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ICH E6(R2) Good Clinical Practice Question and answers 2023/2024 verified to pass $12.99   Add to cart
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ICH E6(R2) Good Clinical Practice Question and answers 2023/2024 verified to pass
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ICH E6(R2) Good Clinical Practice Question and answers 2023/2024 verified to pass- At least 5 members - At least one member whose primary area of interest is in a nonscientific area -At least one member who is independent of the institution/trial site - correct answer What are the minimum require...

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  • December 28, 2023
  • 4
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers

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  • ich e6r2 good clinical practice
  • ich e6r2 good clinical practice question and ans

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  • GOOD CLINICAL PRACTICE
  • GOOD CLINICAL PRACTICE

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ICH E6(R2) Good Clinical Practice

- At least 5 members

- At least one member whose primary area of interest is in a nonscientific area

-At least one member who is independent of the institution/trial site - correct answer What are the
minimum requirements for IRB?



3 years - correct answer The IRB/IEC should retain all relevant records (e.g. written procedures,
membership lists, lists of occupations/affiliations of members, submitted documents, minutes of
meetings, and correspondence) for a period of at least ___ _________ after completion of the trial and
make them available upon request from the regulatory authority(ies).



Protocol and amendments

ICF

Advertisements for subjects recruitment

Investigator's brochure

Evidence of investigator's qualifications. - correct answer Name all five required documents for IRB
review.



D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs - correct answer In which of the
following instances is it necessary to contact the IRB/IEC?



A. Each time a new subject is enrolled

B. If the investigator does not complete enrollment

C. When a subject is found to be noncompliant with the trial medication

D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs



Impartial Witness - correct answer If the subject is unable to read or if a legally acceptable
representative is unable to read, an _______________ should be present during the entire informed
consent decision.

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