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*Hemophilia Pedigree - Father has hemophilia, mother does not. What is the outcome for their kids? - Answer - His daughters would be carriers. This is x-link recessive. *Punnett Square Question - Answer - Co-dominance *What makes LDL? - Answer - High cholestrol Polymerase Chain Reaction (PCR) - Answer - -Produces DNA which can be used to determine if mutation is present. -Uses Template DNA, Nucleotides (dNTPS), DNA Polymerase, and DNA primers *3 Steps of PCR - Answer - 1. *Denaturat...

Males and Females are equally affected - Answer - Autosomal The process of copying DNA in the lab. - Answer - Polymerase Chain Reaction (PCR) Template DNA, Nucleotides (dNTPS), DNA Polymerase, and DNA Primers. - Answer - What is needed for Polymerase Chain Reaction? Denaturing, Annealing, Elongating - Answer - *What are the three steps of a Polymerase Chain Reaction (PCR)? Denaturing (DNA is heated up to separate it) - Answer - *What is the first step of a Polymerase Chain Reaction? ...

Match the situation with the appropriate and effective telecommunication strategy. Answers options may be used more than once or not at all. 1 -An elderly homebound patient is concerned about the palpitations she is feeling. 2 -A nurse is struggling to work full-time in a hospital setting time while completing her Masters. 3 -A cardiologist with a rural office practice has no one to cover his patients when he is away. 4 -A family member is unsure what to do for a home hospice pat...

Informatics - Answer - The science and art of turning data into information. Nursing Informatics * - Answer - -The use of information and technology to support all aspects of nursing practice -Including direct delivery of care, administration, education, and research. Information Literacy - Answer - -The ability to recognize when info is needed as well as the skills to find, evaluate and use effectively. Information - Answer - -Data that has been interpreted Information Science - An...

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Laws - Answer - passed by national legislative bodies; establish authority of national regulatory body Regulations - Answer - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - Answer - "current thinking" of regulatory bodies; non-binding ICH - Answer - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOP...

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? - Answer - 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? - Answer - 1996 What is the National Research Act? - Answer - A set of regulations for the ...

Nuremberg Code (1947) - A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

Nuremberg Military Tribunals: The Doctor's Trial - Answer - War crimes and crimes against humanity: to perform medical experiments upon concentration camp prisoners and other living human subjects, without their consent, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts Nuremberg Military Tribunals: The Doctor's Trial - Answer - The American judges pronounced their verdict on August 20, 1947. Sixteen of ...

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 summary? - Answer - False-they must sign both What is FDA form 3454 - Answer - Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical p...

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 records ? - Answer - Yes Open system (FDA term) - Answer - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data i...

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 form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will con...

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 countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - Answer - Declaration of Helsinki What is the ...

How many days does a sponsor have to report an emergency use of an IP to the FDA? - Answer - 5 working days How many members must sit on an IRB? - Answer - 5 How long must an IRB retain records per 21 CFR 56? - Answer - 3 years after completion of research What are the criteria for IRB approval of research? (7) - Answer - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sou...

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 -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and a...

21 CFR 11 - Answer - Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - Answer - Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - Answer - 50.25 Elements of Inform...

Which of the following is a disclosure of financial interests form? - Answer - FDA Form 3455 Which of the following is a certification of financial interest form? - Answer - FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - Answer - FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Answer - Investigational New Drug Application (1571) In the top right corner, ...

Biometrics - Answer - 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 CFR, Sec. 11.3) Closed System - Answer - An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - Answer - An electronic si...

Cardiac monitoring of a patient in cardiac arrest reveals ventricular fibrillation. In addition to high-quality CPR, what intervention should be a priority for the team? - Answer - Defibrillation. A 28-year-old pregnant patient who resides in transitional housing presents to the emergency department with complaints of feeling feverish and very faint. The patient tells the emergency nurse that she does not know when she became pregnant. Upon palpation, the fundus is not at or above the umbilic...