SOCRA CCRP Exam 62 Questions with

SOCRA CCRP Exam 62 Questions with Correct Answers Timeline of Historical Events - Correct Answer Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - Correct Answer respect for persons, beneficence, justice Application of Respect for Persons - Correct Answer informed consent (autonomy, choose for themselves) Application of Beneficence - Correct Answer risk/benefit analysis Application of Justice - Correct Answer appropriate selection of patients (equality) Language Level ICF - Correct Answer 6th-8th grade

• basic elements of ICF - Correct Answer 1. purpose, duration, and procedures
• risks/discomforts
• benefits
• alternatives
• confidentiality
• compensation/medical treatments injury
• contact information
• voluntary participation and discontinuation at any time

Long ICF - Correct Answer standard consent form Short ICF - Correct Answer a document that elements of ICF, orally stated, understood by participant

• components of consent process for short form - Correct Answer 1. short form

document

• oral presentation of ICF elements
• IRB approved summary
• a witness

When can you use short form? - Correct Answer language, short window ICF monitoring - Correct Answer 1. most recent IRB approved version

• signature present
• subject dated/correct date
• errors corrected by a single line
• all pages present 1 / 2

SAE Reporting Requirement - Correct Answer immediately investigator, 15 days for sponsor UADE Reporting Requirement - Correct Answer 10 days investigator, 10 days for sponsor Consent and Assent for children - Correct Answer Parental consent from 1 or both parents or LAR required, and child assent may be required as determined by IRB Time period where financial disclosure is needed - Correct Answer during the study and one year after completion The primary goal of the IRB - Correct Answer to protect the right and safety of human subjects Composition of IRB - Correct Answer 5 or more members with different backgrounds including 1 scientific, 1 nonscientific, and 1 not affiliated Definition of minimal risk and its expedited review process - Correct Answer no more harm than routine exam; individual reviewer Definition of significant risk and non-significant risk device - Correct Answer SR: the potential for serious risk, support human life, substantial importance NSR: does not meet SR requirement Difference between SR and NSR device studies - Correct Answer SR: Follows all IDE reg., IDE app approved NSR: abbreviated requirements, no IDE app, and sponsor/IRB no report to FDA prior Time required for IRB record retension - Correct Answer 3 years after study completion Two common tools used for reducing bias - Correct Answer Blinding and Randomization Data Safety Monitoring Plan (DSMP) - Correct Answer is used to ensure safety of subjects and validity of data Data Safety Monitoring Board (DSMB) - Correct Answer a group of experts that reviews research data

• primary investigator responsibilties - Correct Answer 1. oversee the conduct of the

trial

• protect the rights, safety, and welfare of subjects
• control the use of the investigational product
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