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Who is most responsible for the appropriate monitoring of clinical trials? - ✔ ✔ ✔ Correct Answer > Sponsor You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want to see which of the following - ✔ ✔ ✔ Correct Answer > 1. Unobscured original entries 2. Traceable source documents 3. An Audit trail A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC allowed to do this task? - ✔ ✔ ✔ Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI
Typology: Exams
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Who is most responsible for the appropriate monitoring of
You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want
Unobscured original entries
Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI
You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a Site. The first course of action you implement is that a __________ be
A subject: who has been 100% compliant thus far has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to
forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the
regulatory authority(ies)
Essential documents should be retained at least ______ after the last approval of a marketing application: or formal discontinuation of clinical development of the investigational
Safeguard the rights: safety: and well-being of all trial subjects Which of the following should the investigator do FIRST if a
Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form
the informed consent interview
the sponsor to request a translation of the informed consent
Per ICH GCP E6: the purpose/elements of trial monitoring differ
Correct Answer > 1. The sponsor should appoint individuals: who are independent of the clinical trials/systems
Members of the armed forces
What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics: Pharmacodynamics
Answer > Phase 1 The principles and practices concerning protection of trial subjects are stated in the ICH Guideline on Good Clinical Practice (ICH E6). These principles have their origins from -
The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used
initial human dose
Dose-tolerance studies: single and multiple dose PK and/or PD studies: and drug interaction studies are examples of what
Characterization of a drug's absorption: distribution: metabolism: and excretion that continues throughout the
Pharmacokinetics According to ICH E8: "Formulations used in clinical trials should be well characterized: including information on ___________
The study subject asks you why the study is called a double
Answer > When the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects and analysis of data are unaware of the treatment assignments According to ICH E8 what type of study would have the following elements? Adequate: and well controlled studies to
parallel dose response studies
bioavailability
A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should
general plan from the beginning Per ICH E8: methods used to evaluate patient usage of the test
protocol and actual usage documented Which trial design is used for the specific purpose of examining
design T or F- The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an
True What is the purpose of the "Data and Safety Monitoring Board
clinical trial: the safety data: and the critical efficacy endpoints T or F- The focus of ICH E9 is on statistical principles: however: it does not address the use of specific statistical procedures or
Answer > 1. The procedure to be followed: the necessary documentation: and the subsequent treatment and assessment of the subject should all be described in the protocol
Which variable in a study should be used to determine the
You are writing an Investigator-initiated clinical research protocol and you need to limit the occurrence of conscious and unconscious bias. Which of the following methods may be
Generalization The Investigator at your site asked you to review a protocol. The investigational product listed in the protocol already has proven clinical benefits for the disease under study. This is
Confirmatory Trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns __________: that is: the residual influence
Answer > Carryover effect Missing data points (values) represent a potential source of bias
What study variable takes in the consideration the decision making process of the treating physician: who must weigh
Correct Answer > Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out
True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know
Independent Data Monitoring Committee
When writing an early phase clinical study plan which of the following do you want to pay attention to if you wish to maximize the chance of observing specific clinical effects of
True or False- All new medications should have generated data
> False True or False- Medicinal products may affect physical and cognitive growth and development: and the adverse event
> True What is it called when a child is given information about a trial
Answer > Assent T or F- Although initial safety and tolerability data is usually obtained in adult trials: some products may reasonably be studied only in the pediatric population even in the initial phases (e.g.: when studies in adults would yield little useful
Correct Answer > True
T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric
T or F- Pharmacokinetic studies in the pediatric population are
Correct Answer > True The two ways to minimize the number of samples obtained
Population PK & Sparse sampling
Correct Answer > False The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed.
Staging
You are reading a Phase 2 protocol: which uses pharmacokinetic sampling in a pediatric population with Sickle Cell Disease. Which of the following options may be true in this
reflect clinical use
You are evaluating a pediatric protocol for a new drug. When reviewing the drug clearance data it is important to know that hepatic and renal functions are first mature in which of the
Correct Answer > Adolescents The pediatric population represents a vulnerable subgroup. Therefore: special measures are needed to protect the rights of
pediatric study participants and to shield them from undue risk. Which of the following should be taken into consideration? -
determine the possible effects on development When each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment
When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses: and one or more control treatments: such as placebo and/or an
A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study
Correct Answer > Non-Inferiority What type of clinical trial most likely requires enrollment of the
Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy)
Answer > 5 (... lay people and medical professionals can be part of the IRB/IEC)
Answer > The Sponsor
standard procedures
members of the medical profession
safety: and well-being of the subjects participating in the trial
in death: is life threatening
noxious and unintended response that is related to any dose
Event
medical occurrence that does not necessarily have a causal relationship with treatment
on human subjects
Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints
WMA in 1964: - Defines the ethical principles for medical research involving human subjects
Representative. (regarding consenting procedures)
Correct Answer > Mission is to provide a unified standard for
Europe: US: and Japan to facilitate the acceptance of clinical trials
consistent with the product information and were present on previous and preclinical trials
accountability records
at least 3 years
Correct Answer > True Incapacitated subjects can provide consent as soon as capacity
Who should send Annual Progress Reports to the IRB/IEC -
The investigator is required to share names of subjects with the
CRAs(monitors) cannot review source documents of subjects who have withdrawn consent. Even if the source document
> True When should research studies involving human subjects be
Answer > before recruiting the first subject Any changes to safety language in an IB should be submitted to
All SAE's must be life-threatening to be considered an SAE
After completion of a study: where should the final trial close-
Correct Answer > in the Sponsor's files During a multi-site clinical study: Whose responsibility is it to
(Monitor) What is the investigator's first priority when a subject wishes to
to obtain the subject's reason for withdrawal CRC's can't adjust IP dose: even if they are a qualified physician
physician they can adjust IP dose Following unblinding in the case of a suspected serious unexpected adverse drug reaction: the treatment assigned to the subject turns out to be the comparator product. Who
manufacturer of the product and/or the regulatory authorities
If there is a a serious unexpected adverse drug reaction in a blinded trial: when should the investigator unblind the subject?
- ✔✔✔ Correct Answer > The investigator unblinds before reporting the SUADR: in order to determine a safe treatment If a subject experiences a heart attack or other unexpected SAE that wasn't documented in the IB: Who must the event be
sponsor and the IRB/IEC The study protocol does not need to include statistical analysis
Subjects can be enrolled using lab results predating when the
What must be done: at the site level: if the protocol is altered
reconsented and the irb/iec should be informed and approve the changes if the trial is to continue If a person is in a life threatening situation that necessitates the test article: and they/their LAR cannot provide consent... what
must the PI do to properly enroll the subj per required
Receive documented approval/favorable opinion by the IRB/IEC prior to enrollment. Then ensure the subjs LAR is informed asap to continue the consent
availability
Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints