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Qualified Person Training > IMP’s > Flashcards

IMP’s Flashcards

1
Q

What is the declaration of Helsinki?

A

Set of Ethical principles regarding human experimentation or clinical trials

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2
Q

What does IRAS Stand for and what is it used for?

A

Integrated Research Application System

Submission of UK CTA for both MHRA and Ethics approval

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3
Q

What do you call the updates to a CTA post approval?

A

Substantial Amendment-
anything that has the potential to impact safety, quality or scientific interpretation of the trial.

Non-Substantial Amendment - minor protocol errors, funding or logistics that has no impact on the trial or its participants.

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4
Q

UK SI for IMPs?

A

2004/1031 as amended by 2019/744

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5
Q

Describe the different types of clinical trial?

A

Phase 0 - Healthy - micro-dosing

Phase 1 - Healthy volunteers - 10-30 participants - understand ADME, Safety and Tolerability.

Phase 2 - Patients and Healthy volunteers - 100 participants - therapeutic efficacy

Phase 3 - Patients - >3000 - further safety / efficacy data, side effects and method development.

Phase 4 - Post Marketing Surveillance, Side effects and New Indictaions

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6
Q

What are the legal duties of an IMP QP?

A

IMP’s are manufactured and assembled to GMP, PSF and CTA

IMP / Comparators Imports from 3rd Countries are manufactured equivalent to GMP

Tested in compliance with the PSF

Certify in a Register or equivalent

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7
Q

What is the Clinical Trial Reg in the EU and when was it Implemented?

A

536 /2014 - 31st Jan 2022

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8
Q

What is the IMP GMP Regulation in the EU?

A

2017 /1569

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9
Q

What Guidance documents do we have for IMP’s?

A

Eudralex Vol 4 - Annex 13 / Annex 16

Eudralex Vol 10 - Clinical Trials Guidance

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10
Q

Where are the legal duties of an IMP QP found?

A

2017/1569 - article 12

SI 2004/1031

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11
Q

What documents should be included in your PSF?

A

Annex 13:-
Specifications / Analytical Methods for Starting materials
Intermediate bulk and Finished Product Specifications and Methods
In Process Testing and Methods
Approved Label Copy
Relevant Clinical Trial Protocols
Randomisation Codes
Technical Agreements
Stability Data
Storage and Shipment Conditions

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12
Q

What Are the labelling requirements for IMP’s?

A

Name / Address of Sponsor
Dosage Form
Route of Administration
Batch Number
Trial Reference Number
Patient ID
Name of Investigator if different from sponsor.
Directions for Use
‘For Clinical Trials Use Only’
Storage Conditions
Expiry Date
‘Keep out of reach of children’

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13
Q

What is in an IMPD?

A

Provides Info on quality of IMP, Comparator and Placebo and data from non-clinical studies.

Quality Data
Non-Clinical Pharmacology and Toxicology Data
Previous Clinical Trial and Human Experience Data.
Overall Risk to Benefit Ratio

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14
Q

Give details on consultation relating to update of 2004:1031

A
  • Patient and Public Involvement
  • Research transparency- register with WHO who will publish results. Results should be shared with patients
  • Clinical trial approval - UK only, Combine Ethics Approval , specific timelines for approvals
  • Research ethics committee- who should be members
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15
Q

What is in a CTA?

A

CMC information on AS and DP
Clinical information relating to IMP
Labels
IMPD and nIMPD
Clinical Trials Protocol
Form
QP Declaration

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16
Q

What is IRAS?

A

Integrated Research Application System

Combine MHRA Approval and Ethics Approval for CTA in UK

17
Q

What is a substantial vs a non-substantial amendment?

A

A substantial amendment is anything that could impact safety or interpretation of scientific documents supporting clinical trial.

Non-substantial- minor protocol error, funding or logistics change

18
Q

What was the amendment to 2004:1031 post Brexit?

A

744

19
Q

Why do we do stressed development studies for IMPs?

A

Understand degradation pathways, aid formulation development, assess potential mutagenic impurities and develop stability indicating methods.

20
Q

Why do we perform development stability studies?

A

Confirm re-test period of proposed drug substance or the shelf life of the proposed drug product.

Support development activities such as formulation, packaging, manufacturing and process development. These studies may include predictive stability studies such as accelerated stability programs.

21
Q

What are the types of auxiliary medication that could be used in a clinical trial?

A

Rescue Medication
Challenge Agents
Medicinal products used to assess the end point in a clinical trial
Background Treatment (Considered the current standard of care)

22
Q

What is IRT and what is it used for in Clinical Trials?

A

Interactive Response Technology
Randomisation and Trial Supply Management

  • Automation of inventory management
  • Automation of drug dispensing
  • Patient visit and inventory data centralised
  • Emergency Code Breaking Patients

A separate system is created for each study.

Qualified Person Training (11 decks)

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