SOCRA CCRP Certification Questions with 100% Correct Answers

CFR Title 21: Part 11 - Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. -must be available and subject to FDA inspection -may be in lieu of paper records or traditional signatures if they meet the above requirements and have been identified in public docket (making it official) Part 11: 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. Part 11: Digital signatures - an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. Part 11: Electronic record - any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Part 11: Electronic signature - A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. Part 11: Handwritten signature - the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. Part 11: Open system - an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. Part 11, Subpart B: Electronic Records Controls for closed systems - Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Includes: -validation of system -ability to generate accurate and complete copies of records for inspection, review, etc. -Protection -limiting system to auth. individuals -secure, time-stamped, audit trails -enforcement of permitted sequencing of steps -authority checks to make sure only auth. people using -establishment and adherence to policies for accountability and deterrence of sig falsification Part 11, Subpart B: Electronic Records Controls for opens systems - Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in §11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. Part 11, Subpart B: Electronic Records Signature manifestations - Must contain: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. Part 11, Subpart B: Electronic Records Signature/record linking - Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. Part 11, Subpart C: Electronic Signatures General requirements - -shall be unique -organization shall verify identity of person providing electronic signature before making it official -person using electronic signature should acknowledge that is is legally binding -Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. Part 11, Subpart C: Electronic Signatures Electronic signature components and controls - (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components(i.e., ID code and password) (i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. (ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. (2) Be used only by their genuine owners; and (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. Part 11, Subpart C: Electronic Signatures Controls for identification codes/passwords - (a) Maintaining the uniqueness of each combined identification code and password (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any unauthorized attempts (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered Part 50 - Protection of human subjects Part 50, Subpart A: General Provisions - (1) A color additive petition (2) A food additive petition (3) Data and info for establishing that the substance is recognized as safe for becoming a component of any food (4) Data and info about a food additive submitted for food additives permitted to be used on an interim basis pending additional study (5) Data and info about a substance for establishing a tolerance for unavoidable contaminants in food and food-packaging (6) An investigational new drug application (7) A new drug application (8) Data and info about the bioavailability or bioequivalence of drugs for human use re: bioequivalence requirement (9) Data and info about an over-the-counter drug for human use for classifying these drugs as generally recognized as safe and effective and not misbranded (10) Data and info about a prescription drug for human use for classifying these drugs as generally recognized as safe and effective and not misbranded (11) [Reserved] (12) An application for a biologics license (13) Data and info about a biological product for determining that licensed biological products are safe and effective and not misbranded (14) Data and info about an in vitro diagnostic product for establishing, amending, or repealing a standard for these products (15) An Application for an Investigational Device Exemption (16 & 17) Data and info about a medical device submitted as part of the procedures for classifying these devices for establishing, amending, or repealing a standard for these devices (18) An application for premarket approval of a medical device (19) A product development protocol for a medical device (20) Data and info about an electronic product (21) Data and info about an electronic product for obtaining a variance from any electronic product performance standard, (22) Data and info about an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard (23) Data and info about a clinical study of an infant formula (24) Data and info submitted in a petition for a nutrient content claim (25) Data and info from investigations involving children submitted in a new dietary ingredient notification Part 50, Subpart A: Clinical Investigation - -One or more human subjects -subject to requirement for prior submission to the FDA or is not subject to requirements for prior submission to the FDA