MDM: Clinical trials DS

Question 1

1. What are the features of Capsugels DB caps which make them suitable for use in clinical trials?

Answer 1

2 piece gelatin or HPMC capsules with a tamper evident design that allows IMP to be blinded without modifying their structure. Wide enough to fit tablet but short enough that swallowing is easy

Question 2

When was the decleration of helskinki last upsated?

Answer 2

2013

Question 3

1. Describe the purpose of the Declaration of Helsinki?

Answer 3

Aims to protect all patients taking part in clinical trials. Makes sure consent is obtained and that it is voluntary. Allows subjects to withdraw themselves at any point

Question 4

1. What is the purpose of an ‘ethics committee’ in the context of clinical trials?

Answer 4

Ethics committee is an independent body that plays the pivotal role in ensuring that a trial is conducted in accordance with GCP guidelines and to safeguard the safety and well-being of subjects participating in a clinical trial.

Question 5

What does informed consent mean?

Answer 5

permission granted in full knowledge of the possible consequences

Question 6

1. Explain the following terms when used in the context of clinical trials:
   
   1. Blinding;

Answer 6

Certain people involved within the trials are unaware of which treatment group a subject has been assigned too. Open label – both the subject and investigators are aware. Single blind – the subject is unaware but investigators are aware. Double blind – the subject and investigators are both unaware

Question 7

Exmplain what randomisation means

Answer 7

The subjects are allocated into a treatment group using an element of chance to reduce bias

Question 8

Explain what sponsor means

Answer 8

A sponsor is an individual, organisation or company which takes responsibility to initates, funds or manage the clincial trial but doesn’t actually conduct the investigation itself

Question 9

1. Where the comparator product is modified to allow a blinded study to take place what must be ensured in these products?

Answer 9

That they look the same, taste the same, sound the same, smell the same and that stability is monitored therefore dissolution and distigration tests should be done to ensure absorbance isn’t altered if SDF

Question 10

1. Briefly explain why the packaging of IMPs is more complex than standard medicinal product?

Answer 10

• Zero tolerance for errors
• packets often contain more than one product
• usually hand assemblied
• blinded therefore contents not identifiable on label

Question 11

1. For how long should the reference and retention samples be retained?

Answer 11

refence sample - a sample of batch starting material and the packaging material

retention - a sample of packaged unit from a batch of finished product

Reference and retention should be kept for at least two years after completion or formal discontinuation of the last clinical trial in which the batch was used, whichever period is the longer.