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what brings you in today Ans- reports needing an annual physical what medical conditions do you have Ans- denies medical conditions what meds do you take Ans- reports taking occasional ibuprofen do you take any prescription meds Ans- denies taking prescription medication do you take any OTC meds Ans- only OTC medication is ibuprofen why do you take advil Ans- takes ibuprofen to relieve menstrual cramps how often do you take advil Ans- takes ibuprofen monthly how many advil do you take at ...

chief complaint Ans- -reports low back pain -describes injury as a "tweak to back" onset of pain Ans- -original injury occurred 3 days ago -sudden onset -happed when lifting heavy box location of pain Ans- -located in low back and butt -does not radiate or migrate -denies neck pain -denies pain between shoulder blades -reports pain is same on both sides of back frequency and duration of pain Ans- -pain lasted 3 days -constant pain severity of pain Ans- -current pain "pretty bad" ...

chief complaint Ans- -reports abdominal pain -reports difficulty with bowel movement asked about orientation Ans- -oriented to own person -oriented to place -oriented to situation -oriented to time asked about onset, frequency, and duration of pain Ans- -reports discomfort for the past 5 days -reports pain with gradual onset that worsened 2-3 days ago asked about location of pain Ans- -reports pain in lower abdomen -reports pain is not localized asked about pain rating on scale Ans- -r...

Established chief complaint Ans- Reports chest pain Asked about onset and duration of chest pain Ans- Reports chest pain started about five minutes ago Reports chest pain has been constant since it began Reports sitting in bed when pain began Asked to rate chest pain on a scale Ans- Reports current pain is 6/10 Asked about on characteristics of the pain Ans- Describes pain as tight and uncomfortable Denies crushing pain Denies gnawing or tearing pain Denies burning pain Asked about loca...

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

45 CFR 46 Subpart A - Correct Answer-"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 Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...

What is an orphan drug program? - Correct Answer-FDA program that provides development of drugs for rare diseases Nuremburg Code - Correct Answer-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - Correct Answer-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - Correct Answer-any unfavorable or unintended event associated with a research study Assent - Correct Answer-a child's af...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Correct 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 ...

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

Biometrics - Correct 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 - Correct 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 - Correct Answ...

Contract Research Organization - Correct 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? - Correct Answer-False-they must sign both What is FDA form 3454 - Correct Answer-Certification Financial Interests and Arrangements of Clinical Investigators What are the three main ...

Nuremburg Code - Correct Answer-The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - Correct Answer-1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjec...

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...

April 30 1996 - Correct Answer-ICH GCP Development Date Quality - Correct Answer-ICH Q Efficacy - Correct Answer-ICH E Safety - Correct Answer-ICH S Multidisciplinary - Correct Answer-ICH M guidance for industry, consolidated guideance - Correct Answer-ICH E 6 Clinical Safety Data Management Definitions and Standards - Correct Answer-ICH E2A Safety pharmacology studies for human pharmaceuticals - Correct Answer-ICH S7A Electronic records, electronic signatures - Correct Answer-21 CFR Par...

Nuremberg Code (1947) - Correct Answer-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 - Correct Answer-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. r...

Which of the following cell structures is the source of energy for a cell? Mitochondria A medical assistant is testing a patients visual acuity using a snellen chart. Which of the following actions should the assistant take? Make sure the patient does not lean forward during the test. During a routine venipuncture, the patient becomes pale and diaphoretic. What condition is most likely to occur in this patient? Syncope A patient calls the clinic to cancel a postoperative appointment and st...

When measuring a infant from head to heel. What exam position should you place the infant in? Supine position What type of patient would you report to the provider if they had a low apical pulse? Infants 6 weeks who has a heart of 80/min What statement do you provide to patients to be in compliance HIPPA? Confidentiality statement 4. What information do you need to provide to the patient when wearing a Holter monitor about marker? When you have symptoms What information is acceptable to ...

a medical assistant is administering heparin subcutaneously to a patient. which of the following actions should the assistant take? inject the medication slowly a medical assistant is contacting a patient to schedule a repeat papanicolaou test due to abnormal assistant should identify that which of the following factors can interfere with test results? using an over the counter vaginal cream prior to the test which of the following dressings should a medical assistant use on a partial thic...

Primary code in CPT consists of how many digits? 5 Correct order of draw Green, Lavender, Gray CBC additive EDTA Patients arrive at their convenience, first come, first served Open Hours Scheduling If the test result shows hemoglobin at 7g/dL, what is the first thing you should do? Notify the provider When performing the palpatory method for measuring blood pressure, how should the CMA inflate the cuff 30 mm above radial pulse cessation How many pounds is 40kg 88 (40x2.2=88)When a patien...

CC Chief Complaint Segment Line between two wave forms P-wave Atrial Depolarization How many 1mm boxes are in a 6 second Rythm strip? 30 one millimeter boxes The SA node represents which waveform on the ekg? Only the P-wave What is the reading you can get from the RR interval? Ventricular Pulse What is the primary stage of Hemolisis? Vascular phase and platelet phase togetherWhat is Electophoresis? Analyzation of the chemical components of blood e.g. hemoglobin, serum, urinem cerebrospina...