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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 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? - ✔✔True Electronic records cannot be used in lieu of paper records. True or False? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔True Who determines the details for electronic submission (e.g. methods of transmission, media, file formats and technical protocol)? - ✔✔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? - ✔✔Act means the Federal Food, Drug and Cosmetic Act. In the FDA's Electronic Signatures regulation, what does the term agency refer to? - ✔✔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? - ✔✔Biometrics What does the term closed system mean with regard to electronic records? - ✔✔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.
Why is validation of systems an important procedure and control for closed systems? - ✔✔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? - ✔✔True. Closed systems are limited to authorized individuals only. T or F? - ✔✔True.
- 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? - ✔✔False. Record changes shall not obscure previously recorded information. In electronic records, what do authority checks ensure? - ✔✔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? - ✔✔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? - ✔✔False Persons who use open systems are not bound to any of the controls or procedures established by the closed system. T or F? - ✔✔False, What three elements are necessary for signed electronic records? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔True.
When signatures are based upon biometrics, they are intended to be used by the signer and his/her designee. T or F? - ✔✔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. - ✔✔1. Maintaining uniqueness of codes and passwords.
- Ensuring periodic check, recall and revision of codes and passwords.
- Following loss management procedures to electronically de-authorize 1ost, stolen or compromised codes and passwords.
- Use of safeguards to detect and prevent unauthorized use of es and passwords.
- 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? - ✔✔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? - ✔✔True What is the definition of "investigator"? - ✔✔An individual who actually conducts clinical investigation. What is the definition of "sponsor?" - ✔✔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. - ✔✔The person is legally competent What is the definition of a "sponsor- investigator?" - ✔✔An individual who both initiates and actually conducts, alone or with others, a clinical investigation. What is the definition of a "human subject?" - ✔✔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? - ✔✔True An IRB is any board, committee, or other group, formally designated by an institution to perform what duties? - ✔✔a. To review biomedical research involving human subjects.
A sponsor-investigator may be a corporation, such as a pharmaceutical company. T or F? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔True Under certain limitations, research may be done for emergency conditions under an informed consent waiver, if approved by an IRB. T or F? - ✔✔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? - ✔✔False.
What role do family members have regarding consent for participation in emergency research studies? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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. - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔True. Other federal, state or local laws may require additional information to be disclosed for informed consent to be legally effective. T or F? - ✔✔True. A copy of the informed consent from must be given to the person signing the form. T or F? - ✔✔True. The approximate number of study subjects must always be specified in informed consent documents. T or F? - ✔✔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 - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔False.
How does the FDA use financial disclosure information from investigators? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔This refers to the term proprietary interest. Who is included in the term clinical investigator as defined in the FDA's financial disclosure regulations? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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 - ✔✔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? - ✔✔True How does the FDA define the term significant payments of other sorts, as it relates to financial disclosure by clinical investigators? - ✔✔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. - ✔✔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? - ✔✔True.
