Preach

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...

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...

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...

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...

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...

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...

What are the 3 Dynamic DNS Providers? - What is the Max amount of backup interfaces for SDWAN? - 10 What is the default IP version setting for sending or receiving the DNS Proxy Packets between the firewall and DNS servers? - IPV4 to IPV4 Which Advanced Network interface setting on the sonicwall allows inital packets or response packets to pass through other interfaces? - Asymmetric Route Support Messaging protocol that was created as a part of IPV6 to perform a number of tasks that a...

What type of specific and advanced threat protection features are enabled by SonicOS - Sanboxing, SSL+SSH+TLS decryption and inspection Up to how many atuo-scheduled cloud configuration backups are supported for each firmware version in the sonicOS firewall? - 3 per firmware Which panel of the SonicOS management option interface is used to define password restrictions? - Manage>Appliance>Base Settings>Login Security The HTTP based management option in SonicOS is disabled by defaul...

What type of specific and advanced threat protection features are enabled by SonicOS - Sanboxing, SSL+SSH+TLS decryption and inspection Up to how many atuo-scheduled cloud configuration backups are supported for each firmware version in the sonicOS firewall? - 3 per firmware Which panel of the SonicOS management option interface is used to define password restrictions? - Manage>Appliance>Base Settings>Login Security The HTTP based management option in SonicOS is disabled by defaul...

A customer has an established base of GVC VPN users with a WAN GroupVPN policy configured. The customer wants to begin an implementation for SSL VPN users. The existing group of GVC VPN users must be converted to SSL VPN users because the SonicWALL security appliance does not support both types of VPN users. - FALSE SSL VPN eliminates the need for remote access authentication. - FALSE Which of the following correctly describes how a bandwidth management rule works? -Can be configured for a...