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SOCRA CCRP EXAM ACTUAL EXAM 200 YEAR 2024/2025 / ACCURATE CURRENTLY TESTING EXAM VERSIONS WITH ACTUAL QUESTIONS AND DETAILED ANSWERS WITH A STUDY GUIDE / EXPORT VERIFIED FOR GURANTEED PASS / LATEST UPDATE€17,17
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SOCRA CCRP EXAM ACTUAL EXAM 200 YEAR 2024/2025 / ACCURATE CURRENTLY TESTING EXAM VERSIONS WITH ACTUAL QUESTIONS AND DETAILED ANSWERS WITH A STUDY GUIDE / EXPORT VERIFIED FOR GURANTEED PASS / LATEST UPDATE
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SOCRA CCRP
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SOCRA CCRP
SOCRA CCRP EXAM ACTUAL EXAM 200 YEAR
2024/2025 / ACCURATE CURRENTLY TESTING
EXAM VERSIONS WITH ACTUAL QUESTIONS
AND DETAILED ANSWERS WITH A STUDY
GUIDE / EXPORT VERIFIED FOR GURANTEED
PASS / LATEST UPDATE
SOCRA CCRP EXAM ACTUAL EXAM 200 YEAR
2024/2025 / ACCURATE CURRENTLY TESTING
EXAM VERSIONS WITH ACTUAL QUESTIONS
AND DETAILED ANSWERS WITH A STUDY
GUIDE / EXPORT VERIFIED FOR GURANTEED
PASS / LATEST UPDATE
Study that investigates the mode of action and/or effects of a drug substance in relation
to its desired therapeutic target - ✔✔ANSW✔✔..Primary Pharmacodynamic Studies
Studies that investigate the mode of action and/or effects of a drug substance not
related to its desire therapeutic target - ✔✔ANSW✔✔..Secondary Pharmacodynamic
Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - ✔✔ANSW✔✔..Core Battery for
Cardiovascular System
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - ✔✔ANSW✔✔..Core
Battery for Respiratory System
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - ✔✔ANSW✔✔..Core Battery for Central Nervous System
Investigational New Drug Application
,FDA - ✔✔ANSW✔✔..Before clinical trials can be initiated, an application containing the
appropriate information must be submitted to regulatory authorities, in the USA this is
called XXXX and submitted to the XXX (21 CFR Part 312)
Unapproved drug to be shipped lawfully for the purpose of conducting investigations of
the drug - ✔✔ANSW✔✔..An IND permits what? (21 CFR Part 312)
Assuring the safety and rights of subjects - ✔✔ANSW✔✔..FDA's primary objective in all
phases of development is...
Phase II and III - ✔✔ANSW✔✔..These phase of trials, the FDA helps assure the quality
of the scientific evaluation is adequate to permit evaluation of the drugs safety and
efficacy (21 CFR Part 312)
The FDA - ✔✔ANSW✔✔..Who determines if Phase II/III studies are likely to yield data
capable of meeting regulatory standards for marketing approval?
1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
4) Phase of development - ✔✔ANSW✔✔..IND information depends on the amount of
information available, these 4 things are: (21 CFR Part 312)
General Investigational Plan
Protocols for specific human studies - ✔✔ANSW✔✔..Initial IND should focus on (21
CFR Part 312)
Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies
- ✔✔ANSW✔✔..Amendments to IND with new or revised protocols (21 CFR Part 312)
Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
protocol (s)
Chemistry and manufacturing information
pharm and tox information
previous human experience with investigational drug - ✔✔ANSW✔✔..A Sponsor
Initiated IND must contain (21 CFR Part 312)
30 Days, unless FDA notifies sponsor of clinical hold
Upon earlier notification, investigations may begin - ✔✔ANSW✔✔..How long does it
take for an IND to go into effect? (21 CFR Part 312)
, 1) To facilitate the availability of promising new drugs available to desperately ill patients
as early in the drug development process as possible, before general marketing begins
2)To obtain additional data on the drug's safety and effectiveness - ✔✔ANSW✔✔..The
purpose of Treatment Use of Investigational Drug (21 CFR Part 312)
1) The drug is intended to treat a serious or immediately life threatening disease
2) No comparable or satisfactory alternative drug/therapy is available to treat the stage
of disease in the intended patient population - ✔✔ANSW✔✔..A treatment protocol or
IND may be filed if: ((21 CFR Part 312)
Phase II/ III trials or
After all the clinical trials have been completed and the sponsor of the controlled clinical
trial is actively pursuing marketing approval of the drug with due dilligence -
✔✔ANSW✔✔..A treatment protocol or IND are usually found in what phase of trials?
30-Day Waiting Period - ✔✔ANSW✔✔..How long is the waiting period before the study
can initiate after the treatment IND is submitted?
Need for investigational drug arises in an emergency situation
Insufficient time to allow for submission of an IND or a treatment IND
Request for specified use by telephone or other rapid means of communication -
✔✔ANSW✔✔..Emergency use of an investigational product (21 CFR Part 312)
5 Working Days - ✔✔ANSW✔✔..How quickly must a site notify the IRB of an
emergency use of investigational drug? (21 CFR Part 312)
1) Notifying the FDA
2) Stopping all studies and notifying the investigators
3)All drug returned to the sponsor or destroyed as directed by sponsor
4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the
IRBs of those reasons - ✔✔ANSW✔✔..Sponsors have the right with withdraw an IND at
anytime, without prejudice by completing the following: (21 CFR Part 312)
April 30 1996 - ✔✔ANSW✔✔..ICH GCP Development Date
Quality - ✔✔ANSW✔✔..ICH Q
Efficacy - ✔✔ANSW✔✔..ICH E
Safety - ✔✔ANSW✔✔..ICH S
Multidisciplinary - ✔✔ANSW✔✔..ICH M
guidance for industry, consolidated guideance - ✔✔ANSW✔✔..ICH E 6
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