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What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: Vali...

1571 IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP 01:05 01:11 IB ...

Crossover when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel when subjects are randomized to 1 of 2 or more arms, each arm being allocated a different treatment. Each treatment will include their inv...

ADR Adverse Drug Reaction AE Adverse Event ALCOAC Accurate, Legible, Contemporaneous, Original, Attributable, and Complete ALT Alanine Transaminase (liver enzyme) AST Aspartate Transaminase (liver enzyme) BID Twice a day BMI Body Mass Index BP ...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times t...

LAR Legally Authorized Representative Essential documents documents which individually and collectively permit evaluation of the conduct of a study and quality of the data produced Who developed the Declaration of Helsinky? the World Medical Association Phase 1 study designe...

Belmont Report (1979) ethical principles and guidelines for the protection of human subjects of research. respect for persons individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person A person capable of d...

What are the liver function tests? (LFT) Liver function tests (also known as a liver panel) are blood tests that measure different enzymes, proteins, and other substances made by the liver. * Albumin, a protein made in the liver * Total protein, This test measures the total amount of protein in t...

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Pos...

A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects 1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subj...

Who is responsible for providing the trial protocol The Sponsor Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced are called..? Essential documents 00:27 01:11 All information in original records a...

What is the purpose of ICH-GCP? To standardize the design, conduct, recording, and reporting of the clinical trials What is the purpose of the IRB/IEC? To protect subject's safety LAR stands for: Legally authorized representative What is the minimum number of members on the ...