









































Study with the several resources on Docsity
Earn points by helping other students or get them with a premium plan
Prepare for your exams
Study with the several resources on Docsity
Earn points to download
Earn points by helping other students or get them with a premium plan
Community
Ask the community for help and clear up your study doubts
Discover the best universities in your country according to Docsity users
Free resources
Download our free guides on studying techniques, anxiety management strategies, and thesis advice from Docsity tutors
ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND ANSWERS |2025/2026 BRAND NEW!!!
Typology: Exams
1 / 49
This page cannot be seen from the preview
Don't miss anything!
Who is most responsible for the appropriate monitoring of
You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want
Unobscured original entries
Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI
You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a Site. The first course of action you implement is that a be
A subject: who has been 100% compliant thus far has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to
forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the
regulatory authority(ies)
Per ICH GCP E6: the purpose/elements of trial monitoring differ
Correct Answer > 1. The sponsor should appoint individuals: who are independent of the clinical trials/systems
Members of the armed forces
What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics: Pharmacodynamics
Answer > Phase 1 The principles and practices concerning protection of trial subjects are stated in the ICH Guideline on Good Clinical Practice (ICH E6). These principles have their origins from -
The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used
initial human dose
bioavailability
A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should
general plan from the beginning Per ICH E8: methods used to evaluate patient usage of the test
protocol and actual usage documented Which trial design is used for the specific purpose of examining
design T or F- The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an
True What is the purpose of the "Data and Safety Monitoring Board
clinical trial: the safety data: and the critical efficacy endpoints T or F- The focus of ICH E9 is on statistical principles: however: it does not address the use of specific statistical procedures or
You are writing an Investigator-initiated clinical research protocol and you need to limit the occurrence of conscious and unconscious bias. Which of the following methods may be
Generalization The Investigator at your site asked you to review a protocol. The investigational product listed in the protocol already has proven clinical benefits for the disease under study. This is
Confirmatory Trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns : that is: the residual influence
Answer > Carryover effect Missing data points (values) represent a potential source of bias
What study variable takes in the consideration the decision making process of the treating physician: who must weigh
Correct Answer > Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out
True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know
Independent Data Monitoring Committee
T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric
T or F- Pharmacokinetic studies in the pediatric population are
Correct Answer > True The two ways to minimize the number of samples obtained
Population PK & Sparse sampling
Correct Answer > False The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed.
Staging
You are reading a Phase 2 protocol: which uses pharmacokinetic sampling in a pediatric population with Sickle Cell Disease. Which of the following options may be true in this
reflect clinical use
You are evaluating a pediatric protocol for a new drug. When reviewing the drug clearance data it is important to know that hepatic and renal functions are first mature in which of the
Correct Answer > Adolescents The pediatric population represents a vulnerable subgroup. Therefore: special measures are needed to protect the rights of
When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses: and one or more control treatments: such as placebo and/or an
A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study
Correct Answer > Non-Inferiority What type of clinical trial most likely requires enrollment of the
Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy)
Answer > 5 (... lay people and medical professionals can be part of the IRB/IEC)
Answer > The Sponsor
standard procedures
members of the medical profession
Event
medical occurrence that does not necessarily have a causal relationship with treatment
on human subjects
Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints
WMA in 1964: - Defines the ethical principles for medical research involving human subjects
Representative. (regarding consenting procedures)
Correct Answer > Mission is to provide a unified standard for