CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set

CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set Clinical Trial process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Clinical event, measurable indicator, subject reported response Brainpower Read More Feasibility of a Study Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study Necessary controls in Clinical trials Inclusion/ exclusion criteria(identify target), randomization(avoid bias), Blinding(avoid observation bias), Primary and secondary endpoints(prove hypothesis) Current Good Manufacturing Practices cGMP Food and Drug Administration (FDA) federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies Investigational New Drug (IND) application to the FDA that contains all the animal and cell testing data Length of time a sponsor must wait before starting clinical trials after IND submission to FDA 30 calendar days Non-significant Risk Devices Tongue depressor, adhesive bandages Premarket Review FDA process to evaluate the safety and effectiveness of devices that support or sustain human life, or which present a potential, unreasonable risk of illness or injury Investigational Device Exemption (IDE) Submission to FDA for significant risk device before a clinical trial can begin, that allows the investigational device to be used to collect safety and effectiveness data required to support Premarket Approval application (PMA) Gold standard of Study Design Randomized, controlled, double-blind Double-blind randomized trial Neither study staff, nor the subject know the assignment until study is completed Study Designs Randomized, controlled, double blind, Observational, Retrospective, Historical QA/QI uses retrospective data obtained through chart reviews to evaluate and improve a process, program, or line of service. phase 1 study Assess safety and tolerability of a study drug in mostly healthy subjects Phase 2 study Focuses on obtaining evidence of therapeutic efficacy indicating that the molecule has the desired effect. Performed in subjects with specific condition targeted by investigational product. Phase 3 Study Uses information gathered from Phase 1 and 2 studies to determine safety and effectiveness. New Drug Application (NDA) Phase 1-3 clinical trials prove drug is effective and safe, this application is submitted to the FDA. Phase 4 Study FDA has approved a drug and it is commercially available, but may be necessary to gather more information about product through controlled clinical trial, also known as a post market trial. Study sponsor Initiator of clinical investigation, overseeing entire process, develops regulatory strategies, funding source, and manages interactions with regulatory authorities. Protocol Formal document containing details of the study design and all the associated procedures to be followed during the course of the study. Deviations from this can risk subject safety, damage integrity of trial data, and jeopardize regulatory approval of product. Basic elements of a protocol Objectives, scientific background, Trial design, Selection and enrollment of subjects, procedure and research events, management of AEs, Statistical considerations, Data collection and recordkeeping, Quality control, assurance of safety of patients is protected. Principal Investigator (PI) The person who is primarily in charge of research on a project that is sponsored or funded by an organization. Also responsible for all study conduct, including protecting human subjects and ensuring the integrity of the data obtained during the course of the trial. Statement of Investigator FDA 1572-Must be signed by all investigators participating under the clinical trial under the IND. This is an agreement by the investigator to conduct the study in compliance with FDA regulations Sub-Investigator Assists the PI by performing delegated tasks that are outlined in the protocol. Study Monitor or CRA Typically employed by the sponsor or CRO and is responsible for evaluating the overall conduct of the trial at a research site. Institutional Review Board (IRB) committee of administrators, scientists, and community members that reviews proposals for research involving human participants. Oversees the ethical and scientific aspects of a study, with special focus on risk of harm vs benefit assessment for participating subjects. Clinical Trial Agreement (CTA) Legal contract between the clinical site, investigator and sponsor. Regulatory, financial and ethical implications will be included. What financial considerations should be included in developing a budget for a pharmaceutical company sponsored study? Investigator oversight, study specific procedures and exams, training, pharmacy, site overhead, subject stipends, data collection, AE and SAE handling, monitoring visits, regulatory an IRB prep, and other activities associated with the study. What is the most important factor to consider in a sites decision to participate in competing clinical trials? There is an imminent risk for struggle in prioritizing study related activities when a site is involved in similar clinical trials for different sponsors. What is the main objective of a phase 2 clinical trial? To test a new molecule in subjects with the disease of interest to obtain safety information and preliminary evidence of efficacy. The FDA is the regulatory agency in the US that oversees the approval process for drugs, biologics, and medical devices. What form needs to be submitted to the FDA before starting a clinical trial with unapproved drug? Investigational new Drug (IND) In a drug study, what is the most important FDA document that is signed by the PI? 1572- Statement of investigator Clinical Trial Agreements (CTAs) are: Contracts between industry sponsors and research sites The cost of renting additional clinic space for clinical research is an example of: Indirect Costs Pre-Award Process developing the grant or contract proposal and budget, negotiating any sub-awards, signing and submitting proposal, providing required certifications and essential documents to the relevant local review committees before the proposal is submitted to sponsor for review. Coverage Analysis Determination of which, if any, subject care costs in a clinical trial must be covered by a study sponsor. Medicare Clinical Trials Policy (CTP) Provides Medicare coverage for Routine costs or qualifying clinical trials when the routine costs are otherwise billable to Medicare outside of a clinical trial. Direct Costs Staffing, pharmacy, IRB, advertising, storage Post Award Process Includes establishing an account, purchasing equipment and supplies, controlling expenses to ensure compliance with the grant or contract terms, reallocations of funds, cost sharing, effort reporting, financial reporting to study sponsor and closeout activities Certificates of Confidentiality (CCoon another way to protect confidential information by allowing researchers to refuse to disclose research data for use in "civil, criminal, administrative, legislative or other proceedings. Will be issued by NIH or HHS agency Continuing Review of an approved (non-exempt) protocol that was approved by the convened IRB: Good Clinical Practice (GCP) international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Types of IRB Reviews Convened board, exempt, or expedited Primary purpose of a Certificate of Confidentiality (COC) is to: Protect identifiable research information from forced disclosure Financial Conflict of Interest (FCOI) significant financial interest that could directly and significantly affect the design, conduct, or reporting of research. US Public Health Service PHS Per PHS, Significant Financial Interest can be defined as: - Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000. -Includes spouses and dependent children Conflict of Interest (COI) Training required every 4 years Significant Equity Interest Any compensation whose value may be affected by study outcome, proprietary interest in the investigational product, equity interest whose value cannot be readily determined through reference to public prices, equity exceeding $50,000 in value, and significant payments of sorts (SPOOS) cumulative of $25,000 Data Safety Monitoring Board (DSMB) an independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk Radiation Safety Committee review is required for studies that: Involve investigational imaging studies and studies that are not clinically indicated Who is responsible for establishing a study's data safety monitoring plan (DSMP) Sponsor Institutional Biosafety Committees (IBCs) are always responsible for review of research: Involving recombinant or synthetic nucleic acids regardless of funding Overall responsibly for personally conducting or supervising the conduct of human subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research lies with the: PI In order to document the delegation of study related tasks, the PI should: Keep a signed and dated delegation log that describes the delegated tasks, identifies that study staff have received training that qualifies them to perform the tasks, and documents dates of involvement in the study. Ascertaining that the subject has understood the information presented in the informed consent form is the responsibility of: PI We have an expert-written solution to this problem! A quality assurance program should include: Policies and procedures, training, audits, and corrective action plans CRCs should cultivate professional relationships with clinic administrators and laboratory directors because: These relationships allow the CRC to solicit assistance with operational issues as they arise Observational Study monitoring board (OSMB) Federal agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions. Office for Human Research Protections (OHRP) a branch of the U.S. Department of Health and Human Services that provides leadership regarding protection of human subjects involved in research activities Open Label Trial Clinical Trial in which investigators and participants know which intervention is being administered _____ is a principle outlined in the Belmont Report that requires researchers to protect their human subjects from any harm Beneficence What are the three principles of the Belmont Report? Respect for persons, beneficence, justice Example of how the Principle of Beneficence can be applied to the a study employing human subjects. Determine that the study has maximized benefits and minimized risks. What describes the principle of informed consent as described by the Belmont Report. Information, comprehension, voluntariness We have an expert-written solution to this problem! Bioavailability the rate at and the extent to which a nutrient is absorbed and used clinical trial any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), whether approved for marketing or not, and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its efficacy and/or safety Controlled subjects are split into at least two groups: those receiving the experimental agent and those receiving a standard treatment for the condition (an active control), no treatment, or a placebo. If subjects are assigned randomly into these groups, the study is a randomized controlled trial. Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Pharmacodynamics The study of what the drug does to the body Pharmacogenomics The study of the influence of genetic factors on drug response that result in the absence, overabundance, or insufficiency of drug-metabolizing enzymes Pharmacokinetics The process by which drugs are absorbed, distributed within the body, metabolized, and excreted. Placebo Inactive substance that looks the same as, and is administered in the same way as , a drug in a clinical trial. FDA Regulation 21 CFR 314.126a "the purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of disease, placebo effect, or biased observation." 21 CFR 11 Electronic Records; Electronic Signatures 42 CFR 11 applicable clinical trials must be registered and have results submitted to the ClinicalT databank. Development of most new drugs from discovery to marketing approval usually takes: 9 years or more Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study? Phase 3 Long term toxicology of an experimental drug in animals most likely refers to which part of drug development? Preclinical Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? Phase I For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? Preclinical Data Legally Authorized Representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research. Protocol Deviation (or Violation) generally an unexplained excursion from the requirements of the protocol that is not implemented or intended as a systematic change International Council for Harmonisation (ICH) international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs. Two important goals of ICH E6 are to assure that: The rights, well-being, and confidentiality of trial subjects are protected and trial data are credible. A primary purpose of the ICH is to: Minimize the need for redundant rsearch The ICH GCP guidelines: Set standards for the design, conduct, monitoring and reporting of clinical research. ICH E6 describes standards that apply to: Investigators, sponsors, and IRBs In the US, following the ICH E6 guideline is: Voluntary for FDA-regulated drug studies ICH E6 Section 5.1 requires the investigator to obtain a statement from who to show compliance with ICH? IRB Regarding subject receipt of a signed and dated copy of the consent forms, what is different for FDA regulations? the FDA regulations allow subjects or LARs to receive either a signed or unsigned copy of ICF. The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Identification of study risks to determine which may safely be omitted from continual monitoring. In terms of explaining the probability of assignment to trial arms in consent forms, which is true? ICH notes that it should be included, but does not specify how the information should be presented. What is the status of ICH in U.S.? Its an FDA guidance