Section 1 - New Apps Flashcards
For non-CTIMPs involving ALC that will have site in England/Wales and Scotland, do they have to submit one or two REC applications
Two. One to a flagged REC in Eng/Wales and one to Scotland A REC.
If CTIMP this doesn’t apply. CT regs outrank ALC
If a research project has many Sub-studies with a protocol for each (plus the main one) should they submit this as one application?
No. Submit one per protocol, preferably to the same REC.
Are stem cell therapies counted as an advanced therapy to be reviewed by a GTAC committee?
Yes
Committees flagged to review CTIMPs. There are two types. What are they?
Type 1
RECs recognised to review phase 1 CTIMPs taking place anywhere on UK, where the participants are healthy or do not have the disease/condition the IMP relates to.
Type 3
RECs recognised to review any other phase trial in addition to first in man studies involving patients with the relevant disease/condition.
Note: phase 1 studies involving patients with the disease/condition can be reviewed by either
If a REC is no longer recognised to review new applications does it still have to review amendments to approved applications?
Yes. Can seek expert advice if needed. But should still give final opinion.
If in doubt regarding if a study is a CTIMP what should be done?
Ask CI/sponsor if they have approached the MHRA regarding this.
If it turns out a non-CTIMP is actually a CTIMP then they will need to withdraw and resubmit.
What research falls under the jurisdiction of social care RECs?
Adult social care research.
Intergenerational studies.
Use of social care databases.
Studies using social sciences methodologies.
MoD REC review what studies?
Those involving the UK armed forces or sponsored/funded by the MoD
What is the cut off date for phase 1 studies?
7 days before.
What is the timeframe for when a study should be validated? Full and PR review
5 working days full.
2 working days PR
Some examples of acceptable scenarios to transfer an app
Not appropriately flagged
Conflict of interest
Contact CI DO before your do it and explain the reason why. Also contact receiving REC to explain.
Once booked to a meeting should you accept amended documents
No. Officially you should not. (Excluding expert advice sought in advance)… they should withdraw.
Does research involving health/service care workers recruited due to their professional role, or healthcare market research need to be reviewed by a REC?
No…
Do tissue banks and research databases need to be reviewed by the REC?
No… this is voluntary but many seek to do his.
Whose responsibility is it to determine if the application is actually research?
Local R&D office.
REC chair can also give informal advice.
