17 januari: GCP responsibilities Flashcards
What are the differences (2) in responsibilities between the IRB and IEC?
1) geography;
2) IRB gives approval, IEC gives favourable opinions
In the review of an ethical submission, what is the general timeline for approval of the ECs (e.g. how many days)?
60 days. unlimited time for xenogenic cell therapy.
Name the 5 investigator obligations/tasks.
- Familiar with appropriate use of IP
- Comply with GCP and applicable regulations
- Permit monitoring and auditing by sponsor
- Permit inspection by regulatory authorities
- Maintain list of appropriate qualified persons to whom significant trial related duties are delegated
Name the 4 investigator resources.
- Recruitment of subjects
- Time to conduct the trial (Sufficient time to properly conduct trial and complete trial within agreed period)
- Appoint qualified staff and adequate facilities for duration of trial
- Inform all involved staff in trial about the protocol, the investigational product and their duties and functions
why is it recommended to inform the primary physicians of the subjects in case of CT participation?
To prevent involving double dippers: People living of CT compensation, involved in multiple simultaneous CTs
What should the investigator submit to the EC (3 things)?
• Investigator should provide current copy of IB and updates during the trial
• Investigator should provide (updated) documents for continuous review
- annual risk assessment
Who is responsible for the IP, on-site, and what are the related responsibilities (3)?
the investigator, but this may also be delegated to the pharmacist.
- proper storage
- compliance with protocol
- informing subjects
In the case of code breaking (as result of e.g. SUSAR of SAE), what should be done with the patients data?
Unblind, and exclude from data analysis (if before database lock)
How long should records be retained, and who is responsible for that?
2 years after last approval of MAA (in ICH region), sponsor’s responsibility.
What kind of agreements (2) are there between the CRO, sponsor, and investigator?
1) financial agreement
2) trial agreement
Which events do you need to report to the sponsor?
All AEs and laboratory abnormalities
Which events do you need to report to the IRB/IEC?
SAEs (e.g. autopsy report to confirm unrelatedness to drug)
When do you prematurely terminate a CT? (5 reasons)
(1) unethical to continue trial, (2) non-efficacy has been demonstrated, (3) control has more effect, (4) funds-related, (5) non-compliance
The sponsor is responsible for quality … and ….? Also, name the related tasks.
assurance (in compliance with protocol, GCP, and regulatory requirements) & control (verification of standards being upheld)
What are sponsor’s responsibilities regarding finances?
- insurance
- potential compensation
- financial agreement w/ investigator
