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 complet
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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
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
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) - 1) Statement that treatment may involve unforseeable risks
2) Circumstances in which subject participation may be terminated
3) Additional costs to subject
4) Consequences of subject's decision to withdraw
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) 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) - 1) No person can participate without their or LAR consent (50.20)
2) Documentation of informed consent is required (50.27)
What are the 4 components of the consent process using a short form? - 1) Short form consent document stating all elements of ICF have been presented orally to pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) 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)? (5 possibilities) - Any untoward occurrence that results in:
1) Death
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
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