FAQ

I have additional questions, where do I apply?

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If you have any questions, feel free to email us at the following email address:

kontakt@ebadaniakliniczne.pl.

What is the Clinical eResearch portal used for?

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A portal dedicated to broadening the knowledge of clinical research and disseminating the latest achievements in medicine and medical sciences. The portal publishes job offers related to the clinical research industry in Poland. We can help you find your dream job.

Who can use the Clinical eStudies portal?

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Anyone interested in clinical trials can use the portal for educational and developmental purposes. Anyone who wishes to find currently ongoing trials in Poland can do so by registering.

Clarification of key terms

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Clinical studies

Any study of a medical product in humans conducted for the purpose of discovering or verifying the clinical, pharmacological, or pharmacodynamic effects of that product. The purpose of a clinical trial may also be to identify adverse effects of an investigational product or to evaluate its absorption, distribution, metabolism, and excretion, to verify the safety and/or efficacy of the product used.

Nonclinical study

Any biomedical research conducted without human subjects (e.g., laboratory, tissue culture, animal studies).

Multicenter study

A clinical trial, conducted under a single protocol, that takes place at several different research centers, hence is conducted by more than one investigator.

Participant in a clinical trial

A person undergoing a clinical trial, whether they receive the investigational product or are a control group.

Blinded studies

The principle of conducting a study is that the parties involved do not know what treatment is being used. In a single-blind study, this usually involves only the person participating in the study. In a double-blind study, the treatment is unknown to the person participating in the study, as well as the investigator, monitor, and in some cases, the person performing the data analysis.

Research center

The place where clinical trial activities are currently being conducted.

The investigational product

A pharmaceutical formulation of the active ingredient or placebo that is either being tested or is a reference (called a control preparation) in a clinical trial. An investigational product is also a previously approved product if it is used in a different form, packaging, or is used for an indication other than those already approved, and if it is used to gather additional information about its previously approved uses.

Randomization

The procedure of selecting study participants into a group receiving an investigational product or a control group (receiving a placebo or active control) in a randomized manner. This is to eliminate bias.

Informed consent to participate in a clinical trial

The process by which a study participant voluntarily affirms his or her willingness to participate in a study by being aware of all aspects of the study relevant to making a decision. Informed consent is documented by the study participant's signature and date on a written informed consent form.

Adverse Event

Any adverse medical event occurring in a patient or subject receiving a pharmaceutical product, regardless of the existence or absence of a causal relationship with the treatment received. Thus, any harmful and unintended subjective symptom (including an abnormal laboratory test result), subjective symptom, or disease, the occurrence of which is temporally coincident with the use of the investigational medical product, whether or not a causal relationship exists, may be considered an adverse event (see ICH Principles for Clinical Safety Data: Definitions and Standards for Expedited Reports (ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)

An adverse drug reaction

In clinical trials preceding the registration of a new medical product or involving a new use of a known drug, especially when its therapeutic dose has not been determined: any harmful and unintended reaction/response to a drug that occurs at any dose should be considered an adverse reaction.

The phrase "drug reaction/response" in the above definition means that a causal relationship between the medical product and the adverse event is at least possible, i.e. cannot be excluded.

For already registered drugs, it is any harmful and unintended reaction/response to a drug that occurs when the drug is administered at the dose normally used in humans for prophylactic, diagnostic, therapeutic, or physiologic function modification purposes (see ICH Principles for Clinical Safety Data: Definitions and Standards for Expedited Reports (ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Source of definitions: Integrated supplement to their E6(R2) version: principles of good clinical practice E6(R2)

Legal aspects

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The Clinical eBusiness Portal cooperates with Klepacz Wąsik i Wspólnicy s.c., a law firm that guarantees the legality of the documents on the portal.

 

Kancelaria Prawna Klepacz Wąsik Wójcik
Radcowie Prawni s.c. w Łodzi
ul. Roosevelta 17, 90-056 Łódź

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