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Exam (elaborations)

CCRP Exam Practice Questions with Answers(2025/2026)

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How many days does a sponsor have to report an emergency use of an IP to the FDA?5 working days How many members must sit on an IRB?5 How long must an IRB retain records per 21 CFR 56?3 years after completion of research What are the criteria for IRB approval of research? (7)1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects How many days does an IRB have to report a change in registration information due to a change in chairperson or contact?90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products?30 days How often must an IRB renew it's registration?3 years What are the 8 basic elements of informed consent per FDA guidelines?1. Statement that the study involves research, purpose and expected duration, description of experimental procedures 2. Description of reasonably foreseeable risks 3. Benefits 4. Disclosure of alternative procedures or courses of treatment 5. Confidentiality measures 6. Compensation and treatments available if injury occurs 7. contact information 8. Participation is voluntary and subject may discontinue at any time What are the criteria for involving children in minimal risk research? (2)1. No greater than minimal risk 2. Assent from kid + consent from parent obtained What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3)1. Risks are justified by benefits 2. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches 3. Assent + consent

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Institution
CCRP Clinical Research Professionals
Course
CCRP Clinical Research Professionals










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Institution
CCRP Clinical Research Professionals
Course
CCRP Clinical Research Professionals

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Uploaded on
March 21, 2025
Number of pages
17
Written in
2024/2025
Type
Exam (elaborations)
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Questions & answers

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CCRP Exam
1. Recent changes in EKG <Ans> Absolute

2. Unstable angina <Ans> Absolute

3. Uncontrolled cardiac arrhythmias <Ans> Absolute
4. Symptomatic severe aortic stenosis or other valvular disease <Ans> Absolute

5. decompensated symptomatic heart failure <Ans> Absolute
6. acute PE or pulmonary infarction <Ans> Absolute

7. acute non cardiac disorder that may affect exercise performance or maybe

aggravated by exercise (infection, thyrotoxisosis) <Ans> absolute
8. acute myocarditis, pericarditis <Ans> absolute

9. Acute Thrombophlebitis <Ans> absolute

10. physical disability <Ans> absolute

11. electrolyte abnormalities <Ans> relative

12. tachyarrhythmias or bradyarrhythmias <Ans> relative

13. high degree AV block <Ans> relative

14. a-fib with uncontrolled rate <Ans> relative

15. hypertrophic obstructive cardiomypathy with peak resting left ventricular out

flow gradient of more than 25mmhg <Ans> relative

16. known aortic dissection <Ans> relative

17. severe resting arterial HTN SBP >200 DBP > 100 <Ans> relative

18. mental impairments leading tounabilityto cooperate <Ans> relative
1/
17

,19. mens waist circumference <Ans> less than 102cm or 40 in

20. womens waist circumference <Ans> less than 88cm or 35in

21. Mens HDL <Ans> >40

22. womens HDL <Ans> >50

23. Ideal LDL level <Ans> <100 mg/dL

24. ideal TG level <Ans> <150

25. ideal total cholesterol <Ans> <200 mg/dL

26. normal fasting blood glucose <Ans> <100 mg/dL

27. DASH Diet <Ans> Strongest evidence to support the Dietary Approach to Stop

Hyper- tension

28. Statin lowering LDL %, Low <Ans> <30%

29. Statin lowering LDL% Mod <Ans> 30-50%

30. Statin lowering LDL% High <Ans> >50%

31. Simvastatin 10mg <Ans> low intensity

32. Peavastatin 10-20mg <Ans> low intensity

33. lovastatin 20mg <Ans> low intensity

34. Fluvastatin 20-40mg <Ans> low intensity

35. pitavastatin 1mg <Ans> low intensity

36. Rosuvastatin 5- 10 mg <Ans> moderate intensity




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, 37. Atorvastatin 10-20mg <Ans> moderate intensity

38. Simvastatin 20-40mg <Ans> moderate intensity

39. Pravastatin 40-80mg <Ans> moderate intensity

40. lovastatin 40mg <Ans> moderate intensity

41. flurastatin XL 80mg <Ans> moderate intensity

42. Pitavastatin 2-4 mg <Ans> moderate intensity

43. rosuvastatin 20-40mg <Ans> high intensity

44. Atrovostatin 40-80mg <Ans> high intensity

45. When should you reassess statin meds <Ans> 4- 12 weeks after initiation and

3-12 months thereafter

46. Exercise DBP >110mmgh <Ans> adverse response to exercise

47. Decrease in SBO >10mmgh <Ans> adverse response to exercise

48. significant ventricular or atrial dysrhythmias <Ans> adverse response to exercis

49. 2nd or 3rd degree heart block <Ans> adverse response to exercise

50. S/Sx of exercise intolerance <Ans>

angina dyspnea

EKG changes suggestive of ischemia

51. when to terminate exercise <Ans> sustaine v tach, multifocal PVC's and

triplets, down slopping St segment >1mm

52. normal ejection fraction <Ans> 50-60%
53. Low ejection fraction <Ans> 35% and below

54. Contraindications for strength training <Ans> unstable angina, uncontrolled
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