Socra CCRP (A+ Graded) Certified Clinical Research Professional (CCRP) Exam (with Complete Solutions) Certified Clinical Research Professional (CCRP) Exam (100% Correct) Certified Clinical Research Associate Exam Study Guide (100% Accurate) CCRP - Certified Clinical Research Associate Exam (A+ Guar...
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When isn't an IND application needed? correct answers IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) correct answers FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigat...
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Add to cartWhen isn't an IND application needed? correct answers IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) correct answers FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigat...
How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answers 5 working days How many members must sit on an IRB? correct answers 5 How long must an IRB retain records per 21 CFR 56? correct answers 3 years after completion of research What are the criter...
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Add to cartHow many days does a sponsor have to report an emergency use of an IP to the FDA? correct answers 5 working days How many members must sit on an IRB? correct answers 5 How long must an IRB retain records per 21 CFR 56? correct answers 3 years after completion of research What are the criter...
What resources do I need to develop a budget? correct answers 1. Schedule of Assessments 2. Institutional Fees 3. Evaluation and Procedure Charges 4. Staff Allocation with Hourly Rates Indirect Cost Rate (IDC) correct answers All procedural and non-procedural line items. Exemptions: subject st...
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Add to cartWhat resources do I need to develop a budget? correct answers 1. Schedule of Assessments 2. Institutional Fees 3. Evaluation and Procedure Charges 4. Staff Allocation with Hourly Rates Indirect Cost Rate (IDC) correct answers All procedural and non-procedural line items. Exemptions: subject st...
21 CFR 11 correct answers Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 correct answers Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Require...
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Add to cart21 CFR 11 correct answers Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 correct answers Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Require...
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: correct answers PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? correct answers The subject's legally acceptable repr...
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Add to cartPrior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: correct answers PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? correct answers The subject's legally acceptable repr...
Adverse Drug Experience (ADE) correct answers Any adverse event associated with the use of a drug in humans, whether or not considered drug related. ADME correct answers Absorption Distribution Metabolism Elimination Adverse Event, Adverse Experience (AE) correct answers An untoward change ...
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Add to cartAdverse Drug Experience (ADE) correct answers Any adverse event associated with the use of a drug in humans, whether or not considered drug related. ADME correct answers Absorption Distribution Metabolism Elimination Adverse Event, Adverse Experience (AE) correct answers An untoward change ...
Who was tried in the Nuremburg Military Tribunals and why? correct answers Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? correct answe...
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Add to cartWho was tried in the Nuremburg Military Tribunals and why? correct answers Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? correct answe...
Research correct answers The systematic study of materials and sources in order to establish facts and reach new conclusions. Ethical correct answers Conforming to an established set of principles or accepted professional standards of conduct. Budget development correct answers The process of ...
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Add to cartResearch correct answers The systematic study of materials and sources in order to establish facts and reach new conclusions. Ethical correct answers Conforming to an established set of principles or accepted professional standards of conduct. Budget development correct answers The process of ...
Contract Research Organization correct answers A 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 short form or ...
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Add to cartContract Research Organization correct answers A 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 short form or ...
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