Section 5: Assessing Site Suitability

Question 1

Do studies occurring in multiple UK nations need one or multiple approvals?

Answer 1

One typically. Only exception is non-CTIMPs involving ALC that have sites in England/Wales and Scotland.

Question 2

When is an assessment for site feasibility required?

Answer 2

CTIMPs, Devices or combination

Question 3

Does a CI also have to be the PI

Answer 3

In non-CTIMP and single site CTIMP yes

Question 4

Does a change in PI constitute a Substantial amendment?

Answer 4

Yes for CTIMPs

Question 5

In general should research sites be identified as the organisation (I.e. NHS trust) or individual locations?

Answer 5

Single organisations

Question 6

For GPS and NHS dentists what is the organisation providing care recorded as?

Answer 6

Clinical Commisioning Group (England)
Health Board (Scotland)
Local Health Board (Wales)
Business Services Organisation (NI)

Question 7

Examples of research sites outside the NHS?

Answer 7

Academic institutes
Research centre funded bybvoluntary sector
Government department
Prison services
Private company 
Private hospital or clinical practice

Question 8

What is a research site?

Answer 8

Organisations responsible for participant related research procedures specified in the protocol (including recruitment and consent)

Question 9

Is a PIC, DCC or TCC a research site?

Answer 9

No. Section 5.23

Question 10

What issues relate to site assessment?

Answer 10

Suitability of PI
Adequacy of facilites
Pharmacy support  (CTIMPs)
Ability to publicise the trial
Ability to support participants
Insurance and indemnity arrangements.

Question 11

Can the REC arrange a site visit?

Answer 11

Not usually required… But but have the discretion to do so (or request a local site conduct the visit)