SOCRA CCRP Exam Bundle Questions And Answers 100% Verified

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten record...

Electronic Records, Electronic Signatures - ANSWER-CFR Title 21: Part 11 Informed Consent - ANSWER-CFR Title 21: Part 50 Financial Disclosure - ANSWER-CFR Title 21: Part 54 Instiutional Review Board - ANSWER-CFR Title 21: Part 56 Investigational new Drug Application - ANSWER-CFR Title 21...

Contract Research Organization - ANSWER-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 the sum...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic fo...

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how...

The Purpose of the IRB is to: - ANSWER-Protect the rights and welfare of human subjects in research What is the minimum number of members required by an IRB - ANSWER-5 Which of the following are necessary to waive consent? A.Subject is unable to give consent B.No time or unable to contact ...

When isn't an IND application needed? - ANSWER-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) - ANSWER--FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -...

April 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER-IC...

Belmont Report was created as part of? - ANSWER-The national Research Act of 1974. Who was the Belmont Report formulated by? - ANSWER-The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? -...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? A. European Union, US and Canada B. Mexico, European Union and US C. US, Russia and European Union D. European Union, Japan and US - ANSWER-D. European Union, Ja...

1. Study invoves research (why and how) 2. Forseeable risks 3. Potential benefits 4. Alternatives 5. Confidentiality 6. Compensation 7. Contacts for answers 8. Voluntary nature - ANSWER-What are the 8 basic elements of an informed consent that are REQUIRED to be discussed and in the form? ...

CRO- transfer of responsibility - ANSWER-Sponsor may transfer responsibility for any or all obligations to a contract research organization. It just needs to be in writing. 21 CFR 312 1572 Form - ANSWER-Commitment of the investigator to sponsor to follow all regulations. Investigator Brochure ...

Timeline of Historical Events - ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - ANSWER-informed consent (autonomy, choose for themsel...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - ANSWER-European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - ANSWER-Australia, Canada, the Nordic countrie...