Clinical trials Flashcards
What is the definition of a clinical trial?
Any investigation in human subjects intended to discover or verify the clinical, pharmacological or pharmacodynamic effects on an investigational product or to identify any adverse reactions to investigational product or to study ADME or investigational product
What is an investigational medicinal product?
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clincal trial, including a product with a MA when used or assembled in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form
What is a notification scheme?
Type A trials- the risk to the patient from the IMP is considered to be no greater than that of standard medical care
What is reconstitution?
Dissolving or dispensing the IMP for administration of the product to a trial subject
OR
Diluting or mixing the IMPs with some other substance used as a vehicle for the purpose of administering it
When should reconstitution occur?
As soon as practicable before administration
Which following conditions need to be met to be a non-interventional trial?
- Products not prescribed in the usual manner in accordance with terms of that authorisation.
- The assignment of any patient involved in study to a therapeutic strategy is not decided in advance
- The decision to prescribe a particular product is not clearly separated from the decision to include the patient in the study
- No diagnostic or monitoring procedure applied
- Epidemiological methods used for analysis of data
2
4
5
What are the 9 steps in the trial cycle?
- Investigator develops protocol for trial
- Identify trial sponsor
- Funding
- Apply for Eudract number
- Apply for clinical trial authorisation and ethics
- Apply for research approval
- Carry out study in compliance with GCP
- Notification of the end of the study
- Submit report of study findings
