Trials phases & procedures

Question 1

Phase for learning the safety of a new drug

Answer 1

Phase 1

Question 2

Phase 2

Answer 2

efficacy
-Proof of concept
-patients with the disease are treated with intended drug

Question 3

Pivotal studies fall into which phase.

Answer 3

Phase 3

Question 4

What type of patients are enrolled to phase 1 trials?

Answer 4

healthy patients

Question 5

What is the purpose of phase 3 studies?

Answer 5

For statistical evidence of efficacy & safety of new drug

Question 6

Phase 4

Answer 6

post marketing surveillance

Question 7

Which trial phase has the largest patient enrollment allotment?

Answer 7

Phase 3 (300-3000)

Question 8

What is the purpose of a phase 4 trial?

Answer 8

-To collect safety information in a larger population & longer time period (multiple years)
-protection of patient’s safety after approval

Question 9

Do medical device trials have phases?

Answer 9

no

Question 10

what are the 2 steps of device trials?

Answer 10

-pilot
-pivotal

Question 11

What devices fall under Class 1?

Answer 11

bandages, gloves, tongue depressers

Question 12

Which class requires pre-market approval?

Answer 12

Class 3

Question 13

What are the rules for significant risk studies?

Answer 13

-full requirements
-Need IDE application approved by FDA

Question 14

What requirements apply to non-significant risk studies?

Answer 14

abbreviated requirements
-do not need IDE application
-Sponsors & IRBs do not need to report to FDA before trial start

Question 15

What does exempt mean in regards to trials?

Answer 15

exempt from investigational device exemption application

Question 16

What are the 3 classifications a sponsor/CRO may receive after inspection?

Answer 16

-Official action indicated
-voluntary action indicated
-no action indicated

Question 17

When does the sponsor give the investigator brochure to the investigator?

Answer 17

Before the start of a trial

Question 18

Who can discontinue the use of an investigational product that causes unreasonable & significant risk to subjects?

Answer 18

The sponsor

Question 19

What does quality control focus on?

Answer 19

identification & correction

Question 20

How and by who is quality control done?

Answer 20

Done through monitoring of trial by the study monitor

Question 21

What makes up investigational product accountability?

Answer 21

-maintain complete records
-reconcile all products from sponsor
-train the use of products to subjects
-check that subjects are following instructions

Question 22

Who controls the use of investigational products?

Answer 22

the PI

Question 23

What are the responsibilities of the PI?

Answer 23

-oversee trial conduct
-protect the rights, safety, & welfare of subjects
-control the use of investigational product

Question 24

What kind of review outcome cannot be done by expedited review?

Answer 24

A study disapproval

Question 25

What are the expedited review criteria?

Answer 25

-some/all of the research involve no more than minimal risk -minor changes in previously approved research during the approval period

Question 26

When can an informed consent waiver be used?

Answer 26

When the research presents no more than minimal risk of harm to subjects -When research involves no procedures where consent is normally required.

Question 27

How many informed consents do subjects sign?

Answer 27

2- one for site file and one to keep

Question 28

Who signs child/minor consents?

Answer 28

one/both parent or the LAR

Question 29

Who signs the short form?

Answer 29

subject & witness

Question 30

Who signs the summary?

Answer 30

Just the witness

Question 31

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

Answer 31

**C** If the IP can’t be assessed then it can’t be be determined if it is safe and effective.