Health Care > EXAM > ACRP-CP CERTIFICATION EXAM 2025/2026 LATEST STUDY QUESTIONS WITH CORRECT ANSWERS GUARANTEED PASS | R (All)
ACRP-CP CERTIFICATION EXAM 2025/2026 LATEST STUDY QUESTIONS WITH CORRECT ANSWERS GUARANTEED PASS | RATED A+
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A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a ... CRC allowed to do this task? - Answer>>> Only when the CRC is a qualified physician and has been delegated this responsibility by the PI A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - Answer>>> Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. 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 you will need to establish a/an - Answer>>> Independent Data Monitoring Committee Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are commonly conducted in later phases to answer what questions? - Answer>>> 1. Food effects on bioavailability 2. Information in sub-populations such as patients with impaired elimination 3. Drug to drug interactions 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? - Answer>>> 1. Recruitment 2. Consent and Assent 3. Minimize risk 4. Minimize distress Following unblinding in the case of a suspected serious unexpected adverse drug reaction: the treatment assigned to the subject turns out to be the comparator product. Who should the sponsor inform? - Answer>>> The manufacturer of the product and/or the regulatory authorities [Show More]
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