{"id":81,"date":"2024-12-17T10:10:12","date_gmt":"2024-12-17T09:10:12","guid":{"rendered":"https:\/\/clinicaltrials4u.pl\/?page_id=81"},"modified":"2025-05-13T11:29:19","modified_gmt":"2025-05-13T09:29:19","slug":"baza-wiedzy","status":"publish","type":"page","link":"https:\/\/clinicaltrials4u.pl\/en\/baza-wiedzy\/","title":{"rendered":"Knowledge base"},"content":{"rendered":"
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Group\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tAdverse Drug Reaction (ADR)<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

What is ADR?<\/strong><\/h3>

ADR (Adverse Drug Reaction)<\/strong>, czyli niepo\u017c\u0105dana reakcja na lek<\/strong>is any harmful and unintended response to a medicinal product that occurs when it is used at standard doses for treatment or prevention.<\/p>

\ud83d\udcd6 Examples of ADRs:<\/strong>
\u2714 Nausea<\/strong>
\u2714 Rash<\/strong>
\u2714 Headache<\/strong>
\u2714 More serious side effects<\/strong><\/p>

Any reaction that was not intended may be classified as an ADR and requires monitoring.<\/p>

Why is ADR monitoring so important?<\/strong><\/h3>

In clinical trials, careful monitoring of adverse drug reactions is crucial for ensuring participant safety and assessing the risks associated with a new medicinal product.<\/p>

Did you know?<\/strong><\/h3>

Sometimes ADRs can lead to the discovery of new medical uses for existing drugs!
Example: Minoxidil<\/strong>, originally developed to treat hypertension, turned out to be effective in\u2026 stimulating hair growth.<\/strong>. \ud83e\uddf4\ud83d\udc69\u200d\ud83e\uddb1<\/p>

Find out more in our post on Instagram<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tAdverse Event (AE) i Serious Adverse Event (SAE)<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

What is an AE?<\/strong><\/h3>

An Adverse Event (AE)<\/strong>, czyli Zdarzenie Niepo\u017c\u0105dane<\/strong>is any unfavorable medical occurrence experienced by a clinical trial participant during the use of an investigational product, regardless of its relationship to the study drug.<\/p>

Examples of AEs include:
\u2714 Headache<\/strong>
\u2714 Fever<\/strong>
\u2714 Rash<\/strong><\/p>

Any deviation from the participant\u2019s pre-study health condition may be considered an AE.<\/p>

What is an SAE?<\/strong><\/h3>

A Serious Adverse Event (SAE)<\/strong>, czyli Powa\u017cne Zdarzenie Niepo\u017c\u0105dane<\/strong>is an AE that meets at least one of the following criteria:<\/p>

\ud83d\udd4a Leads to death<\/strong>
\ud83d\udc94 Is life-threatening<\/strong>
\ud83c\udfe5 Requires hospitalization or prolongation of existing hospitalization<\/strong>
\ud83e\udde0 Results in significant or persistent disability\/incapacity<\/strong>
\ud83d\udc76 Causes a congenital anomaly or birth defect<\/strong><\/p>

What is the difference between AE and SAE?<\/strong><\/h3>

Every SAE is an AE, but not every AE is an SAE.\nThe key differentiating factor is the severity of the event and its impact on the participant\u2019s health.<\/p>

Why is rapid SAE reporting important?<\/strong><\/h3>

Prompt reporting of serious adverse events allows researchers to assess the safety of the investigational product and take appropriate protective actions for study participants.\nIt is a key component of risk monitoring in clinical trials.<\/p>

Find out more in our post on Instagram<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tASSENT \u2013 Active Consent of a Minor<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

Definition<\/strong><\/h3>

“Affirmative agreement of a minor to participate in a clinical trial. The absence of expression of agreement or disagreement should not be interpreted as assent.”<\/p>

Active consent (assent) refers to the conscious and explicit confirmation by a minor of their willingness to participate in a clinical trial.\nThe lack of expressed agreement or disagreement cannot be considered as consent.<\/p>

The Role of Assent in Clinical Trials<\/strong><\/h3>

The process of obtaining assent should be tailored to the child\u2019s age and level of maturity.\nAlthough a minor\u2019s assent does not replace the formal consent required from legal representatives (parents or guardians), it remains a crucial element of ethical clinical research.\nIt demonstrates the child\u2019s understanding of the study and their willingness to cooperate.<\/p>

Legal Regulations Concerning Assent<\/strong><\/h3>

\ud83d\udcdc ICH GCP E6(R3), section 2.8.12:<\/strong>:
\u201cWhen a minor is to be enrolled as a subject, information appropriate to their age and understanding should be provided and discussed during the assent process.\nThe minor\u2019s affirmative agreement should be obtained before participation, whenever feasible.\nIf the subject reaches the age of legal consent during the study, informed consent should be sought in accordance with applicable regulations.\u201d<\/p>

In Poland, the participation of minors in clinical trials is regulated by:
\u2714 Art. 25 of the Act on the Profession of Physician and Dentist<\/strong>
\u2714 Art. 37h of the Pharmaceutical Law<\/strong><\/p>

According to these regulations, the participation of a child in a medical experiment is permitted only with the written consent of a legal representative.<\/strong>In the case of younger children, formal written consent is not required, but obtaining verbal assent, adjusted to the child\u2019s age and maturity, is recommended.\nIf the minor reaches the age of majority during the study, their own written consent must be obtained for continued participation.<\/p>

Find out more about this topic in our post on Instagram<\/a>.<\/strong><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tAudit in Clinical Trials<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

The Importance of Audits in Clinical Research<\/h3>

An audit in clinical trials is not only a regulatory requirement, but above all, a tool to ensure participant safety and the high quality of collected data.\nVerifying compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements is essential for maintaining the reliability and credibility of study results.<\/p>

Key Aspects of Auditing According to GCP (R3 version)<\/h3>

Data Sources<\/h4>

In the audit process, it is crucial that data sources meet the following criteria:<\/p>