Definition of Terms

Question 1

A set of format-based documents for the submission of nonclinical, clinical, and manufacturing information to regulatory authorities for marketing approval to license a rug for sale.

Answer 1

CTD

Question 2

Investigational New Drug (IND)

Answer 2

Application filed within the FDA to conduct clinical trials on a new drug

Question 3

New Drug Application (NDA)

Answer 3

Application submitted to the FDA for marketing approval of a new drug.

Question 4

Clinical Trial Application (CTA)

Answer 4

Request for authorization to conduct a clinical trial in a specific country.

Question 5

Institutional Review Board (IRB)

Answer 5

A committee that reviews and monitors clinical trials to ensure ethical standards.

Question 6

Good Clinical Practice (GCP)

Answer 6

International ethical and scientific quality standards for clinical trials.

Question 7

Protocol

Answer 7

Document detailing the objectives, design, methodology, and organization of a clinical trial.

Question 8

Regulatory Authority

Answer 8

Government agency responsible for regulating the approval of drugs and medical devices (FDA, EMA, Health Canada).

Question 9

Case Report Form (CRF)

Answer 9

A document used to collect data from each trial participant.

Question 10

Data Monitoring Committee (DMC)

Answer 10

Independent group that reviews safety data during a trial.

Question 11

Market Authorization Application (MAA)

Answer 11

Application to obtain permission to market a new product in the EU.

Question 12

Post-Marketing Surveillance

Answer 12

Monitoring of drugs after they have been released on the market.

Question 13

Pharmacovigilance

Answer 13

The practice of monitoring the safety of pharmaceutical products.

Question 14

Biaavailability

Answer 14

The rate and extent to which the active substance is absorbed and becomes available at the site of action.

Question 15

Biological License Application (BLA)

Answer 15

Request for permission to introduce a biologic product into the market.

Question 16

Regulations requiring that manufacturers ensure products are consistently produced and controlled.

Answer 16

Good Manufacturing Practice (GMP)

Question 17

Application for approval to market a generic drug.

Answer 17

Abbreviated New Drug Application (ANDA)

Question 18

A process designed to facilitate the development and expedite the review of drugs that treat serious conditions.

Answer 18

Fast Track Designation

Question 19

Status given to drugs intended to treat rare diseases or conditions.

Answer 19

Orphan Drug Designation

Question 20

Required risk management plans to ensure that the benefits of a drug outweigh its risks.

Answer 20

Risk Evaluation and Mitigation Strategy (REMS)

Question 21

International guidelines on technical requirements for pharmaceuticals.

Answer 21

ICH Guidelines

Question 22

An order issued by the FDA to delay or suspend a clinical trial.

Answer 22

Clinical Hold

Question 23

An instance in which the clinical trial conduct deviates from the approved protocol.

Answer 23

Protocol Deviation

Question 24

A faster review process granted by regulatory agencies for drugs that meet specific criteria.

Answer 24

Expedited Review

Question 25

An inactive substance used as a control in clinical trials.

Answer 25

Placebo

Question 26

European database of all clinical trials conducted in the European Economic Area (EEA)

Answer 26

EUDRACT

Question 27

Standard for submitting applications to regulatory agencies electronically.

Answer 27

eCTD

Question 28

A document summarizing the clinical and non clinical data on the investigational product.

Answer 28

Investigator's Brochure (IB)

Question 29

Any change to a clinical trial protocol that significantly affects participant safety or scientific value.

Answer 29

Substantial Amendment

Question 30

A set of ethical principles for medical research involving human subjects.

Answer 30

Declaration of Helsinki

Question 31

The process of keeping the trial participants, investigators, or both unaware of the assigned treatment.

Answer 31

Blinding (Masking)

Question 32

A primary outcome used to judge the effectiveness of a treatment.

Answer 32

Endpoint

Question 33

The process of assigning trial participants to treatment groups by chance.

Answer 33

Randomization

Question 34

A plan for the ongoing assessment of safety during a clinical trial

Answer 34

Safety Monitoring Plan (SMP)

Question 35

A trial designed to demonstrate that a new treatment is not worse than an existing treatment.

Answer 35

Non-Inferiority Trial

Question 36

A standard treatment or placebo used as a comparison in a clinical trial.

Answer 36

Comparator

Question 37

European Union directive on the conduct of clinical trials.

Answer 37

Directive 2002/20/EC

Question 38

A meeting conducted before a clinical trial begins to prepare the trial site.

Answer 38

Site Initiation Visit (SIV)

Question 39

A company contracted by sponsors to manage clinical trials and related tasks.

Answer 39

Contract Research Organization (CRO)

Question 40

Ensuring compliance with regulatory requirements and GCP>

Answer 40

Quality Assurance (QA)

Question 41

A person responsible for the day-to-day management of clinical trials at the site level.

Answer 41

Study Coordinator

Question 42

The process of collecting, assessing, and reporting safety data to regulatory authorities.

Answer 42

Safety Reporting

Question 43

Module that contains regional administrative information specific to each country.

Answer 43

Module 1

Question 44

Module that contains summaries of quality, nonclinical, and clinical data

Answer 44

Module 2

Question 45

Quality information module

Answer 45

Module 3

Question 46

Safety studies (nonclinical study reports) module

Answer 46

Module 4

Question 47

Collection of human clinical study reports. Efficacy studies module

Answer 47

Module 5

Question 48

Approval for a drug to be marketed in Canada

Answer 48

Notice of Compliance (NOC)

Question 49

Term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product.

Answer 49

dossier (CTD)

Question 50

Drugs for diseases with patient population of less than 200,000 in the US.

Answer 50

Orphan Drugs

Question 51

A report of an individual study of an investigational medicinal product, in which the clinical and statistical description, presentations, and analyses are integrated.

Answer 51

Clinical Study Report (CSR)

Question 52

Evaluate the PD and PK of dugs against reference off-patent drugs.

Answer 52

Bioequivalence