ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE

IDE - ANSWER- Investigational Device Exemtpion: A clinical investigation or
research involving the safety or effectiveness of a device.

General Responsibilities of Sponsors: 21 CFR 312.50-.59 - ANSWER- Sponsors are responsible for selecting qualified investagors, providin gthem witht he information they need to conduct an investigation properly, ensuring proper monitoring of the investigations, ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND, maintianing an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed.

IEC - ANSWER- Independent Ethics Committee (AKA IRB): An independent body constituted of medical professionals and non-medical member, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial
CFR - ANSWER- Code of Federal Regulations: ------

ICH - ANSWER- International Council for Harmonization
E6(R2) = GCP
Need to standardize regulations
Europe, Japan, US
Safety, quality, efficacy
ICH E8 - ANSWER- General Considerations for Clinical Trials

ICH E6 - ANSWER- Guideline for Good Clinical Practice

ICH E9 - ANSWER- Statistical Principles for Clinical Trials

ICH E2A - ANSWER- Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting

Most typical Phase I Study - ANSWER- Human Pharmacology

Phase I - ANSWER- Estimation of initial safety and tolerability

Phase I - ANSWER- Pharmacokinetics and pharmacodynamics

Most typical Phase II Study - ANSWER- Therapeutic Exploratory

Phase II - ANSWER- Determining dosages and regimens for Phase III trials

Phase II - ANSWER- Evaluation of potential study endpoints, therapeutic
regimens, and target populations for further study in Phase III

Most typical Phase III Study - ANSWER- Therapeutic Confirmatory

Phase III - ANSWER- Designed to confirm the preliminary evidence accumulated in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies are intended to provide an adequate basis for marketing approval, and complete the information needed to support adequate instructions for use of the drug.

Phase IV - ANSWER- Various post-approval studies for therapeutic use
Phase IV - ANSWER- Studies that were not considered necessary for approval but
are often important for optimizing the drug's use.

Phase IV - ANSWER- Commonly conducted studies include additional drug-drug
interaction, dose-response or safety studies and studies designed to support use
under the approved indication.

Phase IV - ANSWER- After initial approval, drug development may continue with
studies of new or modified indications, new dosage regimens, new routes of
administration, or additional patient populations.

Special Populations - ANSWER- Some groups in the general population may require special study because they have unique risk/benefit considerations, such as pregnant or nursing women, or children.

Selection of Subjects - ANSWER- The stage of development and the indication to be studied should be taken into account in selecting the subject population, as should prior non-clinical or clinical knowledge. The variability of groups of patients or healthy volunteers studied in early trials may be limited to a narrow range by strict selection criteria, but as drug development proceeds, the populations tested should be broadened to reflect the target population.

Selection of Subjects - ANSWER- Trial subjects should not participate
concurrently in more than one clinical trial.

Selection of Subjects - ANSWER- Women of childbearing potential should be using highly effective contraception. For male subjects, potential hazards of drug exposure in the trial to their sexual partners or resulting progeny should be considered.

Selection of Control Group - ANSWER- Trials should have an adequate control group. Comparisons may be made with placebo, no treatment, active controls, or of different doses of the drug under investigation. Historical controls can be justified in some cases.

Study Endpoint - ANSWER- Occurrence of a disease, symptom, or sign that constitutes one of the target outcomes of the trial, but may also refer to any such disease or sign that strongly motivates the withdrawal of that individual from the trial (humane endpoint).
Primary Endpoint - ANSWER- Endpoint for which subjects are randomized and
for which the trial is powered.

Secondary Endpoint - ANSWER- Endpoints that are analyzed post hoc, for which
the trial may not be powered or randomized.

Surrogate Endpoint - ANSWER- Endpoint that is intended to relate to a clinically
important outcome but does not in itself measure a clinical benefit.

Randomization - ANSWER- In conducting a controlled trial, randomized allocation is the preferred means of assuring comparability of test groups and minimizing the possibility of selection bias. Introduces a deliberate element of chance into the assignment of treatments. In multi-center trials, randomization should be organized centrally.