Control on CTs Flashcards
Which act(s) controls CTs?
MedA and HPA
- All provision in SLs
- Both have CTr and CRMr (Clinical trial and Clinical Research Material regulations)
Do dealers require licenses of any form for CT or CRM drugs?
CRMr r3
No
Define “Clinical research” under the law
Both:
- CT
- Drugs that are used specifically only for research
What are the responsibilities of various dealers who are handling CRM, or any products for CRM/CT
- Ipt: inform HSA bef import
- Mfers: inform HSA bef supply
- All Dealers: keep records
What does CT(r) regulates
Conduct of CTs, NOT observational trials
For every CT, there must be a _______
r4
“Sponsor”
- Either drug coy or doctor
John wishes to start a CT for Drug X. He has already informed HSA. What other requirements must he meet before starting the CT?
r7
- HSA’s authorisation
2. Ethics review by IRB
Every CT, during CT, must:
r5,r13,r14,r15
- Conducted under supervision of “principal investigator”
- Conducted accoridng to GCP and protocol
- Conducted at specified premises
Utah wishes to recruit a trial subject who is 5yo into CT. Regarding this, what must Utah do before and during recruitment of the subject?
r20,r18,r16,r17
“Informed consent”
- Cannot force
- Clearly state its voluntary, can quit anytime
- Full explanation
- Get consent in accordance with procedure, from legal representatives (r18, r16)
What are the labelling rules of investigational products
r26
- Accordance to requirements in Second Schedule
2. If coded, must have decoding key readily accessible for emergency
What are the recording rules of investigational products, and the IMPORTANT role of Sponsor and principle investigator respectively
r23,r24,r25
- Sponsor AND principal investigator keep records
- Principal investigator inform sponsor of Serious AE
- Sponsor must report USDR to HSA within specified period
