SOCRA Exam Study Guide 100%Verified Graded A 2024

When isn't an IND application needed? - IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How many days after FDA receives IND submission does the IND go into effect? 21 CFR 312.40 - (Administrative Actions) An IND goes into effect 30 days after the FDA receives the submission unless the FDA notifies the Sponsor of a clinical hold. When must an IND amendment be submitted and which section outlines this? - (21 CFR Part 312.31) -If there are changes to the protocol that affects safety of subjects, scientific quality of study, or scope of investigation -If a new Investigator is added to the study -Information amendments must be submitted for chemistry/microbiology, pharm/toxicology, or clinical Other submissions: --IND safety reports --Response to clinical hold --Response to FDA request for information --IRB Annual report What are the requirements for expanded access? 21 CFR Part 312.300 (Subpart 1) - -Population must have serious or life-threatening disease or condition -No comparable/significant alternate therapy/treatment -Patient cannot obtain drug under another IND or protocol -Potential benefit outweighs risks of treatment -Expanded access won't interfere with completion of studies that could support marketing approval -Must apply to treatment protocols and should be for individual use (1 person) How many days does Physician or Sponsor have to submit written summary of expanded access to the FDA after use? - 15 days 21 CFR Part 312.34 - Treatment use of an Investigational new drug. During which phases is a treatment protocol usually made available? - During Phase 3 but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been completed and Sponsor of trials is awaiting/pursuing marketing approval. How long is the waiting period before a treatment IND study can be initiated? - 30 days When will the FDA permit use of an investigational drug in widespread use? - -If the criteria for expanded access are met ( benefits outweigh risk, illness is life threatening, or if no alternative treatments are available) -If drug is being investigated in a controlled clinical trial under an IND designed to support a marketing application for the expanded use or all clinical trials are completed. What are the steps for withdrawing and IND? 21 CFR Part 312.38 - A sponsor may withdraw an IND at any time without prejudice by: -Notifying the FDA. -Stopping all studies and notifying the Investigators -Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor. -If the study is withdrawn for safety reasons, the Sponsor must notify Investigators and the IRBs. Which form is used to certify absence of financial interest? - FDA Form 3454 What form is used for the mandatory reporting of serious adverse events? - FDA Form 3500A What is 21 CFR Part 50 Subpart D? - Additional Safeguards for Children in Clinical Investigations What is the FDA Form 482? - Notice of Inspection What is 21 CFR Part 50.20 Subpart B? - General requirements for informed consent What steps must be taken if IND is put on clinical hold? 21 CFR Part 312.42 - -Proposed study: Subjects may not be given the investigational drug. -Ongoing study: No recruiting of new subjects & subjects receiving investigational drug must discontinue therapy unless specifically permitted by FDA in the interest of patient safety. What are the reasons for clinical hold? - -Exposure of unreasonable/significant risk/injury to subjects -Unqualified Investigators (lack of scientific training/experience) -Investigator brochure is misleading, erroneous, or incomplete -IND does not contain sufficient information to assess risk to subjects of proposed studies Phase 1 Clinical Trials - -Usually 20-80 subjects -Meant to assess initial safety and efficacy -Usually single center sites Phase 2 Clinical Trials - -Usually no more than several hundred subjects -Multi-centered sites Phase 3 Clinical Trials are conducted to: - -Confirmation of short-term efficacy and establish long term efficacy -Establish benefit-risk relationship -Provide adequate basis for labeling -Several hundred to several thousand subjects Phase 4 - Post-marketing Continue assessing overall therapeutic value size depends on design When was the Federal Food, Drug, and Cosmetic Act established & why? - 1938; to establish the FDA's jurisdiction over cosmetic and medical devices in the US. What year did they amend the Federal Food Drug and Cosmetic act specifically for medical devices? - 1976 21 CFR Part 812 - Investigational Device Exemption 21 CFR Part 814 - Premarket approval of medical devices Medical Device - Device is NOT dependent on chemical action or being metabolized, and; -also must be recognized in official national formulary or US pharmacopeia -intended for use in the diagnosis, treatment, mitigation or prevention of disease in man or other animals What are the clinical development stages for devices? - 1) Pilot Study 2) Pivotal Study 3) Post-market studies Compared to drugs and biologics, which typically have 1000's of subjects, device studies usually have 100's of subjects Class I (device) - Lowest risk --General controls are sufficient to provide reasonable assurance of the safety and affectiveness