question

Electronic Records, Electronic Signatures

answer

CFR Title 21: Part 11

question

Informed Consent

answer

CFR Title 21: Part 50

question

Financial Disclosure

answer

CFR Title 21: Part 54

question

Instiutional Review Board

answer

CFR Title 21: Part 56

question

Investigational new Drug Application

answer

CFR Title 21: 312

question

New Drug Application

answer

CFR Title 21: 314

question

Investigational Device Exemption

answer

CFR Title 21: 812

question

Pre- Market Approval of Medical Devices

answer

CFR Title 21: 814

question

Protection of Human Subjects

answer

CFR Title 45 Part 46

question

Notice of Inspection

answer

Form 482

question

Inspectional observations

answer

Form 483

question

Statement from the Investigator

answer

Form 1572

question

Certification of Financial Interests

answer

Form 3454

question

Disclosure of Financial Interests

answer

Form 3455

question

Voluntary Adverse Events

answer

Form 3500

question

Mandatory Adverse Events

answer

Form 3500A

question

Cover sheet for IND

answer

Form 1571

question

Protection of Human Subjects, \"the Common Rule\"

answer

CFR Title 45 Part 46

question

Pregnant Women and Fetuses

answer

CFR Title 45 Part 46 - Part B

question

Prisoners

answer

CFR Title 45 Part 46 - Part C

question

Children

answer

CFR Title 45 Part 46 - Part D

question

IRB's

answer

CFR Title 45 Part 46 - Part E

question

1996

answer

Date of GCP and HIPPA guidelines

question

1979

answer

Date of Belmont Report

question

1947

answer

Date of Nuremberg Code

question

1964

answer

Date of Declaration of Helenski

question

The term includes drugs and medical devices for human use.

answer

Test Article

question

In a single-blind experiment, the individual subjects do not know whether they are so-called \"test\" subjects

answer

Single Blind

question

In a double-blind experiment, neither the participants nor the researchers know which participants belong to the control group, as opposed to the test group

answer

Double Blind

question

Any law(s) and regulations(s) addressing the conduct of clinical trials of investigational products

answer

Applicable Regulatory Requirements

question

A systematic and independ examination of trial related activities and documents to determine whether th evaluated trial realted activiites were conducted and the data were recorded, anaylzed and accurately reported according to the protocol, SOPs, GCPs, and regulatory requirements.

answer

Audit

question

Declaration of confirmation that an audit has taken place

answer

Audit Certificate

question

A written evaluation by the sponsor's autidotr of the results of the audit

answer

Audit Report

question

Documentation that allows reconstruction of the course of events

answer

Audit Trail

question

Any investigation in human subject inteded to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or identify any adverse reactions to an investigational product(s)

answer

Clinical Trial or Study

question

An investigational or marketed product, or placebo, used as a reference in a clinical trial

answer

Comparator (Product)

question

Adherence to all the trial-related requirements

answer

Compliance

question

A committe that a sponsor may organize to coordiante the conduct of the multicentre trial

answer

Coordinating Committee

question

An investigator assigned the responsiblity for the cooridnation of investigators and different centres participaing in amulticentre trial

answer

Coordinating Investigator

question

Permission to examine, analyze, verify, and reproduce any reocrds and reports taht areimportant to evaluation of a clinical trial.

answer

Direct Access

question

Documents which individually and collectively permit evaluation of the conduct of a studyand teh quality fo the data produced.

answer

Essential Documents

question

a committe established by the sponsor to assess at itervals the progress of a clincial trial, the safety data, and the critical efficacy endpoints, and to recommed to the sponsor whether to continue, modify, or stop a trial

answer

IDMC - Indpendent Data Monitoring Committee

question

an independed bodythat is constituted of medical and non-medical members, whose responsiblity is to ensure the protection of the rights, safety and well-being of human subjects invovled in a trial and to provide public assurance of that protection by, among other things reviewing and approving the trial protocol, the suitability of the investigators, facilities, methods of consent

answer

Independ Ethics Committee (IEC)

question

any public or private entity or agency or meical or dental facility where clinical trials are conducted

answer

Institution

question

An independent body constituted of medical, scientific, and non-scientific members, whose responsiblity is to ensure the protection of the rights, safety, and well-being of human subject invovled ian trail by, among other things, reviewing approving and prividing continuing review of trial protocol

answer

Institutional Review Board (IRB)

question

A report of intermediate results and their evalutions during the course of a trial

answer

Interim clincial Trial/Study Report

question

A pharmaceutical form of an active ingredient or placebo, being tested or used as a reference in a clincial trial, including a product with a amrketing authroization when used or assembled in a way different from the approvedform.

answer

Investigational Product

question

A person responsible for the conduct of the clincial trial at a trial site.

answer

Investigator

question

A compilation of the clincial and nonclincal data on the investigational prodcuts

answer

Investigational Brochure

question

An individual or juridical or other body authroized under applicable law to consent on behalf of a prospective subject

answer

Legally Acceptable Representitive

question

The act of overseeing the progress of a clinical trial, and ensuring that it is ocnducted, recorded, and reported in a accordiance with the protocol, SOPs, GCP, and regulatory requirements

answer

Monitoring

question

Biometric studies not performed on human subects

answer

Non Clinical Trial

question

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documetned, and reported in compliance with GCP and regulatory requirements

answer

Quality Assurance (QA)

question

The operational techniques and activities, undertaken within the quality assurance system to verify the requriements for quality of the trial-related activities ahve been fulfilled

answer

Quality Control

question

A untward emdical occurrences that may result in death, be life threatining, requires impatient or pro-longed hospitatilzation, results in persisten disaiblity/incapacity

answer

Serious Adverse Event

question

All information in orignal records and certified copies of original records of clincal findings, observations, or other activities ina clinical trial necessary for the reconstruction and evaluation of the trial

answer

Source Data

question

Orignial docuemnts, data, and records (hospital records)

answer

Source Documents

question

An individual, company, institution, or organization which takes responsilbity for the initiation, management, and/or financing of a clinical trial

answer

Sponsor

question

And inidividual who both initiates and conducts a clinical trial

answer

Sponsor - Investigator

question

The location(s) where trial-related activiites are actualy conducted

answer

Trial Site

question

An adverse reaction, the nature of severeity of which is not ocnsistent with the applicable product information

answer

Unexpected Adverse Drug Reaction

question

15 Calendar Days

answer

Serious, unexpected Adverse Drug Reactions have to be reported in how many days?

question

7 Calendar Days

answer

Fatal or Life-Threating Unexpected ADR's have to be reported in how many days?

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