Technical Terms

Question 1

Principal Investigator

Answer 1

Person responsible for the safety and actions of a CT at a site.

If study happening at different sites. Multiple principal Investigators

Question 2

Clinical research Coordinator

Study coordinator

Answer 2

Not a medical practitioner
Person educated in conducting clinical trial
Works with study team for administrative aspects

Scheduling , patient questions, patient contacts etc

Question 3

Investigational New Drug

IND

Answer 3

Study drug before it reaches FDA approval (until phase III)

Question 4

DSMB

Data Safety & Monitoring Board

Answer 4

Group of people appointed independent of a Clinical Trial who assess safety data as the trial goes on

Question 5

Placebo Control

Answer 5

A product that is same as the drug form but without active ingredient

Question 6

Double Blinded

Answer 6

Neither researcher nor participants know if they are receiving a drug or placebo
Prevents bias in study data

Question 7

Types of trials

Answer 7

Treatment trials
Prevention trials
Diagnostic trials
Quality of life trials
Compassionate Use

Question 8

Endpoint

Answer 8

Goals the medication is supposed to achieve

eg 
Symptom improvement
Improve quality of life
Healing
Reduction in need for other medications

Question 9

Special considerations

Answer 9

Parents consent in pediatric clinical trials
Financial consideration for people taking the trials
Continued medication providing for patients who responded well after specified trial endpoint

Question 10

Informed consent

Answer 10

Document for subjects to study and sign as they participate

1. Purpose of study
2. Duration
3. Required procedure
4. Risks
5. Potential benefits
6. Key contacts
7. Institutional requirements

Not a contract. Participants can withdraw anytime they like

Question 11

Statistical power

Answer 11

Sample size (no of participants) has a large impact on ability to detect and measure effects of intervention
This ability is called power.

Larger sample size , more statistical power and cost

Question 12

IEC

Answer 12

Independent ethics committee

Same as IRB (institutional review board)

Question 13

HIPPA

Answer 13

Health insurance portability and accountability act 1996

Question 14

Compassionate use

Answer 14

Use of an unapproved drug still in trials via special forms of investigational new drug Application (IND) or IDE for application of devices.
Used outside of a clinical trial.
For patients with serious or life threatening conditions who aren’t responding to any approved treatment