Section 6: Amendments

Question 1

Do RECs need to be notified of NSAs to CTIMPs?

Answer 1

No

Question 2

What qualifies a SA

Answer 2

Change affecting:
*Safety or physical or mental integrity of participants.

• scientific value of the trial
• Conduct or management of the trial
• quality or safety of any IMP in the trial

Question 3

What is the deadline for an ethical opinion being given?

Answer 3

35 calendar days from valid submission. Aim for 28 days.

Question 4

If an unfavourable is given what can the sponsor Do?

Answer 4

Modify the amendment and send to the REC a minimum of 14 days before it is implemented…

REC must respond in 14 days or it will be implemented.

Question 5

A non-CTIMP is wanting to introduce ALC. How long is the clock?

Answer 5

60 calendar days. Can stop the clock once for more info and can give PO

Question 6

Who reviews SA?

Answer 6

A sub-committee or the full committee. If involvng ALC must go to full that is flagged.

Question 7

Change of sponsor or legal rep…. SA or NSA?

Answer 7

SA

Question 8

Addition of a new site or PI for a CTIMP… SA or NSA?

Answer 8

SA

Question 9

Change in funding arrangements… SA or NSA?

Answer 9

NSA

Question 10

Change in local research site staff (other than PI) … SA or NSA?

Answer 10

NSA

Question 11

Change in sample storage and transport logistics (within duration of project)

Answer 11

NSA