Clinical Trials and GCP

Question 1

what is the ICH?

Answer 1

international council for the harmonisation of technical requirements for pharmaceuticals of human use

Question 2

what is the role of a sponsor?

Answer 2

individual, company, or organisation that initiates, manages, and finances a clinical trial

has overall responsibility for trial conduct and implementing SOPs

Question 3

what is a CRO?

Answer 3

contract research organisation

Question 4

what is SOP?

Answer 4

standard operating procedure

written instructions for how to complete a task

Question 5

what is the IRB/IEC?

Answer 5

institutional review board/independent ethics committee

independent body that reviews and approves clinical trials to protect the rights and safety of participants

Question 6

what is a source document?

Answer 6

document of clinical finding/note e.g. medical records, lab reports, imaging reports, ECGs

Question 7

what is a CRF?

Answer 7

case report form

form used to collect required data from participants from the source document, specifically for the trial

i.e. source document is where the data originates, and the CRF is used to capture and report that data for the purpose of the trial

Question 8

explain how the COMP006 trial will work

Answer 8

two initial administrations of COMP360 given at week 1 and week 9

around 500 participants randomised to receive COMP360 25mg, 10mg, or 1mg (2:1:1)

part A
- screening visit (check eligibility)
- screening period 2-6 weeks (weekly visits as needed to prepare for study drug administration, taper off any prohibited medications)
- baseline visit (baseline assessments (bloods, ECG etc)
- day 1 first dose
- day 23 second dose
- 9 week follow up

part B
- 17 week monitoring
- follow up every 4-5 weeks to assess safety, efficacy, durability of drug
- will also receive re-treatment (same allocation as part A)

part C
- 26 week follow up, every 4-6 weeks
- open label treatment (single 25mg dose)

Question 9

what is the minimum MADRS score a patient must have at screening to be eligible?

Answer 9

minimum of 20

Question 10

when patients enter part B snd C follow up period, they will be assessed for eligibility to receive single randomised re-treatment, what is the MADRS cut-off for this?

Answer 10

1) MADRS of >12 and/or single iten score of ≥4 considered not in remission so assessed for re-treatment eligibility

2) MADRS ≥18 for relapse

Question 11

what is a ePRO?

Answer 11

electronic patient reported outcome

Question 12

what is BPRS?

Answer 12

brief psychiatric rating scale

Question 13

what is the cssrs?

Answer 13

columbia suicide severity rating scale

Question 14

what is the DSST?