in the context of a real-world evidence (RWE) study has several responsibilities, key among them ensuring that all facets of the study align with applicable regulations, guidelines, and established protocols. In a study conducted in multiple countries, each with their unique regulatory requirements, the auditor would typically focus on the following aspects:
[1] Regulatory Compliance: The audit evaluates whether the study aligns with the different regulatory requirements of each involved country. This also includes adherence to international standards and guidelines, such as the Declaration of Helsinki and ISPE GPP, which are recognized globally.
[2] Study Protocol Adherence: The audit checks whether the study is being conducted according to the approved protocol, evaluating the study’s procedures and operations for alignment.
[3] Informed Consent: The process of obtaining informed consent from participants is critical in RWE studies. The audit reviews this process to verify that consent is obtained appropriately and aligns with the local regulations and cultural norms of each country.
[4] Data Collection, Management, and Analysis: The audit examines the processes of data collection, storage, and analysis to ensure accuracy, consistency, and compliance with data privacy regulations. This involves evaluating any electronic data capture systems, as well as the procedures for data validation and error correction.
[5] Safety Reporting: The audit reviews the systems for reporting safety and adverse events, ensuring that all events are recorded and reported properly according to regulatory requirements. The audit also checks for appropriate responses to any adverse events.
[6] Personnel Training and Qualifications: An audit reviews the training records to confirm that all personnel involved in the study have the necessary qualifications and have received suitable training.
[7] Subcontractors and Vendors: If the study employs any subcontractors or vendors (e.g., laboratories or data management companies), the audit reviews their practices and procedures to verify their adherence to required standards.
[8] Study Reports: Lastly, interim and final study reports are reviewed to ensure they accurately represent the study data and meet all required standards for scientific reporting and regulatory submission.
These areas comprise the primary focus of a quality assurance audit for a multi-country RWE study. The overarching goal is to ensure that the RWE study is conducted ethically and appropriately, with reliable and accurate resulting data.

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