CCRP SOCRA | CCRP EXAM PACK GRADED A+

CCRP Exam Graded A+ 21 CFR 11 - ANSElectronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - ANSProtection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements f...

CCRP EXAM WITH VERIFIED QUESTIONS AND ANSWERS How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANS5 working days How many members must sit on an IRB? - ANS5 How long must an IRB retain records per 21 CFR 56? - ANS3 years after completion of research What are...

CCRP SOCRA Exam Graded A+ FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - ANSFood and Drugs, and ICF FDA Part 56 - ANSIRBs FDA Part 312 - ANSinvestigational new drug applicati...

CCRP SOCRA Exam Graded A+ Contract Research Organization - ANSA person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the...

CCRP SOCRA Exam Graded A+ April 30 1996 - ANSICH GCP Development Date Quality - ANSICH Q Efficacy - ANSICH E Safety - ANSICH S Multidisciplinary - ANSICH M guidance for industry, consolidated guideance - ANSICH E 6 Clinical Safety Data Management Definitions and Standards - ANSICH E2A Safety...

CCRP SOCRA Exam Graded A+ When was the Nuremberg Code created? - ANS1947 What did the Nuremberg Code establish? - ANSWorldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? - ANS1979 What do...