Clinical research Questions with Correct Answers
Investigational New Drug (IND) Correct Answer-a new drug that is used
in an investigation. In order to test a nee drug an IND application must
be filed with the FDA prior to starting the study.
protocol Correct Answer-the formal plan for carrying out the
investigation
informed consent Correct Answer-the process by which a subject
voluntarily agrees to be in a research study. They read the informed
consent form (ICF) and the CRC reviews it with them. if the subject is
willing they sign the ICF to affirm their willingness to be in the trial.
efficacy Correct Answer-the ability of an investigational product to
produce beneficial effects. basically means "does the product work?" if
yes yhej it is efficacious
Adverse Drug Reaction (ADR) Correct Answer-an unintended reaction
to a drug taken at a normal dose
Adverse Event (AE) Correct Answer-Any untoward medical occurrence
in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. a change in a persons health
Serious Adverse Event (SAE) Correct Answer-any iutward medical
occurance at any dose that results in death, is life threatening, requires
,hospitalization (or prolonged hospitalization) results in persistent or
significant disability, or is a birth defect.
data management Correct Answer-managing the data, the process if
handling data generated and collected during a trial. it usually involves
data entry, data cleaning, and database management.
Case Report Form (CRF) Correct Answer-a recored kf information
collected from a subject during a trial. the information that is collected is
based on what the protocol specifies.
Investigator Brochure (IB) Correct Answer-contains all information
known about the test product including chemical makeup, mechanisms
of action, clinical and preclinical data. this eventually becomes
something you are probably familiar with-the package insert
Institutional Review Board (IRB) Correct Answer-a committee of
diverse individuals that review studies PRIOR to the study entolling
participants.All studies involving human subjects (with few exceptions
for studies involving minimal risk) must be IRB approved prior to
enrolling subjects. the goal of the IRB is to protect human subjects.
Standard Operating Procedures (SOPs) Correct Answer-written
directions on exactly how procedures are to be performed. the goal is to
maje sure everyone who performs that task does it exactly the same way
everytime.
,Unanticipated Events Correct Answer-problem invikving risk to human
subjects or others participating ina clinical research study. example:
breach of confidentiality, incarceration of subject, suicide attempt,
incorrect labeling of study drug. these need to be collected throughout a
study and reported to the IRB and/or study sponsor.
sponsor Correct Answer-the person it entity who initiates a clinical trial
but they do not actually run the trial
study sites Correct Answer-where studies are actually run. Sites are
where participants are recruited and data is collected.
Clinical research associate (CRA) Correct Answer-typically work for the
CROs. they are responsible for monitoring the study at study sites. They
visit sutes and look at the data collected and make sure the site is
following protocol. they work closely with the CRCs at the study site
clinical research coordinator (CRC) Correct Answer-the ones that
actually carry out the studies at the study sites and collect the study data.
manages the daily operations of tge trial. they are often the ones seeing
the participants and carrying out the protocol. they are respondible to the
investigation.
contact research organization (CRO) Correct Answer-sponsors hire a
CRO to handle the management of the clinical trial. like the sponsor they
do not carry out the clinical trial but rather manage the trials and the
sites that are actually running the study.
, site management organization (SMO) Correct Answer-a group of
investigational sutes that have banded together and are organized
centrally to conduct studies
investigator Correct Answer-s(sometimes called clinical investigator or
more often pricipal investigator (PI)) is an individual who conducts the
clinical investigation. under the immediate direction the investigation
product is dispensed. they are the site leader od the investigation. other
may work for the investigator,such as clinical research coordinators but
ultimately responsibility for the trial lies with the investigator.
Data Safety Monitoring Board (DSMB) Correct Answer-a group of
individuals who periodically review interim unblinded study data to
ensure the safety of the participants in the trial. not all studies require a
DSMB. DSMB reports are submitted to the IRB throughout the study to
help the IRB determine if the study is safe.
international conference on harmonization Correct Answer-the good
clinical practice guidelines were created here. the goal was to design
guidelines that would regukate the conduct if clinical trials nationally
impetus to harmonize Correct Answer-the idea to standardize research
internationally took place in the wake of the thalidomide fall out in
which women were given a medication, thalidomide to help east
morning sickness. the medication led to sever birth defects. thalidomide
was never approved in the us because the FDA refused based in
insufficient safety data
Investigational New Drug (IND) Correct Answer-a new drug that is used
in an investigation. In order to test a nee drug an IND application must
be filed with the FDA prior to starting the study.
protocol Correct Answer-the formal plan for carrying out the
investigation
informed consent Correct Answer-the process by which a subject
voluntarily agrees to be in a research study. They read the informed
consent form (ICF) and the CRC reviews it with them. if the subject is
willing they sign the ICF to affirm their willingness to be in the trial.
efficacy Correct Answer-the ability of an investigational product to
produce beneficial effects. basically means "does the product work?" if
yes yhej it is efficacious
Adverse Drug Reaction (ADR) Correct Answer-an unintended reaction
to a drug taken at a normal dose
Adverse Event (AE) Correct Answer-Any untoward medical occurrence
in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. a change in a persons health
Serious Adverse Event (SAE) Correct Answer-any iutward medical
occurance at any dose that results in death, is life threatening, requires
,hospitalization (or prolonged hospitalization) results in persistent or
significant disability, or is a birth defect.
data management Correct Answer-managing the data, the process if
handling data generated and collected during a trial. it usually involves
data entry, data cleaning, and database management.
Case Report Form (CRF) Correct Answer-a recored kf information
collected from a subject during a trial. the information that is collected is
based on what the protocol specifies.
Investigator Brochure (IB) Correct Answer-contains all information
known about the test product including chemical makeup, mechanisms
of action, clinical and preclinical data. this eventually becomes
something you are probably familiar with-the package insert
Institutional Review Board (IRB) Correct Answer-a committee of
diverse individuals that review studies PRIOR to the study entolling
participants.All studies involving human subjects (with few exceptions
for studies involving minimal risk) must be IRB approved prior to
enrolling subjects. the goal of the IRB is to protect human subjects.
Standard Operating Procedures (SOPs) Correct Answer-written
directions on exactly how procedures are to be performed. the goal is to
maje sure everyone who performs that task does it exactly the same way
everytime.
,Unanticipated Events Correct Answer-problem invikving risk to human
subjects or others participating ina clinical research study. example:
breach of confidentiality, incarceration of subject, suicide attempt,
incorrect labeling of study drug. these need to be collected throughout a
study and reported to the IRB and/or study sponsor.
sponsor Correct Answer-the person it entity who initiates a clinical trial
but they do not actually run the trial
study sites Correct Answer-where studies are actually run. Sites are
where participants are recruited and data is collected.
Clinical research associate (CRA) Correct Answer-typically work for the
CROs. they are responsible for monitoring the study at study sites. They
visit sutes and look at the data collected and make sure the site is
following protocol. they work closely with the CRCs at the study site
clinical research coordinator (CRC) Correct Answer-the ones that
actually carry out the studies at the study sites and collect the study data.
manages the daily operations of tge trial. they are often the ones seeing
the participants and carrying out the protocol. they are respondible to the
investigation.
contact research organization (CRO) Correct Answer-sponsors hire a
CRO to handle the management of the clinical trial. like the sponsor they
do not carry out the clinical trial but rather manage the trials and the
sites that are actually running the study.
, site management organization (SMO) Correct Answer-a group of
investigational sutes that have banded together and are organized
centrally to conduct studies
investigator Correct Answer-s(sometimes called clinical investigator or
more often pricipal investigator (PI)) is an individual who conducts the
clinical investigation. under the immediate direction the investigation
product is dispensed. they are the site leader od the investigation. other
may work for the investigator,such as clinical research coordinators but
ultimately responsibility for the trial lies with the investigator.
Data Safety Monitoring Board (DSMB) Correct Answer-a group of
individuals who periodically review interim unblinded study data to
ensure the safety of the participants in the trial. not all studies require a
DSMB. DSMB reports are submitted to the IRB throughout the study to
help the IRB determine if the study is safe.
international conference on harmonization Correct Answer-the good
clinical practice guidelines were created here. the goal was to design
guidelines that would regukate the conduct if clinical trials nationally
impetus to harmonize Correct Answer-the idea to standardize research
internationally took place in the wake of the thalidomide fall out in
which women were given a medication, thalidomide to help east
morning sickness. the medication led to sever birth defects. thalidomide
was never approved in the us because the FDA refused based in
insufficient safety data
