The site bla - Study guides, Class notes & Summaries

Kansas MPJE Exam 2023 Study guide. When does a pharmacist license need to be renewed in KS? - ANSWER Biennially, June 30th What are the CE requirements in KS? - ANSWER 30hours /2years, board approved, this number is prorated for the year that you are a new grad Intern hour requirement in KS? - ANSWER 1740 hours Intern license expiration in KS? - ANSWER 6 years Regulations on the sale of pseudoephedrine containing products specific to Kansas? - ANSWER Must be 18 or over to purchase Purch...

nuity planning process, which of the following should be identified FIRST in the business impact analysis? Critical business processes for ascertaining the priority for recovery. Which of the following disaster recovery/continuity plan components provides the GREATEST assurance of recovery after a disaster? The alternate facility will be available until the original information processing facility is restored. There are several methods of providing telecommunications continuity. ...

As part of the business continuity planning process, which of the following should be identified FIRST in the business impact analysis? A. Organizational risks, such as single point-of-failure and infrastructure risk B. Threats to critical business processes C. Critical business processes for ascertaining the priority for recovery D. Resources required for resumption of business C. Critical business processes for ascertaining the priority for recovery. Answer: C Explanation: The ident...

30-day hold - correct answer (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 - correct answer Amendme...

SOCRA CCRP QUESTIONS CORRECTLY ANSWERED. How long is the reporting period for equity interest and significant payments? - correct answer study period plus one year Pre-Study Documents (Essential Documents) - correct answer FDA 1572 (drug) or signed investigators agreement (devices) CVs, licenses, ect Fully executed contract and budget Protocol signature sheet Approved informed consent LAB certificates (Clia and CAP) and normal values Lab director's CV IRB membership and assurance # IR...

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and stewardship, medical device innovations, improving FDA expertise and outreach, medical countermeasures innovation, vaccine access, certainty and innovation. 30-Day hold - ANS-Time period between f...

Kansas MPJE Exam 2023 Studyguide. When does a pharmacist license need to be renewed in KS? - ANSWER Biennially, June 30th What are the CE requirements in KS? - ANSWER 30hours /2years, board approved, this number is prorated for the year that you are a new grad Intern hour requirement in KS? - ANSWER 1740 hours Intern license expiration in KS? - ANSWER 6 years Regulations on the sale of pseudoephedrine containing products specific to Kansas? - ANSWER Must be 18 or over to purchase Purcha...

BCMAS Terms Abbreviated New Drug Application - answerApplication to be submitted for FDA approval of generic drugs, where data about bioequivalence or therapeutic equivalence must be clearly demonstrated. Companies are allowed to submit ANDA once the patents of bioequivalent brand- name drugs have expired. Active Pharmaceutical Ingredients (API's) - answerRaw chemical materials that are used to manufacture drugs Adjuvant Therapy - answerAdditional treatment to the main or initial treatme...

Kansas MPJE Exam 2023 Studyguide When does a pharmacist license need to be renewed in KS? - ANSWER Biennially, June 30th What are the CE requirements in KS? - ANSWER 30hours /2years, board approved, this number is prorated for the year that you are a new grad Intern hour requirement in KS? - ANSWER 1740 hours Intern license expiration in KS? - ANSWER 6 years Regulations on the sale of pseudoephedrine containing products specific to Kansas? - ANSWER Must be 18 or over to purchase ...

CCRC Exam Questions and Answers 2023 Protocols 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 -intro of new drug/investigational ...