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Healthcare Clinical Research Specialist > Week 1 > Flashcards

Week 1 Flashcards

1
Q

What is a sponsor in a clinical trial?

A

it is a company that can benefit financially once the drug/deviceis approved for sale

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2
Q

What is a Prinicple investigator is?

A

person that conduct a CT at their clinical site

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3
Q

What authority regulates CT

A

in us FDA; National instate of heallth depending on who is conducting the trial

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4
Q

What is a CRF

A

a case report form. Principle instrument used to collect data in a. CT

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5
Q

What are the two types of CRF?

A

Paper -
or EDC - electronic data collection on computer. Basically a database where someone enters in info. `

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6
Q

What is a CT?

A

Short words: an Experiment

RS study in human subjects that is designed to answer questions about a specific drug/device to use as a possible treatment that can generate safe and efficacy data.

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7
Q

What are they attempting to do or the process in CT (5)

A

Want to generate data set of a drug that is being studied in population of patients,

take data and analyze to determine if its safe and effective,

submit to reg auth,

approval for market,

sell`

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8
Q

A CT involves a__

A

PI

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9
Q

what does a PI do___

A

conducts the trial

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10
Q

Who is the PI Overseen by?

A

IRB

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11
Q

What are the 3 things the IRB will make sure the PI does?

A

Make sure they are designing and conducting it according to the study protocol, Regulatory requirements, GCP Guidelines

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12
Q

Who is A PI usually

A

physician/ doc who works in the academic center where rs is done

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13
Q

Study Protcol?

A

a document that explains exactly how the trial will be conducted, how they will recruit participants

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14
Q

Regulatory req?

A

FDA/NIH have certain reg req that we are req to abide by and conduct by

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15
Q

GCP Guidelines? Which one>

A

One type is the International Conference on Harmoniztion (ICH). Their GCP guidelines are located in section E6.

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16
Q

Who is the data collected by? and on behalf of who?
who is it submitted to?

A

PI; sponsor; FDA for approval

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17
Q

Even if trial is being conducted under jurisdiction of US FDA what is still true?

A

There are times where there are site or trials in EUROPE or SA, CHINA but US FDA still has jurisdiction in those location

they reuquiere PI to adhere to certain reg req even if outside of us

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18
Q

What is the drug dvp timeline?

A

Preclinical testing (03)

Clinical Testing on Human Subjects (4-11)
- Phase 1
-Phase 2
-phase 3
-sometimes phase 4

Drug on sale (12) `

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19
Q

What happens in Preclinical testing?

A

-do lab testing on animals start with mice and move up to larger animals.
-find toxic level in animals to see how much it will take to kill an animal

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20
Q

What occurs in phase 1? who and how many people are involved?

A

There is about 10-100 healthy volunteers. Usually college students.
- figuring out what doses are safe for people to use

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21
Q

What occurs in phase 2? who and how many people are involved?

A

200-1000 volunteers. These people suffer from the medication so heart disease or diabetes.

-start to collect efficacy data: Are these people benefiting from it?

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22
Q

What occurs in phase 3? who and how many people are involved?

A

3000 + Patients. In difference contries and in multiple centers

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23
Q

Phase 3 introduces what?

A

Multiple treatment arms so Blinded, placebo.

Also compares drug with one existing drug.

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24
Q

What phase does the data get submitted to the FDA

A

phase 3

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25
Q

What happens in Phase 4?

A

look at drug already in market. Making sure its still safe and effective. see if anything new is happening.

26
Q

CT Players: Sponsor

A

Company. or entity that produces drug/device that can benefit financially from its approval

ex: Pfizer, Johnson & Johnson

27
Q

CT Players: Clincal Site

A

is headed by the PI. It enrolls patients in the site and conducts trial according to the protocol.

28
Q

Who does the sponsor hire to conduct the trial?

A

PI who usually is doc

29
Q

What will the PI/Doc do during the trial

A

see patients, administer study, collect data, give to sponsor

30
Q

CT Players: IRB

A

They are responsible for the safety of human subjects; oversee PI;

approves:
-study protocol
- informed consent
-STMs (dosing diaries; ads used to attract patients)

31
Q

2 types of IRB

A

Central V. Local

32
Q

Local

A

Part of the academic medical facility

33
Q

Central

A

For-profit companies that oversee RS for sponsors, invesitagors

34
Q

CT Players: Regulatory Auhorities

A

FDA; NIH. Government agency that regulates the approval of sale, distribution, of drug.

35
Q

CT Players: Patients

A

human subjects who volunteer to participate in CT

36
Q

CT Players: CROs

A

they administer and monitor CT on behalf of the sponsors(ParaExcel, PPD)

37
Q

CT LifeCycle: Approved Protocol

A

Documents that explains exactly how study will be conducted, all assessments, vists.

38
Q

CT LifeCycle: Start to select Investigators. What are they looking for in PI’s?

A

Docs who conduct trials.

-someone w/ exp. in CT in past
-doctos who specialize in the area of medication. (if cancer trials need doc who works with cancer patients)

39
Q

CT LifeCycle: Approval Process

A

Approving docs who will participate in trial. Need to have IRB approved for their site before continuing

40
Q

CT LifeCycle: Patient Recruitment and Participation

A

Come in for their visit. Docs conduct visits, perform assessments; and collect data

41
Q

CT LifeCycle: Data Entered and Reviewed

A

Either CROs or Sponsor Pharma Comp. going to clean the data to send to statisticians

42
Q

CT LifeCycle: Statistical Analysis

A

once data cleaned free of errors, Biostatistics will run statistical analysis. They will determine if drug is good or not.

43
Q

CT LifeCycle: Presentation and Publication of report

A

start to present data in conferences.

44
Q

CT LifeCycle: Submit data for registration

A

submit to FDA for registration, approval, sell it

45
Q

More In Depth CT Process: DVP CT plans

A

here they have already done animal testing and pre-clinical testing so now they dvp CT plans. `

46
Q

More In Depth CT Process: Now they write the

A

Protocol

47
Q

More In Depth CT Process: Order all

A

CTMs

48
Q

More In Depth CT Process: DVP C_

A

CRF (electronic/paper)

49
Q

More In Depth CT Process: Prepare IB

A

Investigator Brochure

50
Q

IB?

A

document that explains all the science of the trial; give to docs to read and sign. Will also explain any preclinical testing they did

51
Q

Where in the ICH explains all info needed to be in a brochure?

A

ICH-E6 Section

52
Q

More In Depth CT Process: Protocal

A

Approval

53
Q

More In Depth CT Process: Screen

A

PI

54
Q

More In Depth CT Process: Pre-

A

Initiation visis

-go out and visit sites to make sure its suitable and have all resources needed to conduct trial.

55
Q

More In Depth CT Process: Negotiate (3)

A

budget
-conduct investigator meeting: all docs come together to see if any ?s
-identify study team

56
Q

More In Depth CT Process: Select

A

Investigator

57
Q

More In Depth CT Process: Conduct

A

Trials

58
Q

More In Depth CT Process: A

A

apprivcl

59
Q

Scientific method

A

1-ask ?
2- State hypo
3-Test hypo; experiment
4-analyze data
5-make conc

60
Q

where do CT reside in

A

step 3/4 but touches all in some fashion

61
Q

What does Data management do?

A

cleans data so its accurate before analysis begin.

Healthcare Clinical Research Specialist (1 decks)

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