Clinical Trials Flashcards
What legislation impacts the small scale manufacture and supply of individualised investigative medicinal products?
2004 - Medicines For Human Use (Clinical Trials) Regulations.
2008 - Medicines For Human Use (Clinical Trials) and Blood Safety and Quality.
2014 - EU Regulations 536/2014 repealing 2001/EC.
What was the purpose of the Medicines For Human Use (Clinical Trials) Regulations 2004?
Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.
What was the purpose of the Medicines For Human Use (Clinical Trials) and Blood Safety and Quality?
It dealt with consent for minors and emergency treatment situations.
What legislation identified the formal definition for what a clinical trial is and entails?
Medicines For Human Use (Clinical Trials) Regulations 2004:
Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.
What legislation dealt with consent for minors and emergency situations?
2008 - Medicines For Human Use (Clinical Trials) and Blood Safety + Quality.
What was the point of the EU Regulations 536/2014 repealing 2001/EC?
Improved harmonisation across Europe.
Dealt with transparency of trial information
Imported products
Labelling requirements
Hospital exemptions WRT re-labelling or re-packaging and the preparation of radiopharmaceuticals used as diagnostic IMP
.
In what legislation was GCP outlined?
Medicines For Human Use (Clinical Trials) Regulations 2004:
Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.
What is a clinical trial?
Any investigation in human subjects intended to discover or verify:
- the clinical, pharmacological and/or pharmacodynamic effects of an investigational product and/or to identify any adverse reactions to an investigational product(s) and/or study absorption, distribution, metabolism and excretion of one or more IMPs with the object of ascertaining its/their safety and/or efficacy.
What is an IMP?
Pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product:
- with a MA when used or assembled in a way different from the authorised way etc….
What is the typical trial cycle?
- Investigator develops a protocol for a trial.
- A sponsor for the trial is found.
- Funding is found
- Apply for Eudact number (unique identifier)
- Apply for Clinical Trials Authorisation (CTA) and ethics approval.
CTA will need Investigators Brochure (IB) and Investigational Medicinal Product Dossier (IMPD) - Apply for research approval
- Carry out study in accordance with GCP: notify any amendments/breaches, report adverse events.
- Notification of the end of study
- Submit report of study findings (documents maintained) and archived.
Which legislation dealt with improving harmonisation across Europe and the transparency of trial information
2014 - EU regulations 536/2014 repealing 2001/EC:
Improved harmonisation across Europe.
Dealt with transparency of trial information
Imported products
Labelling requirements
Hospital exemptions WRT re-labelling or re-packaging and the preparation of radiopharmaceuticals used as diagnostic IMP
When do you need an IMP licence?
A pharmaceutical form of an API being tested in a clinical trial.
A clinical trial involving a product with a marketing authorisation when it is used or assembled in a different way from the authorised form
A clinical trial involving a product with a marketing authorisation when it is used for an unauthorised indication
