CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024
285 keer bekeken 4 keer verkocht
Vak
CCRP SOCRA
Instelling
CCRP SOCRA
CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024
The responsibility for ensuring that the investigator understands a
clinical trial lies with which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator ️ C) Sponsor
What is the minimum number of IRB...
CCRP SOCRA Exam - Practice Exam with 100% Correct Answers. The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator ✔️ C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 ✔️ B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject B) Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject C) For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. D) All the above ✔️ D ) All of the above With respect to IRB/IEC membership, both the FDA and the ICH require that: A) A majority of the members' primary area of interest is in a scientific area B) At least one member holds a Ph.D. degree or equivalent C) At least one mem ber's primary area of interest is in a nonscientific area D) A majority of the members are from or have ties to the institution of record ✔️ C) At least one member's primary area of interest is in a nonscientific area In a non -emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval? A) The investigator provides his/her written approval B) The study drug has an FDA approved marketing application C) The FDA provides written app roval of the IND D) Subjects cannot be enrolled until IRB/IEC approval has been obtained ✔️ D) Subjects cannot be enrolled until IRB/IEC approval has been obtained A subject has been enrolled on a study and was randomized to the non -
treatment arm. The p rotocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? A) This subject does not need to undergo any of the study procedures since the subject is enrol led on the non -treatment arm B) This subject should undergo all study procedures as outlined in the protocol C) This subject only needs to undergo the study procedures that pertain specifically to the subject D) This subject can undergo the study procedures whenever it is convenient ✔️ B) This subject should undergo all study procedures as outlined in the protocol A purpose of monitoring clinical trials is to verify that: A) The rights, safety, and well -being of human subjects are protected
Voordelen van het kopen van samenvattingen bij Stuvia op een rij:
√ Verzekerd van kwaliteit door reviews
Stuvia-klanten hebben meer dan 700.000 samenvattingen beoordeeld. Zo weet je zeker dat je de beste documenten koopt!
Snel en makkelijk kopen
Je betaalt supersnel en eenmalig met iDeal, Bancontact of creditcard voor de samenvatting. Zonder lidmaatschap.
Focus op de essentie
Samenvattingen worden geschreven voor en door anderen. Daarom zijn de samenvattingen altijd betrouwbaar en actueel. Zo kom je snel tot de kern!
Veelgestelde vragen
Wat krijg ik als ik dit document koop?
Je krijgt een PDF, die direct beschikbaar is na je aankoop. Het gekochte document is altijd, overal en oneindig toegankelijk via je profiel.
Tevredenheidsgarantie: hoe werkt dat?
Onze tevredenheidsgarantie zorgt ervoor dat je altijd een studiedocument vindt dat goed bij je past. Je vult een formulier in en onze klantenservice regelt de rest.
Van wie koop ik deze samenvatting?
Stuvia is een marktplaats, je koop dit document dus niet van ons, maar van verkoper AcademiaExpert. Stuvia faciliteert de betaling aan de verkoper.
Zit ik meteen vast aan een abonnement?
Nee, je koopt alleen deze samenvatting voor €10,78. Je zit daarna nergens aan vast.
