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30-day hold - ACCURATE ANSWERS (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 120-day Safety Report - ACCURATE ANSWERS Amendment to an NDA containing a safety update due 120 days after the NDA is filed. 180-da...

Similar but more detailed than the Essential Requirements - ACCURATE ANSWERS General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ACCURATE ANSWERS 13485:2016 Which entity affixes it's identification number near the CE Mark? - ACCURATE ANSWERS Notified Body, if involved in the conformity assessment Un-classified devices not requiring CE mark - ACCURATE ANSWERS Custom-made, Invest...

What did the safe medical device act do? - ACCURATE ANSWERS Extended AE reporting to user facilities, required 510ks with SE, recall authority General controls - ACCURATE ANSWERS Establishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? - ACCURATE ANSWERS Class 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA What a...

What type of herbicide can pass into the vapor phase? - ACCURATE ANSWERS Highly volatile herbicide What are herbicide kills only part of the plant that it - ACCURATE ANSWERS Contact herbicide Weeds are plants that grow 3 or more years - ACCURATE ANSWERS Perennial Which of the following factors would have the least effect on the movement of herbicide from the application site? - ACCURATE ANSWERS Type of soil it is applied to and the type of equipment that is used What is the time inte...

According to the FBI Uniform Crime Report, a burglary occurs every: - ACCURATE ANSWERS 14.4 Seconds Most residential burglaries occur... - ACCURATE ANSWERS In broad daylight The common goal of the Electronic Security and Life Safety industry is to: - ACCURATE ANSWERS Improve the safety, peace of mind, and quality of life of the customer CSAA is the acronym for: - ACCURATE ANSWERS Central Station Alarm Association An alarm company yard sign is: - ACCURATE ANSWERS A good burglar deterr...

When programming a DW21, which loop number is used - ACCURATE ANSWERS 1 When educating the customer on custom rules, which of the following rules can work for any system - ACCURATE ANSWERS Arm or disarm the system everyday at a certain time True or False: You are permitted to program the garage door controller tilt sensor as a wireless zone for security monitoring - ACCURATE ANSWERS True What is the first step of optimizing network reliability on a new install? - ACCURATE ANSWERS Identi...

CPT Jones lacks humility and has a reputation of refusing to seek others input and feedback. He demonstrates a tendency to curb organizational buy in and places himself in a position to receive credit from superiors even at the cost of the organizations best interest. Which segment of the Army Leadership Requirements Model is CPT Jones displaying a flaw in? - ACCURATE ANSWERS Character Reference: ADP 6-22, Para 2-31 An Army Professional who applies military-technical and moral-ethical knowle...

What are the first 2 steps to community mobilization? - ACCURATE ANSWERS 1st - identify problems 2nd - set goals and objectives A teacher is making a child stand in the corner with a heavy book on his head. What do you do? - ACCURATE ANSWERS Call CPS. This is abuse. Client privilege - ACCURATE ANSWERS Subpoena from lawyer You don't need to claim privilege if request is coming from family/individual. What are the first two steps of program evaluation? - ACCURATE ANSWERS 1st- Identi...

Ch.1 - What is the primary legislation governing Ontario's retail automotive sector? - ACCURATE ANSWERS The Motor Vehicle Dealers Act, 2002 Check 1.04 Ch.1 - Which body or agency enforces the MVDA? a. Ministry of Government and Consumer Services b. TADA c. OMVIC d. Automotive Business School of Canada - ACCURATE ANSWERS c. OMVIC Check 1.04 Ch.1 - List three functions carried out by OMVIC. - ACCURATE ANSWERS Any three of the following: - Administers and enforces the MVDA - ...

In respiratory alkalosis - ACCURATE ANSWERS - pH is high and PaCO2 is low - Caused by: * HYPERVENTILATION * Hypoxemia from acute pulmonary disorders * Pain * Fear/anxiety * Salicylate or Nicotine overdose * Increased metabolism - Compensation rarely occurs due to aggressive treatment for hypoxemia In respiratory acidosis - ACCURATE ANSWERS "When you're on acid, you're relaxing and HYPOventilating" - pH is low and PaCO2 is high - Caused by: * HYPOVENTILATION * Respi...