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How often shall the stem of an OS&Y Valve be lubricated - Annually The 3 year dry pipe trip test is to be performed by whom? - MP & MFSPC Fire department connections are to be inspected how often? - Quarterly Water motor gongs are to be tested how often? - Quarterly In a water spray fixed system inspection if the strainer is found corroded what color tag is required? - Yellow A sprinkler head with a red frame has a temperature classification of? - Extra High (325 - 375°F) The Hydraulic n...

La ambulancia ambulance La cita appointment, date el hueso roto broken bone la clínica clinic, hospital la tos cough el doctor/la doctora doctor (male/female)

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. Contract Research Organization (CRO) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemptio...

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/she would submit the following form: - FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand f...

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 an exempt way, this should be reported to the IRB in X after the use of the article - 5 days Emergency use of a test article must be reported to the IRB in X time. Any subsequent use is subject to IRB review - 5 days If the IRB contact or chair person info...

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 -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How man...

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 Electronic Records - Audit Trail - Electronic records must use secure, computer generated, timestamped audit trails to independently record the date and time of entries and actions that create, modify or delete records. Electronic Records - Changes - Rec...

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, 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 consider the elect...

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 CFR, Sec. 11.3) Closed System - 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 - An electronic signature based upon cryptogra...

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 - informed consent (autonomy, choose for themselves) Application of Beneficence - risk/benefit analysis Application of Justice - appropriate selection of patients (equality) Language Level ICF - 6th-8th grade 8 basic elements of ICF - 1. purpose, duration, and procedu...