ICH gap analysis hard questions Flashcards
this phase determines therapeutic benefit and is usually done in a larger, specific population
phase 3
Therapeutic use. begins after drug approval
phase 4
providing a unified standard for europe, US, and Japan to facilitate the acceptance of clinical trials is the mission statement of
the ICH
a potential investigator usually only receives a protocol and investigator’s brochure to review from a sponsor after
signing of a confidentiality agreement
who is responsible for the appropriate monitoring of clinical trials?
the sponsor
who conducts quality control activities?
the monitor
the master randomization list can only be found in whose files?
the sponsor’s
who does the investigator need to inform if he/she deviates from the protocol?
the IRB/IEC, the sponsor, the regulatory authorities
why is it a good idea to develop standard procedures?
to ensure that a trial is run consistently, to promote compliance, to assign responsibility
what topics are discussed during the pre-trial visit?
availability of subjects, competing studies, sponsor expectations, laboratory requirements
in general, unused investigational drugs
must be returned to the sponsor
what type of document is the case report form
an essential document that can also be a source document
