CRA TEST

What's the name of the documentation that must be signed and dated by the site prior to scheduling a QV?

A CDA

What is a CRA?

A CRA is a health-care professional who performs many activities related to medical research, particularly clinical trials.

Regulatory Binder

A binder that is located at each site which houses all of the sites are essential documents

Approved budget

A budget if they agree dollar amounts that will be paid to the site for each subject and visit that is perform for the study.

The main ingredient in a drug is called?

A compound

Investigational brochure IB

A comprehensive document summarizing the body of information about an investigational product. It lists information regarding the safety of the drug and statistical data around the adverse events associated with the drug

Clinical trial agreement/contract

A contract between the CRO and the site that states the agreement of what's expected within the study

An investigator is usually?

A doctor or physician

Financial disclosure form

A document that confirms that the PI or sub I does not have any financial interest within the study. it is collected at the beginning and at the end of the study

Note To File NTF

A document that provides a detailed description regarding a discrepancy noted during the clinical study

Clinical Laboratory Improvement Amendments (CLIA)

A laboratory certificate that certifies that lab. The CLIA expires yearly and an updated copy needs to be collected once the CLIA expires

Interm analysis/ Soft Lock IA

A lack of the data answered within the EDC system during set time points of the study. Typically this occurs when certain endpoints are reached. This lock is not a permanent lock. Once the Biostaticians review the data then they will unlock the data.

Database lock DBL

A lock of data entered within the EDC system. No changes or queries can be entered if a DBL occurs. They typically occur at the end of the study and is permanent. End of every phase and end of every study

Site signature delegation log/delegation of authority SSDL/DOA

A log that has everyone at the site listed along with the task they will perform that was delegated by the principal investigator

What's another name for a sugar pill?

A placebo

What is a protocol violation?

A protocol violation is an alter within the protocol guidelines that affects the subjects safety.

Reference ranges RR

A range of numbers in which a value is placed to determine if a result is normal

What is a CV?

A resume that states the individuals skills and background

Source document verification SDV

A review of the data collected from the site to confirm that the data matches what is entered in the EDC system

Standard operation procedure / SOP

A set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOP's and to achieve efficiency, quality outpour and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations

Certified Authorization Professional (CAP)

And additional certificate that some sites have in addition to the CLIA. It is a certification. It is an objective measure of the knowledge, Skills and abilities required for personnel involved in the process of authorizing and maintaining information systems

Protocol Deviation PD

And alter within a protocol guidelines that do not affect the subject safety. Basically deterred away from what's in protocol. Document on log and retain site and have trained staff sign log

Pre-clinical trials are done on??

Animals, microorganisms, and tissue

Pre-clinical studies are performed on?

Animals, microorganisms, tissue

Serious Adverse Event SAE

Any And toward events that may or may not be related to the study drug which results in death, hospitalization for greater than 24 hours, causes congenital anomaly, causes incapacitation, that is life-threatening, or considered medically significant

Adverse Event (AE)

Any untoward event that may or may not be related to the study drug that was not originally identified within the subjects medical history

At which phase are patients NOT healthy?

At phase 2

Clinical Trials are conducted on human volunteers to allow what?

Safety and efficacy date to be collected for health intervention

Pre-site selection visit (PSSV)

This visit is conducted in order to confirm whether the site is qualified to participate in the study. There will only be one qualification visit per site per study

Site initiation visit

This visit is connected once the site has been selected and the site receives A greenlight approval. Greenlight approval is an approval that all essential documents have been collected and the IRB has approved the site ready to participate in the study. There will only be one SIV per site per study

What is the main function of a CRA?

To monitor clinical trials

What's another name for side effects?

Toxicity and adverse events

What does TMF stand for?

Trial Master File

What's 2 other names for a CRA?

Trial monitor, clinical monitor

What information is entered into the CTMS?

Trip reports (TR), Protocol deviations (PD), and site information

T-F Preclinical trials don't have a phase?

True

How many days does the FDA have to approve an application?

30 days

Before any drug can make it to market how many phases must they go thru?

4 phases

How many types of visits are there?

4 visits

What's the drug development process?

- Drug development -Pre-Clinical Studies - Clinical Trials - Phase 1 -Phase 2 -Phase 3 -Phase 4

Monitoring clinical trials consist of what?

-Review subject data associated with the protocol/ study -Ensure the safety and well being of subjects - Provide protocol/ study specific training to site personnel -Review essential documents housed in the regulatory binder - Conduct on-site and phone visits -Complete Trip reports - Communicate with site personnel on a consistent basis

What are the keypoints of a protocol?

1) inclusion/exclusion criteria 2) schedule of assessment 3) study drug 4) SAE/AE 5) prohibited concomitant medication

Electronica data capture (EDC)

A system that house is that an answered by each side participating on a clinical study. Only the site can't enter data. The CRA will have read only access and will only be able to question the data (query) or close the query

Trial Master File (TMF)

A system that must be the exact replica of the essential documents that are housed at the site in the regulatory binder

Drug development is???

A term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery, preclinical research (microorganism/animals) and clinical trials (on humans)

A NDA must be submitted after completion of what phase?

After completion of phase 1, phase 2, phase 3 studies of clinical trials

What is an IM?

An Investigators Meeting is a meeting in which all PIs, SCs, Medical Team, Sponsor Team, and study team are present to provide a formal training together with all the sites that will be participating on the study.

What is an Investigational New Drug Application?

An application filed with the FDA after completion of pre-clinical and prior to human testing

Clinical trial management system (CTMS)

CRA will enter trip reports, track protocol deviations, house all site information

What are the Clinical Study Roles

CRA, PM, COL, CTL, CTM, LCRA, PS, PD, CTS, DM

CRA work in various settings such as pharmaceutical companies, CRO, medical research institutes, and government agencies.

Clinical Research Associates work in what kind of settings?

What's another name for a CRA?

Clinical monitor, trial monitor, or site manager

What does CRA stand for?

Clinical research associate

What does CRO stand for?

Clinical research organization

What is CTCAE? And what is it used for?

Common Terminology Criteria for Adverse Events and it's a tool used at the site to grade adverse events. The grading is from 1-5

What is a New Chemical Entities (NCE)?

Compounds which emerge from the process of drug discovery

Who is present during a SIV?

During a SIV the PI, Sub I, SC, and other key staff are present.

What are the type of systems used in clinical research?

EDC, IVRS, IWRS, TMF, CTMS

Good clinical practice certificates

The training certificate for GCP that confirms that the site staff has been trained

What are the study start up documents/essential documents?

FDF, CV, CTA, SOA, GCP, IB, Protocol Signature Page, ML, Approved Budget

T-F 4 applications are required to be sent in for pre clinical trial?

False

T-F Preclinical trials involve humans?

False

International Council for harmonization (ICH)

ICH is a project that brings together the regulatory authorities of Europe, Japan and the United States and expert from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration

In a double blinded study who knows what the subject is receiving?

In a double blinded study only the Sponsor will know what drug the subject is receiving

What does IRB stand for?

Institutional Review Board

What's another name for a physician in the clinical field?

Investigator

What is dose escalation? And what Phase does it occur?

Is studies so that the appropriate dose for therapeutic use can be found. It occurs in phase 1

What is a MP?

Is the plan that establishes the guidelines for conducting monitoring visits and monitoring related tasks.

When is the only time a patient is not healthy for phase 1?

It's the patient has aids or cancer; other than that all patients must be healthy in phase 1

What is another name for trip report

Monitoring report

The SIV and COV reports are the only reports that will what?

That will be sent back to the site after finalization to be filled in the RB/SFN unless specified

Confidential disclosure agreement

Legal contract between the CRO/ sponsor and the site that outlines Confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties. It is a contract through which the parties agree not to disclose information covered by the agreement.

What are non-blind or open studies? And which phase does this occur in?

Non-blind or open is when both the investigators and the subjects know what drug is being given to them and this occurs in phase 1

Traveling to site are what type of visits?

On-site visits

What is a therapeutic area?

Oncology, Cardiology, General Medicine

What are the clinical site roles?

PI, SC, Sub-I, DC , RC

What's another name for subject?

Patient

At what phase would you see healthy patients?

Phase 1

Many predictable toxicities are detected in what phase?

Phase 1

Which phase involves the 3+3 design?

Phase 1

Which phase is a continuous phase?

Phase 4

Post marketing surveillance Trial

Phase 4 trails are also known as what?

What is another name for a study?

Protocol and clinical trial

What is another name for "enrolled"in clinical trial?

Randomization

Therapeutic area (TA)

Refers to a generalized organ system/disease in which a study is being conducted i.e. oncology, cardiology, general medicine

Another name for a phone visit Is what?

Remote visit

What's another name for patient?

Subject

informed consent form (ICF)

Subject + PI or delegated site personnel

What does the IRB approval?

The IRB approval the protocol, acknowledgement of the IB, ICF, All protocol related material, recruitment advertisement, and the IRB approval letter

Who is the Sponsor?

The actual pharmaceutical or bio-technology company

Investigational Product (Drug)

The actual study drug that is used during a clinical study. Study drug the sponsor is trying to get on market

Sub-investigator/ Co- investigator

The back up physician to the PI that also assists with the conduct of the study

Case report form/electronic case report form CRF/eCRF

The data that is collected and the EDC are CRFs

Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA)

The guidelines/standards set by the FDA for data collection

Who are the key staff at the site?

The key staff at the site are the PI, SC, DC, RC, Pharmacist, and site manager

What are the monitoring guidelines?

The monitoring guidelines are ICH-GCP Guidelines and FDA Guidelines

What is standard of care (SOC)?

The normal care provided per the sites guidelines

Data coordinator

The person on site that enters the subjects data an answer EDC queries

Study Coordinator SC

The person that will be the CRA's primary contact at the site. The SC will be delegated to many tasks such as: entering data, reporting SAE's, ordering study drug, scheduling subjects visits, scheduling monitoring visits, and updating the site's regulatory binder

Phase 2 trials are usually done in Special clinical centers such as?

University Hospitals

Integrated WEB response system (IWRS)

Via Web

Integrated VOICE response system (IVRS)

Via telephone

Patients participating in a clinical trial are always?

Volunteers

-Review subject data associated with the protocol/study -ensure the safety and well being of the subjects - provide protocol/study specific training to site personnel - Review essential documents housed in the regulatory binder - conduct onsite and phone visits -complete trip reports - communicate with site personnel on a consistent basis

What does monitoring clinical trials consist of?

Drug Development is a term used to define the entire process of bringing a new drug or device to the market. It includes: drug discovery, product development, pre-clinical research (microorganisms/animals) and clinical trials (on humans)

What is Drug Development?

Phase 1 trials are done to determine what?

Whether humans and animals show a significantly different response to the drug and to establish safe clinical dosage range

Clinical trial specialist

Who is the assistant to the LCRA?

What is oncology?

study of cancer

What is pharmacokinetics?

the study of drug movement throughout the body