Clinical Research Coordinator Exam

The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is required to return for follow-up visits at 30 days, 6 months, and 1 year. At 30 days, the protocol requires a physical exam, an electrocardiogram, and a chest x-ray. At 6 months, the protocol requires a physical exam and an electrocardiogram. At 1 year, the protocol requires a physical exam, an electrocardiogram, and a chest x-ray. The hospital charges $75 for the physical exam, $50 for the electrocardiogram, and $100 for the chest x-ray. The 30-day and 1-year visits are considered standard of care for the subjects. How much should the CRC budget per subject for the non-standard of care visits? $125 $225 $450 $575

$125

IRB Records

- Kept for a minimum of 3 years following the completion of the study

Human Pharmacology Study

-Assess Tolerance -Define/Describe pharmacokinetics and pharmacodynamics -explore drug metabolism and drug interactions -estimate activity

therapeutic confirmatory study

-demonstrate/confirm efficacy (the ability to produce a desired or intended result). -establish safety profile -provide an adequate basis for assessing the benefit/risk relationship to support licensing -establish dose-response relationship

therapeutic exploratory study

-explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design, endpoints, methodologies

therapeutic use study

-refine understanding of benefit/risk relationship in general or special populations/environments -identify less common adverse reactions -refine dosing recommendation

Term newborn infants

0-27 days

A CRC has received three subject complaints of localized infection at the venipuncture site. The CRC queries the phlebotomist and discovers that when the first stick is unsuccessful, any additional sticks are done with the same needle. This is in violation of the site's SOPs. Which of the following actions should the CRC take? 1. Suggest review of proper specimen collection for the phlebotomist. 2. Document and report the findings. 3. Inform the IRB/IEC of the situation and the corrective action. 4. Report the incidents to the IDMC/DSMB. 1 and 2 only 1 and 3 only 2 and 4 only 3 and 4 only

1 and 2 only

A sponsor/investigator (investigator-initiated research) expands a trial from a single site to four trial sites in different areas of the country. The sponsor/investigator should do which of the following? 1. Monitor compliance with GCP. 2. Report AEs to the sites. 3. Keep investigators informed of new findings. 4. Update investigators regarding subject recruitment. 1 and 3 only 1 and 4 only 2 and 3 only 2 and 4 only

1 and 3 only

Which of the following scenarios are considered SAEs? 1. infection following surgery prolonging hospital stay. 2. pregnancy resulting in normal delivery of twins. 3. boating accident with overnight hospitalization. 4. use of illicit drug during the trial 1 and 3 only 1 and 4 only 2 and 3 only 2 and 4 only

1 and 3 only

A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medications. Which of the following questions should be asked by the CRC? 1. When was the last time your medication dose changed? 2. Have you made any dietary changes in the last month? 3. When was your last chest x-ray and ECG? 4. Do you have any difficulty swallowing oral medications? 1 and 2 only 1 and 4 only 2 and 3 only 3 and 4 only

1 and 4 only

A potential subject for a trial has been mailed an ICF prior to his screening visit. When the subject arrives at the research department for his screening visit, he states he read the ICF and is ready to do the trial. He does not have the copy of the ICF that was mailed to his home with him. According to the ICH Guidelines, which of the following are the BEST actions for the CRC to take initially? 1. Have the subject sign the ICF. 2. Document that the subject reviewed the ICF at home. 3. Tell the subject to keep the ICF mailed to the home as his copy. 4. Confirm the subject's understanding of the ICF. 1 and 2 only 1 and 4 only 2 and 3 only 3 and 4 only

1 and 4 only

A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation, drug accountability log, subject identification code list, documentation of IP destruction, and final report to the IRB/IEC. Which of the following actions should the CRC perform? 1. Send the treatment decoding documentation to the sponsor. 2. Remove the subject identification code list from the material to be sent to the sponsor. 3. Send copies of the IP destruction forms to the sponsor. 4. Remove the drug accountability log from the material to be sent to the sponsor. 1, 2, and 3 only 1, 2, and 4 only 1, 3, and 4 only 2, 3, and 4 only

1, 2, and 3 only

The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigators' meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start-up, the regulatory binder must include 1. an IRB/IEC letter of approval for the amended protocol. 2. an IRB/IEC site evaluation form. 3. the amended protocol. 4. the Investigator's Brochure. 1, 2, and 3 only 1, 2, and 4 only 1, 3, and 4 only 2, 3, and 4 only

1, 3, and 4 only

At a screening visit, a CRC takes the following sitting BPs: 168/100 mm - Hg 166/104 mm - Hg 168/102 mm Hg. The patient's mean sitting diastolic BP is 102 mm Hg. 103 mm Hg. 166 mm Hg. 167 mm Hg.

102 mm Hg

adolescence

12-18 years (16 some places)

A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would MOST likely involve 1. healthy volunteers. 2. pharmacokinetic analysis. 3. placebo control. 4. dose escalation. 1 and 3 only 1 and 4 only 2 and 3 only 2 and 4 only

2 and 4 only

In addition to obtaining a signed informed consent form, which of the following should be documented in the research record? 1. the time and date that the procedures will be performed. 2. that the subject's questions were answered. 3. the names of people present during the consent process. 4. that no trial procedures were performed prior to consenting 1 and 2 only 1 and 3 only 2 and 4 only 3 and 4 only

2 and 4 only

Which of the following are responsibilities of an IDMC/DSMB? 1. assess the financial aspects of a trial 2. assess the progress of a trial 3. recommend initiating a trial 4. recommend stopping a trial 1 and 3 only 1 and 4 only 2 and 3 only 2 and 4 only

2 and 4 only

factoral design

2 or more treatments evaluated simultaneously. look at drug interactions. for drugs A & B groups A alone B alone A & B Neither

According to ICH E11, what would the suggested age catagorization for children be if you were planning a study in "children"? 23 months to 7 years 2 to 11 years 5 to 9 years 12 to 16 years

2 to 11 years

children

2-11 years

ICH GCP Principles

2.1-2.13 Use ethics of Declaration of Helsinki pt safety, clinically sound, informed consent, documented, confidentiality, IP use

The trough blood level for a once-daily drug should be drawn how long after the last dose? Immediately 4 hours 12 hours 24 hours

24 hours

Infants and toddlers

28 days to 23 months

At a trial site, CRCs perform quality assurance as needed throughout the progress of their trials. A CRC notes that five of the seven research nurses failed to document subject understanding of the trial. Which of the following actions should the CRC perform? 1. Inform the sponsor of this practice. 2. Revise the delegation of responsibility. 3. Ensure the subjects have been well informed of the trial. 4. Review the informed consent process with the individual research nurses. 1 and 2 only 1 and 3 only 2 and 4 only 3 and 4 only

3 and 4 only

For how many years, after the completion of a trial, is the IRB/IEC required to retain the relevant records? 2 years 3 years 5 years 10 years

3 years

ICH IRB responsibilities

3.1.1-3.1.9 Subjects documents (ICF, IB , Safety, Payments, PI CV) Continual review (at least annual)

Investigator ICH Qualifications

4.1.1-4.2 Training and edu familiar with IB Comply with GCP Permit monitoring DOA log adequate resources

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? 50% 64% 78% 100%

50%

If the patient's weight is 123lb, what is the weight in kg? 31 48 56 271

56

A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more inclusion/exclusion criteria. How long will it take the CRC to fulfill enrollment? 2 weeks 4 weeks 6 weeks 8 weeks

6 weeks

Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of IP. Each subject received two bottles. Four subjects did not return their trial bottles. How many bottles are available for the CRC to return to the sponsor at the end of the trial? 44 48 92 96

92

Multicenter Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. increase diversity,

A subject has a suspected serious adverse drug reaction with the outcome of death. Per the ICH E2A guideline, which are items that should be submitted to the Sponsor? Select all that apply A de-identified autopsy report, if available The address of the next of kin so that the sponsor can write a letter of condolence Cause of death, and a comment on its possible relationship to the suspected drug reaction The name and address of the subject's General Practitioner (GP)

A de-identified autopsy report, if available Cause of death, and a comment on its possible relationship to the suspected drug reaction

Monitoring Plan

A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial.

Which of the following is NOT one of the required elements of an informed consent form? The purpose of the research A description of benefits that may be reasonably expected from the research A listing of all site personnel who will be involved in the research A contact person for questions about the research

A listing of all site personnel who will be involved in the research

inter-rater reliability

A measure of how similarly two different test scorers would score a test.

Contract Research Organization (CRO)

A person or an organization contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. Sponsor responsibility

Validation of Computerized Systems

A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

Non-inferiority trial

A randomized clinical trial designed to establish that the drug of interest is not inferior to the gold standard therapy. (bioequivalence)

What is an Unexpected Adverse drug reaction?

A reaction that is not consistent with the applicable product information

A subject is participating in a lipid-lowering clinical trial. Before his 12-month visit, the CRC receives an amendment from the sponsor that includes an outcomes measurement instrument at the 12-month visit. The CRC should FIRST provide the subject with which of the following? An amendment for the subject's signature A revised consent form A copy of the outcomes measurement instrument An interpretation of the items on the instrument

A revised consent form

group sequential design

A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. IDMC may be used

Superiority Trial

A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control).

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Surrogate variable

A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical.

12. Your third subject in a Phase III drug trial calls to report that she has developed a rash on her chest 12 hours after taking her second dose of the investigational study drug. She states that it itches and is slightly uncomfortable. She tells you that she has never had a rash and this is totally unexpected. You know from the Investigator Drug Brochure that only 12% of the patients get a rash from this drug. Which of the following options best describes this situation? Adverse Event Adverse Drug Reaction Unexpected Adverse Drug Reaction Serious Adverse Drug Reaction

ADR

In pre-market approval studies, all noxious and unintended responses to a medicinal product, even possibly related to any dose, should be considered which of the following options? Unexpected Serious Adverse Event Adverse Drug Reaction Serious Adverse Event Severe Adverse Drug Reaction

ADR

source data requirements

ALCOA-C Attributable legible contemporaneous original accurate complete

To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and renal function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5 - 65 - ALT 5 - 35 - BUN 4 - 25 - Creat 0.5 - 1.2 - Amylase 56 - 190 - Lipase 4 - 24 - ALK Phos 0 - 110. Which of the following laboratory values would permit the inclusion of the subject in a trial? AST 130; Amylase 380; Creat 3.8; Lipase 48 AST 130; ALT 70; BUN 50; Creat 2.4 BUN 80; Creat 2.4; Amylase 570; Lipase 72 AST 195; ALT 105; Amylase 380; Creat 2.4 Next Question

AST 130; ALT 70; BUN 50; Creat 2.4

compliance

Adherence to all study related requirements

ADR

Adverse Drug Reaction _ relationship between IP and AE is at least reasonably possible life threatening ADR reported to reg agencies within 7 days.

A study subject reports that he has been having headaches for years but they seem to have become more frequent since starting the study drug. The principal investigator believes that the headaches are not related to the study medication. How should the event be reported? Does not require reporting since it is part of the medical history Adverse event, since the headaches have become more frequent Update the medical history to frequent headaches Serious Adverse Event (SAE)

Adverse event, since the headaches have become more frequent

Which essential documents are only required to be maintained with the Investigator/Institution?

Advertisement for subject recruitment (if used) Signed ICF Source Documents Subject ID code list Subject enrolment log Final report by the PI to the IRB/ Reg authority

Sponsor Correspondence

All correspondence between the sponsor and researcher pertaining to the conduct of the study should be included in this section, including site initiation and close-out visit reports and all sponsor/external monitoring visit/audit correspondence. [ICH GCP E6 8.2.19-20, 8.3.10-11, 8.4.4-5]

What's the difference between an AE and an ADR

An ADR is at least possibly related to the IP. An AE is any untoward event.

Independent Data Monitoring Committee (IDMC)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. not part of IRB or IEC. composed of field experts.

Sponsor-Investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3)

Which of the following reports should be sent to the IRB/IEC by the investigator? Annual progress report Monitor visit report Study initiation report Subject enrollment tracking report

Annual progress report

Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions.

What is the timeframe for "expedited" reporting of serious, fatal or life-threatening, unexpected adverse drug reactions to regulatory authorities? As soon as possible, but no later than seven calendar days after first knowledge of the event Two days after first knowledge of the event Two calendar days after the first knowledge of the event One week, unless the subject has died, in which case it is 12 hours

As soon as possible, but no later than seven calendar days after first knowledge of the event

What is it called when a child is given information about a trial and asked if he or she wishes to participate? Proxy Consent Tanner Consent Child's Consent Assent

Assent

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 which of the following options? Select all that apply 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 At least one member who is employed by the study sponsor

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

What essential documents are held in a site's trial master file? Certificates of analysis for IP IP accountability records Subj screening logs Signed ICF All the above B, C, D are correct

B, C, D are correct

Nonclinical Study

Biomedical studies not performed on human subjects.

Regulatory Authorities

Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data.

The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB/IEC approval letter has not yet been obtained. Which of the following should the CRC do FIRST? Request an expedited IRB/IEC review. Reschedule the initiation visit. Call the IRB/IEC to check the status of the letter. Call the sponsor to have the files checked.

Call the IRB/IEC to check the status of the letter.

Fill in the blank on the following statement. 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. Covariates Carryover effect Blinding procedures Metabolites

Carryover effect

All of the following are regulatory documents EXCEPT Informed consent. Protocol signature page. Laboratory certification. Confidentiality agreement.

Confidentiality agreement.

A hypertension trial protocol indicates that subjects should not be randomized on Fridays or Saturdays. During subject screening, a subject meeting all entry criteria is identified. However, the only day that this subject is available for clinic visits is Friday due to his work schedule. The CRC should Randomize the subject and make a note to the trial file. Contact the sponsor regarding the subject's time conflict. Ask the IRB/IEC for permission to randomize the subject. Request an exception from the PI.

Contact the sponsor regarding the subject's time conflict.

During the monitoring visit, a CRA discusses the following queries with the CRC: - dates of the subject visits recorded as month/day/year instead of day/month/year - subjects' identification numbers are missing lead-in zeros - weights are recorded as pounds instead of kilograms - discrepancies in the two subjects' visit dates between source data and CRF entries. Which of the following actions should the CRC take? Direct the subinvestigator to correct the CRFs. Correct errors on the CRFs as discovered. Resolve discrepancies with the PI. Send the unedited CRFs to data management.

Correct errors on the CRFs as discovered.

What do you call the clinical trial design in which each subject is randomized to a sequence of two or more treatments and hence acts as his or her own control for treatment comparisons. Crossover design Adaptive design Parallel design Randomized design

Crossover design

Indicate which terms are not part of ALCOA-C: Current Legible Original Accessible Complete

Current Accessible

What does "DSMB" stand for? Data and Safety Monitoring Board Data and Statistics Monitoring Board Drug Statistics Measurement Bureau Drug Safety Monitoring Board

Data and Safety Monitoring Board

What are the five categories used to define SAEs?

Death Life threatening Congenital anomaly Hospitalization Results in persistent or significant disability

Elements of Informed Consent

Disclosure: Pt has been informed of the nature of the procedure, risks and benefits, alternatives, no guarantee of outcome. Comprehension: Patient can correctly repeat in his or her own words that for which the patient is giving consent. Competence: The patient understands information needed to make this decision. Voluntariness: The patient is voluntarily consenting or refusing.

randomization block design

Divide (stratify) subjects with similar characteristics into blocks, and then within each block, randomly assign subjects to treatment groups.

At the close-out visit, the CRA notices that a subject has omitted information on a baseline diary. What best advice can the CRA give to the investigator? Ask subject to complete it now Fill out the info based on subsequent data Discard the diary Document that the info is missing

Document that the info is missing

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 or clinical research coordinator to take? Record no missed doses in the source document and in the investigational product accountability log Record nothing in the source document or in the product accountability log Immediately report the deviation to the sponsor 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

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

A competent adult subject signs a consent form with an "X" and indicates approval. Which of the following is the BEST action for the CRC to take? Have the consent form notarized. Exclude the subject from the trial. Document why the subject signed with an "X." Have the legal guardian sign the informed consent form.

Document why the subject signed with an "X."

A subject is participating in a clinical trial where only the pharmacist and the sponsor know the identity of the IP. The pharmacist has no direct contact with the trial subject and the clinical team. Which of the following BEST describes this trial type? Open-label Single-blind Double-blind Triple-blind

Double-blind

ICH 8

Drug development process

A clinical trial is being conducted for hormone replacement. The trial includes a diary. Which of the following would be considered an objective parameter? Mood swings Breast tenderness Severity of hot flashes Episodes of vaginal bleeding

Episodes of vaginal bleeding

Safety studies

Evaluate dose tolerance, dose frequency, and duration of exposure

According to ICH Guidelines, the source document should contain which of the following information regarding informed consent? Time the consent form was signed by the subject Date the PI and subject signed the consent form Date and time the consent form was signed by the witness Evidence that the consent form was signed prior to trial-related procedures

Evidence that the consent form was signed prior to trial-related procedures

Which trial design is used for the specific purpose of examining the interaction of A and B? Crossover design Factorial design Parallel Group design Multicenter design

Factorial design

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. Is this a true or false statement?

False

True or False? Due to low blood volumes researchers should not do pharmacokinetic studies in the pediatric population. True False

False

True/false: All Serious Adverse Drug Reactions should be reported using expedited guidelines

False, only serious and unexpected ADRs are subject to expedited reporting

ICH 6

GCP

A CRC is enrolling three subjects for a Phase III trial with restrictive eligibility criteria. The PI indicates that she must leave the office to teach a lecture in 30 minutes. The laboratory will be closing in 1 hour. Which of the following is the MOST appropriate action for the CRC? Ask the PI to perform a complete physical examination. Send the subjects for the protocol-required laboratory test now. Give each subject sufficient time to review the ICF. Allow the subjects to sign the ICF now and review at home.

Give each subject sufficient time to review the ICF.

During a respiratory trial, a subject calls the CRC 1 week before his next scheduled trial visit and reports upper respiratory symptoms and a pea-sized lump in his neck. Which of the following should the CRC do FIRST? Inform the sponsor's medical monitor of the situation. Instruct the subject to contact his primary care physician. Have the subject come to the site for an interim assessment. Cancel the scheduled follow-up visit until symptoms resolve. Next Question

Have the subject come to the site for an interim assessment.

A CRA is preparing to conduct a pre-study visit. Which of the following documents will act as the best resource to provide answers to the investigator's questions regarding the rationale for investigating the investigational product, the dose and regimen, and the risk/benefit ratio? Phase 1 study report IB Sample ICF Investigator meeting handouts.

IB

Which essential documents are required to be maintained with both the Sponsor and the investigator?

IB Protocol ICF financial aspects insurance statement Agreements IRB approvals IRB Board CV's normal lab values med/lab/tests IP instructions IP shipping Decoding procedures Trial initiation Monitoring report Revisions CRFs SAE reports, safety reports IP accountability/destruction Signature sheet record of retained body fluids/tissues clinical study report

Which ICH Guidance pertains to the Pediatric Population? ICH E9 ICH E6 ICH E13 ICH E11

ICH E11

emergency research consent

IRB specific approval LAR if possible consent when appropriate

Investigator - ICH Premature termination

If the trial is terminated for any reason PI should promptly inform subjects. If PI, Sponsor, or IRB terminate study, other 2 should be informed promptly with written explanation

According to GCP guidelines how soon should SAEs be reported? Immediately Within 24 hours Within 3 days Within 5 days

Immediately

A subject is upset and wants to know whom she should contact regarding her rights as a research subject. The CRC should tell her to contact the PI Regulatory authority Risk management department Individual listed in the ICF

Individual listed in the ICF

Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is best described as which of the following options? IRB/IEC Approval Legally Authorized Agreement Intent to Treat Informed Consent Process

Informed Consent Process

IB

Investigator's Brochure document of relevant IP information.

A subject has signed the informed consent form for a hypertension trial. All screening procedures and the physical examination have been completed. The CRC is ready to dispense the single-blind placebo to the subject who asks, "Is that the sugar pill that I read about in that form I signed?" Which of the following should the CRC tell the subject? Only the physician knows what medication you are taking at this time. I don't know what you are taking at this time since the trial is blinded. Yes. Remember everybody has to take the placebo for some time during the trial. It might be the placebo, but we will be checking your blood pressure every week.

It might be the placebo, but we will be checking your blood pressure every week.

Which of the following is a liver function test? TSH LDH BUN HCT

LDH

Investigator - ICH Records and reports

Maintain records correction dated single line retained 2 yrs financial agreement required available to monitor upon request final reports as needed to IRB

Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC? Medical and pharmacy students Prisoners Elderly people living at home serving military personnel

Medical and pharmacy students Prisoners serving military personnel

As per ICH E6 GCP, which groups of potential subjects could be defined as "vulnerable subjects"? Select all that apply Members of the armed forces Patients with incurable diseases People with heart conditions Persons in nursing homes

Members of the armed forces Patients with incurable diseases Persons in nursing homes

What is the medicinal product dosing in the pediatric population usually based on when developing a pediatric heart disease study involving an adult approved drug? Maximum adult dose adjusted for pediatric body size Milligram (mg)/kilogram (kg) body weight Therapeutic index of the medication Mg/square meter body surface area

Milligram (mg)/kilogram (kg) body weight

Who is ultimately responsible for Source Data Verification or SDV? Subject Monitor Coordinator Investigator

Monitor

In the NIC study, patients put on a new nicotine patch every day. At his study visit on 4/13/22 he was dispensed 107 patches. At his 8/8/22 study visit he returned 89 wrappers (patch worn) and 15 unused patches. Was he at least 80% compliant?

No only 77% compliant

IRB composition

No vested interest in the study or outcomes. At least 5 members (at least 1 scientist, at least 1 non-scientist, at least 1 person not affiliated with institution)

In an effort to increase enrollment in an ongoing trial, the sponsor has broadened inclusion/exclusion criteria to increase the allowable creatinine level. The next step the CRC should take is to Notify the IRB/IEC of the change. Revise the ICF. Contact previously ineligible patients. Document the change in existing subjects' CRFs.

Notify the IRB/IEC of the change.

A subject is admitted to the hospital for chest pain and suspected myocardial infarction. This subject gave informed consent for a trial of a new antihistamine 1 week before the onset of any chest pain. The subject took the first dose of test article 2 days ago. The PI determines that the event is probably related to the IP. Which of the following is the BEST course of action for the CRC to take? Reconsent the subject prior to administering further IP doses. Notify the sponsor that the PI believes the event is related to the IP. Wait until the subject is discharged and reschedule the required follow-up visits for the trial. Discontinue the subject from the trial since he will be unable to comply with the timeline requirements. Next Question

Notify the sponsor that the PI believes the event is related to the IP.

A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in their diaries for the first 7 days of the trial. Upon review with the subjects, there were no related complaints. Which of the following should be the CRC's FIRST action? Notify the sponsor. Contact the manufacturer. Inform the remaining 20 subjects. Replace existing thermometers with an alternate model.

Notify the sponsor.

A subject is participating in a lipid-lowering clinical trial. Before the 12-month visit, the CRC receives an amendment from the sponsor, which includes the addition of quality-of-life measures to be collected at the 12-month visit. To ensure appropriate collection of this additional data, the CRC should Collect the data at the scheduled visit by verbally asking the subject the questions as indicated in the revised, approved amendment. Assist the subject by providing additional information for questions which the subject states are unclear. Schedule the subject for an interim visit as soon as possible, and complete the questionnaires. Obtain the appropriate signature on the revised, approved consent, then have the subject complete the questionnaires.

Obtain the appropriate signature on the revised, approved consent, then have the subject complete the questionnaires.

At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, "The doctor told me I was very lucky. I might have died." Having received this information, the MOST appropriate sequence of action is to inform the PI, Sponsor, and IRB/IEC. Sponsor, PI, and IRB/IEC. Sponsor, IRB/IEC, and PI. PI, IRB/IEC, and Sponsor.

PI, Sponsor, and IRB/IEC.

"A design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment" is a description of what kind of trial design? Crossover design Factorial design Parallel Group design Multicenter design

Parallel Group design

Phase II Clinical Studies

Patients with disease being targeted by the study drug Evaluate -Biological effect in target population -Adverse effects that occur in treatment doses -Comparative effect versus other drugs available

Characterisation of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as what? Pharmacokinetics Pharmacodynamics Therapeutic Use Therapeutic Confirmatory

Pharmacokinetics

The type of study that investigates human pharmacology and is the initial administration of the investigational new drug in humans. Phase 1 Phase 2 Phase 3 Phase 4

Phase 1

The main goal of which phase of drug development is to explore therapeutic efficacy in patients? It is important during this phase to determine the dose and regimens that will be used for later trials. Phase 1 Phase 2 Phase 3 Phase 4

Phase 2

Which phase of clinical research has a primary objective to demonstrate or confirm therapeutic benefit? Phase 1 Phase 2 Phase 3 Phase 4

Phase 3

Which phase of clinical research is often called "Therapeutic Use". It begins after drug approval. Phase 1 Phase 2 Phase 3 Phase 4

Phase 4

A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a Phase I trial Phase II trial Phase III trial Phase IV trial

Phase I trial

Which variable in a study should be used to determine the sample size? Composite Variable Global Assessment Variable Primary Variable Secondary Variable

Primary Variable

Intention to Treat (ITT)

Principle whereby data are analyzed according to group assignments, regardless of how subjects actually completed the study.

Which of the following is not a special population mentioned in ICH E8? Pregnant Women Nursing Women Children Prisoners

Prisoners

If a sponsor's attempts to secure compliance have failed, and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator or institution, the sponsor should implement which of the following actions? Select all that apply Promptly notify the regulatory authority(ies) Develop a corrective action plan Reeducate the investigator by a total review of the protocol and required procedures Terminate the investigator's/institution's participation in the trial

Promptly notify the regulatory authority(ies) Terminate the investigator's/institution's participation in the trial

SAE miniumum info

Pt Details IP Con Meds SAE details Reporter name Sponsor details

Sponsor ICH - Overall

Quality Management Quality assurance and Quality Control (QA QC) Contract Research Organization (CRO) Medical expertise trial design Trial mgt, data, record keeping PI selection Allocation of responsibilities pay subjects and PI's financing notification to reg authorities confirm IRB review info on IP manufacturing, packaging, labelling, coding of IP supplying IP record access Safety Info ADR reporting to IRB Monitoring Audit

Which of the following choices "Introduces a deliberate element of chance into the assignment of treatments to subjects in a clinical trial"? Stratification Blinding Randomization Double Blind

Randomization

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? Select all that apply Recruitment Consent and assent Minimizing risk Minimizing distress

Recruitment Consent and assent Minimizing risk Minimizing distress

To qualify for a sinusitis trial, subjects must have a positive sinus x-ray (defined by > 3 mm mucosal thickening) and a history of two episodes of sinusitis treated with antibiotics within the past year. Subjects allergic to penicillin are excluded. The PI has identified a potential subject. On further questioning, it is discovered the subject only had one previous episode of sinusitis that was treated with an antibiotic. The PI insists the subject would be perfect for the trial. Which of the following is the FIRST course of action? Remind the PI about inclusion/exclusion criteria. Enroll the subject in the trial and document the PI's approval. Consent the subject and have her return during the next episode. Call the sponsor for a protocol waiver.

Remind the PI about inclusion/exclusion criteria.

Two weeks after starting an investigational therapy, a subject is rushed to the hospital after experiencing a heart attack. The subject is currently being treated in the Intensive Care Unit (ICU). The ICU doctor has noticed that the subject was enrolled in the trial and has contacted the trial Principal Investigator. Heart attack is not described in the Investigator's Brochure. What actions must be taken by the Principal Investigator? Select all that apply Report to the Sponsor per the protocol timelines for serious, unexpected events. Suspend enrollment until a cause of the event is established Report to the IRB/IEC per their event reporting requirements for serious, unexpected events Revise the informed consent to reflect heart attack as a possible risk

Report to the IRB/IEC per their event reporting requirements for serious, unexpected events Report to the Sponsor per the protocol timelines for serious, unexpected events.

A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must be present. The CRC informs the CRA that the PI will be out of the country during the period when the CRA would like to visit. The CRC should do which of the following? Obtain required PI signatures prior to departure. Reschedule the close-out visit for a later date. Conduct the visit as long as the PI is available by phone. Conduct the visit as long as a subinvestigator is available.

Reschedule the close-out visit for a later date.

A CRA calls a CRC to schedule the final monitoring visit. The sponsor requires that the PI be present. The only dates available for the CRA conflict with the PI's schedule. To prepare for the visit, the CRC should 1. reschedule the visit. 2. have the PI sign all documents prior to the visit. 3. discard unused trial documents. 4. notify the IRB/IRC.

Reschedule the visit.

A serious adverse event is any untoward medical occurrence which at any dose is best described by which of the following statements?

Results in death Is life-threatening Is a congenital anomaly

A site has not received IRB/IEC approval for a protocol submission. The PI instructs the CRC employed by the clinic to begin scheduling subjects for screening appointments. Which of the following is the BEST action for the CRC to take? Conduct chart review and schedule eligible subjects. Review the research database and collate a list of potential subjects. Discuss the trial with eligible subjects during already scheduled visits. Contact potential subjects and assess interest in the trial.

Review the research database and collate a list of potential subjects.

Subjects in a prostate trial are required to undergo four chest x-rays over a 4-week period. To ensure the subject understands safety issues, the IRB/IEC would be MOST concerned that the subject is informed of the Number of x-rays. Interval between x-rays. Effects of radiation on fertility. Risks of the additional radiation.

Risks of the additional radiation.

You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a site. Which of the following options would be the first course of action for you to implement. Second Opinion Monitoring Visit Study Report Root Cause Analysis Suspension of the Trial

Root Cause Analysis

Investigator - ICH Safety reporting

SAE reported immediately to sponsor (unless otherwise specified) AEs identified in protocol as critical Death

Quality Assurance (QA)

SOPs that endure trials are conducted and data are generated in compliance with protocol, GCP, and regulatory Sponsor responsibility

What is the purpose of the IRB/IEC? Safeguard the rights, safety, and well-being of all trial subjects To monitor clinical trials To design trial protocols To choose the appropriate Principal Investigator at the Site level

Safeguard the rights, safety, and well-being of all trial subjects

Which essential documents are only required to be maintained with the Sponsor?

Sample of labels attached to investigational product containers Certificates of analysis of investigational products shipped Master Randomization list Pre trial monitoring report Monitoring visit reports (plus pre and final) Audit certificate Treatment allocation and decoding documentation

Which are NOT requirements to be kept in investigator files (select all that apply) Sample of labels attached to investigational product containers Certificates of analysis of investigational products shipped Decoding procedures for blinded trials Monitoring visit reports Documentation of investigational products and trial-related shipment materials Treatment Allocation and decoding documentation

Sample of labels attached to investigational product containers Certificates of analysis of investigational products shipped Monitoring visit reports Treatment Allocation and decoding documentation (returned to Monitor to document any decoding that occurred)

6. 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. Which of the following options best describes this situation? Severe event unrelated to the drug Unexpected Adverse Drug Reaction Serious Adverse Drug Reaction Severe Adverse Drug Reaction

Serious Adverse Drug Reaction

What's the difference between "severe" and "serious" when referring to adverse events?

Serious relates to life threatening severe is degree of specific symptom (severe rash)

Unexpected Adverse drug Reaction

Severity not consistent with IP information Serious UAE (non life threatening) must be reported to regulators within 15 days.

What are the three ways to minimize the number of samples obtained from each pediatric patient? Select all that apply Sparse sampling Smaller collection tubes Population PK Use of indwelling catheters

Sparse sampling Population PK Use of indwelling catheters

Per ICH E8, methods used to evaluate patient usage of the test drug should be what? Documented Specified in the protocol and actual usage documented Determined in the design development stage Listed in the Protocol Appendix

Specified in the protocol and actual usage documented

Who is responsible for designing the clinical trial protocol? Investigator Sponsor Institution IRB/IEC

Sponsor

trial management, data handling and record keeping

Sponsor responsibility Establish a Independent data-monitoring committee (IDMC)if needed Ensure electronic systems meet sponsor requirements maintain an audit trail for changed data maintain security/ limited access

Investigator selection

Sponsor responsibility ensure qualified provide PI with trial info obtain investigator agreement

Which option below includes the details that must be described in a protocol? info on the bio-availability of an IP names and addressees of the responsible IEC Statistical methods being employed the quality assurance auditing procedures

Statistical methods being employed

Phase IV Clinical Trial

Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

According to ICH E8, which of the following are response variables that are chosen to assess the drug's effects? Principal objective of the study Study endpoints Control group Design of the study

Study endpoints

The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken one caplet orally b.i.d. for chronic hip pain. Subjects are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug accountability issue? Subject A returns 24 pills after 10 days on trial. Subject B returns 12 pills after 8 days on the trial. Subject C returns 29 pills after 5 days on the trial. Subject D returns 42 pills after 1 day on the trial.

Subject B returns 12 pills after 8 days on the trial.

Quality Management- Sponsor

System to manage quality through all trial phases.

The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed. What is this assessment called? Sexual Maturation Staging Jackson Staging Tanner Staging Sexual Activity Staging

Tanner Staging

Phase III Clinical Trial

Testing of drug on patients to assess efficacy, effectiveness and safety (usually multi-center trials on a much larger patient groups). The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Data and Safety Monitoring Boards or DSMBs, have the power to recommend which of the following? Select all that apply That the sponsor should continue the trial That the sponsor should modify the trial That the sponsor should stop the trial That the sponsor should start a new trial

That the sponsor should continue the trial That the sponsor should modify the trial That the sponsor should stop the trial

Which of the following options describes the term "severe" in regards to ICH?

The Intensity of a specific event

content validity

The degree to which the content of a test is representative of the domain it's supposed to measure

Who is responsible for the investigational product at a site during the study? The Sponsor The monitor The investigator the pharmacist

The investigator

Pharmacokinetics

The process by which drugs are absorbed, distributed within the body, metabolized, and excreted.

What details need to be documented in the subject source documentation when an Adverse Event (AE) occurs?

The severity of the event, When the event occurred, Setting in which the event occurred

Who is ultimately responsible for data quality and integrity in a contracted clinical trial? The CRO The sponsor The IRB/ IEC an IDMC

The sponsor

A subject presents at a site with her husband, after pre-qualifying on a phone screen. She states that she is legally blind and cannot read the ICF. A Braille ICF is not available. This subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent for this subject? The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding. Her husband can sign the ICF for her after it has been read to the subject and she verbally states her understanding. This subject does not qualify as she is unable to read the ICF herself and a Braille consent form is not available. An investigator must co-sign the ICF after it has been read to the subject and she verbally states her understanding and has signed the ICF.

The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.

According to ICH E6, who must sign the Informed Consent Form or ICF? Select all that apply The person who conducted the informed consent discussion The subject or the subject's legally acceptable representative A member of the IRB/IEC The monitor

The subject or the subject's legally acceptable representative The person who conducted the informed consent discussion

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? Further hypotheses for later research The target population Selection of investigators Unblinding procedures

The target population

Which of these is not a required component of the ICF? (select all that apply) Subject's responsibilities The circumstances under which a subject may be withdrawn from the study The type of compensation That the monitor will be granted direct access to the subject's medical records for verification of trial and procedures How many subjects will be enrolled Description of how much time is involved with each study visit That subjects do not waive any legal rights by signing the consent form Contact information for learning about their rights as research participants

The type of compensation (payments need to be included but not specific type) Description of how much time is involved with each study visit That subjects do not waive any legal rights by signing the consent form (this phrase is not needed, but consent cannot waive or appear to waive any legal rights)

double dummy

The use of matching placebo to ensure blinding, when all patients receive two formulations (drug and placebo); i.e., active tablet plus placebo liquid compared to placebo tablet and active liquid.

Form FDA- 1572

This form is required for clinical research studies involving drugs or devices regulated by the FDA and is the investigator's agreement to perform the study according to applicable federal regulations. [ICH GCP E6 8.2.6, 8.3.4]

Form FDA- 1571

This form is the cover sheet for investigator-sponsored IND applications as well as the cover sheet for all subsequent correspondence to the FDA concerning the investigator-sponsored IND such as annual progress reports, safety reports, modifications etc. Form FDA 1571 is not required for INDs sponsored by a pharmaceutical company. [ICH GCP E6 8.2.6, 8.3.4]

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 To ensure that the monitor is performing his or her duties correctly To ensure accuracy of data and to carry out data analysis To approve the trial protocol

To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints

* Master Randomization List

To document method for randomization of trial population LOCATION: -Sponsor -Third Party -if applicable

informed consent content

Trial purpose treatments/ procedures subject responsibilities experimental aspects risks and benefits alternatives to study payment/ expenses voluntary monitors, auditors, IRB... see med records confidentiality new info contact info termination reasons duration # of people in trial

Which of the following is MOST useful for scheduling trial procedures? Site screening log Subject enrollment log Trial schedule of events Trial team vacation/leave calendar

Trial schedule of events

True or False? Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients. True False

True

True or False? The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC)? True False

True

True or False? 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 False

True

A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospitalization. Nausea with vomiting does not appear in the Investigator's Brochure. The investigator should rate this event as Expected and serious. Expected and not serious. Unexpected and serious. Unexpected and not serious.

Unexpected and serious.

A dementia participant show up to an appointment with a person who is not their designated caregiver. They do not meet the minimum 4 hours per week to qualify as a caregiver. What is the best thing the RC can do. Do the visit using the new person Skip the visit Call the caregiver Discharge the participant from the study

Unknown

Sponsor Responsibilities shipping and handling IP

Wait until IRB approve PI maintain records of shipping, receipt, disposition, return, and destruction maintain system for IP retrieval and for the disposition of unused IP.

Which of the following would require prior consent when screening a subject? Subject demographics Relevant medical history Washout from medication Routine diagnostic lab tests

Washout from medication

The study subject asks you why the study is called a double blind study. You explain double blind as what? When the subject and the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects are unaware of the treatment assignments Two people in the study, the Investigator and pharmacist, are unaware of the treatment assignments When a placebo is used in a study to eliminate bias Treatment assignment is not known by the study participant but the Investigator is aware

When the subject and the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects are unaware of the treatment assignments

Investigator - ICH progress reports

Written at least annually Prompt reporting where required (significant changes to trial conduct)

Statistical analysis plan

Written before study starts. may be separate from protocol.

Drug metabolites

a byproduct of the body breaking down a drug into a different substance. Some metabolites stay in the body much longer than the parent drug, often being taken in by growing hair.

Investigator - ICH Communication with IRB

approval before trial provide IB Documents

Investigator - ICH informed consent

as per GCP updated as needed/ approved by IRB no coercion ICF cannot waive or appear to waive legal rights use plain language given time to decide/ address questions impartial witness if unable to read decreased ability or children agree to the extent of ability copy

Primary variables

capable of providing the most clinically relevant evidence. Usually an efficacy variable. used to determine study size.

Sponsor Responsibilities making on IP

coding and labeling IP determine temp and storage packaging allow blind to be broken rapidly take steps to make sure IP is stable throughout study

trial to show dose-response relationship

confirm efficacy determine maximum dose and start dose determine dose adjustment create data for dose-response curve

Coordinating investigator

coordinates investigators at different centers for a mulit-center trial.

Quality Management- risk based approach

critical process and data ID risk ID risk eval risk control risk communication risk review risk reporting

Intra-rater reliability

degree of agreement among repeated administrations of a diagnostic test performed by a single rater

PRE-TRIAL MONITORING REPORT

document that the site is suitable for the trial. site eval

investigational product accountability at the site

document the IP has been used per protocol.

Monitoring Visit Report

document the findings of the monitor

Trial Initiation Monitoring Report

document the trial procedures were reviewed with the PI and staff

documentation of IP destruction

documents destruction of unused IP by sponsor or at site.

crossover design study

each participant serves as his own control - in a two period crossover design, each would receive either intervention or control (A or B) in the first period and the alternate treatment (A or B) in the second period - major advantage: variability is reduced b/c the measured effect of the intervention is the difference in that participant's response TO the intervention and control - this decrease in variance allows use of a smaller sample size, generally longer but each is exposed to all treatments

secondary variables

either supportive measurements related to primary objective or measurements of affects related to the secondary objectives.

Quality Control (QC)

ensure data reliability and have been processed correctly Sponsor responsibility

clinical trials

experiments that study the effectiveness of medical treatments on Human Subjects

True or False? Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. True False

false

Investigator - ICH Randomization

follow trials randomization procedures, unblind per protocol, explain premature unblinding.

protocol

includes objective, design, methodology, statistical considerations, and trial organization.

Investigator - ICH overall

investigator qualification adequate resources medical care to trial subjects communication with IRB compliance with protocol IP randomization informed Consent reporting (progress, safety, termination, Final)

Subject Identification Code list

kept in reg binder. list of pt/ codes

LDH

lactate dehydrogenase test used to check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs.

As per ICH GCP, what information is the investigator NOT required to share with the IRB/IEC? Details of subject payments Significant protocol changes names of all subjects whose study participation ended early Written explanation if a study is terminated or suspended by sponsor

names of all subjects whose study participation ended early

A 10-year-old child who reads well is asked to participate in a clinical research trial for a non-life-threatening condition. He reads the assent form given to him and decides not to participate in the study. What should the research professional do? Have the child talk to his doctor not enroll the child encourage the child's parents to convince him ease the child's concerns by introducing him to other participants

not enroll the child

Investigator - ICH Investigational Product

on site accountability delegate to IDS IP delivery, inventory, distribution, sponsor returns (IP details for these) IP storage as specified by sponsor explain IP product use to participants

Due to the limited number of participants in a pediatric trial, what phase of the research will garner the most significant amount of safety and efficacy information? Phase 1 Phase 2 phase 3 post-marketing

post-marketing

confidentiality

prevent (unauthorized) disclosure of pt info OR sponsor info

Sponsor Responsibilities info on IP

provide PI with IB update PI with any significant changes

Medical expertise

qualified medical personnel readily available to advise on trial. Sponsor responsibility

Investigator - ICH Medical care

qualified physician AE Med care tell pt PCP if possible Obtain reason for study D/C

Treatment allocation and decoding documentation

returned to sponsor to document any decoding that occured

IRB procedures

rosters scheduling initial and continuing review pre approve deviations Specify that investigator should promptly report- Deviations, increase subj risk, serious and unexpected ADRs, new info written documents: trial related decisions, reason for decision, appeal procedure.

A study subject develops drug-induced nephritis and is admitted to hospital. Which option best describes this situation? ADR unexpected ADR serious ADR a life-threatening ADR

serious ADR

What's the time frame for reporting serious ADRs that are not life threatening? What's the time frame for reporting Fatal or Life-Threatening Unexpected ADR's? (To regulatory authorities, not the sponsor.

serious ADRs that are not life threatening- 15 days Fatal or Life-Threatening Unexpected ADR's- 7 days

seriousness vs severity

seriousness is based on outcome usually life threat Severity is intensity of specific event (severe headache)

Investigator - ICH compliance with protocol

should conduct trial by protocol pre-approve deviations if possible document reporting to IRB

letter of indemnity

sponsor provided insurance for financial claims against the PI.

ICH 9

statistical principals

Parallel Group Design

subject's are randomized to one of two or more arms, each arm being allocated to a different treatment. Treatments include investigational product and one or more control treatments (placebo)

Audit

systematic examination of a company's accounting system to determine whether its financial reports reliably represent its operations

sponsor

takes responsibility for the initiation, management, and/ or financing of a clinical trial

Phase 1 clinical trials

testing a new drug on a small group of healthy individuals. to find out what a safe dosage is, if there are any side effects and how the body reacts to drug

A subject is reviewing an informed consent for a hypertension study with the CRC. The consent includes a lengthy paragraph on discomforts and risks. The subject is concerned about the risks and remarks about them. What will be the most appropriate response from the CRC in such a case? The regulatory authorities require that all known side effects be listed Hypertension medis can cause numerous side affects, but most of them are not serious the PI will answer your questions this is a reference list to collect relevant data on AE's during the study.

the PI will answer your questions

Randomization

the best defense against bias, in which each individual is given a fair, random chance of selection

carryover effects

the residual effects from the first part of an experimental study that may bias the results of the second part of a crossover study if a sufficient washout period between the two arms of the study is not implemented (stable disease state also needed) good for bioequivalence of 2 formulations same med

pharmacological

the use of drugs to treat a disease

clinical study reports

to document results and interpretation of trial.

Non-Clinical Studies

toxicology pharmacology pharmacokinetics (characteristics of drug, target disease, route of administration...)

drug-drug interactions

when the effect of a medication is changed, enhanced, or diminished when taken with another drug, including herbal substances