SOCRA CCRP PREP EXAM QUESTIONS AND ANSWERS 2025, Exams of Nursing

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SOCRA CCRP PREP EXAM

QUESTIONS AND ANSWERS 2025

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.

2 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)

4 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

root cause analysis, and creating a corrective and preventive action plan (CAPA)

6 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

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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.

9 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

2. date of site visit

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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

12 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

13 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.