SOCRA CCRP QUESTIONS AND ANSWERS 2024-2025 LATEST REVISED (ACTUAL EXAM) GRADED A+., Exams of Clinical Medicine

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SOCRA CCRP QUESTIONS AND

ANSWERS 2024-2025 LATEST REVISED

(ACTUAL EXAM) GRADED A+.

FDA Part 11 - Solution electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - Solution Food and Drugs, and ICF FDA Part 56 - Solution IRBs FDA Part 312 - Solution investigational new drug application FDA Part 812 - Solution investigational drug exemption FDA Form 482 - Solution Notice of inspection FDA Form 483 - Solution Letter of investigational observations/citation of noncompliance that specifies how long you have to respond. FDA Form 3454 - Solution Certification - Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 - Solution Disclosure - Financial Interests and Arrangements of Clinical Investigators FDA Form 3500 - Solution For Voluntary Reporting of Adverse Events and Product Problems FDA Form 3500A - Solution For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting investigator vs. sponsor vs. sponsor-investigator - Solution I: conducts trial S: initiates trial (manages and finances) S-I: conducts and initiates trial

minimal risk - Solution probability and magnitude of harm and discomfort are not greater than those encountered in day-to-day life Why should an individual be given ample time and sufficient opportunity to consider whether or not to participate? (2 reasons) - Solution 1) minimize coercion

2. understandable language What are exceptions to ICF general requirements? (for emergency use with IRB approval) - Solution 1) life-threatening situation necessitating use of test article
3. patient cannot communicate
4. insufficient time to communicate with legal representative
5. no alternative treatment with equal or greater likelihood of saving subject's life ___________ reports emergency use to __________ within ______ days - Solution investigator to IRB in 5 working days How soon should documentation be submitted to IRB after emergency use? - Solution within 5 days ICF should contain - Solution 1) explanation of purpose, duration of subject participation, etc.
6. any possible risks
7. any possible benefits
8. alternative treatments
9. confidentiality and possibility of FDA inspection
10. contact info
11. participation is voluntary
12. removal of PHI from biospecimens and if they will include genome sequencing
13. details of termination/option to withdraw short form - Solution states elements of ICF were presented orally to subject/legal rep, requires witness Who signs short form? - Solution patient and witness; PI and witness also sign summary

When a short form is required, is the patient given a copy of the short form, the summary, or both? - Solution both FDA 50.5 Part D - Solution obtaining assent form children (cannot be greater than minimal risk) clinical investigation involves what? - Solution a test article and one or more human subjects emergency use - Solution use of test article when the situation is life- threatening and there is no standard acceptable treatment available, with no time to obtain IRB approval IRB - Solution Institutional Review Board; designated to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects What is the primary purpose of the IRB? - Solution to assure protection of rights and welfare of human subjects "active protocol" - Solution initial review and continuing review every 12 months How often do IRB's have to renew registration? - Solution every 3 years IRB must send any info changes within ____ days of change - Solution 90 IRB requirements - Solution 1) at least 5 members

2. 1 member whose primary concerns are in the scientific area
3. 1 member whose primary concerns are in a nonscientific area
4. 1 member not affiliated with the institution
5. no IRB members can have conflicts of interest
6. the IRB can invite individuals with expertise in complex areas Vulnerable people - Solution children, prisoners, pregnant women, physically or mentally disabled people, economically or educationally disadvantaged people

True or False: As long as there is a potential for benefit, extremity of risk does not matter - Solution risk must be reasonable in relation to anticipated benefits CRF 56.110 Subpart D - Solution FDA may restrict, suspend, or terminated institution's or IRB's use of expedited review to protect rights and wellbeing of subjects Examples of research that can utilize expedited review - Solution research involving no more than minimal risk, minor changes in approved research Who has the power to disqualify an IRB? - Solution the Commissioner, notice is then sent to FDA When and why is joint review used? - Solution for multi-institutional studies to avoid duplication of effort IEC - Solution Independent Ethics Committee, includes IRBs IND should be labeled with ____________ - Solution Caution: new drug with no false or misleading claims IND Phase 1 - Solution initial introduction to determine metabolism, pharma actions of drug on humans, side effects, to gain early evidence of effectiveness. for 20-80 patients IND Phase 2 - Solution evaluate effectiveness of drug for particular indication, determine short term side effects and risks. for 100s of patients IND Phase 3 - Solution expanded controlled and uncontrolled clinical trials, preliminary effectiveness, additional safety info, evaluation of benefit- risk relationship, basis for physician labeling. for 100s-1000s of patients When to protocol, content, investigator, etc. Changes need to be submitted as amendments? - Solution 30-day intervals prior to implementation IP must provide what in protocol? - Solution -drug substance and formula -effects on animals and humans -safety and effectiveness -possible risks and side effects

-pharma and toxicology reports (any in vitro and effects on fetus) -radioactivity and absorption of dose adverse event - Solution any untoward medical occurrence associated with the use of a drug (whether or not it is related to drug) serious AE - Solution -life-threatening (or results in death) -results in hospitalization or prolongation -substantial disruption of ability to conduct normal life -congenital anomaly/birth defect suspected AE - Solution reasonable possibility drug caused AE, causal relationship unexpected AE - Solution if not listed in investigator brochure, not specifically observed, or not consistent with risk info Who must review safety info of investigational drug? - Solution sponsor __________ must notify ________ and ________________ of safety risks regarding an IND within _____ days - Solution sponsor must notify FDA and investigators within 15 calendar days Sponsor must report AEs that are ________ and ________ - Solution serious and unexpected (if there is evidence to suggest causal relationship with drug) ___________ must report study endpoints to __________ - Solution sponsor to FDA How soon do sponsors have to report any fatal or life-threatening AEs? - Solution within 7 days of initial notification Who provides annual reports and when? - Solution sponsor, within 60 days of IND anniversary clinical hold - Solution order issued by FDA to sponsor to delay or suspend proposed trial -no new subjects and current subjects should be taken off therapy unless FDA allows them to continue in the interest of patient safety

ground for clinical hold - Solution -exposure to unreasonable and significant risk -unqualified PI -misleading investigator brochure -IND does not contain sufficient info to assess risks -reproductive toxicity risk -other major safety issues If an IND is on a clinical hold for more than one year, ______________________________ - Solution it is place on inactive status by FDA IND goes into effect _______ days after submission to FDA unless notified prior - Solution 30 2 reasons for inactive status - Solution 1) IND is under clinical hold for 1+ year

2. no subjects enrolled for 2+ years IND that is inactive for ___________ can be terminated - Solution 5 years True or False: Sponsor is not required to submit annual reports for INDs of inactive status. - Solution True, and they must submit an amendment if they wish to become active again purpose of phase 2 meetings - Solution safety of proceeding to phase 3 and developing methods of presentation and submission of data in the marketing application ________ can transfer responsibilities to CRO - Solution sponsor Who selects monitors? - Solution sponsor Primary purpose of trial monitoring - Solution 1) rights and well-being of human subjects
3. accurate, complete, and verifiable data
4. compliance with protocol and GCP FDA form 1572 - Solution investigator statement

sponsor should keep IP records for how long? - Solution 2 years FDA form 312.64 - Solution Investigator reports:

1. progress
2. safety
3. final
4. financial disclosure Who is responsible for making sure IRB complies with part 56? - Solution investigator IRB 312 subpart E - Solution Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses requirements for drugs intended to treat life-threatening or severely debilitating illnesses - Solution -medical risk-benefit judgement by FDA and relative experts to grant marketing approval -no comparable or satisfactory alternative plan define immediately life-threatening/severely debilitating - Solution major irreversible morbidity (high likelihood of death) serious disease - Solution A disease or condition associated with morbidity that has substantial impact on day-to-day functioning Phase 4 studies - Solution post market studies that may reveal additional side effects, adverse effects and drug interactions Tor F: Countries are not to stockpile investigational drug as this prevents access of the drug to other countries. - Solution False: IND may be stockpiled in anticipation of national emergency with approval from FDA and HHS 2 specialized regulatory organizations - Solution 1) Center for Drug Evaluation and Research (CDER)
5. Center for Biologics Evaluation and Research (CBER)

If an IDE is approved, what is it exempt from? - Solution the requirements of the following sections of Federal Food, Drug, and Cosmetic Act: -Misbranding under section 514 -Premarket approval under section 515 -Banned device regulation under section 516 -Records and reports under section 519 -Restricted device and manufacturing practice requirements under section 520 IDE approval - Solution permits the use of a device that would otherwise be required to comply with performance standards or have premarket approval to conduct investigation, cannot be significant risk device IDE cannot be ______________________ device - Solution significant risk device implant - Solution a device that is placed into a surgically or naturally formed cavity in the human body that is intended to stay there for 30+ days noninvasive - Solution when applied to diagnostic device or procedure, device does not penetrate or pierce the skin or mucous membranes of the body or enter in any other location True of False: if a device is IDE and IRB has been notified, it can be marketed - Solution false, and it must be labeled with "Caution" How long should investigator or sponsor maintain records? - Solution 2 years FDA shall consider the use of investigation device under a treatment IDE if:

• Solution 1) device is intended to treat or diagnose a serious/life- threatening disease or condition

2. no compatible or satisfactory alternative device or therapy is intended to treat or diagnose the stage of the disease or condition
3. the device is under investigation in a controlled clinical trial for the same use under an approved IDE or clinical trials have been completed
4. sponsor of investigation is actively pursuing marketing approval/clearance of investigational device

_____________ of a treatment IDE shall submit progress reports on a ____________ basis to ____________ until filing marketing application - Solution sponsor must submit on a semi-annual basis to reviewing IRBs and FDA (after submitting marketing app reports become annual) unanticipated AE must be reported by ___________to _______________in ________ business days - Solution investigator to sponsor in 10 days and then sponsor to FDA within 10 working days List 4 situations that must be reported by investigator to sponsor within 5 working days. - Solution 1) withdrawal of IRB approval

2. deviations
3. not obtaining ICF
4. significant risk device determinations When obtaining informed consent, the PI should adhere to _____________ and the ethical principles that have their origin in ________________. - Solution GCP and Declaration of Helsinki Sponsor responsibilities if IRB approval is withdrawn - Solution sponsor shall notify FDA, IRBs, and investigator within 5 working days The investigator should give the final report to ________________ within ______________________ following study completion. - Solution to sponsor within 3 months Sponsor responsibilities if FDA approval is withdrawn - Solution sponsor shall notify IRBs and investigator within 5 working days If a device is recalled, ___________ should notify ____________ withing _________ days - Solution sponsor should notify FDA within 30 days If the sponsor determined that an unanticipated adverse device effect present unreasonable risk to patients, what should occur? - Solution termination no later than 5 working days after sponsor's determination, and no later than 15 working days after sponsor first received notice of effect FDA 45 Code of Federal Regulations Part 46 - Solution public welfare/protection of human subjects

(with general ICF requirements) What is research? - Solution systematic intervention designed to develop or contribute to generalizable knowledge What is NOT research? - Solution -scholarly or journalistic activities including collecting and using info -public health surveillance activities -collection and analysis of info, biospecimen, or records by a criminal justice agency authorized by law -authorized national security activities cooperative research - Solution projects involving one or more institution, each is responsible for safeguarding the rights and welfare of human subjects but must rely on approval of only ONE IRB Cooperative research projects with multiple institutions should enter into what? - Solution joint review agreement and rely on IRB of another institution According to _________ how long should IRB records be retained? - Solution 45 Code of Federal Regulations Part 46: Public Welfare, 3 years _______ may request to review documentation and reports from ________

• Solution FDA request from investigator (who should permit the request) ICF should not include _____________ - Solution exculpatory language in which subject waives legal rights or releases investigator/sponsor/institution from liability of negligence When is a waiver or alteration of consent acceptable? - Solution o Study, evaluated, or examine a public benefit/service program o No more than minimal risk o If research involves using PHI then it was used because it cannot be avoided No adverse effects on rights or welfare of subjects An IRB may waive the requirement for an investigator to obtain signed consent for some or all subjects if?? - Solution 1) that the consent would

be the only linking document resulting in potential harm from breach of patient confidentiality

2. research presents no more than minimal risk and involves no procedures for which consent is normally required outside of research Where is the Common Rule? - Solution 45 CFR Part 46; protects human subjects under HHS 45 Code of Federal Regulations part 46 Subpart B - Solution additional protections for pregnant woman, human fetuses, and neonates involved in research conducted or supported by Department of Health and Human Services (DHHS) 45 Code of Federal Regulations part 46 Subpart C - Solution additional protections pertaining to research conducted or supported by Department of Health and Human Services (DHHS) involving prisoners as subjects 45 Code of Federal Regulations part 46 Subpart D - Solution additional protections pertaining to research conducted or supported by Department of Health and Human Services (DHHS) involving children as subjects fetus - Solution product conception from implantation through delivery dead fetus - Solution no heartbeat, respiratory activity, muscle movement, or pulsation of umbilical cord neonate - Solution newborn nonviable neonate - Solution a neonate after delivery that, although living is not viable acceptable risk level for mother and fetus - Solution no greater than minimal risk and consent of both parents required viability and research - Solution research will have no part in determining viability. viability must be determined prior to participation IRBs when prisoners are involved - Solution majority should not be associated with the prison but one member of the board shall be a prisoner or prisoner rep

assent - Solution child's affirmative agreement to participate in research, parental permission is still required Children - Solution Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted Can wards participate in research? - Solution yes but only if they have an advocate serving as the child's legal guardian IRB must register and comply with ________ and ___________ - Solution Office of Human Research Protection; and Health and Human Services OHRP - Solution Office for Human Research Protections HHS - Solution Health and Human Services How long is IRB registration effective for? - Solution 3 years What is MedWatch? - Solution a voluntary FDA adverse event reporting system, should include reporting person, AE details, product details, affected person demographics, manufacturer info Belmont Report goals - Solution to identify basic ethical principles in research with human subjects Who wrote the Belmont Report? - Solution National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research What is the difference between practice and research in the Belmont report? - Solution Practice: interventions that are designed solely to enhance the well-being of an individual (that have a reasonable expectation of success) Research: activity designed to test a hypothesis, draw conclusions, and develop generalizable knowledge Belmont Report 3 Basic Ethical Principles - Solution 1) respect for persons

2. beneficence

3. justice respect for persons - Solution 1) treating persons as autonomous agents (acknowledge)
4. protecting those with diminished autonomy (protect) beneficence - Solution 1) do not harm
5. maximize benefits and minimize harm injustice - Solution when some benefit to which a person is entitled is denied without good reason or when burden is imposed unduly Belmont Report applications (General Principles of research conduct) - Solution 1) Informed consent
6. risk/benefit assessment
7. selection of research subjects 3 elements of ICF according to Belmont Report - Solution 1) information (benefits and risks)
8. comprehension (may include comprehension tests)
9. voluntariness coercion - Solution when an overt threat of harm is intentionally presented in order to obtain compliance Undue Influence - Solution offer of excessive, unwarranted, inappropriate, or improper reward in order to obtain compliance (often occurs when one person is in position of authority) Unjustifiable pressures - Solution often occur when people are in positions of authority or have commanding power Should benefits be judged by probability or compared to risk of harm? - Solution compared to risk of harm assessment of risk and benefits: What are the 3 factors? - Solution 1) determination of validity of presuppositions of research
10. nature, probability and magnitude of risk
11. estimate of harm assessed by known facts or other available studies

to socially balance justice and benefits/risks, ...? - Solution research should specify who and should not participate based on the buren to bear Tor F: injustice specifically pertains to the study in question - Solution false, it goes beyond the study and is societal Declaration of Helsinki physician statement - Solution the health of my patient will be my first consideration and I shall act in the patient's best interest when providing medical care Who is responsible for the protection of research subjects? - Solution medical physicians and professionals, not the subject According to the Declaration of Helsinki, while the primary purpose of medical research is to ____________________, this goal can never take precedence over the ___________________ - Solution generate new knowledge; rights and interests of individual research subjects When is research for vulnerable groups justified? - Solution in response to health needs of said group and cannot be conducted in non-vulnerable group When is consent not needed? - Solution if the patient is physically unable, legal rep is unreachable, IRB has approved, must benefit, and minimal risk/burden *patient or rep must consent when available ASAP dissent - Solution when a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, legal rep must also approve If a patient chooses to withdraw, this should not affect ____________ - Solution patient-physician relationship When can a placebo be used? - Solution -when no proven intervention exists -when comparing interventions

Can a physician use unproved interventions? - Solution yes but only if physician deems appropriate to save life or reduce suffering and with patient consent Declaration of Geneva - Solution a declaration of physicians' dedication to the humanitarian goals of medicine, a declaration that was especially important in view of the medical crimes which had just been committed in Nazi Germany GCP - Solution international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects ICH Harmonised Guideline for Good Clinical Practice E6 (R2) - Solution describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process Ethical principles from ICH GCP draw from which document? - Solution Declaration of Helsinki ICH GCP guidance is the current thinking/recommendation of whom? - Solution FDA (recommendation, not legally enforcable) ICH - Solution international conference of harmonisation What countries recognize ICH GCP? - Solution EU countries, Japan, and US (guidance was developed using GCP from US, EU, Japan, Canada, Australia, and WHO) blinding/masking - Solution one or more parties in the trial is unaware of the treatment assignment audit - Solution A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related

activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirement(s). Should have an audit trail and documentation of completion If an auditor identifies noncompliance, what should they do? - Solution sponsor should take action and perform root cause analysis, then implement corrective and preventative measures Who conducts audit? - Solution sponsor selects people who are independent of trial and qualified IDMC - Solution Independent Data Monitoring Committee True or False: Since the PI is primary in communicating with the IRB, it is not necessary for any contact between sponsor and IRB. - Solution False, sponsor should obtain contact info about IRB from the PI or institution Regarding new information, the sponsor should update the ________________ - Solution investigator's brochure Overall aim of Investigator's Brochure - Solution to provide investigators with clear understanding of possible risks and adverse reactions relative to the clinical study _____________ is responsible for providing Investigators brochure to ______________ and then they provide it to __________________ - Solution sponsor to PI and then PI to IRB T or F: both sponsor and PI need IRB approval documents, even though PI is in direct communications - Solution True both need approval from IRB If a trial is single blind, who is blinded: patient or PI/treatment team? - Solution patient coordinating committee - Solution A committee that a sponsor may organize to coordinate the conduct of a multicenter trial (with coordinating investigator)

CRO - Solution Contract Research Organization, contacted by sponsor to perform one or more of sponsor's trial-related duties impartial witness - Solution person independent of the trial but involved in ICF process multicenter trial has one ______ and multiple ______ - Solution one protocol and multiple sites 2 methods to reduce/avoid bias - Solution randomization and blinding Is centralized monitoring on or off site? - Solution remote evaluation of accumulating data performed in a timely manner, supported by appropriately qualified and trained people, can reduce time needed to monitor on-site Investigator's Brochure - Solution A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. T or F: Adverse events must have a causal relationship with IP. - Solution False, AE is any untoward medical occurrence while a patient is in a trial- may or may not be causal adverse drug reaction (ADR) - Solution all noxious and unintended responses to a medicinal product, causal relationship is at least a possibility unexpected ADR - Solution an adverse event that is not consistent with Investigator's Brochure Severe refers to __________ and serious refers to _________________ - Solution intensity; outcome Who should report protocol deviations to IRB? - Solution investigator Protocol deviation and/or protocol amendment must be submitted to: - Solution IRB, sponsor, and any other regulator authorities

nontherapeutic trials - Solution trials with no anticipated direct clinical benefit to subject; subject should be able to consent without legal rep unless subject cannot consent and risk is low True or false: if sponsor terminates, they should inform the PI and IRB. - Solution False, then inform PI and PI informs IRB In the event either investigator or sponsor terminates, who informs the IRB? - Solution investigator If IRB terminates, who do they inform? - Solution PI, and PI informs sponsor Upon trial completion, who informs IRB? - Solution investigator If a sponsor transfers any or all of its duties or functions to a CRO who is ultimately responsible for the quality and integrity of the trial data? - Solution sponsor distinction of expected vs unexpected AEs - Solution from perspective of previously observed, not on basis of what might be anticipated from pharmalogical properties unexpected=not consistent with info in relevant source docs If one AE has been expedited reported and source docs are being amended and the same AE occurs in another patient, how should reporting be handled? - Solution expedited reporting is still required for any more reports until source docs are officially amended All ADRs that are ___________ and ___________ are subject to expedited reporting - Solution serious and unexpected (Does not need to be reported if serious but expected) Should an event that is serious but expected be expedited in reporting? - Solution no Should an event that is serious but not considered related to the study product be expedited in reporting? - Solution no

If an ADR is serious and expected appears to have an increase in the rate of occurrence that is clinically important, does it meet standards for expedited reporting? - Solution yes (affects the benefit/risk product assessment and use in the trial) causality assessment - Solution an evaluation performed by a medical professional or sponsor concerning the likelihood that a therapy or product under study caused or contributed to an adverse event Fatal or life threatening ADRs should be reported within ___________ calendar days and complete report should be sent within ________ additional calendar days to regulatory agencies - Solution 7; 8 serious unexpected ADRs must be reported within __________ calendar days after sponsor first knowledge - Solution 15 What is the widely accepted standard for expedited AE reporting? - Solution CIOMS-I, and reports should be sent to required regulatory parties How and why to break blinding of a patient - Solution if a serious AE is judged to be reportable, only break blind for one patient and only to those who need to know (not statisticians) Do placebo reactions fall under ADR, for expedited reporting, or neither? - Solution Neither Nuremberg Code - Solution ethical code of conduct of ten principles for research that uses human subjects Declaration of Helsinki - Solution 32 principles regarding research compared to normal medical care and distinction of benefit to patients and/or research Tuskegee Syphilis study - Solution 600 low income Black men not told they had syphilis but were given free medical care. Denied treatment for trial ___________________ was created after the Tuskegee trial - Solution Belmont Report

The Common Rule - Solution 1980s: HHS protection of human subjects 2018: updated to include biospecimen and data minimum number of IRB members - Solution 5 source doc vs. CFR (case report form) - Solution source doc: where info is 1st recorded CRF: study specific form (designed to record info specified in protocol) FDA form 3500 vs 3500A - Solution 3500: voluntary reporting any AE to FDA 3500: mandatory reporting of drug or medical device AE to FDA FDA Part 50.20 - Solution general requirements for informed consent FDA Part 50.23 - Solution exception from general ICF requirements FDA Part 50.24 - Solution exception from informed consent requirements for emergency research FDA Part 50.25 - Solution elements of ICF FDA Part 50.27 - Solution documentation of ICF FDA 56.110 - Solution Expedited review procedures for research with no more than minimal risk and for minor changes in approved research In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? a. The investigator provides his/her written approval b. The study drug has an FDA approved marketing application c. The FDA provides written approval of the IND d. Subjects cannot be enrolled until IRB/IEC approval has been obtained - Solution d. Subjects cannot be enrolled until IRB/IEC approval has been obtained 21 CFR Part 314 - Solution Applications for FDA Approval to Market a New Drug

21 CFR Part 814 - Solution Premarket Approval of Medical Devices Informed consent documents must contain which of the following? a. A description of the scientific background for conducting the investigation b. An explanation of the purpose of the investigation c. Contact information for the sponsor of the investigational drug/device d. A description of the investigator's responsibilities - Solution b. An explanation of the purpose of the investigation With respect to IRB/IEC membership, both the FDA and the ICH require that a. A majority of the members' primary area of interest is in a scientific area b. At least one member holds a Ph.D. degree or equivalent c. At least one member's primary area of interest is in a nonscientific area d. A majority of the members are from or have ties to the institution of record - Solution c. At least one member's primary area of interest is in a nonscientific area