Pass the ACRP Certified Professional Exam ACRP-CP Questions and answers with ValidTests

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 IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child’s ability to understand the trial’s risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.

GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.

"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child’s comprehension level."

Objectives:

Ensure appropriate ethical practices in pediatric research.

Align with local regulatory requirements for assent.

Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.

According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.

"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights."

Objectives:

Ensure compliance with inspection requirements.

Maintain transparency with regulatory authorities.

In a multi-center clinical trial, the Sponsor-Investigator holds ultimate responsibility for the overall conduct of the study. This includes ensuring compliance with the protocol, maintaining data integrity, and overseeing all participating sites. The Sponsor-Investigator must ensure that each site follows the same procedures and standards to maintain consistency across the trial.

According to GCP guidelines, the Sponsor-Investigator must take responsibility for all aspects of a multi-center trial, including site coordination and data management.

"The Sponsor-Investigator assumes ultimate responsibility for the conduct of a multi-center clinical trial, ensuring protocol compliance and data consistency."

Objectives:

Maintain accountability across multi-center sites.

Ensure uniformity in trial conduct.

The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.

GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.

"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity."

Objectives:

Ensure accurate data transposition from source to CRF.

Maintain high standards of data quality and reliability.

An Electronic Data Capture (EDC) system must include an audit trail to ensure data integrity. This audit trail records every data entry, modification, and deletion along with timestamps and user identification. It is a critical feature for maintaining traceability and accountability in clinical research, allowing for the reconstruction of data changes and ensuring compliance with Good Clinical Practice (GCP).

GCP guidelines mandate that electronic data systems used in clinical trials must maintain an audit trail to ensure data integrity and traceability.

"An audit trail is essential in an EDC system to document all data entries, changes, and deletions to maintain data integrity."

Objectives:

Ensure data integrity through traceable record-keeping.

Maintain compliance with regulatory standards.

The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study’s outcomes.

GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.

"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity."

Objectives:

Ensure comprehensive data recording.

Maintain accuracy and completeness in study records.

Before proceeding with any trial-related activities, including subject screening, the site must first obtain IRB/IEC approval. This approval ensures that the study has been reviewed for ethical considerations, risk assessment, and adherence to regulatory requirements. Without IRB/IEC approval, initiating the study would violate ethical guidelines and regulatory standards.

GCP guidelines mandate that no clinical trial procedures, including screening, commence without prior IRB/IEC approval.

"IRB/IEC approval must be obtained before initiating any study-related activities, including screening and subject recruitment."

Objectives:

Ensure ethical compliance before study initiation.

Protect participant rights and safety.

The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.

This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.

"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective."

Objectives:

Maintain impartiality in ethical review.

Ensure diverse representation within the IRB/IEC.

The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.

According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.

"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection."

Objectives:

Maintain compliance with regulatory requirements.

Facilitate data verification and quality assurance.