SOCRA Certification Exam-with 100% verified solutions-2024.docx, Exams of Advanced Education

Download SOCRA Certification Exam-with 100% verified solutions-2024.docx and more Exams Advanced Education in PDF only on Docsity! SOCRA Certification Exam-with 100% verified solutions-2024 Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? Yes Open system (FDA term) System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data into CHOP - controlled databases) Closed system (FDA term) Environment in which SYSTEM ACCESS is controlled by the same people responsible for the content of the system (I.E. I control the Robotic Database access AND its contents) What are some FDA Standards to meet when operating a closed record system? 1. Must be able to tell if records have been altered or invalid 2. Must be able to copy records for agency review 3. Protect records throughout retention period 4. Limit system to authorized individuals only 5. Use time-stamped audit trails of modification etc 6. Use operational system checks and restrictions 7. Use authority checks to make sure only authorized individuals are using the system 8. Use device checks to validate data input 9. Make sure those authorized to use system have appropriate training, education, experience 10. Have written policies that deter data falsification 11. Audit and control the maintenance of the actual system What are some FDA standards to meet when using an Open System? All those mentioned for the closed system. 1. Document encryption as appropriate What information should a handwritten SIGNATURE block contain? 1. Printed name of signer 2. Date and Time when signature was executed 3. The MEANING associated with the signature (approval? responsibility? authorship?) Signature and record linking ? Signatures must be linked to their respective electronic records to make sure they cannot be copied, falsified, transferred etc. Do researchers need to request permission from the FDA to use electronic signatures in place of regular signatures? Yes What controls should an E-SIGNATURE contain? Employ at least 2 identification components - such as an identification code AND a password. Name some CONTROLS for the identification components (i.e. identification code and password) for e-signature? 1. no 2 people should have the same identification controls (password... code) 2. Identification codes and passwords should be periodically checked, revised, etc. 3. Deauthorize lost, stolen, missing codes and passwords 4. Periodically test your devices that generate these codes Can an informed consent contain exculpatory language? NO! Cannot say things like "you are waiving your right to damages" etc When may an experimental drug or device be used on a patient WITHOUT informed consent? ((EMERGENCY USE)) 1. the investigator and an independent physician agree that the patient is -life threatening situation -informed consent cannot be obtained - there is no time to obtain consent from th esubject's legal representation -there is no recognized therapy that provides equal or greater likelihood of saving life - within 5 working days this must be evaluated by another independent physician -documentation must be submitted to the IRB within 5 working days -the president can authorize use on the military (lots of information on this military stuff..) When is it okay to skip informed consent and perform ((EMERGENCY RESEARCH))? 1. Human subjects are in life threatening danger, available treatments are unproven or unsatisfactory, and collection of valid science is needed 2. Obtaining consent is not feasible -subjects can't consent due to medical state -can't feasibly get LAR consent in time -no reasonable way to identify ahead of time individuals who will be eligible for participation 3. Participation holds the prospect of direct benefit to subjects -Additional safeguards are in place for vulnerable subjects -All research is in complianace with FDA part 50, subpart D Can an IRB suspend or terminate research? Yes. If unanticipated harm, or if researchers are not following IRB requirements How long are IRB records required to be maintained after completion of a study? 3 years (and accessible!). FDA can shut it down if IRBs are not keeping records appropriately Are there a lot of required documentations and records by the IRB? Yes. Lots of written procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc. Everything needs to be documented! Does the FDA have the power to shut down, stop studies, etc if an IRB is not operating in compliance? Yes! Can full on disqualify if they repeatedly dont comply. When does a research drug need an IND? If it can't be legally marketed or shipped, it needs an IND. If you're hoping for a label change or a new indication for use, it needs an IND. When does a research drug NOT need an IND? It is already legally able to be marketed. Your research doesn't aim to change label or current use. If it doesn't increase risk, or go in unstudied populations etc. Do you need an IND for a placebo drug? NO Do you need an IND for a UNLABELED indication of an approved product? No, and this is confusing to me. Do investigational new drugs need to be clearly labeled as such? Yes Can sponsors charge for an investigational drug? Yes, but it has to be regulated and approved by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be burdensome on the sponsor in order for them to charge for it. What are the three phases of investigational drug studies? Describe and provide average # of subjects. Phase 1 - initial introduction of IND into humans. Determine metabolism and pharmacologic actions, pharmacokinetics. 20-80 subjects. Phase 2 - Controlled clinical study to evaluate effectiveness for a particular indication. Determine short term side effects and risks. Several hundred subjects. Phase 3 - Gather additional information about safety and efficacy, needed to evaluate overall benefit-risk ratio. Hundreds to thousands of subjects. What does an Investigator's Brochure contain? Drug substance, formula, structural formula. summary of animal data, summary of any human data. Pharmacokinetics in animals/humans. Summary of safety and efficacy, risks and side effects (to the extent known) Is an IND application brief? No it needs a billion and one things, like a grant but way worse. Summarizing the state of the union on this drug across time and nations How does an SAE differ from an AE? SAE contains death, life-threatening state, inpatient hospitalization (or prolongation thereof), incapacity, birth defect. Do researchers need to submit annual reports updating the FDA on their IND? YES! lots of details needed. How soon after an IND is submitted can investigators begin their studies? 30 days What is a "clinical hold" in regard to an IND? Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. Why might a clinical hold be issued? unreasonable risk is posed to human subjects, investigators are not qualified, brochure is misleading, IND is not sufficient, reproductive toxicity, etc. OR approved for marketing by another study. OR shown to be ineffective. Can the FDA terminate an IND? Yes, for mostly the same reasons why they would impose a clinical hold Can an IND be deemed "inactive" but not "terminated"? Yes. if no subjects are entered for 2 years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status. Does the FDA spell out suggested meetings as well as dispute resolution for sponsors and investigators? Yes Who is ultimately responsible for the proper conduct of a study? Sponsor. They select monitors and investigators. Do investigators need to supply sponsors with a whole host of information, kind of like a grant application? Yes Who receives the investigator's brochure? Every participating clinical investigator How long does a sponsor need to keep records after a marketing application for a drug is approved? 2 years Can FDA inspect whenever they want? Yes i think so What are the responsibilities of the investigator? Uphold their investigator's agreement and conduct study according to plan. Obtain informed consent. What type of records to investigators need to keep, and for how long after marketing approval? Disposition of drug records, case histories. For 2 years. Who submits annual reports to FDA, the investigator or the sponsor? The sponsor. Who submits reports of SAEs, and to whom? The investigators report to the sponsor, and also to the IRB i think Can a clinical investigator be disqualified? Why might that be the case? Does the FDA define the term children in terms of years? No. A child is someone who cannot legally consent to treatments or procedures in research (defined locally) Describe some instances when children MAY be included in research. -Minimal risk -risk is small in comparison to direct anticipated benefit -NO OTHER WAY of obtaining this information -appropriate preclinical trials -yield knowledge about a disease or condition -adequate assent/consent in place When is assent not needed? -Children are incapacitated/not sound to assent -Benefit is so great to the child -minimal risk Are there instances in which both parents need to consent for a child to participate in research? YES. I suppose more than minimal risk? of course, there are exceptions Are there exceptions for parental consent when a child is neglected or abused? Yes When can WARDS be included in research? If the research is directly related to their status as wards. If they are part of a big group... like a (non-ward) school, where excluded them would be inappropriate What government office do IRBs register under? OHRP (office of human research protections) When an IRB submits appropriate information to OHRP and is registered, how long is their registration active for? 3 years FDA Notice Of Inspection (482) An FDA Inspector presents this form which details rights, policies etc when they arrive on- site to Inspect an organization FDA Inspectional Observations (483) Lists (negative) observations during an inspection. A copy has to be given to organization. This form should include recommended corrective action. The action CAN be taken immediately with the inspector. FDA Statement of Investigator (1572) Provided to Sponsor. This is the "Investigator's Agreement" that they will uphold stated practices and communications and record keeping. The investigator also submits qualification information about themselves. FDA Certification - Financial Interests/Arrangements of Clinical Investigators (3454) This is the form that certifies that investigators have NO financial conflict of interests exist. Certified! FDA Disclosure - Financial Interests/Arrangements of Clinical Investigators (3455) If financial conflicts of interest exist, use this form to DISCLOSE Them! Attach the details of the conflict to this form. FDA Voluntary Reporting of AEs and Product Problems (3500) voluntary reporting of Aes, probems, use errors. These are less serious AEs FDA Mandatory Reporting for use by User-Facilities, Distributors, Manufacturers (3500A) 3500A is MANDATORY and includes details of serious AEs that led to death or serious injury Which FDA reporting form can also be used by patients? 3500 (not life threatening) Quick Overview: BELMONT REPORT (year and summary) The Belmont Report is a summary of the agreements about ethics of human research from the Commission that was created by the 1974 National Research Act. These deliberations occurred in 1976. Quick Overview: NUREMBURG CODE A set of 10 ethical principles for human experimentation. Developed in 1947 as a result of trials held in Nuremburg, Germany for medical personnel involved in the Nazi biomedical experimentation/torture/murder in concentration camps. Quick Overview: DECLARATION OF HELSINKI A set of ethical principles for medical research on human subjects originally set forth in 1964. Developed by the WORLD MEDICAL ASSOCIATION (WMA) Quick Overview: ICH HARMONISED GUIDELINE FOR GCP GCP is international guidelines for conduct of TRIALS. Developed by an international health council in 1990s to harmonize international guidelines that were already put forth. Meant to faciliate clinical trials internationally, especially between US, EU, Japan, and Switzerland. It serves to both protect subjects AND to assure data quality / good practice. Quick Overview: Paperwork reduction act of 1995 The purpose was to reduce the Burden of paperwork held by the public (or people involved in trials). Basically, before you have people fill out forms... it HAS to be approved by Office of Management and Budget. Why is the Belmont report such named? The Commission created by the National Research Act held its deliberations at the Belmont Conference Center of the Smithsonian. Please name the 3 Broad Sections of the Belmont Report 1. Boundaries between Practice and Research 2. Basic Ethical Principles (there are 3) 3. Applications (there are 3) What are the 3 basic ethical principles outlined in the belmont report? Respect for Persons, Beneficence, and Justice What are the 3 "Applications" Outlined in the Belmont report? Informed Consent Assessment of Risk and Benefits Selection of Subjects How does the Belmont report distinguish between Practice and Research? Practice: Interventions SOLELY designed to benefit and individual, already have a reasonable expectation of success. Research: an activity to test a hypothesis, develop generalizable knowledge. Formal protocol and procedures defined. respect for persons treating persons as autonomous agents and protecting those with diminished autonomy (relates to children, prisoners, mental disability, respect for peoples opinions and judgements) Beneficence (Definition) Maximize possible benefits and minimize possible harms. Belmont Report: Justice fair balance between those who participate and those who benefit. (good distribution of BURDENS vs. Benefits) you can't study prisoners to benefit larger society (and other examples) What are the 3 important elements of informed consent, as outlined in the Belmont Report applications? Information, Comprehension, Voluntariness Describe the differences in information, comprehension, voluntariness Information is WHAT is presented. Comprehension is HOW it is presented (time, organization, layman's terms, simple english). Voluntariness is freedom from coercion and influence (like from powerful people/power imbalance/threats) How should selection of subjects be systematically approached? Adults before children, capable before incapable, free before unfree etc. Free from social, racial cultural biases. Why is the Nuremburg Code such named? Came about from the trials held in Nuremburg Germany to prosecute unethical human experimentation in concentration camps Describe (in brief) the 10 principles set forth by the Nuremburg Code 1. Voluntary Consent of the subject 2. Fruitful results unprocurable by other methods 3. Based on animal results and natural history 4. Avoid ALL unnecessary suffering 5. Cannot conduct study in which death or disability will reasonably occur 6. Degree of risk should NEVER outweigh societal benefit after every site visit, the monitor should submit a report tot he sponsor. reco's, criticisms, etc. How often should monitors visit? Decided by the sponsor - can be relative to the risk involved in the study. Does the ICH GCP spell out the sections of a protocol? Yes! you can guess Does the ICH GCP spell out recommended format of an investigator's brochure? yep The ICH GCP spells out all essential trial documents, WHEN they should be employed, and WHO keeps them (sponsor vs. investigator) okay! Who needs to keep documentation of IRB approval? Both - sponsor & investigator How does the definition of an ADR change when a drug goes from pre-approval to post- approval? Pre-approval, ANY dosage that causes bad reaction is an ADR. AFTER approval, an ADR is only a bad reaction at an approved dose (i.e. an overdose.. or a microdose wouldn't be appropriate)_ If a IB lists "kidney problems" as an adverse side effect, and youre patient develops a specific type of nephritis, would that be considered Expected? No. If it brings new light, new SPECIFICS to the table on side effects... it is still considered unexpected and reporting that problem would be BENEFICIAL!!! What type of ADR needs to be reported in an EXPEDITED manner? (2 criteria) SERIOUS AND UNEXPECTED Are there situations, other than a serious and unexpected ADR, which require expedited reporting? Yes. For example, if an expected reaction is happening at a higher-than-expected rate. A new animal study finding. Lack of efficacy in patients with life threatening disease. Describe the timeframe for expedited reporting FATAL or LIFE-THREATENING and UNEXPECTED ADRs ASAP, but no later than 7 calendar days by first knowledge of the sponsor. A COMPLETE report will be required within 8 additional calendar days Describe the timeframe for expedited reporting- SERIOUS, UNEXPECTED ADRs (not life- threatening) ASAP, but no later than 15 calendar days after first knowledge by the sponsor What form is used to report serious, unexpected ADRs? CIOMIS-I is widely used, but it doesn't matter as long as it contains specified information