Section 2 Full Apps Flashcards
How many full meetings a year?
10.
Can have additional ones when need to discuss matters relating to organisation or training.
What is the cut off date for receiving applications
14 calendar days prior (7 for phase 1 CHIMPs in healthy volunteers)
How many applications should be reviewed at each meeting
4-6 on average… No more than seven.
Lead reviewers… is allocation obligatory? In what meetings? What tasks must they perform?
A lead must be allocated (second is recommended but optional) for full, PR and SC meetings.
Must use lead reviewer sheet. Not required for them to share.
When should papers be sent to members?
No later than 10 calendar days before the meeting.
Can CIs make formal presentations at the meeting?
No… Do not permit (section 2.26)
What are he condiitons for a meeting to be quorate?
Seven members. Including an officer, one lay/lay+ and one expert
Note:: CTIMPs need a Lay+ member in attendance
If a meeting isn’t quorate what happens?
Committees can discuss but only give preliminary advice… will need to be booked to another meeting. Clock doesn’t stop.
How many members can be co-opted for a meeting.
Up to two… head of approval support will allow more than 2 of no CTIMPs are being reviewed.
Can a member that is not attending submit written comments in advance?
Yes provided this is done three working days prior. Should be mentioned in minutes.
Can a referee vote on the outcome?
No. Only provide expert advice.
Three procedures for getting referee input. What are they?
- AO writes to expert before the meeting to seek advice. Copy of the advice should be made available to members or tabled at the meeting.
- Invite referee to attend the meeting. Record their input in the minutes. Cannot question CI or vote in the meeting.
- Seek expert advice within 5 days of the meeting (template on HRA hub). At meeting should set clear terms in case of what the decision will be based on experts advice. (Clock doesn’t stop)
CTIMP involving minor (under age of 16). What expert input is needed?
Paediatric care professional member. Should provide input on clinical, ethical and psychosocial problems posed by trial.
If member cannot attend meeting. Should submit written advice prior.
CTIMP involving adults lacking capacity. What expert input is needed?
Input from a member with expertise in treatment of disease and the treatment of the relevant patient population.
If member cannot attend meeting. Should submit written advice prior.
Do DOIs apply to external observers?
Yes. Need to confirm no conflict of ibteredt5
