CCRP Exam Prep: Chemistry, Manufacturing, Controls, & Non-Clinical Studies, Exams of Nursing

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Chemistry, Manufacturing and Controls and non-clinical studies require an ______ to be filed. - CORRECT ANSWER >>The NDA for a drug or biologic is filed when the sponsor considers there is sufficient info to meet the regulatory requirement for approval. FDA regulates scientific studies that are designed to ___ ___ to support the ___ and ____ of investigational drugs (human and animal), biological products and medical devices. - CORRECT ANSWER >>develop evidence / safety and effectiveness US CFR GCP: Laws and regulations are intended to ensure integrity of clinical data and which product approvals are based and to ___ - CORRECT ANSWER >>help protect the rights, safety and welfare of human subjects. CFR 21 Part 11 is in regard to____ - CORRECT ANSWER

Electronic records, electronic signatures

CFR 21 Part 50 is in regard to ___ - CORRECT ANSWER

Informed Consent CFR 21 Part 54 is in regard to___ - CORRECT ANSWER Financial Disclosure CFR 21 Part 56 is in regard to___ - CORRECT ANSWER Institutional Review Boards (IRBs) CFR 21 Part 312 is in regard to___ - CORRECT ANSWER Investigational New Drug Application (IND) CFR 21 Part 314 is in regard to___ - CORRECT ANSWER New Drug Application (NDA) CFR 21 Part 812 is in regard to___ - CORRECT ANSWER Investigational Device Exemption (IDE) CFR 21 Part 814 is in regard to___ - CORRECT ANSWER Premarket Approval of Medical Devices (PMAMD)

CFR 45 Part 46 is in regard to___ - CORRECT ANSWER

Federal Research 45 CFR 46 Part A Common Rule - CORRECT ANSWER >>HHS regulations for PROTECTION OF HUMAN SUBJECTS in research ICH E series covers: - CORRECT ANSWER >>Efficacy Guidelines ICH E2A covers: - CORRECT ANSWER >>Clinical Safety Data Management ICH E3 covers: - CORRECT ANSWER >>Clinical Study Reporting ICH E6 covers: - CORRECT ANSWER >>Good Clinical Practice (GCP) ICH E7 covers: - CORRECT ANSWER >>Geriatric Populations ICH E8 covers: - CORRECT ANSWER >>General Considerations for Clinical Trials

ICH E9 covers: - CORRECT ANSWER >>Statistical Principles ICH E11 covers: - CORRECT ANSWER >>Pediatric Populations ICH Q series covers: - CORRECT ANSWER >>Quality Guidelines ICH S series covers: - CORRECT ANSWER >>Safety Guidelines ICH M series covers: - CORRECT ANSWER >>Multidisciplinary Guidelines ICH E6 GCP definition - CORRECT ANSWER >>International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6(R2) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects ICH E6 GCP Countries - CORRECT ANSWER >>E6 GCP guidance provides unified standard for the EU, Japan and the US to facilitate mutual acceptance of clinical tata by regulatory authorities in those jurisdictions.

Guidance developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization. ICH E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1) - CORRECT ANSWER >>ICH E6(R2) integrated addendum affects the full clinical trial cycle and research enterprise. Focus is on increasing human subject protections and data integrity through better study design and conduct. Most changes affect the sponsor. Origin from the Declaration of Helsinki. ICH E6 (R2) GCP: Integrated Addendum to ICH E6 (R1) - Focus of Revisions - CORRECT ANSWER >>Using a risk management approach in designing studies. Promoting the use of risk-based and centralized monitoring in managing studies. Addressing the reporting and follow-up of significant noncompliance (including conducting a root cause analysis, and creating a corrective and preventive action plan (CAPA) ALCOA-C stands for: - CORRECT ANSWER >>attributable, legible, contemporaneous, original, accurate, and complete

Nuremberg Code (1947) - CORRECT ANSWER >>Was developed as a result of the trial regarding "medical experiments" conducted by German physicians and administrators during WWII in thousands of prisoners without their consent. Nuremberg Code's 10 principles: - CORRECT ANSWER

Focuses on the research subject where Informed Consent is the core.

1. Voluntary Consent is essential
2. Trial should yield fruitful results
3. Trial should be designed and based on results of animal experiments and knowledge of the natural history of the disease or other problem under study that the results will justify the performance of the experiment 4.Will avoid all unnecessary physical and mental suffering and injury 5.None should be conducted where there is reason to believe that death or disability or injury will occur
4. Degree of risk to not exceed that determined by the humanitarian importance of the problem to be solved.

7. Proper preparation made and adequate facilities provided to protect the subject against injury, disability or death 8.Is conducted only by scientifically qualified persons 9.Subject and withdraw at any time 10.PI must be prepared to end trial at any stage if has probable cause trial will result in injury, disability or death to the subject Declaration of Helsinki - CORRECT ANSWER >>World Medical Association (WMA) - A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is addressed primarily to PHYSICIANS. Declaration of Helsinki / General Principles - CORRECT ANSWER >>While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Belmont Report (1974) / Practice vs. Research - CORRECT ANSWER >>Practice refers to interventions that are designed solely to enhance the well-being of an individual patient or client that has a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. Research designates an activity designed to test an hypothesis, permit conclusions to be drawn, and develop or contribute to generalizable knowledge. Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. Belmont Report Ethical Principles - CORRECT ANSWER

Respect for persons: Individuals should be treated as autonomous agents capable of deliberation about personal goals. Beneficence: Do no harm, maximize benefits and minimize harms Justice: Fairness in distribution of burdens and benefits FDA 1572 is the - CORRECT ANSWER >>Statement of Investigator Commitment

Sponsor Responsibilities - CORRECT ANSWER >>Ensure proper monitoring, creates monitoring plans, submits safety reports, submits annual study reports to the IND / IDE, 21 CFR 54 is in regard to - CORRECT ANSWER >>Financial Disclosure by Clinical Investigators "Clinical Investigator" means: - CORRECT ANSWER >>Only a listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects - having a significant role in the study. This definition also includes the spouse and each dependent child of such an investigator or subinvestigator. Form FDA 3454 is in regard to: - CORRECT ANSWER >>Clinical investigators who have no disclosable financial interests in or arrangements with the sponsor of the covered clinical study Form FDA 3455 is in regard to: - CORRECT ANSWER

Financial Disclosure of the PIs, Sub-Is etc. [The named individual (PI, Sub-I etc.) has participated in financial arrangements or holds financial interests that are requires to be

disclosed as follows..." The form should include an attachment with detailed information about the financial interests and arrangements and a description of the steps taken to minimize potential for bias.] Who is responsible for registering trials and submitting results? - CORRECT ANSWER >>Sponsor of the trial or, the PI if designated by sponsor, grantee, contractor or awardee so long as the PI is responsible for conducting the trial has access to and control over the data from the trial, has the right to publish results of trial and ability to meet all requirements for the submission of the trial info. What is the purpose of study monitoring? - CORRECT ANSWER

1. Ensure rights and wellbeing of human subjects are protected;

2. ensure reported trial data are accurate, complete and verifiable from source documents;
3. the study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations Monitor reports per visit must include what 6 items? - CORRECT

ANSWER >>1. investigators name and site location

2. date of site visit
3. monitors name
4. site personnel contacted
5. summary of what information was reviewed
6. significant findings and corrective actions What FDA Form is the "Statement of Investigator"? - CORRECT ANSWER >>Form FDA 1572 What is the primary component of the 1572? - CORRECT ANSWER >>PI attesting they will personally conduct or supervise the trial. Financial Disclosure attestations must include: - CORRECT ANSWER >>1. Any compensation made to the investigator by any sponsor of the covered clinical study where the value of compensation could be affected by study outcome
7. They have a proprietary interest like patent, trademark, copyright or licensing,
8. Any equity interest like stock.

How long must the Investigators report financial disclosures? - CORRECT ANSWER >>Trial lifecycle PLUS 1 year after the trial ends. Any ____ _____ of any sponsor of the covered study if the sponsor is a publicly held company and the __________ exceeds $________ in value. - CORRECT ANSWER >>equity interest, interest, $50k Drug Development: General Principles of IND Submission are CFR._ - CORRECT ANSWER >>21 CFR 312. Initial IND focuses on (3 items): - CORRECT ANSWER >>1. General investigational plan

2. Summary of preclinical studies
3. Protocols for specific human studies Take a deep breath. - CORRECT ANSWER >>It's ok to take breaks.

Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease AND articles intended to affect the structure or any function of the body is the definition of _____

• CORRECT ANSWER >>Drug Article not approved for marketing in the US as a drug AND an approved drug that is not used according to the approved label or used in a new combination of approved drugs is an ________ ________. - CORRECT ANSWER >>Investigational Drug A Clinical Investigation is defined by CFR.(letter) - CORRECT ANSWER >>21 CFR 312.3(b) An ____ _____ ____ application must be secured prior to interstate shipment of any new drug that is not lawfully marketed in the US as a drug for the purpose of conducting clinical investigations. - CORRECT ANSWER >>IND application (Investigational New Drug) What 5 criteria must all be met if a study can be considered exempt from requiring IND: - CORRECT ANSWER >>1. Study is not designed to support approval of a new indication or a change in label.

2. The study is not intended to support a significant change in the advertising for a prescription drug product.
3. The study does not involve a route of administration, dosage level, patient population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug.
4. The study is conducted in compliance with the IRB and informed consent regulations. 5.The study is conducted in compliance with regulations regarding promotion for investigational drugs. The FDA must approve an IND exemption. T / F - CORRECT ANSWER >>False. The FDA does not need to approve, the IRB does. An IND goes in to effect ______ days after the FDA acknowledges receipt unless the FDA notifies the sponsor of a clinical hold. - CORRECT ANSWER >>30 days after A new Drug Application (NDA) is CFR_ - CORRECT ANSWER >>21 CFR 314

A decision on NDAs is supposed to be within ____ months after submission. - CORRECT ANSWER >>12 months "Expanded Access" is also sometimes referred to as_____________ __________. - CORRECT ANSWER

Compassionate use Expanded access is for a patient with: - CORRECT ANSWER An immediate life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug or device) when there is no comparable or satisfactory alternative options available. This phase uses normal volunteers, tightly controlled in an inpatient setting with very small numbers of subjects. - CORRECT ANSWER >>Phase 1 This phase is an initial demonstration of efficacy in subjects with a condition, and used to obtain short term safety data, multicenter, well controlled, relatively small number of enrollees. - CORRECT ANSWER >>Phase 2

This phase confirms short term efficacy and safety, establishes long term efficacy and safety, assesses overall therapeutic value, supports final labeling content, several hundred to several thousand subjects. - CORRECT ANSWER >>Phase 3 This phase is post market. Addresses FDA requirement for additional information not in the NDA, continues assessment of overall therapeutic value. Surveillance for less common AEs. - CORRECT ANSWER >>Phase 4 Medical Devices are regulated by FDA under CFR_ - CORRECT ANSWER >>21 CFR 812

• "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component, part or accessory
• Recognized in the official National Formulary, or the US pharmacopeia or any supplement to them
• Intended for use in the diagnosis of disease or conditions, or in the cure, mitigation, treatment or prevention of disease in man or other animals

• Intended to affect the structure or any function of the body of man or other animals
• Which does NOT achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is NOT dependent upon being metabolized for the achievement of its intended purposes." - CORRECT ANSWER

"Medical Device" The general purpose of the device or it's function. - CORRECT ANSWER >>Intended use. The disease or condition the device will diagnose, treat, prevent, cure or mitigate including a description of the patient population for which the device is intended. - CORRECT ANSWER Indications for use. Act that established the FDAs jurisdiction over cosmetics and medical devices. - CORRECT ANSWER >>Federal Food, Drug and Cosmetic Act (1938) First major amendment specifically for devices. Establishes the three regulatory classes for medical devices based on degree of

control necessary to assure various types of devices are safe and effective. - CORRECT ANSWER >>Medical Device Amendments (1976) What is 21 CFR Part 803 - CORRECT ANSWER >>Medical Device Reporting What is 21 CFR Part 812 - CORRECT ANSWER

Investigational Device Exemption (counterpart to IND requirements 21 CFR 312) What is 21 CFR Part 820 - CORRECT ANSWER >>Quality system Regulations (counterpart to GMP requirements) What is 21 DFR Part 814 - CORRECT ANSWER >>Premarket Approval of Medical Devices (counterpart to NDA requirements 21 CFR 314) What is 21 CFR Part 860 - CORRECT ANSWER >>Medical Device Classification Procedures

What Device class has lowest risk: clinical trials generally not required - CORRECT ANSWER >>Class I Ex: Elastic bandages, exam gloves, hand-held surgical instruments What Device class is Moderate risk: usually required 510(k) filing, might require PMA, generally requires some clinical data - CORRECT ANSWER >>Class II Ex: Powered wheelchairs, infusion pumps, surgical drapes What Device class is Highest risk: PMA usually required, clinical trials absolutely necessary - CORRECT ANSWER >>Class III Class III devices have insufficient information to assure safety and effectiveness solely through general or special controls. Ex: replacement heart valves, silicone gel-filled breast implants, implanted cerebella stimulators, implantable pacemaker pulse generators The mechanism the sponsor uses to submit documents to the FDA for a device. - CORRECT ANSWER >>IDE - Investigational Device Exemption

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device w/o complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution. T/F - CORRECT ANSWER >>True What is "SR" in regard to device development. - CORRECT ANSWER >>Significant Risk. Determination is based on risk of the device to the subject as it will be used in the study. What is "NSR" in regard to device development. - CORRECT ANSWER >>Non Significant Risk Determination is based on risk of the device to the subject a it will be used in the study. Any device study that does not meet SR criteria. A ___ ____ study that is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject. - CORRECT ANSWER >>SR Device Study is an implant, • is used in supporting or sustaining human life, • is of substantial importance in diagnosing, curing, mitigating or

treating disease, or otherwise prevents impairment of human health, or • otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. • Misdiagnosis and/or error in treatment caused by inaccurate test results would be considered a significant risk Who makes the initial determination if a study is SR or NSR? - CORRECT ANSWER >>The sponsor. If NSR, the sponsor submits device description, rationale for determining NSR status, and protocol to the investigator who provides to the IRB If IRB concurs, the sponsor sends device description, rationale for determining NSR status, IRB concurrence and protocol to the FDA If either the sponsor or IRB consider the device to be SR, the sponsor consults CDRH about submitting an IDE FDA can override the determination by either sponsor or IRB; FDA determination of SR or NSR is final Sponsor's NSR abbreviated requirements: - CORRECT ANSWER >>• Label device

• Maintain records
• Ensure investigators maintain records and make reports
• Obtain IRB approval; SR vs. NSR designation

• Ensures informed consent is obtained (IRB can waive if minimal risk)
• Submit reports
• Monitor the study
• Refrain from promotion and other practices What are labeling requirements under 812.5 - CORRECT ANSWER >>-The name and place of business of the manufacturer, packer, or distributor;
• the quantity of contents, if appropriate; and
• the statement, "CAUTION Investigational device. Limited by Federal (or United States) law to investigational use." The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions. _____ __ _____ _________ means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device
• if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational

plan or application (including a supplementary plan or application), or

• any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. - CORRECT ANSWER >>Unanticipated adverse device effect Sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs and investigators within _____ _____ _____ after the Sponsor first received notice of the adverse effect. - CORRECT ANSWER

10 WORKING days Sponsor must withdraw IRB approval within ______ of an unanticipated adverse device effect. - CORRECT ANSWER >>5 working days Sponsor must withdraw FDA approval within _____ of an unanticipated adverse device effect. - CORRECT ANSWER >>5 working days Sponsor must update current list of investigators for device trials _________ - CORRECT ANSWER >>Every 6 months

The legally marketed device(s) to which equivalence is drawn is known as the: - CORRECT ANSWER >>Predicate device(s). A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate. _______________ _______________is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. - CORRECT ANSWER >>Substantial equivalence (SE) A claim of substantial equivalence does not mean the device(s) must be identical. If FDA concurs with the Sponsor determination of "substantially equivalent", the FDA notifies the Sponsor that the device is ____________ for marketing. - CORRECT ANSWER

"Cleared"

________________ ______________ is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. - CORRECT ANSWER >>Premarket approval (PMA) Implementing tracking systems, Reporting device malfunctions, Reporting serious injuries or deaths, Registering establishments where devices are produced or distributed are all a part of __________ ___________. - CORRECT ANSWER

Postmarket Surveillance _____________ ______________ ____________ one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. - CORRECT ANSWER >>Medical Device Reporting (MDR) Manufacturers, device user facilities, and importers are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. They are ______________ ______________. - CORRECT ANSWER Mandatory reporters