SOCRA CERTIFICATION EVALUATION EXAM 2026
QUESTIONS AND ANSWERS SURE A+
✔✔What are the steps for withdrawing and IND? 21 CFR Part 312.38 - ✔✔A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA.
-Stopping all studies and notifying the Investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor.
-If the study is withdrawn for safety reasons, the Sponsor must notify Investigators and
the IRBs.
✔✔Which form is used to certify absence of financial interest? - ✔✔FDA Form 3454
✔✔What form is used for the mandatory reporting of serious adverse events? - ✔✔FDA
Form 3500A
✔✔What is 21 CFR Part 50 Subpart D? - ✔✔Additional Safeguards for Children in
Clinical Investigations
✔✔What is the FDA Form 482? - ✔✔Notice of Inspection
✔✔What is 21 CFR Part 50.20 Subpart B? - ✔✔General requirements for informed
consent
✔✔What steps must be taken if IND is put on clinical hold? 21 CFR Part 312.42 - ✔✔-
Proposed study: Subjects may not be given the investigational drug.
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug
must discontinue therapy unless specifically permitted by FDA in the interest of patient
safety.
✔✔What are the reasons for clinical hold? - ✔✔-Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified Investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
,-IND does not contain sufficient information to assess risk to subjects of proposed
studies
✔✔Phase 1 Clinical Trials - ✔✔-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
✔✔Phase 2 Clinical Trials - ✔✔-Usually no more than several hundred subjects
-Multi-centered sites
✔✔Phase 3 Clinical Trials are conducted to: - ✔✔-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 - ✔✔Post-marketing
Continue assessing overall therapeutic value
size depends on design
✔✔When was the Federal Food, Drug, and Cosmetic Act established & why? -
✔✔1938; to establish the FDA's jurisdiction over cosmetic and medical devices in the
US.
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical Device - ✔✔Device is NOT dependent on chemical action or being
metabolized, and;
-also must be recognized in official national formulary or US pharmacopeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1) Pilot Study
2) Pivotal Study
3) Post-market studies
Compared to drugs and biologics, which typically have 1000's of subjects, device
studies usually have 100's of subjects
✔✔Class I (device) - ✔✔Lowest risk
, --General controls are sufficient to provide reasonable assurance of the safety and
affectiveness
Ex. elastic bandages, examination gloves, hand-held surgical instruments
✔✔Class II (device) - ✔✔Moderate risk, usually requires a 510k (Pre-Market submission
made to FDA)
--General controls are insufficient to assure safety and effectiveness.
--Special controls include: special labeling requirements, mandatory performance
standards, post-market surveillance
Ex: powered wheelchairs, infusion pumps, and surgical drapes
✔✔Class III (device) - ✔✔Highest risk, usually requires a 510k (Pre-Market submission
made to FDA)
-Usually those that support or sustain human life
-Important for preventing impairment of human health
-Present a potential risk of illness or injury
Ex. implant, used in supporting or sustaining human life
✔✔Pre-Market Approval (PMA) - ✔✔Required process of scientific review (usually class
III) to ensure reasonable safety and effectiveness of device.
*Must be FDA "approved" or NOT cleared before marketing per 21 CFR Part 814
✔✔Pilot Studies (device) - ✔✔Exploratory
Includes small numbers of subjects
✔✔Pivotal Studies (device) - ✔✔Determine safety and effectiveness
Include most of overall subject numbers
✔✔Post-market Studies - ✔✔Design improvement
Expansion of safety and effectiveness data
Development of new uses
✔✔What are the abbreviated requirements for device studies? 21 CFR Part 812.2(b) -
✔✔Abbreviated Requirements:
-Label device
-Ensure Investigators maintain records and make reports
-Obtain IRB approval: significant risk (SR) vs non-significant risk (NSR)
-Informed consent
-Monitoring of studies
-Refrain from promotion
✔✔Exemption for Investigation of a Device
Abbreviated Requirements 21 CFR Part 812.2(c) - ✔✔Categories of investigations
considered to have approved IDE applications, unless FDA has notified sponsor
otherwise.
QUESTIONS AND ANSWERS SURE A+
✔✔What are the steps for withdrawing and IND? 21 CFR Part 312.38 - ✔✔A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA.
-Stopping all studies and notifying the Investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor.
-If the study is withdrawn for safety reasons, the Sponsor must notify Investigators and
the IRBs.
✔✔Which form is used to certify absence of financial interest? - ✔✔FDA Form 3454
✔✔What form is used for the mandatory reporting of serious adverse events? - ✔✔FDA
Form 3500A
✔✔What is 21 CFR Part 50 Subpart D? - ✔✔Additional Safeguards for Children in
Clinical Investigations
✔✔What is the FDA Form 482? - ✔✔Notice of Inspection
✔✔What is 21 CFR Part 50.20 Subpart B? - ✔✔General requirements for informed
consent
✔✔What steps must be taken if IND is put on clinical hold? 21 CFR Part 312.42 - ✔✔-
Proposed study: Subjects may not be given the investigational drug.
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug
must discontinue therapy unless specifically permitted by FDA in the interest of patient
safety.
✔✔What are the reasons for clinical hold? - ✔✔-Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified Investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
,-IND does not contain sufficient information to assess risk to subjects of proposed
studies
✔✔Phase 1 Clinical Trials - ✔✔-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
✔✔Phase 2 Clinical Trials - ✔✔-Usually no more than several hundred subjects
-Multi-centered sites
✔✔Phase 3 Clinical Trials are conducted to: - ✔✔-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 - ✔✔Post-marketing
Continue assessing overall therapeutic value
size depends on design
✔✔When was the Federal Food, Drug, and Cosmetic Act established & why? -
✔✔1938; to establish the FDA's jurisdiction over cosmetic and medical devices in the
US.
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical Device - ✔✔Device is NOT dependent on chemical action or being
metabolized, and;
-also must be recognized in official national formulary or US pharmacopeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1) Pilot Study
2) Pivotal Study
3) Post-market studies
Compared to drugs and biologics, which typically have 1000's of subjects, device
studies usually have 100's of subjects
✔✔Class I (device) - ✔✔Lowest risk
, --General controls are sufficient to provide reasonable assurance of the safety and
affectiveness
Ex. elastic bandages, examination gloves, hand-held surgical instruments
✔✔Class II (device) - ✔✔Moderate risk, usually requires a 510k (Pre-Market submission
made to FDA)
--General controls are insufficient to assure safety and effectiveness.
--Special controls include: special labeling requirements, mandatory performance
standards, post-market surveillance
Ex: powered wheelchairs, infusion pumps, and surgical drapes
✔✔Class III (device) - ✔✔Highest risk, usually requires a 510k (Pre-Market submission
made to FDA)
-Usually those that support or sustain human life
-Important for preventing impairment of human health
-Present a potential risk of illness or injury
Ex. implant, used in supporting or sustaining human life
✔✔Pre-Market Approval (PMA) - ✔✔Required process of scientific review (usually class
III) to ensure reasonable safety and effectiveness of device.
*Must be FDA "approved" or NOT cleared before marketing per 21 CFR Part 814
✔✔Pilot Studies (device) - ✔✔Exploratory
Includes small numbers of subjects
✔✔Pivotal Studies (device) - ✔✔Determine safety and effectiveness
Include most of overall subject numbers
✔✔Post-market Studies - ✔✔Design improvement
Expansion of safety and effectiveness data
Development of new uses
✔✔What are the abbreviated requirements for device studies? 21 CFR Part 812.2(b) -
✔✔Abbreviated Requirements:
-Label device
-Ensure Investigators maintain records and make reports
-Obtain IRB approval: significant risk (SR) vs non-significant risk (NSR)
-Informed consent
-Monitoring of studies
-Refrain from promotion
✔✔Exemption for Investigation of a Device
Abbreviated Requirements 21 CFR Part 812.2(c) - ✔✔Categories of investigations
considered to have approved IDE applications, unless FDA has notified sponsor
otherwise.
