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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
3. Informed consent will be sought from subjects or LARs 5. Informed consent will be documented
4. There is adequate provision of monitoring
5. 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?
6. Statement that the study involves research, purpose and expected duration, description of experimental procedures

2. Description of reasonably foreseeable risks 3. Benefits
3. Disclosure of alternative procedures or courses of treatment
4. Confidentiality measures
5. Compensation and treatments available if injury occurs 7. contact information
6. 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
7. 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)
8. Risks are justified by benefits
9. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches
10. Assent + consent What are the criteria for involving children in greater than minimal risk research with no direct benefit? (4)
11. Risks are minor increase over minimal risk
12. Intervention presents experiences that are reasonable commensurate with normal medical and living situations
13. 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 When was the Declaration of Helsinki released? 1964 Who developed the Declaration of Helsinki? World Medical Association (WMA) What is the Declaration of Helsinki? Document that laid out general principles physicians should follow to conduct research with humans, based on Nuremberg Code. First effort of medical community to regulate itself When was the Belmont Report released? 1979 Who created the Belmont Report? National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (at direction of National Research Act 1974)

What are the 3 principles in the Belmont Report?

1. Respect for Persons: informed consent required and individuals with diminished autonomy get special protections
2. Beneficence: maximize benefit to research while minimizing risk to subjects
3. Justice: one group of people shouldn't assume risks for the benefit of another (equality and diversity of participants) In what order were historical declarations for human subjects protection released? Nuremberg Code > Declaration of Helsinki > Belmont Report At what reading level should ICFs be written? 6th-8th grade What FDA guideline lists the basic elements of informed consent? 21 CFR 50 (50.25) What are the additional elements of informed consent per FDA guidelines? (7)
4. Statement that treatment may involve unforseeable risks
5. Circumstances in which subject participation may be terminated
6. Additional costs to subject
7. Consequences of subject's decision to withdraw
8. Statement that new findings will be provided to subject

9. of subjects in study

10. clinicaltrials.gov statement (as applicable) Who ultimately approves an ICF? IRB - sponsor can provide sample form Describe the 2 most important points to consider when consenting patients (per 21 CFR 50)
11. No person can participate without their or LAR consent (50.20)
12. Documentation of informed consent is required (50.27) What are the 4 components of the consent process using a short form?
13. Short form consent document stating all elements of ICF have been presented orally to pt/LAR
14. Oral presentation of required elements
15. IRB-approved summary of what is said
16. Witness present during presentation

How do you document short form consent?

1. Subject/LAR signs short form consent
2. Witness signs short form consent and summary
3. Person obtaining consent signs summary

• Copy of short form consent and summary are given to subject/LAR How do you document long form consent? Subject/LAR signs long form consent Do you keep informed consent records for patients who withdraw during study? Yes CRA should monitor what elements of consent process? (5)

1. Subject signed most recent version of form
2. Subject signature and name are both present
3. Subject dated themselves and date is correct
4. Errors were corrected adequately
5. All pages of ICF are present What is Source Data Verification? (SDV) CRF or other data collection instruments are compared to original source of information to confirm data accuracy What is Source Data Review (SDR) Review of source documentation to check quality, and review and ensure protocol compliance What is the definition of an adverse event (AE)? Sign, symptom, illness or untoward experience that develops or worsens during a study, regardless of relation to study treatment How are AEs documented?

• In AE CRF for sponsor (or other study collection mechanism)
• In medical record What 3 components of AE documentation should CRAs monitor?

1. Ensure AEs are recorded in study files and medical record

2. Make sure protocol procedures were followed
3. Check that responsible person assessed AE for seriousness, causality and expectedness What is the definition of a serious adverse event (SAE)? ( possibilities) Any untoward occurrence that results in:
4. Death
5. Life threatening
6. Requires hospitalization or prolongation of hospitalization
7. Results in significant disability
8. 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?
5. Risk is justified by benefit
6. 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?
7. Risk is minor increase over minimal
8. Intervention experience is reasonably comparable to clinical care
9. 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?
4. Research > minimal risk w/ no benefit must be directly related to wards or conducted in setting where majority of kids aren't wards
5. 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)
6. FDA Form 3454 - no financial interests
7. FDA Form 3455 - complete disclosure statement
8. 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?
9. Compensation to PI affected by study outcome
10. Proprietary interest in tested product
11. Equity interest in sponsor of study whose value can't be determined during time or study or for 1 yr after
12. Stock in sponsor $50k+ held during study and for 1 yr after
13. 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)
7. One member with scientific expertise
8. One member who is non-scientific
9. One member not affiliated with the institution
10. Both men and women What 11 components should IRB applications include?
11. Purpose of research
12. Scientific rationale
13. Research setting
14. Whether participants will be vulnerable to coercion/undue influence
15. Inc/exc criteria
16. Recruitment/enrollment procedures
17. Method of advertising
18. Time required to participate
19. Procedures
20. Payment amount and schedule
21. Risks/benefits What is the definition of minimal risk? Probability and magnitude of harm anticipated aren't greater than those ordinarily encountered in daily life during performance of routine physical or psychological exams/tests (21 CFR 56.102(i) When may an IRB use expedited review processes? (2) One or both:
22. Some or all of research is no more than minimal risk
23. Minor changes in previously approved research during approval period

What are the three types of medical device studies listed under IDE regulation (21 CFR 812)?

1. Significant risk
2. Non-significant risk
3. Exempt Who determines whether a device trial is SR, NSR or exempt? Sponsor/investigator makes suggestion > IRB makes decision > FDA confirms What are the 4 criteria that define a significant risk device? (21 CFR 812.3(m))
4. Intended as an implant
5. Represented to be for use in supporting/sustaining life
6. Use is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of health

• All of the above: and presents potential for serious risk to health, safety or welfare of subjects

4. Otherwise presents potential for serious risk to health, safety or welfare of subjects What is the definition of a Non-Significant Risk device? Doesn't meet criteria of a significant risk device. Not necessarily a minimal risk study. What regulations must SR studies follow? (2)
5. Follow all IDE regulations in 21 CFR 812
6. Have IDE application approved by FDA prior to study start What regulations must NSR studies follow? (3)
7. Follow abbreviated IDE regulations (21 CFR 812(b))
8. Don't need IDE application approved by FDA
9. Sponsors/IRBs don't have to report to FDA prior to study start What are the 7 options for exempt device studies?
10. In distribution before 5/
11. Device substantially equivalent to one meeting criteria 1 and is used following FDA labeling
12. Diagnostic device that meets 4 criteria (not invasive, introduce energy or used w/o confirmation by other diagnostic device)
13. Undergoing consumer testing, modification testing or combination testing if subjects not at risk
14. Veterinary use
15. Lab animal use
16. Custom device unless being tested for commercial distribution

If device meets even 1 of the criteria for exemption, what is the regulatory process? IRB review and approval - no FDA notification required Who reviews a SR device study first, FDA or IRB? FDA; IRB assists in making determination but requires approved IDE to issue approval What is the key regulatory difference between SR and NSR device review? SR requires FDA approval through IDE then IRB approval; NSR only requires IRB approval What FDA regulations govern IRB documentation requirements? 21 CFR 56. What 7 activities must IRBs maintain documentation of?

1. Research proposals and attachments
2. IRB meeting minutes
3. Continuing review
4. Correspondence btw IRB/investigators
5. IRB member list
6. Written IRB SOPs
7. Statements of significant new findings provided to subjects What 4 attachments to research proposals should IRBs maintain documentation of?
8. Scientific evaluations
9. Approved ICFs
10. Progress reports
11. Reports of subject injuries What 5 items should be documented in IRB meeting minutes?
12. Attendance at meeting
13. Actions taken by IRB
14. Vote on actions, including # voting for, against or abstaining
15. Basis for requiring changes or disapproving research
16. Written summary of discussion of issues and resolution What 5 descriptive items should IRB members be documented by?
17. Name
18. Degrees
19. Representative capacity
20. Indication of experience (board certifications, etc.)

5. Employment or other relationship btw member and institution What 5 considerations should be used for IRBs maintaining documentation electronically?
6. IRB records should be secure
7. Access should be limited with appropriate clearance
8. Paper/electronic back up should be stored clear from hazards
9. Written procedures for documentation and maintenance should be developed/implemented
10. 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)
11. General outline of planned investigation
12. Estimated duration of study
13. Maximum # of subjects involved What criteria does the FDA require of Phase 2 and 3 protocols? (7)
14. Outline of study protocol
15. Approximation of subject # treated vs controls
16. Clinical uses of treatment to be investigated
17. Characteristics of subjects by age, sex, condition
18. Clinical observations and lab tests to be conducted
19. Duration of study
20. 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)
21. General information
22. Trial objective and purpose
23. Trial design
24. Selection and withdrawal of subjects
25. Treatment of subjects
26. Statistics What additional sections are commonly used by sponsors in protocols? (8)
27. 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
9. Title
10. Protocol #
11. Date
12. Name/address of sponsor and monitor
13. People authorized to sign protocol
14. Name/contact for medical expert
15. Name/contact for sites
16. Name/contact for physicians responsible for medical decisions
17. Name/contact for labs and other technical depts What 8 items should be included in the "Background Information" section of the protocol?
18. Name/desc of IP
19. Findings from nonclinical studies
20. Findings from clinical trials
21. Risks/benefits known
22. Route of admin, dosage, regimen and treatment period for IP
23. Statement of compliance with protocol, GCP and applicable requirements
24. Desc of population to be studied
25. References to relevant lit that provide background What 2 study designs are most commonly used in clinical trials?
26. Parallel
27. Crossover What 3 items do statisticians consider to evaluate sample size?
28. Magnitude of IP effect expected between treatment arms (Effect size)
29. Variability of outcome
30. 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?
3. Triple blind: sponsor/investigator/subjects are blinded
4. Double blind: investigator/subjects blinded
5. Single blind: subjects blinded
6. Open label: no blinding What are the 3 types of control groups used in trials?
7. Placebo
8. Standard of Care
9. Historical control When is SOC used as opposed to placebo in clinical trials? When placebo would be unethical and harmful to patients