Data and Statistics
International
INDs
General
Potpourri
100

The number of patients planned to be enrolled into a clinical trial.  

What is sample size?

100

The date of the first worldwide approval permitting clinical trials to begin.

 What is the International Birth Date?

100

The time period between submitting an IND and when the Sponsor can initiate a study. This time line may be extended if FDA does not agree with the proposed protocol.

What is 30-Day hold?

100

The name of the FDA's 1572 Form.

What is "Statement of Investigator?"

100

IRB, REC, and REB are examples.

What are Ethics Committees?

200

Measurements taken at the first visit are recorded as _______________ data.

What is Baseline Data?

200

The number of member states in the European Union.  

What is 27?

200

 The first administration of an investigational drug into humans.  These studies are closely monitored and are designed to determine metabolism and pharmacologic actions of the drug in humans.  

What is Phase 1?

200

If preliminary analysis of phase 2 results appear promising, FDA may ask the sponsor to submit ________________

What is a Treatment Protocol?

200

A drug intended to treat a condition affecting fewer than 200,000 persons in the United States.

 What is an orphan drug?

300

If you randomly select a card from a deck of 52, what is the probability that you will select a face card (including the Aces)?

What is 16/52 (or 4/13) (or 0.308)?

300

This agency moved from London to Amsterdam after Brexit.  

What is the EMA (European Medicines Agency?)

300

A study design in which neither the subject nor the investigator knows the identity of the drug being administered.  

What is a double-blind study?

300

CTD

What is the Common Technical Document?

300

A report submitted by the sponsor to FDA of a suspected adverse reaction that is both serious and unexpected.

What is an INDSR?

400

In the following data set: 2, 4, 5, 17, 33, 101, 130, the number 17 is _________________

What is the Median?

400

Inaugurated in 1990, this agency is unique in that it brings together regulatory authorities and representatives from the worldwide pharmaceutical industry to discuss scientific and technical aspects of drug registration.  

What is the International Council for Harmonization of Technical Requirements for Drugs for Human Use (ICH)?

400

A written submission to FDA by the sponsor which describes obligations being assumed by a CRO.

What is a Transfer of Obligations?

400

A situation in which no subjects have been entered into a trial for 2 years or more or the IND has been on clinical hold for more than 1 year.

What is Inactive Status?

400

HHS

What is the Department of Health and Human Services?

500

A value frequently accepted as defining statistical significance.  

What is p = <0.05?

500

A registry of clinical trials, providing information on study objectives, eligibility criteria, study locations, and investigators.  Administered by the US National Library of Medicine, National Institutes of Health, and used worldwide.

500

Codified in 21 CFR 312.33 this report must be submitted to FDA within 60 days of the anniversary of the date that the IND went into effect.  

What is an IND Annual Report (we will also accept "What is a DSUR?").

500

A certification which accompanies an initial IND submission, signed by the sponsor confirming compliance with ClinicalTrials.gov regulations.

What is FDA Form 3674?

500

An order issued by FDA to the sponsor to delay or suspend a proposed clinical investigation.  

What is a Clinical Hold?