Trials phases & procedures Flashcards
Phase for learning the safety of a new drug
Phase 1
Phase 2
efficacy
-Proof of concept
-patients with the disease are treated with intended drug
Pivotal studies fall into which phase.
Phase 3
What type of patients are enrolled to phase 1 trials?
healthy patients
What is the purpose of phase 3 studies?
For statistical evidence of efficacy & safety of new drug
Phase 4
post marketing surveillance
Which trial phase has the largest patient enrollment allotment?
Phase 3 (300-3000)
What is the purpose of a phase 4 trial?
-To collect safety information in a larger population & longer time period (multiple years)
-protection of patient’s safety after approval
Do medical device trials have phases?
no
what are the 2 steps of device trials?
-pilot
-pivotal
What devices fall under Class 1?
bandages, gloves, tongue depressers
Which class requires pre-market approval?
Class 3
What are the rules for significant risk studies?
-full requirements
-Need IDE application approved by FDA
What requirements apply to non-significant risk studies?
abbreviated requirements
-do not need IDE application
-Sponsors & IRBs do not need to report to FDA before trial start
What does exempt mean in regards to trials?
exempt from investigational device exemption application
What are the 3 classifications a sponsor/CRO may receive after inspection?
-Official action indicated
-voluntary action indicated
-no action indicated
When does the sponsor give the investigator brochure to the investigator?
Before the start of a trial
Who can discontinue the use of an investigational product that causes unreasonable & significant risk to subjects?
The sponsor
What does quality control focus on?
identification & correction
How and by who is quality control done?
Done through monitoring of trial by the study monitor
What makes up investigational product accountability?
-maintain complete records
-reconcile all products from sponsor
-train the use of products to subjects
-check that subjects are following instructions
Who controls the use of investigational products?
the PI
What are the responsibilities of the PI?
-oversee trial conduct
-protect the rights, safety, & welfare of subjects
-control the use of investigational product
What kind of review outcome cannot be done by expedited review?
A study disapproval
What are the expedited review criteria?
-some/all of the research involve no more than minimal risk
-minor changes in previously approved research during the approval period
When can an informed consent waiver be used?
When the research presents no more than minimal risk of harm to subjects
-When research involves no procedures where consent is normally required.
How many informed consents do subjects sign?
2- one for site file and one to keep
Who signs child/minor consents?
one/both parent or the LAR
Who signs the short form?
subject & witness
Who signs the summary?
Just the witness
Which of the following describes an adequate & well-controlled trial?
A- the trial is closely monitored
B- the IP meets GMO standards
C- the effects of the IP can be assessed
D- Source documentation is verified for all subjects
C
If the IP can’t be assessed then it can’t be be determined if it is safe and effective.
