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CRA (OPS) practice questions

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Question 1Ethical and Regulatory Foundations of Clinical Research

Which Belmont Report principle is most directly operationalized by the requirement to obtain informed consent from research participants?

  1. Justice
  2. Respect for persons Correct answer.
  3. Scientific validity
  4. Beneficence

Explanation

Respect for persons requires acknowledging individual autonomy and providing additional protection for those with diminished autonomy; informed consent is the practical expression of that principle. Beneficence and justice are the other two Belmont principles and address risk-benefit and fairness in subject selection.

Question 2Ethical and Regulatory Foundations of Clinical Research

The Nuremberg Code states which requirement as its very first principle?

  1. That participation be voluntary and based on informed consent Correct answer.
  2. That injured participants be compensated by the sponsor
  3. That the experiment be preceded by animal experimentation
  4. That every experiment be reviewed by an independent ethics committee

Explanation

The first principle of the Nuremberg Code declares that the voluntary consent of the human subject is absolutely essential. Prior committee review developed later through the Declaration of Helsinki and national regulations.

Question 3Ethical and Regulatory Foundations of Clinical Research

The Declaration of Helsinki is issued by which body?

  1. The World Medical Association Correct answer.
  2. The United States Food and Drug Administration
  3. The International Council for Harmonisation
  4. The Council for International Organizations of Medical Sciences

Explanation

The Declaration of Helsinki was first adopted in 1964 by the World Medical Association and is addressed primarily to physicians conducting research with human beings. CIOMS publishes separate international ethical guidelines, and ICH publishes the GCP guideline.

Question 4Ethical and Regulatory Foundations of Clinical Research

Under ICH E6, which document describes the objectives, design, methodology, statistical considerations and organization of a trial?

  1. The clinical study report
  2. The case report form
  3. The investigator's brochure
  4. The protocol Correct answer.

Explanation

ICH E6 defines the protocol as the document that describes the objective(s), design, methodology, statistical considerations and organization of a trial. The investigator's brochure summarizes the investigational product, the case report form captures data, and the clinical study report presents final results.

Question 5Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR 56.107, an IRB must have at least how many members?

  1. Seven
  2. Five Correct answer.
  3. Twelve
  4. Three

Explanation

FDA regulations require an IRB to have at least five members of varying backgrounds, including at least one member whose primary concern is scientific, one whose primary concern is nonscientific, and one who is not affiliated with the institution.

Question 6Ethical and Regulatory Foundations of Clinical Research

Which item is required in the informed consent document for FDA-regulated research under 21 CFR 50.25?

  1. A description of the foreseeable risks or discomforts Correct answer.
  2. The names of all site staff who will perform study procedures
  3. The sponsor's projected market price for the product
  4. The identity of other participants enrolled at the site

Explanation

21 CFR 50.25(a)(2) requires a description of any reasonably foreseeable risks or discomforts to the subject. Commercial projections, staff rosters and the identities of other participants are not required consent elements.

Question 7Ethical and Regulatory Foundations of Clinical Research

For research involving children under 45 CFR 46 Subpart D, assent ordinarily means:

  1. The investigator's documented rationale for enrolling a minor
  2. The child's affirmative agreement to participate Correct answer.
  3. A court order permitting the child to participate
  4. A legal guardian's signature authorizing enrollment

Explanation

Assent means a child's affirmative agreement to participate in research; mere failure to object should not be construed as assent. Permission from parents or a guardian must be obtained separately, and the IRB determines whether assent is required.

Question 8Ethical and Regulatory Foundations of Clinical Research

Which group receives dedicated additional protections under a specific subpart of the U.S. Common Rule?

  1. Employees of the sponsoring company
  2. Persons who hold health insurance
  3. Students enrolled at the research site
  4. Prisoners Correct answer.

Explanation

The Common Rule contains subparts providing additional protections for pregnant women, human fetuses and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D). Employment status, student status and insurance coverage are not addressed by those subparts.

Question 9Ethical and Regulatory Foundations of Clinical Research

A minimal-risk study falls within a category on the federal expedited review list. Who may conduct the review?

  1. The full convened IRB, because expedited review applies only to studies with no procedures at all
  2. The IRB chair or one or more experienced reviewers designated by the chair Correct answer.
  3. The FDA, after the site submits a written request for an expedited determination
  4. The sponsor's medical monitor, provided the site investigator signs the approval

Explanation

Under 45 CFR 46.110 and 21 CFR 56.110, the IRB chair or one or more experienced reviewers designated by the chair may review research that involves no more than minimal risk and fits an expedited category. The review may not disapprove research; it may only approve or refer to the full board.

Question 10Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR 56.109(f), IRB continuing review of ongoing research must occur at intervals appropriate to the degree of risk but not less than:

  1. Every two years
  2. Every six months
  3. Every three years
  4. Once per year Correct answer.

Explanation

The regulation requires continuing review at intervals appropriate to the degree of risk but not less than once per year. More frequent review may be required for higher-risk research.

Question 11Ethical and Regulatory Foundations of Clinical Research

Which situation best meets the definition of an unanticipated problem involving risk to subjects?

  1. Any adverse event that occurs during the trial, regardless of whether it was expected or related
  2. A protocol amendment that was submitted to the IRB without prior approval
  3. A record-keeping deficiency identified during a sponsor audit
  4. An unexpected event related to the research that suggests an increased risk of harm Correct answer.

Explanation

An unanticipated problem is unexpected, related or possibly related to participation in the research, and suggests that the research places subjects at a greater risk of harm than was previously known or recognized. All three elements must be present.

Question 12Ethical and Regulatory Foundations of Clinical Research

Under ICH E6, how should an investigator report serious adverse events to the sponsor?

  1. Within 15 calendar days of the investigator becoming aware
  2. Immediately, unless the protocol or investigator's brochure states otherwise Correct answer.
  3. Only in the annual report submitted at the end of the study
  4. Within 5 working days of first becoming aware of the event

Explanation

ICH E6 section 4.11.1 requires the investigator to report all serious adverse events immediately to the sponsor, except for those that the protocol or investigator's brochure identifies as not requiring immediate reporting. Follow-up reports may then be provided in writing.

Question 13Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR 312.32, a sponsor must notify FDA of an unexpected fatal or life-threatening suspected adverse reaction no later than:

  1. 15 calendar days after initial receipt of the information
  2. 30 calendar days after initial receipt of the information
  3. 7 calendar days after initial receipt of the information Correct answer.
  4. 24 hours after initial receipt of the information

Explanation

21 CFR 312.32(c)(2) requires telephone, fax or email notification within 7 calendar days for unexpected fatal or life-threatening suspected adverse reactions. Other serious and unexpected suspected adverse reactions are reported within 15 calendar days.

Question 14Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR 312.62, an investigator must retain clinical trial records for at least:

  1. Two years after approval of a marketing application, or two years after the investigation is discontinued Correct answer.
  2. One year after the database has been locked and the treatment codes unblinded
  3. Ten years after the results of the study have been published in a peer-reviewed journal
  4. Five years after the last participant completes the final study visit at that site

Explanation

The investigator must retain records for 2 years after a marketing application is approved for the drug, or, if no application is approved or the application is not approved, 2 years after the investigation is discontinued and FDA is notified. Longer retention may be required by the sponsor or other regulations.

Question 15Ethical and Regulatory Foundations of Clinical Research

To approve a waiver of informed consent under the Common Rule, an IRB must find that:

  1. The sponsor agrees in writing and the investigator has disclosed no conflicts of interest
  2. Minimal risk, impracticable without the waiver, and no adverse effect on rights and welfare Correct answer.
  3. Participants will be debriefed afterward and receive compensation for their time
  4. The research is minimal risk and will enroll fewer than 100 participants overall

Explanation

45 CFR 46.116(f) requires four findings: the research involves no more than minimal risk, the waiver will not adversely affect participants' rights and welfare, the research could not practicably be carried out without the waiver, and, when appropriate, participants will be given pertinent information afterward.

Question 16Ethical and Regulatory Foundations of Clinical Research

Under the HIPAA Privacy Rule, a valid research authorization must include:

  1. The date the IRB approved the study
  2. A copy of the investigator's curriculum vitae
  3. A statement that the participant waives all rights to privacy and access to records
  4. A description of the information to be used or disclosed and its purpose Correct answer.

Explanation

45 CFR 164.508(c) requires a description of the information, who may disclose it, who may receive it, the purpose, an expiration date, the individual's signature, and required statements about revocation and redisclosure. A waiver of all privacy rights would not be a valid authorization.

Question 17Ethical and Regulatory Foundations of Clinical Research

Which element is required to conduct emergency research under the exception from informed consent in 21 CFR 50.24?

  1. Approval of the protocol by the FDA Commissioner personally
  2. A guarantee that no subject will be billed for the investigational product
  3. Consultation with representatives of the community where the research will be conducted Correct answer.
  4. Written consent from a legally authorized representative within six hours of enrollment

Explanation

21 CFR 50.24 requires community consultation, public disclosure before and after the study, and IRB approval under the exception, in addition to other safeguards. Written surrogate consent is not required before enrollment because obtaining it is not feasible in the emergency setting.

Question 18Ethical and Regulatory Foundations of Clinical Research

For research involving more than minimal risk, 21 CFR 50.25 requires the consent document to explain:

  1. Whether compensation and medical treatment are available and whom to contact Correct answer.
  2. That the sponsor will pay all medical costs of any research-related injury
  3. That injuries occurring during the study will not be reported
  4. That participants accept the risk of injury without recourse

Explanation

21 CFR 50.25(a)(6) requires an explanation of whether any compensation and medical treatments are available if injury occurs, and where further information can be obtained. It does not require payment, nor may it ask subjects to waive their rights.

Question 19Ethical and Regulatory Foundations of Clinical Research

An IRB member is a paid consultant to the sponsor of a protocol under review. What should the member do?

  1. Recuse only if the study involves more than minimal risk
  2. Vote on the study but abstain from discussing risks and benefits
  3. Disclose the conflict and be excluded, except to provide information the IRB requests Correct answer.
  4. Serve as primary reviewer because of specialized knowledge of the product

Explanation

21 CFR 56.107(e) prohibits an IRB member with a conflicting interest from participating in the review, except to provide information requested by the IRB. The member may not vote or count toward the quorum.

Question 20Ethical and Regulatory Foundations of Clinical Research

Under the FDAAA clinical trial registration requirements, an applicable clinical trial must be registered on ClinicalTrials.gov no later than:

  1. At the time the protocol is submitted to the IRB
  2. Within 30 days after the last participant completes the study
  3. On the day the first participant is enrolled
  4. 21 calendar days after the first participant is enrolled Correct answer.

Explanation

FDAAA requires the responsible party to register an applicable clinical trial no later than 21 calendar days after the first human subject is enrolled. Results information is subsequently submitted within specified timeframes after completion.

Question 21Ethical and Regulatory Foundations of Clinical Research

Under 45 CFR 46.406, research involving children that presents more than minimal risk with no prospect of direct benefit may be approved only if the risk is:

  1. A minor increase over minimal risk Correct answer.
  2. Outweighed by a payment made to the child's family
  3. No greater than the risks ordinarily encountered in daily life
  4. Reviewed and approved by a pediatric specialist instead of the IRB

Explanation

Section 46.406 permits such research only when the risk represents a minor increase over minimal risk, the interventions are reasonably commensurate with those inherent in the child's actual or expected medical situation, and the research is likely to yield generalizable knowledge about the child's disorder or condition.

Question 22Ethical and Regulatory Foundations of Clinical Research

Under ICH E6, an investigator may deviate from the protocol without prior sponsor agreement and IRB approval only when:

  1. It is needed to eliminate an immediate hazard to a trial participant Correct answer.
  2. The sponsor grants verbal approval after the deviation has occurred
  3. The deviation is minor and can be documented at the next monitoring visit
  4. The deviation lowers the overall cost of conducting the study

Explanation

ICH E6 section 4.5.4 permits departure from the protocol without prior approval only to eliminate an immediate hazard to trial subjects, or when the change concerns only logistical or administrative aspects of the trial. Any such deviation should be documented and reported promptly.

Question 23Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR Part 11, which control helps ensure that electronic records are trustworthy and reliable?

  1. Shared passwords so that site staff can enter data quickly
  2. Annual printing of all electronic records onto paper
  3. Secure, computer-generated, time-stamped audit trails Correct answer.
  4. Encryption of records only after the study is completed

Explanation

21 CFR 11.10(e) requires use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records. Shared accounts and delayed encryption undermine attribution and integrity.

Question 24Ethical and Regulatory Foundations of Clinical Research

How did the 2018 revised Common Rule change continuing review requirements?

  1. Continuing review must now occur every six months for all minimal risk studies
  2. Continuing review is required annually regardless of the level of risk
  3. Continuing review is no longer required for research eligible for expedited review Correct answer.
  4. Continuing review has been eliminated for all FDA-regulated research as well

Explanation

The revised Common Rule at 45 CFR 46.109(f)(1)(i) eliminated continuing review for research eligible for expedited review, unless the IRB determines otherwise. FDA has not harmonized this provision, so FDA-regulated research remains subject to continuing review under 21 CFR 56.109.

Question 25Ethical and Regulatory Foundations of Clinical Research

Under the 2018 revised Common Rule, informed consent must begin with:

  1. A concise presentation of the key information needed for a decision Correct answer.
  2. A separate statement authorizing the use and disclosure of protected health information for research
  3. A complete copy of the statistical analysis plan for the trial
  4. An itemized schedule listing every study procedure and study visit

Explanation

45 CFR 46.116(a)(1) requires consent to begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding why one might or might not want to participate. The remaining elements then follow in an organized manner.

Question 26Ethical and Regulatory Foundations of Clinical Research

The requirement to obtain voluntary informed consent from research participants is most directly grounded in which Belmont Report principle?

  1. Justice and fair selection
  2. Respect for persons Correct answer.
  3. Scientific integrity
  4. Beneficence and nonmaleficence

Explanation

The Belmont Report's principle of respect for persons requires that individuals be treated as autonomous agents and that those with diminished autonomy receive protection. Obtaining voluntary informed consent is the practical expression of that principle. Beneficence and justice address other obligations, such as minimizing harm and distributing burdens fairly.

Question 27Ethical and Regulatory Foundations of Clinical Research

Under 45 CFR 46.102, which description best fits the regulatory definition of research?

  1. A laboratory test ordered by a clinician to guide one patient's care
  2. A quality improvement project intended solely to improve care in one clinic
  3. A systematic investigation yielding generalizable knowledge Correct answer.
  4. A case report presented at a departmental clinical conference

Explanation

The Common Rule defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities intended only for local operational improvement or individual patient care generally fall outside that definition.

Question 28Ethical and Regulatory Foundations of Clinical Research

A consent form states that by enrolling, the subject waives the right to sue the institution for negligence. Under 21 CFR 50.20 and 45 CFR 46.116, this language is:

  1. Permitted if the subject initials that paragraph
  2. Prohibited as exculpatory language Correct answer.
  3. Acceptable if the IRB approves it
  4. Acceptable only in minimal-risk studies

Explanation

Both 21 CFR 50.20 and 45 CFR 46.116 prohibit exculpatory language through which a subject is made to waive, or appear to waive, any legal rights or release the institution from liability for negligence. IRB approval or subject initials cannot make such language permissible.

Question 29Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR 56.107, an IRB reviewing FDA-regulated research must include at least one member who is:

  1. A person who once enrolled as a subject
  2. A physician holding a current state license
  3. Directly employed by the study sponsor
  4. Concerned mainly with nonscientific areas Correct answer.

Explanation

21 CFR 56.107 requires an IRB to have at least five members with varying backgrounds, including at least one member whose primary concerns are in nonscientific areas and at least one member who is not affiliated with the institution. Physician licensure, sponsor employment, and prior subject status are not membership requirements.

Question 30Ethical and Regulatory Foundations of Clinical Research

For an IRB to approve proposed research under 21 CFR 56.111, which finding is required?

  1. Every enrolled subject will receive direct medical benefit
  2. The study sponsor has purchased liability insurance
  3. Risks are minimized and reasonable versus benefits Correct answer.
  4. The study will enroll at least one hundred subjects

Explanation

21 CFR 56.111 requires the IRB to find, among other things, that risks to subjects are minimized and that risks are reasonable in relation to anticipated benefits and the importance of the knowledge sought. Direct benefit to every subject, sponsor insurance, and a minimum enrollment number are not approval criteria.

Question 31Ethical and Regulatory Foundations of Clinical Research

Under 45 CFR 46 Subpart B, research involving pregnant women may proceed only if, among other conditions:

  1. The father's consent is required in all cases
  2. The fetus will receive direct benefit in every case
  3. The research presents no more than minimal risk
  4. Prior animal and nonpregnant human data exist Correct answer.

Explanation

Subpart B requires, where scientifically appropriate, that preclinical studies including studies on pregnant animals and clinical studies including studies on nonpregnant women have been conducted to assess potential risks to pregnant women and fetuses. Direct fetal benefit is not required in every study, and Subpart B permits some research above minimal risk under specified conditions.

Question 32Ethical and Regulatory Foundations of Clinical Research

Under 45 CFR 46 Subpart C, research involving prisoners may be permitted when the study:

  1. It is conducted by an employee of the prison
  2. It studies a condition affecting prisoners as a class Correct answer.
  3. It is limited to minimal risk and no inconvenience
  4. It offers payment that offsets the costs of incarceration

Explanation

Subpart C permits prisoner research only within specified categories, one of which is research on conditions particularly affecting prisoners as a class. Conduct by a prison employee is a conflict issue rather than a permission category, and payment designed to offset incarceration costs is not permissible.

Question 33Ethical and Regulatory Foundations of Clinical Research

Under the 2018 revised Common Rule, cooperative research involving multiple U.S. institutions generally must:

  1. Use a data safety monitoring board
  2. Rely on a single IRB for review Correct answer.
  3. Obtain separate IRB approval at each site
  4. Be exempt from IRB review

Explanation

45 CFR 46.114 generally requires institutions engaged in cooperative research to rely on a single IRB for review, subject to specified exceptions. Separate review at each site was the prior default but is no longer generally required. Exemption and data monitoring board use are separate determinations.

Question 34Ethical and Regulatory Foundations of Clinical Research

Under 21 CFR Part 54, which financial interest of a clinical investigator must be disclosed to FDA?

  1. A mortgage on the investigator's home
  2. Sponsor equity worth more than $50,000 Correct answer.
  3. Salary paid by the investigator's institution
  4. A diversified mutual fund holding

Explanation

21 CFR Part 54 requires investigators to disclose certain financial interests in the sponsor, including equity interests, with a $50,000 threshold applicable to publicly traded sponsor equity. Ordinary institutional salary and personal debts such as a mortgage are not reportable interests.

Question 35Ethical and Regulatory Foundations of Clinical Research

Under the Declaration of Helsinki, use of a placebo control is generally acceptable when:

  1. The institutional review board waives review of the protocol
  2. The condition being studied is not life-threatening for any participant
  3. No proven intervention exists or withholding poses no serious risk Correct answer.
  4. The sponsor requests a placebo control for commercial reasons

Explanation

The Declaration of Helsinki permits placebo or no-treatment controls where no proven intervention exists, or where compelling methodological reasons justify withholding an intervention and subjects will not be exposed to serious or irreversible harm from placebo. The severity of the condition alone, sponsor preference, or IRB waiver does not make placebo use acceptable.

Question 36Ethical and Regulatory Foundations of Clinical Research

A subject says, "I know the trial assigns treatment by chance, but my doctor chose this study because it will cure me." This reasoning best illustrates:

  1. Undue inducement of the subject
  2. Confirmation bias in analysis
  3. Selection bias in enrollment
  4. Therapeutic misconception Correct answer.

Explanation

Therapeutic misconception occurs when a research participant conflates the goals of clinical research with individualized medical treatment and expects personal therapeutic benefit from study participation. Undue inducement concerns excessive offers, selection bias concerns sampling, and confirmation bias concerns interpretation of data.

Question 37Study Preparation and Site Qualification

What is the primary purpose of a pre-study qualification visit conducted by a sponsor or CRA?

  1. To close out the study and reconcile remaining investigational product
  2. To train site staff on protocol procedures before enrollment
  3. To verify that source documents match the case report forms
  4. To assess the site's suitability to conduct the trial Correct answer.

Explanation

A pre-study visit evaluates whether the site has adequate facilities, qualified staff, and access to a suitable subject population before the sponsor selects it. Source data verification belongs to routine monitoring, protocol training to the initiation visit, and product reconciliation to close-out.

Question 38Study Preparation and Site Qualification

Which document most directly evidences that an investigator is qualified by training and experience to conduct a trial?

  1. The investigator brochure receipt log maintained by the site pharmacy
  2. The site's written standard operating procedures
  3. A signed, dated curriculum vitae from the investigator Correct answer.
  4. The study budget and its payment schedule

Explanation

GCP requires documentation of the investigator's qualifications through education, training, and experience, which is conventionally captured in a signed and dated curriculum vitae kept in the trial master file and investigator site file. The other documents address procedures, finances, or product receipt rather than qualifications.

Question 39Study Preparation and Site Qualification

At what point must Institutional Review Board or Ethics Committee approval be in place for a trial?

  1. Once the sponsor has signed the clinical trial agreement
  2. After the first subject has provided informed consent
  3. After the site initiation visit has been completed and documented
  4. Before any study procedure is performed on a subject Correct answer.

Explanation

No study-related procedure may be carried out on a subject, including screening, until the protocol and informed consent form have been reviewed and approved by the responsible review board or ethics committee. Contract execution and initiation visits do not substitute for this approval.

Question 40Study Preparation and Site Qualification

During a feasibility assessment, which information best indicates whether a site can meet a trial's enrollment target?

  1. The number of intensive care beds at the institution
  2. The site's prior-year count of eligible patients Correct answer.
  3. The hospital's annual spending on advertising
  4. The number of journal articles the investigator has published

Explanation

Enrollment potential is estimated from the number of patients who meet the protocol's eligibility criteria and are actually seen at the site. Publications, advertising spend, and intensive care capacity do not directly reflect the size of the accessible eligible population.

Question 41Study Preparation and Site Qualification

What is the main objective of a site initiation visit?

  1. To train site staff on the protocol before enrollment begins Correct answer.
  2. To verify that the site's data are accurate and complete
  3. To archive the trial master file after study completion
  4. To determine whether the site should be selected for the trial

Explanation

The initiation visit occurs after selection and approval, and its focus is to ensure the site team understands the protocol, procedures, and documentation requirements before the first subject is enrolled. Data verification is a monitoring activity and selection is decided at qualification.

Question 42Study Preparation and Site Qualification

Before a sponsor shares a draft protocol with a candidate site, which agreement is normally put in place?

  1. A master service agreement
  2. An indemnification agreement
  3. A confidentiality disclosure agreement Correct answer.
  4. A clinical trial agreement

Explanation

A confidentiality disclosure agreement protects proprietary and patient information exchanged during feasibility discussions, before any commitment to participate exists. The clinical trial agreement and indemnification terms are negotiated later, once the site is selected.

Question 43Study Preparation and Site Qualification

Which item must be in place before a site may begin screening subjects?

  1. The site's close-out letter from the sponsor
  2. The final monitoring report
  3. The final clinical study report ready for submission
  4. A signed and dated investigator agreement Correct answer.

Explanation

Before enrollment, the investigator must have signed the protocol or an investigator agreement, confirming commitment to conduct the study according to the protocol and applicable regulations. Study reports, close-out letters, and monitoring reports are generated much later in the trial lifecycle.

Question 44Study Preparation and Site Qualification

Which observation made during a qualification visit should be flagged as a potential barrier to site participation?

  1. The site's freezer has no temperature monitoring records Correct answer.
  2. The site has a written SOP for informed consent
  3. The site has a dedicated, locked room for investigational product
  4. The site has a calibrated centrifuge with current records

Explanation

Investigational products requiring frozen storage must be kept within defined conditions with documented monitoring, so the absence of temperature records indicates a control gap. The other observations describe satisfactory infrastructure or documentation.

Question 45Study Preparation and Site Qualification

How should the investigator document which site staff are authorized to perform specific protocol tasks?

  1. By completing a delegation log listing each staff member's duties Correct answer.
  2. By collecting a signed informed consent from each staff member
  3. By recording each staff member's arrival time in the site log
  4. By issuing each staff member a copy of the protocol

Explanation

The investigator delegates study tasks in writing, and the delegation log records which staff members are authorized for which activities along with signatures and dates. Distributing protocols or keeping attendance records does not establish authorization.

Question 46Study Preparation and Site Qualification

Which laboratory documentation should a CRA obtain from a site's local laboratory during qualification?

  1. The laboratory's purchase orders for reagents
  2. The laboratory's employee holiday schedule
  3. An accreditation certificate and reference ranges for protocol tests Correct answer.
  4. The laboratory's marketing brochure

Explanation

The site file should contain evidence that the local laboratory is certified or accredited and that normal reference ranges for the tests named in the protocol are available for interpretation of results. Marketing materials, staffing schedules, and purchasing records do not support data quality.

Question 47Study Preparation and Site Qualification

Which statement best describes the GCP training expectation for site staff working on a trial?

  1. Only the principal investigator must be trained, and only once
  2. Training is optional if the site has prior research experience
  3. Records are kept only by the sponsor, never by the site
  4. Each staff member involved should have documented GCP training Correct answer.

Explanation

All personnel who perform study-related duties should be trained in GCP and in the protocol, and the training should be documented and current. Prior experience does not remove the requirement, and both sponsor and site retain records.

Question 48Study Preparation and Site Qualification

A principal investigator at a candidate site is already running five trials that draw on the same patient population. What is the most appropriate action during qualification?

  1. Exclude the site automatically because of the other trials
  2. Assess whether the investigator has capacity to meet enrollment Correct answer.
  3. Ask the sponsor to increase the enrollment target for this site
  4. Defer the assessment until the first subject has been enrolled

Explanation

Competing studies are a risk factor rather than an automatic disqualification, so the CRA evaluates whether the investigator has sufficient time, staff, and patient availability for the added trial. Enrollment targets cannot simply be raised, and waiting until enrollment starts forfeits the purpose of qualification.

Question 49Study Preparation and Site Qualification

For an investigational product that requires refrigerated storage, which pharmacy feature is most relevant during qualification?

  1. A monitored refrigerator with documented temperature records Correct answer.
  2. A separate waiting room for study subjects
  3. A cash register for dispensing payments to subjects
  4. A secured cabinet for the site's office supplies

Explanation

Product requiring cold storage must be held in a monitored refrigerator with continuous temperature documentation and adequate space for the study supply. Payment systems, waiting areas, and office supply storage do not affect product integrity.

Question 50Study Preparation and Site Qualification

Why does a CRA review the site's source documentation practices during qualification?

  1. the site destroys records after each subject visit
  2. the site stores paper records at an off-site warehouse
  3. data are attributable, legible, contemporaneous, original, and accurate Correct answer.
  4. the site records all data only in an electronic system

Explanation

Source documentation must meet the ALCOA principles so that reported data can be verified and reconstructed. Whether records are electronic or paper is a matter of system choice, but retention and integrity must always be maintained.