Pass the ACRP Certified Professional ACRP-CP Questions and answers with ExamsMirror

The sponsor is required to report serious unexpected adverse events (SAEs) to the regulatory authorities within 15 calendar days from the date of awareness. This reporting period is mandated to ensure that any new safety information that may affect the risk/benefit profile of the investigational product (IP) is promptly communicated, thereby protecting participant safety.

GCP guidelines specify that serious, unexpected, and related AEs must be reported to regulatory authorities within 15 days of being known to the sponsor.

"Serious unexpected adverse reactions that may affect the safety profile of the IP must be reported within 15 calendar days to the regulatory authorities."

Objectives:

Ensure timely reporting of safety information.

Protect the safety of trial participants.

The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.

This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.

"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes."

Objectives:

Ensure informed consent for data access.

Facilitate compliance with auditing requirements.

A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.

GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.

"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results."

Objectives:

Maintain transparency in data analysis.

Ensure scientific rigor in evaluating study outcomes.

The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.

This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.

"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal."

Objectives:

Ensure transparent procedures for participant withdrawal.

Maintain data integrity while respecting participant autonomy.

A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.

GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.

"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product."

Objectives:

Identify effective dosing regimens.

Evaluate therapeutic efficacy for targeted conditions.

An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.

GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.

"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound."

Objectives:

Protect the rights of individuals with literacy challenges.

Maintain ethical standards in the consent process.

The PI is responsible for maintaining training records of site personnel, which demonstrate compliance with the sponsor’s requirements for conducting the trial. Proper documentation of training ensures that all team members are knowledgeable about the protocol and study procedures.

GCP guidelines mandate that the PI maintains adequate records to demonstrate that all personnel involved in the study are properly trained and qualified.

"Training records of site personnel must be maintained to verify that the team is adequately trained on the protocol and their specific responsibilities."

Objectives:

Maintain training compliance.

Document personnel qualifications for quality assurance.

The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.

According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.

"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection."

Objectives:

Understand the sponsor’s role in trial initiation.

Ensure compliance from the outset of the study.

Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high-quality, reliable, and verifiable clinical trial records.

GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.

"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards."

Objectives:

Maintain data integrity and reliability.

Adhere to best practices in clinical documentation.

The Investigator’s Brochure (IB) contains comprehensive information about the investigational product (IP), including its pharmacokinetic and pharmacodynamic properties, preclinical and clinical trial data, and any known side effects. The IB provides a scientific basis for the study protocol and helps investigators understand the potential risks and benefits.

GCP guidelines state that the IB must include relevant scientific data, including pharmacokinetic and pharmacodynamic profiles.

"The IB should provide data on the pharmacokinetics and pharmacodynamics of the investigational product to inform clinical practice."

Objectives:

Provide comprehensive data on investigational products.

Support safe and informed clinical decision-making.