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Hrasop > Terms > Flashcards

Terms Flashcards

1
Q

CAG? Name, role and legislation considered.

A

Confidentiality Advisory group. Provide expert advice to HRA on whether research accessing patient info without consent should be approved under section 251 of the NHS Act 2006

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2
Q

Legislation relating to clinical trials of IMP

A

Medicines for Human Use (Clinical Trials) Regulations 2004

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3
Q

What is the DHHS?

A

Department of Health and Human Services - Federal government department that regulates health research in the USA

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4
Q

What does DMC stand for?

A

Data Monitoring Committee

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5
Q

GTAC… what is it?

A

A REC designated as a gene therapy advisory committee

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6
Q

What legislations established the HRA?

A

Care Act 2014

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7
Q

HTA: Name and role of organisation

A

Human Tissue Authority: regulates the removal, storage and use of human tissue for research, medical treatment, post-mortem exam, education, training and public displays.

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8
Q

ICH: name and what is it

A

International Conferense for Harmonisation

Collaboration of regulators and pharmaceutical industry in Europe, USA and Japan to establish common standards (GCP) for clinical trials.

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9
Q

Investigators Brochure purpose?

A

Summarises clinical and non-clinical data relating to IMP that are relevant to the study of the drug in humams

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10
Q

MHRA: Name of organisation, why formed and role

A

Medicines and Healthcare Products Regulatory Agency.

MHRA (Medicines) is the Compotenty authority for the UK relating to EU directive and clinical trials regulations.

MHRA (devices) is the Compotenty authority for the UK relating to medical devices regulations 2002

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11
Q

What is a modified amendmemt?

A

Resubmission of an amendment following an unfavourable opinion.

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12
Q

Phase 1 trials

A

Clinical study of pharmacology of a IMP when administered to humans, where the researchers have no knowledge of any evidence that the product is likely to be beneficial to subjects

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13
Q

PRS

A

Proportionate Review Service

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14
Q

Receiving REC

A

The REC that first receives an application, regardless of whether it was transferred to another REC

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15
Q

UKECA: name and role

A

United Kingdom Ethics Committee Authority

Provide legal reconition to RECs allowing them to give an ethical opinion of research occurring in the UK

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16
Q

Substantial amendment.

CTIMP process?
Non-CTIMP process

A

CTIMP
Must notify ethics committee and MHRA… needs FO from REC and notice of no objection from MHRA

Non-CTIMP
Must notify REC, except where a new site of PI at a NHS site is added

17
Q

SUSAR

A

Suspected Unexpected Serious Adverse Reaction

18
Q

UKREDG

A

UK Research Ethics Deceolopment Group… group comprised of RES operational managers from each country in the UK

19
Q

HRA working day?

A

8am to 4pm Mon-Fri

Hrasop (8 decks)

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