Package deal::SOCRA Exams Compilation

Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the...

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 ...

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 mu...

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...

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 in...

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. T...

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 broc...

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 T...

SoCRA Certification Test Questions and answers already graded A+| Updated & Verified | 2024