SOCRA CCRP ACTUAL Exam 2025, Exams of Nursing

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SOCRA CCRP ACTUAL TEST 2025

Phase 0 clinical trial (PK) Pharmokinetics and (PD) Pharmodynamics. Very small in #'s 1st in Humans -is it consumable for humans? Phase 0 clinical trial True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by Congress? True True or false: the FD&C act can be found in the US code, which contains all general in permanent US laws beginning at 21 U.S.C.301? True Food, Drug, and Cosmetic Act of 1938 Requires new drugs must be proven safe before marketing 21 CFR 10.115 what are Guidance documents Documents prepared for FTA, staff, applicants, sponsors, and the public that describe the agencies interpretation or policy and regulatory issues. Phase 1 clinical trials Safety phase Small in #'s Healthy subjects used -Is it safe? Phase 1 clinical trial

Phase 2 clinical trials Efficacy "Proof of concept" Larger #'s Those with the disease (issue) needing treatment Phase 2 clinical trial Phase 3 clinical trials "Pivotal Study" Larger #'s Those with the disease -seeks statistical evidence Phase 3 clinical trials Phase 4 clinical trials "Post market surveillance" General public Longer years of data collection Post regulatory approval -what are the long term effects Phase 4 clinical trial What is 21 CFR 10. The good guidance practice regulations Medical device classifications Pilot (smaller #'s) &

Instigators brochure Insurance statement Pretrial monitoring report, Trial initiation monitoring report Clinical study report Essential document-investigators brochure Document showing relevant and current scientific info about the investigational product provided by the investigator Essential document-investigators brochure Essential document-insurance statement Document that compensation to subject for trial related injury, will be available Essential document-insurance statement Essential document-pretrial monitoring report Document that the site is suitable for the trial. Essential document-pretrial monitoring report Essential document-trial initiation monitoring report Document that the trial procedures were reviewed with the investigator and the staff Essential document-trial initiation monitoring report Essential document-clinical study report Documents the results and interpretation of the trial. Essential document-clinical study report

Attributable Legible Contemporaneous Original Accurate. CFR 312. ALCOA The investigator or those the investigator assigns and delegates to the task. CFR 812. Who must maintain case histories during the study? FDA Forms 482 notice of inspection 483 inspectional observations 1572 statement of the investigator 3454 certification of financial interest and arrangements of the clinical investigator 3455 disclosure, financial interest and arrangement of clinical investigators 3500 for voluntary reporting of adverse event and product problems 3500A for use by user/facilities, mandatory reporting FD&C Act Federal Food, Drug, and Cosmetic Act of 1938 The FDA operates within these guidelines. 21 USC 301 FD&C Act Alcoa

and well-being of human subjects involved in a trial. Can be forms as a review board or a committee - institutional, regional, national or supranational IEC LAR Legally Acceptable Representative Individual or judicial or other body authorized to consent, on behalf of a prospective subject concerning their participation in a clinical trial LAR QA Quality Assurance All those planned and systematic actions established to ensure the trial is performed and data is generated documented and reported in compliance with GCP and applicable regulatory requirements QA QC Quality Control Operational techniques and activities undertaken within quality assurance systems to verify that the requirements for quality of the trial related activities have been fulfilled. QC SAE Serious adverse event

Any untold medical occurrence that may result in... death Or is life-threatening Or requires hospitalization or prolonging of existing admission Or results in persistent or significant disability/incapacity Or is a congenital anomaly/birth defect SAE SADR Serious Adverse Drug Reaction Any untold medical occurrence that may result in... death Or is life-threatening Or requires hospitalization or prolonging of existing admission Or results in persistent or significant disability/incapacity Or is a congenital anomaly/birth defect SADR UADR Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (investigator's brochure) UADR Sponsor-Investigator An individual who both initiates and actually conducts, alone or with others, a

Food and Drug Administration Modernization Act of 1997: Brought major reform to nearly everything the FDA regulates. The purpose of the FDAMA was to make the FDA more efficient and to make it easier for patients to get early access to medical products. Among other things, the FDAMA reauthorized PDUFA; provided strong industry incentives to develop pediatric uses of drugs and antibiotics; gave the FDA the authority to exempt many lower-risk devices from 510(k) premarket review, etc. FDAMA DHHS U.S. Department of Health and Human Services DHHS ICH International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. ICH ANDA Abbreviated new drug application ANDA Corrective and preventative action CAPA Regulates the use of biologics including serums, vaccines, and blood products. CBER (Center for Biologics Evaluation and Research) CDER (Center for Drug Evaluation and Research) The unit of the FDA with responsibility for oversight of all non-biologic drugs and selected biologics (including monoclonal antibodies, enzymes, growth factors and

FDAMA

proteins). CDER approves such drugs for clinical trials, sets drug manufacturing standards, approves drugs for US marketing, reviews drug labeling and promotions and monitors marketed drugs for unexpected or severe health risks CDRH (Center for Devices and Radiological Health) sets and regulates the standards for radiation equipment Clinical trial A scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug or vaccine) using consenting human subjects CSO (FDA) consumer, safety officer CTMS Clinical Trial Management System PMN or 510k Premarket notification SADR Serious Adverse Drug Reaction SAE Serious Adverse Event SMO Site Management Organization SR Significant risk device The ACT The federal food, drugs, and cosmetic act WL Warning Letter: Most serious FDA post-audit letter requires immediate action within 15 days.

Investigator's Drug Brochure Investigator brochure IDE Investigational Device Exemption IEC Independent Ethics Committee IND Investigational New Drug (application) IRC International review committee ISO International Organization for Standardization/Industry Standards Organization IVD In Vitro Diagnostic MDR Medical Device Report Common form abbreviations = NAI No action indicated Common form abbreviations = NCS Not clinically significant NIDPOE Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter NOOH Notice of opportunity for hearing Common form abbreviations = OAI Official action

Office of compliance or office of the commissioner OCI Office of criminal investigations OHRP Office of Human Research Protection (DHHS) ORA (FDA) Office of regulatory affairs PMA Pre-market application or Premarket approval application 45 CFR Part 46.116 & 117 Process if obtaining informed consent, must comply with the requirements of 116. Documentation of informed consent must comply with 117. The new rule is intended to help ensure the and of clinical data and the of human subjects Quality Integrity Protection Conformance with GCP is one way to help ensure clinical data is Credible, accurate, and ethically procured. The FDA believes that all of the following 80s should be considered as unanticipated problems that must be reported to the IRB except for

OC

Clinical trials, transformation, initiative The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. If the O US clinical investigation is submitted in support of a device, marketing application, a sponsor must retain the required records (time frame) after the agency decision on that application or submission. For at least 2 Years. OHRP Office for Human Research Protections The use of the word "should" in guidances means that something is. Recommended and or suggested. The FDA regulations provide safeguards for children, enrolled in clinical investigations, described in 21, CFR part 50 sub part D Sponsor investigators are required to retain records and reports (time frame) years after a marketing application is approved for a drug Two years A sponsor investigator can request that an IND be placed on inactive status, if no subjects are entered into clinical trials for a period of years. Two years or more under an IND. Or if all investigations under an IND remain on clinical hold for one year or more. Within days of the anniversary date that the IND went into effect, a sponsor investigator must submit a brief annual report of the progress of the trial.

A sponsor investigator is responsible for reviewing all information, relevant to the safety of the investigational drug and notifying the FDA of any unexpected, fatal or life-threatening suspected adverse reaction as soon as possible, but no later than calendar days after receipt of the information. Seven calendar days Form FDA 3674 Certification of Compliance The FDA's primary objectives in reviewing, and IND are to Help protect the rights and safety of subjects, in phase 2 and 3, as well as helping sure the quality of the clinical trials is adequate to evaluate the drugs effectiveness, and safety. Investigator's Brochure A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. This may include the chemical, toxicology, and pharmokinetic aspects of the investigational drug, as well as it safety, and efficacy from any Prior clinical trials. The sponsor shell obtain commitment from the investigator to probably update the financial disclosure statement (time frame) If any relevant changes occur during the course of the investigation, or for up to one year following completion of the study. Serious, unexpected reactions that are not fatal or life-threatening must be filed as soon as possible, but after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting 15 calendar days 60 days

*Personally conduct or supervise the study *Obtain informed consent *Report adverse events *Properly train staff, and employees *Maintain adequate an accurate records *Ensure that an IRB that complies with 21, CFR 56 oversees the study Agrees to comply with all of the requirements and 21 CFR 312 Investigator rules responsibilities and obligations 21 CRF 312. Ensuring that an investigation is conducted, according to the signed investigator statement, investigational plan, and applicable regulations. Protecting the rights, safety, and welfare of subjects under their care. Controlling the use of drugs under investigation. For drug studies the FDA form 1572 is used. What do you use for medical device studies? An investigator agreement is used instead of the FDA form, 1572. An investigator agreement agrees to conduct the study according to the same terms as the 1572 form. Who is responsible to develop the study protocol and it's content? For investigator initiated studies the investigator is responsible. For sponsor initiated studies, the investigator is generally provided with a protocol from the sponsor.

Who is responsible for developing the informed consent documents? The investigator should develop informed consent documents that contain the basic an additional elements of the informed consent process. All informed consent documents should be reported to the IRB prior to implementation so they may get approval Safety reports - drug studies For drug studies 21 CFR 312.64 b requires that investigators report, any serious adverse events, whether or not considered drug related to the sponsor, immediately after discovery. This includes SAE's also listed in the investigational brochure or protocol. SAE (drug studies) reporting - when? SAE reporting to the sponsor should he IMMEDIATELY. SAE reporting to the reviewing IRB is required PROMPTLY upon discovery, and non-serious adverse events are to be recorded and reported to the sponsor following description in the protocol. UADE reporting (device studies) - when to Report? Unexpected adverse device effects must be reported to the sponsor into the reviewing IRB ASAP, but no later than 10 working days after discovery. Suspected Unexpected Serious Adverse Reaction (SUSAR) SUSAR. An SAE that occurs during research with a medicinal product/device may be a SAR or a SUSAR. SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected Serious Adverse Reaction. July 27, 1981