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What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? Investigators brochure During a multi site clinical study: whose responsibility is it to report subject recruitment rate? The CRA An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and protocol therapy was initiated. The subject showed
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significant improvement in his clinical condition: and regained consciousness. The Investigator should inform the subject about the study and Obtain consent from the subject for the study A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB approval. The site can begin enrolling subjects after... A signed clinical trial agreement between the site and sponsor is in place. A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects? A research assistant who is certified to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB. What benefit information should be included in the ICF? Wording indicating that there is no expected benefit should be included A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB? PI Which of the following required elements should be included in a clinical trial protocol? Subject inclusion and exclusion criteria
When should a research study involving human subjects be registered in a publicly accessible database? Before recruiting the first subject In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? The subjects legally acceptable representative A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study? Consenting in the presence of figure of authority The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Phase I Who is ultimately responsible for all aspects of the research conducted at a site? Principal investigator An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials and credibility of data GCP What event resulted in the Nuremburg Cod of 1949 Nazi Medical Experiments Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of the PI and Sponsor In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment rate? The CRA A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be Phase II What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? IB When considering participation in a study: the investigator should determine if he/she sees enough patients who would qualify for the study When would an impartial witness be needed during the consent process for an illiterate subject? To observe the consent process During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? electronic medical record A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research-specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects? A research assistant who is certified to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB/IEC. What benefit information should be included in the ICF? Wording indicating that there is no expected benefit should be included.
When should a research study involving human subjects be registered in a publicly accessible database? Before recruiting the first subject An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and protocol therapy was initiated. The subject showed significant improvement in his clinical condition: and regained consciousness. The Investigator should inform the subject about the study and obtain consent from the subject for the study. After completion of a study: the final trial close-out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? The sponsor's files A site is in the start-up phase of an industry-sponsored phase 3 trial: and has received IRB/IEC approval. The site can begin enrolling subjects after a signed clinical trial agreement between the site and sponsor is in place. In a multi-arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC? PI Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain an audit trail: data trail: and edit trail. Which entity is primarily charged with considering subject rights and well-being during clinical trials? Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC?
- Medical, pharmacy, dental, and nursing students:
- Prisoners
- Serving military personnel T or F- The terms "serious" and "severe" are synonymous according to ICH False
An Unexpected Adverse drug reaction is A reaction that is not consistent with the applicable product information ICH safety definitions can be found in ICH E2A An Adverse Event (AE) that is severe in intensity May not meet the definition of serious T or F- Information discovered during the course of a clinical investigation that might materially influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to regulatory authorities. True Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. This is considered a/an Serious Adverse Drug Reaction T or F- A subject in your diabetes research study developed colon cancer: which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening. False In pre-market approval studies: all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered Adverse Drug Reaction You were just informed that you have a research patient that is receiving intensive treatment in an emergency room for allergic bronchospasm. This should be considered as A serious adverse event
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as Informed Consent Process T or F- The IRB/IEC may request additional information be given to subjects when: in the judgment of the IRB/IEC: it would add meaningfully to the protection of the rights: safety and/or well-being of the subjects. True The IRB/IEC should consist of a reasonable number of members: who collectively have the qualifications and experience to review and evaluate the science: medical aspects: and ethics of the proposed trial. It is recommended that the IRB/IEC should include
- At least five members
- At least one member whose primary interest is non-scientific
- At least one member who is independent from the Institution/trial site Which of the following is NOT one of the required elements of an informed consent form? A listing of all site personnel who will be involved in the research How can an Adverse Drug Reaction (ADR) be defined? As a noxious and unintended response to the investigational drug Who is most responsible for the appropriate monitoring of clinical trials? 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
- Unobscured original entries
- Traceable source documents
- 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?
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 conducted. Root Cause Analysis 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 take? Document that the subject has 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 sponsor should
- Promptly notify the regulatory authority(ies)
- Terminate the investigator's/institution's participation in the trial Essential documents should be retained at least ______ after the last approval of a marketing application: or formal discontinuation of clinical development of the investigational product. 2 years What is the purpose of the IRB/IEC? Safeguard the rights: safety: and well-being of all trial subjects Which of the following should the investigator do FIRST if a Serious Adverse Event (SAE) occurs? Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form (ICF)?
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 for later trials.
- Selection of the initial human dose
- Safe duration of drug exposure
- Physiological and toxicological effects of a new drug T or F- The intention of ICH E8 is to describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medicinal products. True Dose-tolerance studies: single and multiple dose PK and/or PD studies: and drug interaction studies are examples of what phase of clinical research? Phase One Characterization of a drug's absorption: distribution: metabolism: and excretion that continues throughout the development plan is defined as Pharmacokinetics According to ICH E8: "Formulations used in clinical trials should be well characterized: including information on ___________ whenever feasible." Bioavailability The study subject asks you why the study is called a double blind study. You will explain double blind as 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 establish efficacy
- Randomized parallel dose response studies
- Clinical safety studies
- Studies of mortality/morbidity outcomes
- Large simple trials
- Therapeutic Confirmatory Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are commonly conducted in later phases to answer what questions?
- Food effects on bioavailability
- Information in sub-populations such as patients with impaired elimination
- Drug to drug interactions A trial where the treatment assignment is not known by the study participant because of the use of placebo or other methods of masking the intervention: but the study team knows Single blind 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 expect to Include children in the general plan from the beginning Per ICH E8: methods used to evaluate patient usage of the test drug should be Specified in the protocol and actual usage documented Which trial design is used for the specific purpose of examining the interaction of A and B? Factorial design T or F- The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC)? True What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" To assess the progress of a clinical trial: the safety data: and the critical efficacy endpoints
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 considered what type of trial? 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 of treatments in subsequent treatment periods. Carryover effect Missing data points (values) represent a potential source of bias in a clinical trial. (True or False) True What study variable takes in the consideration the decision making process of the treating physician: who must weigh benefit and risk in making product use decisions. 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 at any stage of clinical development. 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 you will need to establish a/an 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 interest? The target population
True or False- All new medications should have generated data on the use in the pediatric population? False True or False- Medicinal products may affect physical and cognitive growth and development: and the adverse event profile may differ in pediatric patients. True What is it called when a child is given information about a trial and asked if he or she wishes to participate? 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 information or expose them to inappropriate risk). True T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. False T or F- Pharmacokinetic studies in the pediatric population are generally conducted in patients with the disease. True The two ways to minimize the number of samples obtained from each pediatric patient are
- Population PK & Sparse sampling
- Use of indwelling catheters T or F- It is common to extrapolate efficacy from studies in adults or even in older pediatric patients to the preterm newborn infant to decrease the amount of blood taken. False
- Safety considerations
- Efficacy and safety of alternative treatments What does ICH E11 say about long-term surveillance of children in clinical trials? It may be needed to 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 comparisons Crossover 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 active comparator Parallel 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 design they will use to test the efficacy of the IP? Non-Inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy) Minimum number of membors on an IRB/IEC 5 (... lay people and medical professionals can be part of the IRB/IEC) Who is responsible for providing the protocol The Sponsor The purpose of the SIV is to
- review standard procedures
- review the protocol
- review the blank eCRFs: Minimum SAE reporting requirements
- Subject details (ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details Vulnerable subjects
- Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners IRB/IEC Evaluates
- The rights: safety: and well-being of the subjects participating in the trial
- The subject selection procedure
- The scientific tenability of the trial Serious Adverse Event (SAE)
- Results in death: is life threatening
- Requires inpatient admission
- Prolonged admission
- Congenital anomaly
- Persistent incapacity
- Death itself is not neccessarily an SAE*
- Must be reported by sponsor to authorities within 15 calendars days from sponsors first knowledge of the event *Seriousness does not equal severity in that Serious requires reporting while severe may not.. Severe may just be used to describe an AE Adverse Drug Reaction (ADR)
