Life Sciences Training Quiz

Who is the Sponsor of a clinical trial?

The local Regulatory Health authority

The clinical trial site where the trial is conducted

The pharma company

The CRO if the trial is outsourced by the pharma company

What are the responsibilities of the Investigator?

To conduct the clinical trial in accordance with the clinical trial protocol and GCP

To maintain the Trial Master File

To treat and follow-up on trial patients

To ensure that the investigational product is manufactured according to regulatory requirements

What are the responsibilities of a CRO?

To ensure trial participants are treated according to the clinical trial protocol

To ensure the clinical trial is approved by Ethics Committees

To take responsibility of trial activities according to the scope of the contract btw. Sponsor and CRO

To make the payments to Investigators

The Ethics Committee must

Protect the well-being of trial participants

Ensure scientific evaluation of medicines

Send trial drugs to all sites

Help Investigator conduct the trial

The purpose of a Phase III clinical trials is

To determine the first dose for human trials

To provide statistically significant data on clinical efficacy and safety of the investigational drug in the patient population

To establish clinical proof of concept

To test the investigational drug in animals

A Marketing Authorization can be obtained via

The centralized procedure for all States in US

Union or National authorization in EU

A CRO working on behalf of Sponsor

Ethics Committees in EU

The Product Information contains

SmPc

Clinical Trial Authorization

Package leaflet

Labelling

What are the challenges of the linguistic review process with EMA’s centralized procedure?

Product Information in all EU languages must be provided on Day 210

The timelines are fixed by regulatory authorities and narrow

Lionbridge does not have SOPs for EMA projects

There are strict format requirements for Product Information

In a Randomized Controlled Clinical Trial

A control treatment arm is always included

The trial participant must voluntarily give consent before any treatment is allocated

The statistical analysis is performed before the data are unblinded

The allocation of either active drug, placebo or comparator medication is random

Any patient with the disease has the right to participate in the trial

Good Clinical Practices (GCP)

Is a set of internationally recognized requirements on the design, conduct, recording and reporting of clinical trials involving human subjects

Is not relevant for the Investigator since he decides how patients are treated

Requires that all site staff are trained and qualified for conduct of a clinical trial

Defines a list of all essential documents required at Sponsor and at investigational sites

Safety (which claims are true)

All Adverse Events have a causal relation to the investigational drug

Serious Adverse Events must be reported within 24 hours by Investigator

Sponsor must submit Periodic Safety Update Reports to regulatory authorities

Adverse Events that are not related to the investigational drug will not need to be part of the clinical trial report

Which stakeholders do I need to talk to if I want to explore sales/growth opportunities in the clinical area:

The Medical Writer who is authoring the clinical trial protocol

The investigational site

Clinical Operations

Procurement or outsourcing

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