FDA Regulations for IRBs, Investigators, and Sponsors in Drug and Device Trials, Exams of Nursing

Download FDA Regulations for IRBs, Investigators, and Sponsors in Drug and Device Trials and more Exams Nursing in PDF only on Docsity! CCRP Exam How many days does a sponsor have to report an emergency use of an IP to the FDA? - ✔5 working days How many members must sit on an IRB? - ✔5 How long must an IRB retain records per 21 CFR 56? - ✔3 years after completion of research What are the criteria for IRB approval of research? (7) - ✔1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects How many days does an IRB have to report a change in registration information due to a change in chairperson or contact? - ✔90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? - ✔30 days How often must an IRB renew it's registration? - ✔3 years What are the 8 basic elements of informed consent per FDA guidelines? - ✔1. Statement that the study involves research, purpose and expected duration, description of experimental procedures 2. Description of reasonably foreseeable risks 3. Benefits 4. Disclosure of alternative procedures or courses of treatment 5. Confidentiality measures 6. Compensation and treatments available if injury occurs 7. contact information 8. Participation is voluntary and subject may discontinue at any time What are the criteria for involving children in minimal risk research? (2) - ✔1. No greater than minimal risk 2. Assent from kid + consent from parent obtained What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3) - ✔1. Risks are justified by benefits 2. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches 3. Assent + consent What are the criteria for involving children in greater than minimal risk research with no direct benefit? (4) - ✔1. Risks are minor increase over minimal risk 2. Intervention presents experiences that are reasonable commensurate with normal medical and living situations 3. Intervention is likely to yield generalizable knowledge that is vital 4. Assent + consent Sponsors must report SAEs to the FDA within how many days of discovering the event? - ✔15 calendar days (21 CFR 312.32) Investigators must report SAEs to a sponsor within how many days of discovering the event? - ✔Immediately (21 CFR 312.64) Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4) - ✔1) Serious and unexpected suspected adverse reactions 2) Findings from other studies that suggest a significant risk in humans 3) Findings from animal or in-vitro testing that suggest risks to humans 4) Increased rate of occurrence of serious suspected adverse reactions Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days? - ✔10 working days (21 CFR 812.15) Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days? - ✔10 working days (21 CFR 812.15) When was the Nuremberg Code issued? - ✔1947 What are the 10 points made in the Nuremberg Code? - ✔1) Voluntary informed consent should be obtained 2) Research should yield benefit to society 3) Research should be based on animal work 4) Avoid unnecessary suffering 5) Don't do research resulting in death or disabling injury 6) Risks should be justified by benefits 7) Proper prep and adequate facilities should be used 8) Conducted by scientifically qualified people 9) Subject can withdraw whenever 10) Researchers can end the study if risks are too great 2) Life threatening 3) Requires hospitalization or prolongation of hospitalization 4) Results in significant disability 5) Results in congenital abnormality/birth defect What FDA regulations govern SAE reporting? - ✔21 CFR 312 What is the medical device equivalent of an SAE? - ✔Unanticipated Adverse Device Effect (UADE) What is the definition of a UADE? - ✔- Any serious adverse effect on health/safety, or any life-threatening problem or death associated with a device (if the effect was not already identified in a pre-market application) - Any other unanticipated serious problem associated with device as related to welfare of subjects What FDA regulations govern UADE reporting? - ✔21 CFR 812 (.15 and .3) What regulations govern research with pregnant women and fetuses? - ✔45 CFR 46 Subpart B What requirements must be met to conduct research with pregnant women/fetuses? - ✔1) With preclinical and clinical data on non-pregnant women assessing risk to pregnant women 2) Risk to fetus may result in direct benefit for woman or fetus, or risk is not greater than minimal + knowledge can't be obtained any other way 3) Risk is least possible 4) Consent obtained 5) Research benefitting fetus only requires mom+dad consent 6) Individuals providing consent understand impact on neonate 7) Assent + permission for pregnant children required 8) No inducements offered to terminate pregnancy 9) Researchers have no part in decisions to terminate pregnancy 10) Researchers have no part in determining viability of neonate When is father's consent not required for research involving neonates? - ✔- When there is prospect of benefit to mom - When dad unavailable, incompetent or temporarily incapacitated - Rape/incest What regulations provide research protections to children? - ✔45 CFR 46 Subpart D What is the legal age to provide consent in US? - ✔Varies by state, but generally 18 IRBs must classify research involving children into what categories? (4) - ✔1) Minimal risk only 2) Greater than minimal risk but may provide direct benefit 3) Greater than minimal risk with no potential benefit but generalizeable knowledge could be obtained 4) Presents opportunity to understand, prevent or alleviate a serious problem affecting health/welfare of kids, but not otherwise approvable What 2 criteria must research in kids with > minimal risk and prospect of benefit meet to be IRB-approved? - ✔1) Risk is justified by benefit 2) Relationship of risk to benefit is at least as favorable as any alternative What 3 criteria must research in kids with > minimal risk and no benefit meet to be IRB- approved? - ✔1) Risk is minor increase over minimal 2) Intervention experience is reasonably comparable to clinical care 3) Knowledge will be generalizeable What criterion must otherwise unapprovable research in kids meet to be IRB-approved? - ✔Presents opportunity to further understand, prevent or alleviate a significant problem affecting health/welfare of children and conducted with sound ethical principles Who determines whether consent is needed from child, mom and/or dad? - ✔IRB What 3 criteria should IRB consider when determining assent requirements? - ✔1) Nature of research 2) Child's age, status and condition 3) Whether all or some of children to be included will be capable of assenting What should happen when a child research subject turns 18? - ✔Re-consent What 2 additional protections are afforded child wards of the state? - ✔1) Research > minimal risk w/ no benefit must be directly related to wards or conducted in setting where majority of kids aren't wards 2) Advocate must be appointed by IRB to give consent for study participation and protect child's interests What FDA regulations govern financial disclosure? - ✔21 CFR 54 In what ways may sponsors provide investigator financial disclosures to the FDA? (3) - ✔1) FDA Form 3454 - no financial interests 2) FDA Form 3455 - complete disclosure statement 3) FDA Form 3454/option 3 - no financial disclosure obtained after due diligence What relationships are considered when reporting a financial disclosure? - ✔Investigator, spouse and dependent children What 5 scenarios require financial disclosure? - ✔1) Compensation to PI affected by study outcome 2) Proprietary interest in tested product 3) Equity interest in sponsor of study whose value can't be determined during time or study or for 1 yr after 4) Stock in sponsor $50k+ held during study and for 1 yr after 5) Significant payments of $25k+ from sponsor to investigator during study and for 1 yr after For what time period must financial interests be disclosed? - ✔During course of study + 1 yr after completion (Course of study: from date PI signs agreement with sponsor to date all subject follow up completed or study cancelled) What FDA regulations govern IRB related topics? - ✔21 CFR 56 IRBs must develop SOPs for which 6 items? - ✔1) Conducting initial and continuing review 2) Reporting findings and actions to investigator and institution 3) Determining which project require more review 4) Ensuring prompt reporting of changes in research activity 5) Ensuring changes are not initiated without IRB approval 6) Ensuring prompt reporting to IRB, sponsor and FDA about UAPs, noncompliance, suspension and termination What criteria should IRBs strive to achieve in membership (4) - ✔1) One member with scientific expertise 2) One member who is non-scientific 3) One member not affiliated with the institution 4) Both men and women What 11 components should IRB applications include? - ✔1) Purpose of research 2) Scientific rationale 3) Research setting 4) Whether participants will be vulnerable to coercion/undue influence 5) Inc/exc criteria 6) Recruitment/enrollment procedures 7) Method of advertising 8) Time required to participate 9) Procedures 10) Payment amount and schedule 11) Risks/benefits 3) Paper/electronic back up should be stored clear from hazards 4) Written procedures for documentation and maintenance should be developed/implemented 5) Commercially available systems should meet above considerations What FDA regulations govern the contents of a clinical trial protocol? - ✔21 CFR 312.53(c)(3) What criteria does the FDA require for Phase 1 protocols? (3) - ✔1) General outline of planned investigation 2) Estimated duration of study 3) Maximum # of subjects involved What criteria does the FDA require of Phase 2 and 3 protocols? (7) - ✔1) Outline of study protocol 2) Approximation of subject # treated vs controls 3) Clinical uses of treatment to be investigated 4) Characteristics of subjects by age, sex, condition 5) Clinical observations and lab tests to be conducted 6) Duration of study 7) Copies or description of CRFs to be used What regulatory body offers more guidance on protocol structure/contents? - ✔ICH GCP guideline What are the sections that ICH GCP recommends be included in a protocol? (6) - ✔1) General information 2) Trial objective and purpose 3) Trial design 4) Selection and withdrawal of subjects 5) Treatment of subjects 6) Statistics What additional sections are commonly used by sponsors in protocols? (8) - ✔1) Table of contents 2) Study procedures 3) Data safety monitoring plan 4) Adverse events 5) Data quality assurance 6) Administrative considerations 7) References 8) Appendices What 9 items should be included in the protocol "General Information" section - ✔1) Title 2) Protocol # 3) Date 4) Name/address of sponsor and monitor 5) People authorized to sign protocol 6) Name/contact for medical expert 7) Name/contact for sites 8) Name/contact for physicians responsible for medical decisions 9) Name/contact for labs and other technical depts What 8 items should be included in the "Background Information" section of the protocol? - ✔1) Name/desc of IP 2) Findings from nonclinical studies 3) Findings from clinical trials 4) Risks/benefits known 5) Route of admin, dosage, regimen and treatment period for IP 6) Statement of compliance with protocol, GCP and applicable requirements 7) Desc of population to be studied 8) References to relevant lit that provide background What 2 study designs are most commonly used in clinical trials? - ✔1) Parallel 2) Crossover What 3 items do statisticians consider to evaluate sample size? - ✔1) Magnitude of IP effect expected between treatment arms (Effect size) 2) Variability of outcome 3) Probability of observing effect (Power) How is power calculated? - ✔Using effect size and variability - usually a higher # of subjects is needed for higher power What are 2 methods used to reduce bias? - ✔1) Blinding 2) Randomization What are the 4 types of blinding? - ✔1) Triple blind: sponsor/investigator/subjects are blinded 2) Double blind: investigator/subjects blinded 3) Single blind: subjects blinded 4) Open label: no blinding What are the 3 types of control groups used in trials? - ✔1) Placebo 2) Standard of Care 3) Historical control When is SOC used as opposed to placebo in clinical trials? - ✔When placebo would be unethical and harmful to patients When are historical controls used in a clinical trial? - ✔When other controls aren't practical or ethical; but similarity between patients in historical control group and current treatment group is important What are historical controls? - ✔Prior data from similar patients with the disease to be studied, or data from same patient in crossover study What 9 items does ICH GCP guideline recommend be included in Trial Design section? - ✔1) Primary/secondary endpts 2) Type/design of trial 3) Measures to avoid bias 4) Treatments - dose, packaging, regimen 5) Duration of participation 6) Stopping rules 7) Accountability procedures for IP 8) Maintenance of randomization codes 9) Data to be recorded on CRFs/source data What 4 items should be included in a protocol to describe Withdrawal criteria? - ✔1) When/how to withdraw subjects 2) Type/timing of data collection for withdrawn subjects 3) Whether subjects will be replaced 4) Follow up for subjects withdrawn from IP treatment What 5 items should be included in the "Treatment of Subjects" section of the protocol? - ✔1) Name, dose, regimen, route of admin and treatment period for IP 2) Meds/treatments not permitted before and during trial 3) Procedures for monitoring subject compliance 4) IP storage and accountability 5) Return/destruction of IP What is a DSMB? - ✔Group of experts that review research data to ensure subject safety and data validity per a DSMPlan What 3 items should be discussed in a DSMP? - ✔1) Procedures for DSMB to oversee progress 2) Plans for DSMB to assure data accuracy and protocol compliance 3) How DSMB will review reporting of UAPs, AEs to sponsor, FDA and IRB What 4 items should be included in the Adverse Events section of the protocol? - ✔1) Safety parameters 2) Methods/timing for assessing, recording and analyzing safety parameters 3) Procedures for reporting and recording AEs and illnesses 4) Type/duration of followup for AEs 2) If IP is subject to Controlled Substances Act, investigator will take adequate precautions, including IP storage in secure location and limit access 3) Retain records for drug storage, tracking use, accounting, drug disposition (dates, quantity and use) 4) Reconcile IP received from sponsor 5) Train correct use of IP with each subject 6) Check subject is following instructions properly 7) Return unused supplies to drug sponsor or destroy drug on site should investigation be terminated, suspended or completed What are an investigator's responsibilities regarding IP in a device trial? 21 CFR 812 - ✔Similar to drug trials, but investigator must administer IP or supervise appropriate staff to do so What 6 items should be recorded by investigator's to maintain adequate IP records - ✔Dates, quantities, batch/serial numbers, expiration dates and code #s of: 1) Product delivery to site 2) Inventory at site 3) Dispensed IP 4) Usage by subject 5) Returned product 6) Disposed product What are an investigator's responsibilities during study visits? (5) - ✔1) Perform/oversee trial-related procedures 2) Provide medical decisions or ensure a qualified investigator does 3) Assess subject compliance 4) Evaluate subjects' response to treatment 5) Assess AEs and provide medical care What are an investigator's responsibilities regarding follow up care? (2) - ✔1) Provide or refer subject for medical care needed for intercurrent illnesses 2) Inform subject's PCP as needed How is source data defined by ICH GCP guidelines? - ✔Information in original records and certified copies of clinical findings, observations, or other trial activities necessary for reconstruction and evaluation of the trial How are source documents defined by ICH GCP guidelines? - ✔Original documents, data and records How does the FDA defined source data or documents, and in what regulations? - ✔As medical records and case histories - 21 CFR 312.62(b) and 21 CFR 812.140(3) How is a case history defined by 21 CFR 312.62(b) and 812.140(3)? - ✔Records of all observations and other data pertinent to the investigation for each individual administered the IP or control - Include CRFs and supporting data - Include consent forms and medical records What must case histories document, per 21 CFR 312? - ✔Informed consent obtained prior to participation in the study What does ALCOA stand for? - ✔Attributable Legible Contemporaneous (when was information obtained and was it corrected) Original Accurate What 5 items should be available when making corrections to source documents? - ✔1) Old value/text 2) New value/text 3) Date of correction 4) Name/initial of person making the correction 5) Reason for the change (as necessary) When can a CRF be considered a source document? - ✔When CRF is signed, dated and initialed by person recording the information What FDA regulation states that investigators can discontinue/withdraw a subject's participation in a trial at any time? - ✔21 CFR 50.25(b)(2) What 3 items should be documented when a subject is discontinued from a trial? - ✔1) Source: whether discontinuation resulted from investigator decision or subject 2) Reason 3) Impact: whether withdrawal was from all components of the research or just primary intervention When does subject discontinuation require reporting to the IRB? - ✔If trial is greater than minimal risk and IRB has stated that it must be notified when subjects discontinue When does subject discontinuation require reporting to the FDA? - ✔Not stated in regulation, but when discontinuation is due to AE or SAE What 4 reports must investigators provide to a sponsor? (per 312.64) - ✔1) Progress reports (annual report) 2) Safety reports (AEs/SAEs) 3) Final report 4) Financial disclosure report (during study and 1 yr after) What FDA regulation requires investigators to keep records of deviations from protocol with dates and reasons? - ✔21 CFR 812.140(a)(4) What regulations describe the essential documents to be kept in trial conduct? - ✔ICH GCP guideline, section 8 What are essential documents? - ✔Documents that permit evaluation of the conduct of the trial and quality of data produced What essential documents must be kept by both an investigator and sponsor before a trial? (15) - ✔1) IB 2) Protocol, amendments 3) CRFs 4) Financial agreement 5) Insurance (if applicable) 6) Agreements btw sponsor, investigator, CRO, etc. 7) IRB approval 8) IRB composition 9) Regulatory authority approval/notification 10) CVs for investigator and sub-Is 11) Lab normal ranges 12) Lab certification, CV 13) IP records 14) Decoding procedure 15) Trial monitoring report What essential documents need only be kept by the investigator before a trial? (1) - ✔Advertisements What essential documents need only be kept by the sponsor before a trial? (4) - ✔1) Sample of IP labels 2) Certificates of analysis for IP 3) Master randomization list 4) Pre-trial monitoring report What essential documents must also be kept with a 3rd party before a trial? (2) - ✔1) Decoding procedure 2) Master randomization list What additional documents must be kept by both investigator and sponsor during a trial? (10) - ✔1) Amendments to protocol, IB, CRFs and all pre-trial documents 2) IP destruction records 3) Communications 4) Completed CRFs and corrections 4) Define how progress will be monitored What is the definition of a sponsor per 21 CFR 312.3? - ✔Person who takes responsibility for and initiates a clinical investigation. Doesn't actually conduct the investigation personally unless the person is a sponsor-investigator. Companies that employ investigators to conduct a study are sponsors. What is the definition of a sponsor-investigator per 21 CFR 312.3? - ✔Individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. What are the roles and responsibilities of a sponsor, per 21 CFR 312.50? (6) - ✔1) Select qualified investigators 2) Provide investigators with information they need to conduct investigation 3) Ensure proper monitoring of the investigation 4) Ensure investigation is conducted in accordance with general plan/protocols in IND 5) Maintain IND 6) Ensure FDA and all investigators are informed of new AEs or risks What FDA regulation specifies sponsor roles and responsibilities? - ✔21 CFR 812.40 How should sponsors choose qualified investigators, per 21 CFR 312.53(a)? - ✔Select them as qualified by training and experience as appropriate experts to investigate a drug As a sponsor, what information is needed from investigators prior to clinical trial participation? - ✔1) Signed investigator agreement 2) CV 3) Signed protocol 4) Financial disclosure What FDA regulation governs the documents a sponsor should get from an investigator before trial initiation? - ✔21 CFR 312.53(c) What are the core components of an FDA 1572? (7) - ✔1) Investigator's name/address 2) Protocol name/code 3) Name of facilities 4) Name/address of lab 5) Name/address of IRB 6) Names of sub-Is 7) Commitment to regulations What 8 items does an investigator commit to when signing an FDA 1572? - ✔1) Follow protocol and make changes only after sponsor notification 2) Comply with FDA reqs 3) Personally conduct/supervise investigation 4) Inform subjects that drugs are investigational 5) Follow informed consent and IRB approval requirements (21 CFR 50 and 56) 6) Report AEs to sponsor 7) Read/understand info in IB 8) Ensure all staff are informed of their obligations What FDA regulation governs financial disclosure? - ✔21 CFR 54 What FDA regulation defines the contents of an Investigator's Brochure? - ✔21 CFR 312.23(a)(5) What 5 items should be present in an IB? - ✔1) Description of drug and formulation, including structural formula 2) Pharmacological and toxicological effects of the drug 3) PK and biological disposition of drug 4) Safety and effectiveness in humans 5) Possible risks and side effects What do FDA regulations mandate for sponsors regarding the IB? (2) - ✔1) Provide to each participating clinical investigator before the investigation begins (21 CFR 312.23(a)(5)) 2) Keep investigators informed of new observations discovered by or reported to the sponsor regarding AEs and safe use (21 CFR 312.55(b)) Who is ultimately responsible for a clinical trial being conducted according to regulations? - ✔Sponsor or sponsor-investigator via Clinical Trial Monitor or CRA What do FDA regulations state about monitors? - ✔Sponsors shall select monitors qualified by training and experience to monitor the progress of the investigation (21 CFR 312.53(d)) What are a monitor's responsibilities per ICH GCP 5.18? (16) - ✔1) Maintain communication btw sponsor and investigator 2) Verify investigator qualifications and resources 3) Verify IP accountability 4) Verify protocol compliance 5) Verify informed consent obtained 6) Ensure investigator has current IB, documents and supplies 7) Ensure investigator and staff adequately trained/informed 8) Verify investigator/staff perform trial fxns according to protocol and appropriate delegation 9) Verify eligible subject enrollment 10) Report recruitment rate 11) Verify source documents 12) Verify investigator reporting is complete/accurate 13) Check CRF entries and errors 14) Accurate reporting of AEs 15) Ensure investigator retains essential documents 16) Communicate deviations from protocol, SOPs and regulations What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? - ✔1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presents unreasonable and significant risk to subjects - assure disposition of out-standing drug and provide full report to FDA How long does a sponsor have to report study closure and full report to FDA if drug presented an unreasonable and significant risk to subjects? - ✔5 working days Who is responsible for generating a protocol per regulations, sponsor or investigator? - ✔21 CFR 312.53(c): investigator provides to sponsor (not usually case) 5.6.1-2 ICH GCP: sponsor utilizes qualified individuals as appropriate throughout all stages of trial process from protocol design to analysis; sponsor should provide investigators with protocol, updated IB and time to review information before entering into agreement In what 3 ways does a sponsor ensure investigators obtain informed consent before starting a subject in trial? - ✔1) Obtain signed FDA 1572 2) Provide sample ICF with all elements to investigator 3) Ensure appropriate monitoring What FDA regulations dictate AE/SAE reporting? - ✔1) 21 CFR 312.32 2) 21 CFR 812.46 What are IND safety reports? - ✔Reports from a sponsor to the FDA and all investigators about any potential serious risks associated with the IP - generated by sponsor and submitted within 15 calendar days of notification What are the 4 types of incidences that require an IND safety report for drug studies? - ✔1) Serious and unexpected suspected adverse reactions 2) Findings from other studies that suggest significant risk in humans 3) Findings from animal/in-vitro testing that suggest significant risk in humans 4) Increased rate of occurrence of serious suspected adverse reaction from previous protocol/IB Within how many days should a sponsor notify the FDA of the completion/termination of a SR device trial? - ✔30 working days Within what time period must a sponsor submit a final report to the FDA, all IRBs and all investigators after completion/termination of SR device trial? - ✔6 months Who is responsible for ensuring investigators are compliant with GCP requirements? - ✔Sponsors - obtain signed FDA 1572 or Investigator's Agreement stating investigator will comply with GCP, so usually require training What 4 items must sponsors provide procedures/instructions to investigators about? (Per ICH GCP 5.14.3) - ✔1) Handling/storage of IP 2) Receiving/dispensing of IP 3) Retrieval of unused IP 4) Return of unused IP to sponsor if authorized and in compliance What does ICH GCP 5.18.3 state regarding monitoring of investigators by sponsors? - ✔Sponsor should ensure trials are adequately monitored. Sponsor determines appropriate extent and nature of monitoring. There is usually a need for on-site monitoring before, during and after a trial. Sometimes, sponsor may determine central monitoring + investigators meeting and training is sufficient What regulation dictates that investigators and staff should be adequately trained? - ✔ICH GCP 5.18.4 Whose responsibility is it to ensure investigators and staff are trained? - ✔CTM or CRA What 5 types of reports must be made from an investigator to a sponsor? - ✔1) Safety occurrences 2) Protocol deviations 3) Progress reports 4) Final report 5) Financial disclosure report What 6 requirements does ICH GCP state for sponsors regarding IP accountability? - ✔1) Ensure timely delivery of IP to investigators 2) Maintain records of shipment, receipt, disposition, return and destruction 3) Maintain system for retrieving IP and documenting it 4) Maintain system for disposition of unused IP and documenting it 5) Take steps to ensure IP is stable over period of use 6) Maintain sufficient quantities of IP, record of batch sample analyses and characteristics, and retain samples as possible until analyses of trial data are complete What does ICH GCP 5.1.1 dictate regarding SOPs? - ✔Sponsors are responsible for implementing and maintaining QA/QC systems with written SOPs What is a FDA Form 1571? - ✔Cover page for IND application; lists information provided in submission What is FDA Form 1572? - ✔Statement of investigator What is FDA Form 3454? - ✔Certification of financial disclosure for investigators with no financial disclosures What is FDA Form 3455? - ✔Disclosure statement for financial disclosure of clinical investigators who have disclosable interests What is an IND? - ✔Application to FDA to seek permission to test a new drug or biologic in clinical trial involving people What are the 4 types of INDs? - ✔1) Commercial IND: sponsor 2) Investigator IND: sponsor/investigator 3) Emergency Use IND: emergency situations not allowing time for full IND 4) Treatment IND: for drug/biologic showing promise in testing for serious or immediately life-threatening conditions while final clinical testing and FDA review are taking place What are the 3 components of an IND? - ✔1) Animal pharmacology and toxicology studies 2) Manufacturing information 3) Clinical protocols and investigator information How many days must a sponsor wait after submitting an IND to conduct investigations? - ✔30 calendar days What is an IDE? - ✔Application to FDA to seek permission to test new medical device or in-vitro diagnostic in clinical trial involving people Which types of clinical studies must submit an IDE? - ✔Those that support an eventual premarket approval application and some 510(k) (notification) applications What is a MEDWATCH Form 3500? - ✔Voluntary reporting for healthcare professionals and consumers to report AEs found in course of clinical care What is a MEDWATCH Form 3500b? - ✔Consumer-friendly version of Form 3500 What is a MEDWATCH Form 3500a? - ✔Mandatory reporting form for sponsors, manufacturers, distributors, importers and user facilities to report AEs What type of final report is required for drug studies? - ✔None per FDA regulation; ICH GCP requires clinical trial report by submitted to appropriate regulatory agency as required When and to whom should final reports be submitted for SR studies? - ✔Notify FDA within 30 working days of study closure; submit final report to FDA, IRBs and investigators within 6 months When and to whom should final reports be submitted for NSR studies? - ✔Sent to all IRBs within 6 months of completion/termination What are the 7 recommendations for electronic document systems described in ICH GCP 5.5.3? - ✔1) Ensure eData processing systems conform to sponsor's established SOPs for completeness, accuracy, reliability and consistency 2) Maintain SOPs 3) Ensure systems document data changes and don't delete entered data 4) Maintain security system that prevents unauthorized access to data 5) Maintain list of individuals that can make data changes 6) Maintain backup of data 7) Safeguard blinding What FDA regulations are for electronic records and signatures for a closed system? - ✔21 CFR 11 What is a closed system? - ✔Access to system is controlled by people who oversee the content What is an open system? - ✔Access to system is not controlled by people who oversee the content (record can be read, modified or compromised by others) For what 3 reasons to sponsors conduct QA audit visits? - ✔1) Show quality oversight 2) Identify potential issues and improvements 3) Identify potential regulatory risks that may jeaopardize product approval How long should sponsors keep study records for drug trials? - ✔2 years after approval of marketing application or 2 years after shipment/delivery of IP discontinued and FDA notified How long should sponsors keep study records for device trials? - ✔2 years after investigation is terminated/completed or 2 years after date that records are no longer required for supporting a PMA or notice of completion of product development protocol What are the 6 components of a Quality System? - ✔1) Personnel roles/responsibilities 2) Training