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Real World Evidence (RWE) 101 – SOPs and Regional Regulations

RWE 101 – SOPs and Regional Regulations

In the realm of quality assurance (QA), it’s vital that standard operating procedures (SOPs) are crafted in a way that accurately and specifically reflects the control measures, tasks, and processes that the organization can directly influence and manage. Here are several reasons why it is not advisable to include processes in SOPs that you have no control over, such as country-specific regulations for Real-World Evidence (RWE) studies:
[1] Inaccuracy and Inconsistency: Country-specific regulations can vary significantly and may change over time. The organization has no control over these changes and thus cannot guarantee that their SOPs will stay up-to-date with the current regulations in each country.
[2] Potential for Non-Compliance: If the SOP includes processes dictated by external regulations that subsequently change, the company might unknowingly be in non-compliance. This could lead to regulatory consequences, including fines or other penalties.
[3] Confusion: Inclusion of country-specific regulations in the SOPs can cause confusion among the staff who are required to follow these procedures. If an SOP describes a procedure that is not applicable or is different in their specific context, this could lead to errors, misunderstandings, or non-compliance.
[4] SOP Management Complexity: SOPs should be as concise, clear, and easy to manage as possible. By including country-specific regulations, the SOPs become more complex and harder to maintain, which increases the risk of errors and decreases efficiency.
Instead of including country-specific regulations in SOPs, a better approach would be to make SOPs generic enough to accommodate various situations, while ensuring compliance with overarching international or regional regulations. Furthermore, local teams should be trained and have access to resources that detail the country-specific regulations applicable to them. They could also have local operating procedures or instructions that explain how the SOP should be implemented in light of these regulations.
Finally, there should be a process in place to ensure that the organization is constantly up-to-date with any changes in country-specific regulations and can adjust its procedures accordingly. This might involve dedicated personnel or teams, use of regulatory consultancy services, or subscription to regulatory update feeds. These processes would lie outside the SOPs, but would be critical to maintaining regulatory compliance.

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Real World Evidence (RWE) 101 – SOPs and Regional Regulations2023-08-07T20:02:24+00:00

Real World Evidence (RWE) 101 – Standard Operating Procedures

RWE 101 – Standard Operating Procedures

Standard Operating Procedures (SOPs) are critical for the operation of any business, particularly in regulated industries like pharmaceuticals where precision, safety, and compliance with regulatory requirements are paramount. For a pharmaceutical company, SOPs for observational studies and clinical trials should be separated due to the distinct nature and objectives of each type of study. Here are the main reasons:
[1] Different objectives: Clinical trials are experiments designed to evaluate the safety and efficacy of a new drug or intervention. On the other hand, observational studies are non-interventional; they involve the collection of data without altering the patients’ usual treatment or environment, aiming to observe and analyse patterns, effects, or outcomes.
[2] Regulatory requirements: Clinical trials are highly regulated, with strict GxP requirements from bodies like the FDA or EMA. Observational studies, while still regulated, do not fall under the same stringent GxP requirements. Having separate SOPs ensures compliance with the correct set of regulations for each type of study.

[3] Study design and conduct: The design and conduct of clinical trials and observational studies are significantly different. For instance, clinical trials are generally randomized, controlled, and blinded studies. In contrast, observational studies may involve case-control studies, cohort studies, or cross-sectional studies. Different SOPs can specify the appropriate designs, methods and checks for data collection, storage, and analysis in each case.

[4] Patient consent and confidentiality: In clinical trials, patients provide informed consent for the specific interventional treatment they will receive. In observational studies, while consent is still required, it’s often related to access and use of their medical data rather than a specific treatment. Thus, separate SOPs can address these differing requirements.
[5] Risk Management: Risks and safety considerations also vary between clinical trials and observational studies. The risks of clinical trials often relate to the new drug or intervention being tested, while observational studies’ risks typically concern data protection and patient privacy.
[6] Reporting Results: Different types of studies may also have different reporting requirements, including timelines, formats, and recipients of the information (e.g., regulatory authorities, ethics committees, sponsors).
By having separate SOPs, companies ensure that all these aspects are appropriately addressed, leading to better quality, more ethical research, and improved compliance with regulatory requirements. It also helps in training and guiding staff effectively in their roles for different studies.

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Real World Evidence (RWE) 101 – Standard Operating Procedures2023-08-07T19:53:39+00:00

HONG KONG| Updated Operational Guidelines and Procedures for the University of Hong Kong Human Research Ethics Committee

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HONG KONG| Updated Operational Guidelines and Procedures for the University of Hong Kong Human Research Ethics Committee2023-03-27T13:58:18+00:00
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