Clinical trials in Ireland: [Essay Example], 449 words GradesFixer

Haven't found the right essay?

Get an expert to write your essay!


Professional writers and researchers


Sources and citation are provided


3 hour delivery


Haven't found the right essay?

Get an expert to write your essay!

This essay has been submitted by a student. This is not an example of the work written by professional essay writers.

Clinical trials in Ireland

  • Category: Health
  • Subcategory: Medicine
  • Topic: Therapy
  • Pages: 1
  • Words: 449
  • Published: 11 February 2019
  • Downloads: 17
Download Print

Pssst… we can write an original essay just for you.

Any subject. Any type of essay.

We’ll even meet a 3-hour deadline.

Get your price

121 writers online

Download PDF

Clinical trials conducted within Ireland and the European Union must comply with the European Union clinical trial legislation. (3) It applies to the conduct of clinical trials on human subjects involving medicinal products. The legislation defines the steps that must be taken regarding adverse event reporting and the timeline investigators and sponsors alike must comply with. The legislation does not distinguish between the different phases of a clinical trial.

An adverse event is defined as “any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment.” a serious adverse event is defined as “Any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.” It is the responsibility of the investigator to report any serious adverse events to their sponsor immediately, unless said event is identified as not requiring so in the protocol. The investigator must make this report no later than 24 hours after they became aware of the serious adverse event.

The reporting of non-serious adverse events, which fall under the definition of an adverse event, and/or laboratory abnormalities will follow the agreed upon reporting requirements in the clinical trial protocol. The time periods in which they should be reported should also be specified in said protocol.

A suspected unexpected serious adverse reaction (SUSAR) is a reaction that has not been predicted in the protocol. The investigator has no more than 7 days to report such reactions to the sponsor. Further information regarding the reaction must then follow within an additional 8 days. They should include the specifications of the event, as well as possible guidance in the protocol. Once the sponsor has been made aware of the SUSAR they have the responsibility to report the information to the competent authorities concerned and the Ethics Committee within a maximum of 15 days. Each Member State shall then immediately enter the SUSAR to an investigational medicinal product into the European database, which will only be able to be accessed by the Agency, the Commission and certain Member States.

The European database referred to is the Eudravigilance Clinical Trials Module. This system monitors the safety of medicines. It reports any suspected adverse reactions related to medicines, which enables early detection of potential safety issues.

The investigator does not need to actively monitor participants in the trial after it has ended, unless it says otherwise in the protocol. Adverse reactions do not include misuse and/or abuse of the product. It implies a possible causal relationship between the event and medicinal product.

Remember: This is just a sample from a fellow student.

Your time is important. Let us write you an essay from scratch

100% plagiarism free

Sources and citations are provided

Cite this Essay

To export a reference to this article please select a referencing style below:

GradesFixer. (2019, February, 11) Clinical trials in Ireland. Retrived July 5, 2020, from
"Clinical trials in Ireland." GradesFixer, 11 Feb. 2019, Accessed 5 July 2020.
GradesFixer. 2019. Clinical trials in Ireland., viewed 5 July 2020, <>
GradesFixer. Clinical trials in Ireland. [Internet]. February 2019. [Accessed July 5, 2020]. Available from:
copy to clipboard

Sorry, copying is not allowed on our website. If you’d like this or any other sample, we’ll happily email it to you.

By clicking “Send”, you agree to our Terms of service and Privacy statement. We will occasionally send you account related emails.


Attention! this essay is not unique. You can get 100% plagiarism FREE essay in 30sec

Recieve 100% plagiarism-Free paper just for 4.99$ on email
get unique paper
*Public papers are open and may contain not unique content
download public sample

Sorry, we cannot unicalize this essay. You can order Unique paper and our professionals Rewrite it for you



Your essay sample has been sent.

Want us to write one just for you? We can custom edit this essay into an original, 100% plagiarism free essay.

thanks-icon Order now

Hi there!

Are you interested in getting a customized paper?

Check it out!
Having trouble finding the perfect essay? We’ve got you covered. Hire a writer uses cookies. By continuing we’ll assume you board with our cookie policy.