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SOCRA FDA timelines questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 7 pages •
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...
SOCRA exam| 168 questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 31 pages •
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...
SOCRA Exam questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 76 pages •
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...
SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 58 pages •
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...
SoCRA Certification Test Questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 20 pages •
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...
SOCRA CCRP exam questions and answers already graded A+| Updated & Verified | 2024
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...
- Exam (elaborations)
- • 10 pages •
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...
SOCI Final Study Guide Questions with Complete Solutions
SOCI Final Study Guide Questions with Complete Solutions
- Exam (elaborations)
- • 4 pages •
SOCI Final Study Guide Questions with Complete Solutions
skills and techniques USAHS Midterm Exam with Verified solutions| Rated A+
what is contact precautions? - used to prevent transmission of infectious agents that are spread by direct or indirect contact with patient or environment. when would you use contact precautions? - excessive wound drainage, fecal incontinence, other discharges from body with increased risk of transmission what are the Contact precautions guidelines? - wash hands before and after entering, gloves, gown (when in direct contact with patient or environment), 3ft between beds and dedicated equip...
- Exam (elaborations)
- • 19 pages •
what is contact precautions? - used to prevent transmission of infectious agents that are spread by direct or indirect contact with patient or environment. when would you use contact precautions? - excessive wound drainage, fecal incontinence, other discharges from body with increased risk of transmission what are the Contact precautions guidelines? - wash hands before and after entering, gloves, gown (when in direct contact with patient or environment), 3ft between beds and dedicated equip...
Secure Software Design Study Guide - C706 Questions and Answers with Verified Solutions
Confidentiality - Information is not made available or disclosed to unauthorized individuals, entities, or processes. Ensures unauthorized persons are not able to read private and sensitive data. It is achieved through cryptography. Integrity - Ensures unauthorized persons or channels are not able to modify the data. It is accomplished through the use of a message digest or digital signatures. Availability - The computing systems used to store and process information, the security controls...
- Exam (elaborations)
- • 23 pages •
Confidentiality - Information is not made available or disclosed to unauthorized individuals, entities, or processes. Ensures unauthorized persons are not able to read private and sensitive data. It is achieved through cryptography. Integrity - Ensures unauthorized persons or channels are not able to modify the data. It is accomplished through the use of a message digest or digital signatures. Availability - The computing systems used to store and process information, the security controls...
Secure Software Design C706 - Test Prep Questions and Answers with Verified Solutions| 2024
Which statement is true of a software development life cycle? A Workload testing should be performed while designing the functional requirements. B Parallel testing verifies whether more than one system is available for redundancy. C A software programmer should be the only person to develop the software, test it, and submit it to production D Unit testing should be performed by the developer and the quality assurance team. - Answer D is correct. Unit testing should be performed by th...
- Exam (elaborations)
- • 14 pages •
Which statement is true of a software development life cycle? A Workload testing should be performed while designing the functional requirements. B Parallel testing verifies whether more than one system is available for redundancy. C A software programmer should be the only person to develop the software, test it, and submit it to production D Unit testing should be performed by the developer and the quality assurance team. - Answer D is correct. Unit testing should be performed by th...
The TEFL Academy - Assignment B (PPP grammar lesson table)
The Tefl Academy, Assignment B, Board Plan
Ammo 18 Exam Questions and answers with 100% correct solutions | A+ Grade
Metal Coils Endorsement (NYS) Questions and Answers Graded A
Employment Law for Business and Human Resources Professionals Revised Fourth Edition Kathryn J. Filsinger
no answers. useless