In the context of clinical trials and applicable regulatory guidelines, which of the following refers to original documents and records including hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete,
microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial? Show
Other sets by this creatorWhich member of the research team is responsible for the conduct of the study and the other research team members? Principal Investigator (PI) It's important to remember that while a PI can delegate tasks, they cannot delegate <>. responsibility If the PI of a biomedical study is not a physician, how should the PI ensure that medical decisions in the study are arrived at competently? There should be a physician in a sub-investigator position who is responsible for medical decisions in the study The PI is responsible for ensuring that their investigation is conducted according to which three things? - Signed investigator agreement What is the overarching primary job of the PI? To protect the rights, safety and welfare of the study subjects. Obtaining informed consent, maintaining records, reporting findings, and reporting updates back to applicable regulatory authorities are all responsibilities of which member of the research team? The PI ICH E6 defines a <> as any individual member of a clinical trial team designated and supervised by the investigator at the trial site to perform critical trial-related procedures and to make important trial-related decisions. sub-investigator T/F: Since they have higher standing, education, and relevant experience than low-ranking members of the clinical trial team (like technicians), sub-investigators may assume official responsibility for certain key tasks, such as ensuring that all human subjects have been properly consented. False - the buck stops with the PI, no matter what, every single time. Which research team member is focused on the smooth day-to-day operation of the study, and assist the PI in implementing the research protocols? Clinical Research Coordinator (CRC) Which research team member acts as a liaison between the PI and the sponsor? Clinical Research Coordinator (CRC) T/F: Although the PI is ultimately responsible for all record-keeping, everyone on the trial staff has a duty to contribute to keeping good and complete records. True The specific manner of record-keeping should be outlined in the <> and adhered to consistently. protocol/study plan Throughout the study, the <> verifies that the site is meeting its duty to maintain proper records. sponsor T/F: When a study is completed, the PI's duty of record keeping also ends. False According to ICH E6 part 8, the site is required to retain certain documents. Name several things which must be retained. -everything submitted to the IRB Per regulations, for how long must a study's site records be kept? For two years after the last marketing action is taken on the thing being studied. In practical terms, the site records of a biomedical study are usually kept for how long, and in what way? Indefinitely. They need to be kept in a system that allows for document identification, search, and retrieval. What is typically the first step in selecting a trial site? Gather preliminary data. This entails examining a site's past work and experience, and looking into their available resources to make sure the site is qualified and able to generate high-quality data and recruit study participants.
If a site's preliminary data review indicates that the site is a promising candidate for becoming a study site, what's the next step taken? A site qualification visit by the monitor/sponsor The <> is an opportunity for the sponsor to assess whether or not the site is qualified to conduct the study. Site qualification visit
T/F: A candidate site can remove themselves from consideration during a site qualification visit should they choose to. True. Done is the sponsor is difficult to work with, or the sponsor does things the site doesn't agree with or condone. The <> should be an open, two-way street that encourages questions, dialogue and flexibility. Site qualification visit Once the site is <>, they will then be initiated and begin recruiting subjects. qualified The site qualification visit must occur prior to <>. site startup If a site and a sponsor have worked together in the past, parts of the site qualification visit may occur in what context? Remotely The <> is tasked with completing the site qualification visit and relaying the results back to the sponsor. CRA The term <> refers to refers to the entity who takes responsibility for the initiation, management, and/or financing of a clinical trial. sponsor Sponsor/investigators (the same person is the sponsor and the PI) are most often seen in which context? University hospitals What are four categories of staff representing the sponsor during a study? 1. Clinical and safety staff Which sponsor representative acts as the "eyes and ears" of the sponsor agency, and assures subject protection, monitors compliance with guidelines, ensures product accountability, verifies CRF data against source documents, and ensure complete regulatory documentation? Clinical Research Associate (CRA) Which sponsor representative defines goals and requirements for the trial, motivates and keeps staff on track for a timely study completion, and helps plan and execute the study? Clinical Project Manager (CPM) A <> is a person or company that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor. Contract Research Organization (CRO) T/F: Delegating tasks to a CRO does not absolve the sponsor of their official responsibilities. True The IRB should be composed of medical, scientific, and <> members. non-scientific IRBs can be one of two types: <> and <>. institutional, independent When many sites on a study use the same independent IRB, that IRB is called a - central IRB T/F: Typically, if performing research through a university, researchers must use the university's IRB. True <> IRBs are generally faster to review applications and may have specific expertise on the study type being conducted, but they are also usually very expensive. Independent What are some of the pros and cons that have to be weighed when selecting an independent IRB? - Institutional policies What kind of things does an IRB handle during an ongoing study? - Review protocol amendments What does the IRB do after the completion of a study? - Review the study termination report How long must an IRB keep records on a study? 3 years after research completion What is included in an IRB's record keeping? - Correspondence The site and sponsor must keep their clinical trial records for how long? What about the IRB? - 2 years after last marketing action Aside from deciding which new drugs, devices and biologics are allowed on the market, what are the activities of the FDA? - Develops and enforces regulations The <> plays a role in counterterrorism by responding to public health threats and ensuring the safety of the food supply. FDA In the FDA, immediately under the office of the commissioner are which two offices? Office of Medical Products and Tobacco, and Office of Global Regulatory Operations and Policy Under the Office of Global Regulatory Operations and Policy is which office? Office of Regulatory Affairs The Office of <> inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. Regulatory Affairs The Office of <> is responsible for cross-center activities ensuring the protection of subjects involved in clinical trials for FDA-regulated products and that non-clinical research is conducted according to Good Laboratory Practices (GLP) requirements. Bioresearch Monitoring Operations The Office of <> consists of a specialized workforce that conducts inspections, investigations, and compliance activities for blood and tissue products as well as vaccines and other biological products regulated by the Center for Biologics Evaluation and Research. Biological Products Operations The Office of <> provides advice and counsel to ORA and FDA leaders regarding medical device and radiological health program operations, including emergency response activities. Medical Device and Radiological Health Operations The Office of <> provides advice and counsel to ORA and FDA leaders regarding pharmaceutical products field operations and emergency response activities. Pharmaceutical Quality Operations The Office of <> provides advice and counsel to ORA and FDA leaders regarding human and animal food products, field operations, and emergency response activities. Human and Animal Food Operations The Office of <> provides direction, assistance, management and oversight of field import operations, including investigational and compliance activities. Enforcement and Import Operations The <> Program is a rigorous compliance and enforcement program aiming to ensure that the tobacco industry follows the law and regulations designed to reduce the health burden of tobacco use. Tobacco Operations T/F: If a drug, device, or biologic is to be marketed outside of the US, no additional oversight is required, as the US FDA process is considered the gold standard internationally. False. Marketing outside of the US requires going through the country of interest's approval process. What is the function of CBER? Regulates biological products for human use under applicable federal laws. What is the function of CDER? Regulates OTC and prescription drugs. What is the function of CDRH? Assures safe, effective, and high-quality medical devices and radiation-emitting products. All individuals involved in clinical research have a role in: A. Helping to develop safe and effective therapies while ensuring the rights, safety, and welfare of the subjects have been protected. B. Ensuring that the FDA audits every single research site. C. Assisting the data managers in the final analysis of the data sets. D. Generating clean data while ensuring that the sponsor earns as much revenue as possible. A You are a Principal Investigator looking to hire a new Clinical Research Coordinator for your site, which has 7 ongoing studies. You interview two candidates. Jane Parrish arrives on time but has misplaced her resume. She has been a coordinator for 10 years. Jane is an extrovert and loves building new relationships and contacts with sponsors and subjects. She prefers to work under tight, direct supervision with heavy handed management and does not like to multitask. Patrick Snipes arrives on time and has brought his resume in a neatly organized packet detailing his accomplishments in his past 2 years as a coordinator. Patrick is an introvert, but details many instances of building close, trusting relationships with sponsors and subjects. He works well independently and enjoys taking on studies which have active and aggressive timelines. He prides himself on his knowledge of and adherence to GCP. Who is the better choice to be your new coordinator? A. Patrick Snipes A According to the article, which non entry-level clinical research role needs to be able to point out the deficiencies related to the work of others and hence must not be adverse to conflict? A. Biostatistician D In which field are product development timelines typically shorter? A. Medical Device A Who has the responsibility to protect human subjects? Choose the best answer. A. CRAs D It is OK for a Sponsor to transfer some obligations to a Contract Research Organization verbally. A. True False (must be done in writing) You are the project manager helping the Sponsor to select a site for your research study. This study is a pediatric oncology trial. You have four options. Dr. Harrison has 45 years of experience in breast cancer clinical trials. Dr. Welch has been doing pediatric clinical trials for the last 24 years and specializes in podiatry. Dr. Gui has 15 years of experience in pediatric oncology, has a masters in clinical research management, and has been doing clinical trials for 2 years. Dr. Staples has 1 year of experience in pediatric oncology and has never been involved in a clinical trial. Which PI would be the best choice to participate in your trial? A. Dr. Gui A Which document demonstrates that the PI has the education, training, and experience to be an expert in the clinical investigation of the drug under investigation? A. Statement of Investigator C What should a sponsor do when they discover a PI is not complying with the general investigational plan? Choose the best answer. A. Promptly secure compliance or discontinue shipments of investigational new drug B. Call all the subjects at that site and ask them about their experiences with the PI on the trial C. Document the noncompliance and continue the study as planned D. Immediately notify the FDA and start a federal investigation into the qualifications and misconduct of the PI A T/F: FDA is allowed to inspect the sponsor or the site at any reasonable time. True For how long must the investigational site retain records if the drug under study is not approved for the study indication? A. Indefinitely D Define "clinical trial monitoring". The act of overseeing the progress of a clinical trial and ensuring that it is conducted in accordance with the study protocol, applicable SOPs, GCP, and regulatory requirements. T/F: Some studies require more intensive monitoring, and others can take a more relaxed approach. True Which entity determines the appropriate nature and extent of monitoring? Sponsor T/F: All study monitoring must be done in-person. False, for some studies remote monitoring is allowed Monitors ensure that all report forms perfectly match the original source recording, in a process known as <>. source document verification (SDV) In addition to ensuring SDV, what other duties does a monitor have? - Look for data entry errors and missing data What has allowed for more remote monitoring as opposed to in-person monitoring only? - Technology allows it to occur Centralized monitoring involves the review of <>, not just reviewing data from a central location. centralized data <> allows for proactive oversight of data consistency, completeness, and distribution pattern without having to visit the data site. Remote monitoring <> is a newer monitoring style that recognizes that a lot of time is spent monitoring information and processes that have little impact on the overall outcome of the study or on subject safety. Risk-based monitoring Risk-based monitoring provides sponsors with the ability to evaluate and plan for risks before a study starts and continuously adapt monitoring activities to areas that have the most potential to impact <> and <>. patient safety, data quality What are the three key ideas in risk-based monitoring? - The sponsor assesses the risk at the protocol, program, and site level <> help determine when a risk might turn into an actual issue. Risk indicators The <> is responsible for submitting the monitoring visit report at the end of a monitoring visit. CRA What are the responsibilities of the CRA (aka clinical trial monitor)? - Acts
as a line of communication Who is responsible for selecting qualified monitors? A. The PI C What is the purpose of clinical trial monitoring? A. Ensure subjects are being compensated, ensure reliable data, and ensure IRB approval of the trial B. Ensure subject protections, ensure IRB approval, and ensure that the PI has no financial conflict of interest C. Ensure subject protections, ensure reliable data, and ensure compliance D. Ensure compliance, ensure subjects are being compensated, and ensure that the PI has no financial conflicts of interest C While doctors new to research will not necessarily be turned away during a site qualification visit, they may require - additional training and oversight beyond what is standard What are some considerations for site qualification assessed by the CRA during an SQV? - Does the investigator have research experience The best recommendation for a potential investigator in a phase III diabetic clinical trial is a physician who has: 1. A private practice with a limited patient base A. 3 and 4 only A During the site initiation visit (SIV), the <> will ensure that the site is ready to begin enrolling subjects. CRA The SIV occurs after the site has received <> approval for the study and the investigational product has been shipped by the sponsor. IRB What should the CRA be sure to address during the SIV? - Review applicable regulations The <> is the opportunity for the sponsor to communicate to the site what their expectations are and how the site can be successful. SIV How does the clinical trial monitor ensure compliance with FDA mandated regulation for the control of an investigational product? A. By ensuring that a site is properly trained on the storage an maintenance of the investigational product B. By providing the site with the FDA approved investigational product accountability logs C. By not allowing anyone other than the PI handle the investigational product at the site D. By doing an investigational accountability check before the site gets sent the investigational product A T/F: Since the facilities and laboratory equipment are checked during qualification, the CRA does not need to recheck them at the initiation visit unless the sponsor specifically requests it. False The sponsor is responsible for monitoring the progress of a clinical investigation. In order to meet this requirement, the CRA will conduct <>. interim monitoring visits (IMVs) The sponsor should create a <> that lays out the plan for interim monitoring visits. clinical monitoring plan (CMP) What is the most common type of monitor visit to the site by the CRA? interim monitoring visits What is the most common objective for an IMV? Source data verification - CRA reviews subject data on case report forms and matches it to source documents T/F: IMVs can be done in-person or remotely. True Which of the following does not usually occur until an interim monitoring visit? A. Performing data verification A The <> is almost always present during an IMV because they are most capable of answering questions related to the collection of data. study coordinator Who maintains the regulatory binder? study coordinator What are some broad categories of things the CRA addresses during an interim monitoring visit? - Screening and enrollment (meeting goals?) Each time the CRA visits the site for an IMV, they will view the site's <>. regulatory binder Study participants must sign <> and <> forms to allow the CRA to view their records as a part of an IMV. HIPAA, informed consent T/F: One thing checked during an IMV is whether appropriate people are completing tasks that have to be delegated from the PI or sponsor, such as consenting participants. True T/F: In double blind studies, there is usually a blinded as well as an unblinded monitor to ensure that the investigational product is handled properly and not accidentally given to anyone not supposed to take it. True
During an IMV, the CRA may verify that the investigational product is being dispensed and handled appropriately by doing what? Checking that the product is stored with the correct temperature, humidity, light, etc. and by counting pills, measuring levels (of liquid product) and checking dispensary logs. Any noncompliance discovered on an IMV should be corrected by running a <> analysis and outlining corrective action. If noncompliance continues, the site should be terminated. root cause T/F: The PI is responsible for reporting the termination of a site to regulatory authorities. False - it is the sponsor's responsibility How is a serious adverse event (SAE) defined? Any adverse event that occurs at any dose and leads to death, a life-threatening condition, inpatient hospitalization, prolonged hospitalization, disability, or congenital anomaly/birth defect. Define research fraud. The act of knowingly, willfully, and repeatedly making false statements or submitting false information with the intent to deceive. <> is any significant non-compliance from good clinical practices. Misconduct Altered, omitted and manufactured data are all examples of <>. fraud With which of the following documents should a qualified monitor be familiar? A. Names and addresses of study subjects D What are the major things handled during a close out visit? - Ensure all data is collected and verified The study coordinator and <> must be present during the close out visit. PI At the conclusion of the trial, the sponsor may do which next steps? - Submit a marketing application to the FDA The CRA calls the site to confirm the close-out visit date, but the CRC says "The PI will be out of town that day but most of the trial files should be available for the visit." What should the CRA do? A. Conduct the visit as planned and document attendees in the close-out report B. Reschedule the visit for a day when all the files and the PI will be available C. Instruct the CRC that all files must be available and review the obligations of the PI with a sub-investigator D. Review the available files then conduct a later follow-up visit with the PI. B Which of the following are responsibilities of the monitor? I. Verifying that written informed consent was obtained before each subjects participation in the trial II. Personally recruiting subjects to participate in the trial they are monitoring III. Verifying that investigators are following the approved protocol IV. Developing and implementing written SOPs for the study site V. Checking the accuracy and completeness of CRF entries ~~~ A. III, II, V C Which of the following should be used to determine the extent and nature of monitoring? A. The purpose, complexity, and endpoints
of the study A True or False: The clinical trial monitor must ensure that they are informing the FDA of any CRF entry error they find during the course of clinical trial monitoring. False Which of the following should be included on the monitoring visit report? A. Name of the Principal Investigator at the site B. The name of study subjects whose informed consent were verified during the visit C. Number of subjects who had 100% source data verification during the visit D. The date and time of the follow up monitoring visit A What is one reason that FDA has encouraged sponsors to adopt a risk-based approach to clinical trial monitoring? A. FDA believes that risk-based monitoring will improve sponsor oversight of clinical trials. B. FDA believes that risk-based monitoring will improve site compliance as it requires the CRAs to do more data verification C. FDA sees risk-based monitoring as a way to review less information during review of marketing applications D. Risk-based monitoring allows the CRAs to spend less time reviewing subject data and more time reviewing data queries which will make monitoring clinical trials more efficient A Which activity does FDA believe can be done better through the use of remote monitoring? A. Analyzing site performance metrics, and clinical data to identify trial sites that have poor performance or potential noncompliance B. Conducting site initiation visits to determine that the site is ready to start enrolling study subjects C. Verifying clinical trial site facilities and laboratories that will be processing samples and uploading data electronically to subject records D. Performing investigational product accountability on medical devices that are distributed to patients with the use of electronic systems A What should the sponsor consider during the identification of critical data and processes? A. The quantity and type of source data that needs to be verified B. The method in which source data will be collected C. The number of study subjects enrolled in the trial D. The electronic system being used to collect subject data A When the sponsor is identifying critical data to determine the best approach to monitoring, which of the following would be considered critical? A. Verification of informed consent B. Ease of use of the electronic system where case report forms are completed C. How many CRAs are assigned to a project D. The type of blinding being used in the study A What is the next step the sponsor should take after identifying critical data and processes? A. Conduct a risk assessment to identify potential risks that may affect the collection of critical data B. Finalize the clinical monitoring plan C. Review their approach to monitoring with a representative of the FDA D. Determine how many CRAs will be needed in order to effectively monitor the conduct of the trial with the purposed monitoring strategy A Which of the following should be considered when developing a monitoring plan? Select all that apply. A. Complexity of the study design B. Types of study endpoints C. Number of subject who will be enrolled D. The experience of the study staff at a research site A and B If the sponsor of a clinical trial is planning on delegating the task of monitoring the clinical trial to a Contract Research Organization, what do FDA regulations require that they do? A. Have a written transfer of obligations from the sponsor to the CRO B. Ensure that the CRO has appropriate monitors for the study C. Document that the CRO has done this type of research before D. The sponsor cannot delegate monitoring to any other entity A T/F: Since they are in the minority, research in vulnerable populations is never acceptable. False. But it must be done correctly, and with ongoing careful consideration to the protection of the study participants. T/F: It is good practice to perform responsible research in certain vulnerable populations, such as children and pregnant women, because it's important to develop therapies that work best for the unique needs of these people. True Where can we find guidelines on the protection of research participants from vulnerable populations? ICH E6(R2) - US Title 45 part 46 Prisoners and military servicepeople are considered vulnerable because - they are both part of a strictly hierarchical organization which could reasonably punish them or withhold benefits if they refused to participate in a study
Give several examples of vulnerable populations, when considering research ethics. - Unemployed and/or impoverished people US Title 45 part 46 is also known as the <>. Common Rule The major focus of the Common Rule, or US Title 45 part 46, is - the protection of human research participants Title 45 CFR 46<> concerns the ethics and protections of pregnant people, fetuses, and neonates. B Per the module, which of the following is NOT a consideration that should be made before performing research on pregnant people? A. Previous research on the investigational product B. Risks and Benefits C. In research with nonviable fetuses ex utero, is any intervention proposed that would shorten or prolong the natural course of dying D. From whom must consent be obtained E. Any effect the investigational product may have on the person's future fertility F. Is abortion encouraged for research purposes G. Any applicable laws which may prohibit the research H. Are the investigators involved in any decisions about an abortion process related to research E Usually, if a study participant becomes pregnant while in a research study, and the pregnancy is not an intended endpoint or desired variable to the study, the researchers will tell the participant to <>, and then after birth, the child will <>. stop taking the study drug right away, be followed by the researchers for years to observe for any adverse effects What two things should be included in a consent form to anticipate the possibility of a research participant becoming pregnant while taking study medication? 1. A statement that the risks of the drug to a fetus are unknown 2. A statement that the participants should inform the researchers right away when they learn of their pregnancy In studies done on pregnant women that focus on a health need of the mother, the needs of the (mother/fetus) usually take precedent, unless - mother, the health benefit to the fetus is high and the risk to the mother is minimal. T/F: Drug trials of products meant for adults often will include participants who are lactating, in order to study the excretion of the drug in the breast milk. True In studies relevant to a pregnancy, the IRB must determine what before the study can proceed? That the potential risk to the fetus is minimal (no greater risk than a standard procedure would pose)
Title 45 CFR 46<> discusses the ethical treatment of prisoners in research. C A famous example of abusive treatment of prisoners in clinical research was <>. MK Ultra MK Ultra involved the administration of <> to prisoners, in an effort to develop <>. hallucinogens, biological weaponry When conducting a study on prisoners, it is important that the IRB <>. have a prisoner-related member who can advocate for the prison population What are the three instances in which study on prisoners is justified? 1. Study of prisoners as a class When performing research on prisoners, it is important to carefully examine for any evidence of <>, <>, or undue influence on the prisoners from the prison itself. duress, coercion US Title 45 CFR 46<> focuses on the research ethics regarding children. D Per the module, which of the following does NOT need to be considered before starting research on children? A. Benefit to the children B. Risk to the children C. The reading level of the children D. Previous research on the product E. Who needs to give consent F. Do the children need to provide assent G. The best type of study design C Before conducting research on children, it is important to ensure that their <> is protected, that they weren't coerced, and that the needs and concerns of the <> are handled appropriately. dignity, family In some cases, children in research studies are assigned a/an <> to be present during the consent process. advocate T/F: A vulnerable person may include someone with a physical, mental, or social limitation. True What is the most important factor to consider when protecting human subjects? A. The rights, safety, and well-being of the subjects B. That there are enough subjects to enroll in the trial C. That the FDA approval is in order D. That the PI is qualified to do research on human subjects E. That the investigational product has a good chance of making it to market A Which document covers the laws and regulations for performing ethical research on humans? US CFR Title 21, as well as 45 CFR part 46, which is specific to federally-funded research 45 CFR part 46 is an ethical guideline document specific to <> research with human subjects. federally-funded ICH E6 Part 2 discusses the requirements for the ethical behaviors of the <> and <>. IRB, trial sponsor The Declaration of Helsinki is a set of ethical guidelines written by <>. The World Medical Association T/F: Responsible research conduct may change over the years, or even over the course of a study. True (e.g., a new breakthrough while a study is ongoing that sheds light on our understanding of the disease being tested) "Research for research's sake" is unethical per which document? The Declaration of Helsinki T/F: A study may not be justifiable if there is already a safe and effective treatment on the market for the disease being studied. True Minimizing risk is an important example of <> in research. Non-maleficence T/F: A participant may become vulnerable as the result of participating in a study. True An independent committee which reviews collected data on an ongoing basis in order to ensure participant safety is known as a <>. DSMB, or data safety monitoring board Participant information and data collected through research studies is not subject to <> requests. Freedom of Information Act (FOIA) T/F: Ethical violations can potentially lead to fines, jail time, or de-barment, wherein a research isn't allowed to do research again. True What is the single most important aspect of the ethical conduct of clinical research? Informed Consent The first mention of requiring consent in US research regulations was in which year? 1962 At minimum, how many members should be on an IRB? 5 There should be at least one <> and one person independent of the institution on an IRB. layperson T/F: Each IRB should have at least one person on it who is not a part of the institution. True US Title 21 CFR <> contains the general requirements for informed consent. 50 US Title 21 CFR 50 lays out four major guidelines for informed consent. What are they? -
An investigator may not involve a human being in a research study unless an - An investigator is required to give the prospective subject adequate time to - The information given to the subject shall be in a language that is - An informed consent may not include any exculpatory language T/F: As a researcher, it is important to include a statement in every informed consent document that explains that you and your institution are not liable for breaches in participant confidentiality. False. An informed consent may not include any exculpatory language. Which guideline document states that in informed consent, there can be no exculpatory language, the participant must have enough time to consider their options, there must not be any coercion, and that the language must be understandable to the participant? ICH E6 (R2), Section 4.8 If a research study involves protected health information and involves consent from subjects, "Will my Health Information be Used During this Study?" What are the 8 basic elements of informed consent? 1. Research What are the six additional elements of informed consent, as laid out by 21 CFR 50? 1. Unforeseeable
risks The person conducting the informed consent must <> the form, and the subject must receive a signed and dated copy of the informed consent form. sign and date T/F: A subject must receive a signed and dated copy of their informed consent form. True Name some common mistakes in language when obtaining informed consent. - Implying that the drug is FDA approved What are some ways that "undue influence" can occur? • Unrealistic subject expectations What are some ways site staff may help facilitate subject comprehension? • Send out information in advance When verifying comprehension, it's important to avoid questions which are <>. leading
When an investigator anticipates enrolling non-English speaking subjects, the protocol must reflect - the methods for assuring full understanding, possibly with the assistance of an interpreter or by using translated ICD(s) What must be collected on a form in instances where the participant cannot sign? The signature of the person obtaining consent, the subject's legal representative, and an impartial witness What is the name of the document to be used for people who need to be consented and cannot sign? U.S. Title 21 CFR 50.25 - Short Form ICF document Who determines if the assent of a child subject is needed, and how to document it? IRB Generally, children older than <> and cognitively-impaired adults are given an opportunity to assent. 7 T/F: If a child subject does not give their assent when asked, the parent or legal guardian may override their wishes. False State the informed consent exception requirements for emergency situations. Patient has a life threatening condition AND patient is unable to communicate, AND no time to obtain consent from legally authorized representative AND no alternative treatment is available that provides an equal or grater likelihood of saving life. - Based on physician's judgment Consent forms must begin with a concise summary of <>
that is most likely to assist a prospective subject in understanding the reasons why "key information" 2018 regulations require that certain clinical trial consent forms be posted on a government website. This requirement applies to studies that are federal agency, 60 If a patient leaves a study early, their information must be <>. anonymized Informed consent should be signed and dated in front of <>. a witness T/F: It's ok the date an informed consent form if they forget to do so. False - this is a federal offense What's the biggest bottleneck in research? Recruitment, Re-enrollment and retention T/F: A budget is required by ICH E6. True <> are a great place to start when building a budget. Study procedures Before beginning a study, participants will have a full medical exam and a/an <>, the average being recorded in their record. EKG in triplicate What are three major sources of hidden costs in a study? - Amendments Staff (should/should not) participate in budget negotiations. should not The IRB mainly communicates with which entity during negotiations? The site In the US, studies are done in accordance with which ethical guideline? What about for international studies? The Belmont Report. ICH E6. If a PI signs the protocol signature page, they are in <>. compliance <> can be done without patient consent, but <> cannot. Pre-screening, screening <>% of patients said they hadn't done a clinical trial because they didn't know one was available. 69 Recruitment must be IRB approved, but <> doesn't have to be. direct advertising In advertisements, you can only say "new treatment" if - you also say that the drug is investigational The FDA (does/doesn't) approve drug research. doesn't Payment cannot be advertised as a <>, but can be advertised as a "recruitment incentive". benefit Which document addresses the security, quality and integrity of data that the FDA considers equivalent to paper records, like e-signatures. 21 CFR Part 11 eSource is used as the source and the <>, saving time on data analysis. case report form The electronic database for collected data is called a/an <>. EDC/eCRF What is the major downside to eCRF? The program can mis-read handwriting. It has to be audited in an ongoing fashion. <> allow subjects to record things offsite that might have otherwise been missed. eDiaries eDiaries are time-stamped, easy to read, and increase <> in data processing. efficiency Serious Adverse Events must be immediately reported to the <> and the <>. sponsor, IRB Who serves as a liaison between the sponsor and the site? Monitor The IRB reviews trials at least <>. annually IRB review and acknowledgment approves the <> and the <>. protocol, patient materials The IRB only needs to acknowledge receipt of the <> and <>. investigator's brochure, SAE reports Data must be stored for <> years after the trial conclusion. two Financial and COI information must be disclosed for up to <> post-study. one year T/F: The FDA will return for an inspection after the conclusion of the study. True Who is ultimately responsible for product accountability at the study site?Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. The Investigator is responsible to ensure control of investigational product.
Which one of the following is an important component of drug accountability?Components of the Drug Accountability Record
Lot number. Expiration date. The amount of drug received, used, returned, or thrown away. The amount of drug left.
Who is responsible for making the initial risk determination for device being used in a study?7. Who decides whether a device study is SR or NSR? Sponsors are responsible for making the initial risk determination and presenting it to the IRB.
Who is responsible for making the initial risk determination for a device being used in a study the IRB the FDA the manufacturer of the device the sponsor investigator?studies must follow the abbreviated IDE requirements at 21 CFR 812.2(b), including informed consent and IRB review, and do not require submission of an IDE application to FDA. The sponsor is responsible for making the initial risk determination, SR or NSR, and presenting it to the IRB.
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Who is ultimately responsible for product accountability at the study site quizlet?
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