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Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections

RWE 101 – Real World Evidence (RWE) 101 – Audits vs Inspections

In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, but they differ primarily in their purpose, scope, and the parties conducting them.

1. AUDIT: An audit is usually a more routine, self-regulated evaluation of the RWE processes and controls in place to ensure regulatory compliance, data quality, and data integrity. These audits may be performed by internal staff (internal audit) or by an external independent party (external audit). They focus on examining the documentation, systems, and procedures that are in place to ensure they are in compliance with regulatory standards, policies, and best practices. The ultimate goal of an audit is to provide assurance that the RWE produced is reliable, valid, and can be trusted for making health care decisions.

2. INSPECTION: An inspection is typically a more formal, structured examination conducted by regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Inspections often occur less frequently than audits and are usually more comprehensive and rigorous. They’re conducted to ensure that the data and processes being used comply with regulatory standards, guidelines, and laws. An inspection often focuses not only on compliance but also on enforcement, with potential consequences for significant non-compliance, including fines, penalties, and potentially barring the use of the collected RWE in regulatory decision-making.

In summary, while both audits and inspections aim to ensure regulatory compliance and high-quality, reliable RWE, audits are often more routine and self-directed evaluations, while inspections are formal evaluations conducted by regulatory bodies with an emphasis on compliance and enforcement.

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Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections2023-08-09T14:51:12+00:00

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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Real World Evidence (RWE) 101 – Audits2023-08-07T21:01:15+00:00
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