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CCRP Exam 2024 Questions & Answers Solved 100% Correct!!
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CCRP Exam 2024 Questions & Answers Solved 100% Correct!!
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Name: Score:273 Multiple choice questions
Definition 1 of 273
Select them as qualified by training and experience as appropriate experts to investigate a drug
How should sponsors choose qualified investigators, per 21 CFR 312.53(a)?
When must a sponsor submit a brief report of investigation progress to FDA for drug trials?
How long should sponsors keep study records for drug trials?
What 5 types of reports must be made from an investigator to a sponsor?
Term 2 of 273
What do FDA regulations state about monitors?
Pre-clinical testing about the solubility, stability and formulation of a new drug in different
forms (capsules, tablets, aerosol, injectable and iv)
Sponsors shall select monitors qualified by training and experience to monitor the progress
of the investigation (21 CFR 312.53(d))
Notice of initiation of disqualification proceedings and opportunity to explain (nidpoe)
Individual who both initiates and conducts an investigation, and under whose immediate
direction the investigational drug is administered or dispensed.
Term 3 of 273
How often must an IRB renew it's registration?
6 months
90 days
30 days
3 years
,Term 4 of 273
What are the phases of device trials?
1) Investigator's name/address
2) Protocol name/code
3) Name of facilities
4) Name/address of lab
5) Name/address of IRB
6) Names of sub-Is
7) Commitment to regulations
Compare new dug against SOC or placebo; first introduce drug to disease population
1) Pilot
2) Pivotal
21 CFR 312.53(c)(3)
Term 5 of 273
What is an IND?
Application to FDA to seek permission to test a new drug or biologic in clinical trial
involving people
Disclosure statement for financial disclosure of clinical investigators who have disclosable
interests
A petition to the fda to change the labeling of an approved drug
A request to a regulatory agency for post-market surveillance of a drug
Term 6 of 273
What is a FDA Form 1571?
Patient consent form for clinical trials
Record of adverse events during a clinical trial
Cover page for IND application; lists information provided in submission
Form for tracking drug manufacturing processes
,Term 7 of 273
What are 5 common issues the FDA finds during site inspection?
1) Failure to follow investigational plan and signed investigator agreement
2) Protocol deviations
3) Inadequate recordkeeping
4) Inadequate accountability for IP
5) Inadequate subject protection, including informed consent issues
1) Short form consent document stating all elements of ICF have been presented orally to
pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) Witness present during presentation
1) Perform/oversee trial-related procedures
2) Provide medical decisions or ensure a qualified investigator does
3) Assess subject compliance
4) Evaluate subjects' response to treatment
5) Assess AEs and provide medical care
1) Rationale for study
2) Indications
3) General approach
4) Clinical trials to be conducted in 1st yr following submission
5) Estimated # of pts in trials
6) Risks anticipated on basis of animal data or previous studies
, Term 8 of 273
What 5 items should be present in an IB?
1) Triple blind: sponsor/investigator/subjects are blinded
2) Double blind: investigator/subjects blinded
3) Single blind: subjects blinded
4) Open label: no blinding
1) Description of drug and formulation, including structural formula
2) Pharmacological and toxicological effects of the drug
3) PK and biological disposition of drug
4) Safety and effectiveness in humans
5) Possible risks and side effects
Dates, quantities, batch/serial numbers, expiration dates and code #s of:
1) Product delivery to site
2) Inventory at site
3) Dispensed IP
4) Usage by subject
5) Returned product
6) Disposed product
1) Outline of study protocol
2) Approximation of subject # treated vs controls
3) Clinical uses of treatment to be investigated
4) Characteristics of subjects by age, sex, condition
5) Clinical observations and lab tests to be conducted
6) Duration of study
7) Copies or description of CRFs to be used
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