SOCRA Exam Questions and Correct Answers 2025, Exams of Nursing

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SOCRA Exam^ Questions and^ Correct^ Answers 2025

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Correct Answer-False. The general provisions for electronic 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 electronic signatures, initials, and other general signing equivalent to full handwritten signatures, unless specifically excepted by regulations effective after August 20, 1997. True or False? - Correct Answer- True Electronic records cannot be used in lieu of paper records. True or False?

• Correct Answer-False. Electronic records that meet the requirements may be used in lieu of paper forms, unless paper records are specifically required. provisions are subject to whose inspection? - Correct Answer-The FDA's inspection Provided they meet the requirements, persons can use electronic records lieu of paper records, for records required to be maintained, but not submitted to the agency. True or False? - Correct Answer-True. Persons can use electronic records in lieu of paper records for documents required to be submitted to the agency provided the document has been identified as a type of submission that the FDA will accept in electronic format. T or F? - Correct Answer-True. Documents submitted to the FDA that are not specified in the public docket as acceptable in electronic form, will not be considered as official if they are submitted in electronic form. T or F? - Correct Answer-True Who determines the details for electronic submission (e.g. methods of transmission, media, file formats and technical protocol)? - Correct Answer-The intended receiving agency unit will determine the details of electronic submission.

In the FDA's regulations covering electronic signatures, what does the term Act refer to?

• Correct Answer-Act means the Federal Food, Drug and Cosmetic Act.

In the FDA's Electronic Signatures regulation, what does the term agency refer to? - Correct Answer-Agency refers to the Food and Drug Administration What is the term that means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions(s) where those features and/or actions are both measurable and unique to that individual? - Correct Answer-Biometrics What does the term closed system mean with regard to electronic records? - Correct Answer-Closed system means environment in which system access is controlled by persons who are responsible for the content of the electronic records that are in the system. An electronic signature is 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. T or F? - Correct Answer-False. This is the definition for the term digital signature. Any combination of text, graphics, data, pictorial, audio, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system is known as what? - Correct Answer-Electronic Record. Electronic signature and digital signature are synonymous terms. or F? - Correct Answer-False. Electronic signature means a computer data complilatiom of any symbol or series of symbols executed and authorized by an individual to be the legally binding equivalent of the handwritten signature. A digital signature is based upon cryptographic methods or originator authentication, a set of computed by using rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. What type of signature is the scripted name or legal mark of an individual preserved with a writing or marking instrument such as a pen or stylus? - Correct Answer- Handwritten signature How does open system differ from closed system with regards to the FDA's Electronic Records regulations? - Correct Answer-In an open system access is not controlled by persons who are responsible for the content of electronic records that are on the system Why is validation of systems an important procedure and control for closed systems? - Correct Answer-Validation of systems ensures accuracy,

reliability, consistency of intended performance, and the ability to discern invalid or altered records

The ability to generate complete and accurate copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency is a control established for closed systems. T or F? - Correct Answer-True. Closed systems are limited to authorized individuals only. T or F? - Correct Answer- True.

21. A procedure in place as a control for closed systems includes the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries. Changes made to the records may obscure and delete previous recorded information, so that the most current information, will always be accessible. T or F? - Correct Answer-False. Record changes shall not obscure previously recorded information. In electronic records, what do authority checks ensure? - Correct Answer- Authority checks ensure that only authorized individuals can use the system, electronically sign a record, access the computer system's input and output devices, alter a record, or perform other operations at hand. A control procedure for closed systems requires the determination that persons who develop, maintain or use electronic record/electronic signature systems have the proper training, education and experience to perform the assigned task. T or F? - Correct Answer-True. Persons or organizations desiring to use electronic records are not required to have written policies that hold individuals accountable and responsible for actions initiated under the electronic signatures, because the nature of electronic records does not permit falsification. T or F? - Correct Answer- False Persons who use open systems are not bound to any of the controls or procedures established by the closed system. T or F? - Correct Answer-False, What three elements are necessary for signed electronic records? - Correct Answer-a. The printed name of the signer b. The date and time when the signature was executed. c. The meaning of the signature (such as review, approval, authorship). Why is it necessary to link electronic signatures and handwritten signatures to the appropriate electronic records? - Correct Answer-Linking ensures that the signatures cannot be excised copied, or otherwise transferred to falsify an electronic record by ordinary means.

Each electronic signature can only be reused by one other person beyond the originator. T or F? - Correct Answer-False. Each one shall be unique and unable to be reused or reassigned to anyone else. An organization must first verify the identity of the individual wishing to use an electronic signature. T or F? - Correct Answer-True. Certification of electronic signatures used on or after August 20, 1997 can be done electronically. T or F? - Correct Answer-False. Certification must be done in writing and sent to the FDA's Office of Regional Operations. Once a person certifies their signature, an agency cannot request further certification, since it was originally certified and submitted in writing. T F? - Correct Answer-False. An agency can request further certification or testimony as to the legally binding equivalent or the signer's handwritten signature. When an electronic signature is not based upon biometrics, how many distinct identification components must be employed? - Correct Answer- distinct components such as password and ID code must be used. Each and every time a user executes the electronic signature, all signature components must be employed, even if the signings take place during one continuous period of controlled system access. T or F? - Correct Answer-False. During one continuous period of controlled access the first signing employs all signature components, with subsequent signings employing at least one component. 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. T or F? - Correct Answer-True. When signatures are based upon biometrics, they are intended to be used by the signer and his/her designee. T or F? - Correct Answer-False. Electronic signatures based upon biometrics are designed to ensure that they cannot be used by anyone other than their genuine owners. There are five controls in place for identification codes and password procedures. Name all of them. - Correct Answer-1. Maintaining uniqueness of codes and passwords.

2. Ensuring periodic check, recall and revision of codes and passwords.

3. Following loss management procedures to electronically de-authorize 1ost, stolen or compromised codes and passwords.
4. Use of safeguards to detect and prevent unauthorized use of es and passwords.
5. Testing of devices such as tokens or cards that bear or generate codes and passwords to ensure proper and consistent functioning. To which five classes of products do the informed consent regulations in 21 CFR 50 apply? - Correct Answer-Drugs Medical Devises Biological products Electronic products Food (including dietary supplements and infant formulas) and color additives With respect to 21 CFR 50, the definition of "family member" includes persons with close association with a subject who may not be related by blood. T or F? - Correct Answer-True What is the definition of "investigator"? - Correct Answer-An individual who actually conducts clinical investigation. What is the definition of "sponsor?" - Correct Answer-A person who initiates clinical investigation but does not actually conduct the investigation. For emergency consent, a family member may be a spouse, parent, child (including an adopted child), brother, sister and spouse of a brother or sister, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship, provided this person meets what criteria. - Correct Answer-The person is legally competent What is the definition of a "sponsor- investigator?" - Correct Answer-An individual who both initiates and actually conducts, alone or with others, a clinical investigation. What is the definition of a "human subject?" - Correct Answer-An individual who is or becomes a participant in research, either as a recipient of the test article, or as a member of a control group. Regarding the informed consent regulations, the term "institution" and "facility" are deemed to be synonymous. T or F? - Correct Answer-True

An IRB is any board, committee, or other group, formally designated by an institution to perform what duties? - Correct Answer-a. To review biomedical research involving human subjects. b. To approve the initiation of biomedical trials involving humans as subjects.

c. To conduct periodic reviews of trials which were previously approved. A human subject may be either a healthy human or a patient. T or F? - Correct Answer- True. For the purpose of informed consent, human food additives, color additives, medical devices, and drugs intended for human use are all considered test articles while electronic products are not. T or F? - Correct Answer-False, Electronic products, like the other items are considered test articles What is the definition of "minimal risk," as defined by 21 CFR 50? - Correct Answer-A situation in which the probability and magnitude of anticipated harm or discomfort are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. What is the definition of "legally authorized representative," according to the FDA informed consent regulations? - Correct Answer-An individual judicial body, authorized or other group under applicable law to consent on behalf of a prospective subject to the subject's participation in research procedures. What is the definition of a clinical investigation as it pertains to the FDA's informed consent regulations? - Correct Answer-Clinical investigation means any experiment that involves a test article and one or more human subjects that is either subject to FDA requirements, or not subject to FDA requirements, but is intended to be submitted to, or held for inspection by the FDA, as part of a marketing application. A sponsor-investigator may be a corporation, such as a pharmaceutical company. T or F? - Correct Answer-False. A sponsor-investigator must be an individual. What stipulation is mandated for the length of time a prospective research subject is given to determine whether or not to participate in a research trial? - Correct Answer- Sufficient opportunity to consider whether or not to participate must be allowed, under circumstances which minimize the possibility of coercion or undue influence. Under what conditions may an investigator enter a human subject into a research study employing the exception from general informed consent requirements? - Correct Answer-a. Prior to enrolling a subject, both the investigator and an independent physician certify in writing:

i. The subject is in a life-threatening situation which necessitates use of the test article, is unable to give legally informed consent,

ii. Time is insufficient to obtain consent from the subject's legal representative, iii.And there are no alternative methods or therapies available that provide an equal or greater chance of saving the subject's life. An informed consent document may not include any exculpatory language through which the subject or subject's representative releases or appears to release which parties from liability or negligence? - Correct Answer-The investigator, the sponsor, the institution or its agents. If an investigator employs the exception from general requirements process for obtaining consent, within how many days must a full report of the circumstances be reported to the IRB? - Correct Answer-Within five working days after use of the test article Following enrollment of a subject into a study under the exception from general requirements criteria for obtaining consent, a written review by a physician not associated with the investigation must be submitted to the IRB within 10 working days. T or F? - Correct Answer-False. Within 5 working days after use of the test article. Subject to extensive requirements including documentation and ethical reviews, the U. S. President may approve the use of investigational drugs for military personnel without first obtaining informed consent when the DoD is the sponsor of an IND. T or F? - Correct Answer-True With emergency research involving waiver of consent, public disclosure of the research before and after the research within the local community is required. T or F? - Correct Answer-True. IRBS must ensure special criteria are met prior to approving emergency research that will allow subject entry without first obtaining informed consent. T or F? - Correct Answer-True Under certain limitations, research may be done for emergency conditions under an informed consent waiver, if approved by an IRB. T or F? - Correct Answer-True The FDA provides no regulatory basis to conduct research if written informed consent cannot be obtained from subjects prior to entry into a study. T or F? - Correct Answer- False. Research may be conducted with waived consent for emergency conditions, or under the general exception from informed consent criteria.

If clini vestigations could not normally be completed in patients with emergency conditions, due to inability to obtain informed consent, special criteria exist to enable such research to be done. T or F? - Correct Answer- True What must investigators commit to when conducting research under emergency conditions, relative to obtaining informed consent for subjects who are unable to give consent? - Correct Answer-Attempting to contact a family member or legally authorized representative within a protocol- specified therapeutic window to determine if they object to the subject's participation in the research. Prior to approving emergency research, an IRB must assure that additional protections are in place regarding the rights and welfare of prospective subjects. Name at least two of these additional protections. - Correct Answer-a. Consultation with community representatives b. Public disclosure to the community regarding risks, prior to the study. c. Public disclosure of the results d. Establishment of an independent data monitoring committee e. Attempting to contact a family member, if feasible, to ask whether he or she objects What role do family members have regarding consent for participation in emergency research studies? - Correct Answer-Family members are to be consulted with by investigators to determine if the object to subject's participation, or continuation in a research study, and are to be fully informed of the investigation, if feasible, even if the subject dies. If a subject enrolled in an emergency research study without informed consent remains incapacitated, how soon must a legally authorized representative or family member be made aware of the content of the informed consent document? - Correct Answer-At the earliest feasible opportunity If a subject entered into a research study under waived consent criteria dies before legally authorized representatives or family members can be contacted, these affiliates must be informed about the investigation. T or F?

• Correct Answer-True If an IRB makes a decision not to approve research under waived consent criteria due to perceived non-complianc regulatio or ethical concerns, whom must the IRB notify? - Correct Answer-The clinical investigator and the sponsor.

Subjects enrolled in emergency research with waived consent, must be informed about the study if their condition improves, even if a legally authorized representative or family eno member consented on their behalf, or did not object to their participation. T or F? - Correct Answer-True

If a sponsor is notified by an IRB that a research investigation intended to be conducted under the waived consent emergency research regulations cannot be approved, whom must the sponsor notify of this decision? - Correct Answer-a. The FDA b. Any other investigators conducting or anticipating to conduct the same or a similar investigation c. Other IRBs that have been asked to review and approve the same or substantially equivalent research. What is the therapeutic window within which an investigator must attempt to contact family members or legally authorized representatives, prior to entering a subject without consent in an emergency research study? - Correct Answer-The therapeutic window is defined in the investigational plan (protocol), and is based on scientific evidence. A basic element of informed consent requires a statement that the study involves research. State the items that should be described about the research. - Correct Answer-a. An explanation of the purposes of the research b. expected duration of the subject's participation. c. A description of procedures to be followed. d. Identification of any procedures which are experimental. How much information must informed consent statements include regarding potential risks or discomforts to study subjects? - Correct Answer-Any reasonably foreseeable risks or discomforts must be described A statement regarding potential benefits to subjects or others is a required element of informed consent. T or F? - Correct Answer-True. If no reasonable alternative procedures or treatments are available to subjects in a research study, the informed consent must state this fact. T or F? - Correct Answer- True A statement regarding the extent of confidentiality of a subject's study records must be included in all informed consent documents, including the possibility that the FDA may inspect the records. T or F? - Correct Answer- True. If a research study involves more than minimal risk to subjects, a

statement regarding compensation and whether any medical treatments are available for potential injury is required. T or F? - Correct Answer-True.

All consent forms must contain a statement describing whom the subject may contact for answers to their questions about the research, and whom to contact in the event of a research-related injury. T or F? - Correct Answer- True. According to FDA informed consent regulations, a subject may discontinue participation in a study at any time without sacrificing what? - Correct Answer-Without penalty or loss of benefits to which the subject is otherwise entitled. Informed consent has numerous required elements as well as several optional elements. T or F? - Correct Answer-False. In addition to the elements required in all informed consent documents, there are additional elements that, if applicable to the study, must be included. IF a study involves potential risk to an embryo or a fetus, a statement describing the risk must be included in the informed consent document. T or F? - Correct Answer-True IF an investigator may terminate a patient's participation in a study without first obtaining consent from the subject, a statement regarding these circumstances should be included in the informed consent form. T or F? - Correct Answer-True. Any additional costs to study subjects that may result from participation in the research should be included in the informed consent. T or F? - Correct Answer-True, If a subject-initiated withdrawal from a study would potentially cause harm to a subject, a statement regarding the procedures for orderly termination must be included in the informed consent. T or F? - Correct Answer-True. Other federal, state or local laws may require additional information to be disclosed for informed consent to be legally effective. T or F? - Correct Answer-True. A copy of the informed consent from must be given to the person signing the form. T or F? - Correct Answer-True. The approximate number of study subjects must always be specified in informed consent documents. T or F? - Correct Answer-False. It is an additional element which must be included whenever appropriate. Information on new findings developed during the course of the research must be provided to the investigator; he or she may then decide whether to

inform subjects. T or F - Correct Answer-False. A statement of significant new findings must be provided to study subjects which may relate to the subject's willingness to continue participation in the research.

A consent form may be either a written document which includes the required elements or an IRB- approved short form stating that the required elements of informed consent have been presented orally to a subject or subject's legally authorized representative. T or F? - Correct Answer-True. As long as a subject receives a thorough oral explanation of the informed consent form, the investigator is not required to allow the subject extra time to read the consent form prior to signing it. T or F? - Correct Answer-False. Subjects must be given adequate opportunity to read it, prior to signing it. Obtaining oralinformed consent using a short form always requires witness. T or F? - Correct Answer-True. Which two items must a study subject or legally authorized representative record on an informed consent document at the time informed consent is given? - Correct Answer- The signature of the person givin sent and date consent is given. When a short form consent process is used, the subject, or his or her representative, is required to sign and date only the short form. T or F? - Correct Answer-True A witness to the short form informed consent process must sign the IRB- approved written summary of what was said to the subject, but not the short form itself. T or F? - Correct Answer-False. The witness must sign both the summary and the short form. In the short form consent process the subject or subject's legally authorized representative must receive copies of which documents? - Correct Answer- The subject or subject's representative must receive the short form consent and the IRB-approved summary of what was presented orally A "telephone" consent from a caregiver is generally acceptable to enroll a patient as a subject in a clinical trial who is currently hospitalized. T or F? - Correct Answer-False. Written consent of a subject or his or her legally authorized representative is required, unless specific federal regulation, which exempts written consent, can be applied. The purpose of disclosing financial information and interest in a particular clinical study is to support the FDA's evaluation of marketing applications for drugs, biologics and devices. T or F? - Correct Answer-True, The FDA may consider studies of data inadequate if steps have not been

taken in the design, conduct, reporting, and analysis to minimize bias. T or F? - Correct Answer- True

Name a few of the potential sources of bias in relation to financial matters and clinical studies. - Correct Answer-a. Financial interest of the clinical investigator in the outcome of the study. b. Proprietary interest in the product (e.g. a patent, trademark, copyright, etc.) c. Equity interest in the sponsor. How does the FDA use financial disclosure information from investigators? - Correct Answer-It is used in conjunction with other information to assess the reliability of the data. What does compensation affected by the outcome of clinical studies mean? - Correct Answer-Compensation affected by the outcome of clinical studies means compensation that could be higher for a favorable outcome than for an unfavorable outcome of a study What is meant by significant equity interest in the sponsor of a covered study? - Correct Answer-Significant equity interest in the sponsor of a covered study refers to any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (i.e. interests in a nonpublicly traded corporation), that exceeds $50,000, during the time the investigator is carrying out the investigation and for one year following completion of the study. What term refers to property or other financial interest in the product including a patent, trademark, copyright of licensing agreement? - Correct Answer-This refers to the term proprietary interest. Who is included in the term clinical investigator as defined in the FDA's financial disclosure regulations? - Correct Answer-The term clinical investigator includes only listed investigators or sub- investigators who are directly involved in the evaluation or treatment of research subjects. The term also includes the spouse and each dependent child of the investigator. As related to financial disclosure, the term covered clinical study includes any human study of a drug or device submitted in a marketing application or reclassification petition that the FDA or applicant relies on to establish effectiveness. T or F? - Correct Answer- True. The term covered clinical study includes any human study witha drug or device submitted to the FDA in a marketing application or reclassification petition, in which a single investigator makes a significant contribution to the demonstration of safety. T or F? - Correct Answer-True Generally, most Phase I trials are not included in the FDA's definition

covered clinical studies, as relates to financial disclosure by clinical investigators. T or F? - Correct Answer-True

According to the FDA's financial disclosure regulations, treatment protocols, parallel track protocols and large open safety studies at multiple sites always require investigator financial disclosure. T or - Correct Answer-False. These types of studies generally are not considered covered clinical studies Applicants submitting marketing applications or reclassification petitions to the FDA may consult with the FDA as to which studies constitute "covered clinical studies." T or F? - Correct Answer-True How does the FDA define the term significant payments of other sorts, as it relates to financial disclosure by clinical investigators? - Correct Answer- Payments made by the sponsor of a covered study to the investigator or institution that exceed the value of $25,000 US, during and for one year after the completion of the study. This does not include the costs of conducting the study Define the term applicant as it relates to the FDA's financial disclosure regulations. - Correct Answer-A party who submits a marketing application to the FDA for approval of a drug, device or biologic product. The term sponsor of the covered clinical study means the party supporting a clinical study at the time it was carried out. T or F? - Correct Answer-True. Applicants who request marketing approval for drugs, biologics or devices are only required to submit the appropriate financial certification or disclosure statements to the FDA for studies the applicant sponsored. T or F? - Correct Answer-Financial certification or disclosure statements must be submitted whether or not the applicant directly contracted for the study The applicant must submit a list of all clinical investigators, who are full-time and part- time employees of the sponsor for each covered study. T or F? - Correct Answer-True, Applicants must submit lists of all clinical investigators who are not full-time or part-time employees of the sponsor for each covered study. T or F? - Correct Answer-True. Clinical investigators subject to the investigational new drug or investigational device exemption regulations are required to provide sponsors with adequate information to enable the sponsor to comply with the financial disclosure regulations. T or F? - Correct Answer-True. What financial information must an applicant submit to the FDA for investigators in covered clinical studies? - Correct Answer-The applicant is required to submit either a certification that none of the financial

arrangements in 21 CFR 54.2 exist, or disclose the nature of those existing arrangements for each clinical investigator.

If an applicant, using due diligence to obtain financial information required in 21 CFR 54, is unable to obtain the information from a clinical investigator, what additional action must the applicant take? - Correct Answer-The applicant must certify the FDA that despite due diligence being taken, the information was not obtainable and include the reason. Sponsors submitting marketing applications for drugs, biologics, or devices are required to include From FDA 3454, which attests to the absence of financial interests and arrangements for those investigators who provided such information to the sponsor. T or F? - Correct Answer-True. The Chief Financial Officer or another responsible corporate official of the sponsor must personally sign and date Form FDA 3454. T or F? - Correct Answer-True. If a submitted Form FDA 3454 does not cover all clinical data in the application, what additional information shall be included? - Correct Answer- The applicant shall include a list of the studies covered by the certification. Name the four areas in which clinical investigators must provide financial disclosure. - Correct Answer-Receipt of: i. Compensation affected by the outcome of the study. ii. Significant payment of other sorts iii.Significant equity interest in the sponsor iv.Proprietary interest in the tested product In addition to providing financial disclosure information from investigators, what must the sponsor include in marketing applications with Form FDA 3455? - Correct Answer-A statement of any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments. Should an investigator's financial arrangements with the sponsor of a covered study change during or for one year following the completion of the study, what must the investigator do? - Correct Answer-The investigator must promptly update the information with the sponsor. If the required financial certification or disclosure information is not submitted to the FDA in a marketing application, what actions may result? - Correct Answer-The FDA may refuse to file the marketing application. In assessing the potential of an investigator's financial interest to bias a study, the FDA will take into account the design and purpose of a study. T or