CRP 106 Lecture 2 Flashcards
1
Q
Investigator responsibilities (ICH GCP) (13)
A
- qualifications and agreements
- adequate resources
- medical care of participants
- communications with IRC/IEC
- compliance with protocol
- investigational product(s)
- randomization and unblinding
- Informed consent
- records and reports
- progress reports
- safety reporting
- premature termination or suspension of trial
- final report(s)
2
Q
Sponsor responsibilities (ICH GCP) (11)
A
- IP manufacturing, packaging, labelling, and coding
- supplying and handling IP
- record access
- safety information
- ADR reporting
- monitoring
- audit
- non compliance
- premature termination or suspension of trial
10.clinical trial reports - multicentre trials
3
Q
essential documents definition
A
documents that allow evaluationof the conduct of the trial and quality of the data produced
