SOCRA certification exams bundle, VERIFIED|

SoCRA Certification Exam Questions and answers, rated A+ Biometrics - -A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 C...

SOCRA Practice Test Questions and answers, rated A+ Which of the following is a disclosure of financial interests form? - -FDA Form 3455 Which of the following is a certification of financial interest form? - -FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he...

SOCRA Exam Questions & Answers, rated A+. Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - -False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retr...

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

SOCRA Exam Review Questions and answers, rated A+ When isn't an IND application needed? - -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) - --FDA Form 1571 -FDA Form 1571 cover sheet -...

Socra CCRP, Questions and answers, Verified/ Contract Research Organization - -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 w...

SoCRA Study Guide: Review Questions and answers. VERIFIED/ IRB approval - -the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contr...

SoCRA Exam Review Questions and answers, VERIFIED/ What is an orphan drug program? - -FDA program that provides development of drugs for rare diseases Nuremburg Code - -set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - -Amendment to Food Drug ...

SOCRA CCRP Exam Review Questions and answers, VERIFIED/ Timeline of Historical Events - -Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - -respect for persons, beneficence, justice Application of Respect for Persons - -informe...

SOCRA CCRP Exam Practice Questions and answers, VERIFIED/ 21 CFR part 11 regulates? - -Electronic Signatures What is the name of FDA Form 483? - -Inspectional Observation What does 21CFR56 regulate? - -Institutional Review Boards An application for Investigational Device Exemption is part of 2...

SOCRA CCRP Exam Review questions and answers, VERIFIED/ April 30 1996 - -ICH GCP Development Date Quality - -ICH Q Efficacy - -ICH E Safety - -ICH S Multidisciplinary - -ICH M guidance for industry, consolidated guideance - -ICH E 6 Clinical Safety Data Management Definitions and Standards ...

SOCRA CCRP, Exam Review Questions and answers, rated A+ Phase 0 clinical trial (PK) Pharmokinetics and (PD) Pharmodynamics. Very small in #'s 1st in Humans -is it consumable for humans? - -Phase 0 clinical trial True or false: the federal food, drug, and cosmetic act is United States, fede...

SOCRA CCRP Exam Review Questions and answers, rated A+ FDA Part 11 - -electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - -Food and Drugs, and ICF FDA Part 56 - -IRBs FDA Part 312 - -investigat...

SOCRA EXAM Review Questions and answers, rated A+ EIR - -Establishment Inspection Report 21 CFR Part 11 - -Electronic records & electronic signatures 21 CFR Part 50 - -Protection of human subjects; general requirements of ICF; ICF if patient is in coma, life threatening conditions 21 CFR Par...

CCRP SOCRA Exam - Practice Exam #1: Exam Review Questions and answers, VERIFIED/ The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number o...

SOCRA Exam Review Questions and answers, rated A+ What is the minimum number of Institutional Review board (IRB) members? - -5 The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be? - -77 The responsibility for ensuring that the inv...

SoCRA Exam Review Questions and answers, rated A+ 45 CFR 46 Subpart A - -"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Revi...

SOCRA CCRP Certification Exam Review Questions and answers/ verified. Nuremburg Code - -The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - -1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work...

SOCRA (CCRP) Exam Practice Questions & Answers, rated A+ 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: - -Persons with diminished autonomy are entitled to ...

MEGA SOCRA CCRP EXAM CONTENT. Questions and answers, VERIFIED/ 5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior t...

SOCRA Exam Review Questions and answers, VERIFIED/ Electronic Records - -Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine ...

SOCRA FDA Exam review Questions and answers, Verified/ If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article - -5 days If an article is used in...

SOCRA Practice 1 Exam Review Questions and answers, rated A+ True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored b...

SOCRA certification: Class Questions and answers, Week 1-5. VERIFIED/ The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - -European Union, Japan and United States What organizations are represented in the ICH ...