SOCRA CERTIFICATION COMPREHENSIVE EXAM UPDATED
QUESTIONS AND SOLUTIONS RATED A+
✔✔A source document is any document found that is associated with a clinical trial. -
✔✔a. true
b. false X (A source document is any document where the date are FIRST recorded)
✔✔A sponsor will not ship a study drug until they have received all of the following
documents: - ✔✔- IRB approved protocol, IRB approved informed consent form, IRB
approval letter, IRB approved recruitment materials
- Signed and completed 1572, CV's and financial disclosures from everyone listed on
1572
- Current lab certifications and normal ranges
✔✔Certification of absence of financial interest would also be known as: - ✔✔Form
3454
✔✔What is the minimum number of IRB members? - ✔✔5
✔✔The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased
by 30%. The new dosage would be? - ✔✔77
✔✔The responsibility for ensuring that the investigator understands a clinical trial lies
with - ✔✔the sponsor
✔✔Significant risk device is defined as an investigational device that is: - ✔✔a.
Intended as an implant and presents a potential for serious risk to the health, safety, or
welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and
presents a potential risk to the health, safety, or welfare of a subject.
c. for a use of substantial importance in diagnosing, curing, mitigating, or treating
disease, or otherwise preventing impairment of human health and presents a potential
for serious risk to the health, safety, or welfare of a subject.
Answer: All the above
✔✔A purpose of monitoring clinical trials is to verify that: - ✔✔The rights, safety and
well-being of human subjects are protected.
✔✔A sponsor may transfer responsibility for any of all of the obligations to a -
✔✔Contract Research Organization (CRO)
✔✔A contract research organization shall be responsible for : - ✔✔- Control of the Drug
- Selecting Investigators
- Obtaining information from the investigators
, ✔✔The clinical investigator will update the financial disclosure information if any
relevant changes occur during the investigation's course and for ____ following the
study's completion. - ✔✔1 year
✔✔The contract research organization shall select a monitor that is
________________. - ✔✔-Qualified by experience
- Qualified by training
✔✔A ____ lists the investigator's education, training, and experience that qualifies the
investigator as an expert in the clinical investigation of the drug for the use under
investigation. - ✔✔1. Curriculum vitae
2. Statement of qualifications of the investigator
✔✔The sponsor shall monitor investigations to identify when an IRB determines that it
cannot approve the research because it does not meet the criteria for exception or
because of other relevant eithical concerns - ✔✔a. true X
b. false
✔✔Before the investigation begins, the sponsor shall give each participation clinical
investigator a/an _______. - ✔✔Investigator Brochure
✔✔____ means the party who submits a marketing application to FDA for approval of a
drug device or biologic product. - ✔✔Clinical Investigator
✔✔The applicant must completely and accurately disclose or certify information
concerning the financial interests of a clinical investigator who is a full-time or part-time
employee of the sponsor for each covered clinical study. - ✔✔a. true
b. false X
- Must Disclose everyone, not just those who are full time or part time.
✔✔What is an informed consent? - ✔✔What is informed consent? consent given by a
patient to a procedure after understanding the facts and the risks
✔✔What is 21 CFR 56.109 subpart C? - ✔✔IRB review of research
✔✔21 CFR 56 Subpart B is IRB documentation - ✔✔a. true
b. False X
- 21 CFR 56 subpart B is organization and personnel
✔✔The form ___ is used for investigational new drugs (or IND) - ✔✔1571
QUESTIONS AND SOLUTIONS RATED A+
✔✔A source document is any document found that is associated with a clinical trial. -
✔✔a. true
b. false X (A source document is any document where the date are FIRST recorded)
✔✔A sponsor will not ship a study drug until they have received all of the following
documents: - ✔✔- IRB approved protocol, IRB approved informed consent form, IRB
approval letter, IRB approved recruitment materials
- Signed and completed 1572, CV's and financial disclosures from everyone listed on
1572
- Current lab certifications and normal ranges
✔✔Certification of absence of financial interest would also be known as: - ✔✔Form
3454
✔✔What is the minimum number of IRB members? - ✔✔5
✔✔The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased
by 30%. The new dosage would be? - ✔✔77
✔✔The responsibility for ensuring that the investigator understands a clinical trial lies
with - ✔✔the sponsor
✔✔Significant risk device is defined as an investigational device that is: - ✔✔a.
Intended as an implant and presents a potential for serious risk to the health, safety, or
welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and
presents a potential risk to the health, safety, or welfare of a subject.
c. for a use of substantial importance in diagnosing, curing, mitigating, or treating
disease, or otherwise preventing impairment of human health and presents a potential
for serious risk to the health, safety, or welfare of a subject.
Answer: All the above
✔✔A purpose of monitoring clinical trials is to verify that: - ✔✔The rights, safety and
well-being of human subjects are protected.
✔✔A sponsor may transfer responsibility for any of all of the obligations to a -
✔✔Contract Research Organization (CRO)
✔✔A contract research organization shall be responsible for : - ✔✔- Control of the Drug
- Selecting Investigators
- Obtaining information from the investigators
, ✔✔The clinical investigator will update the financial disclosure information if any
relevant changes occur during the investigation's course and for ____ following the
study's completion. - ✔✔1 year
✔✔The contract research organization shall select a monitor that is
________________. - ✔✔-Qualified by experience
- Qualified by training
✔✔A ____ lists the investigator's education, training, and experience that qualifies the
investigator as an expert in the clinical investigation of the drug for the use under
investigation. - ✔✔1. Curriculum vitae
2. Statement of qualifications of the investigator
✔✔The sponsor shall monitor investigations to identify when an IRB determines that it
cannot approve the research because it does not meet the criteria for exception or
because of other relevant eithical concerns - ✔✔a. true X
b. false
✔✔Before the investigation begins, the sponsor shall give each participation clinical
investigator a/an _______. - ✔✔Investigator Brochure
✔✔____ means the party who submits a marketing application to FDA for approval of a
drug device or biologic product. - ✔✔Clinical Investigator
✔✔The applicant must completely and accurately disclose or certify information
concerning the financial interests of a clinical investigator who is a full-time or part-time
employee of the sponsor for each covered clinical study. - ✔✔a. true
b. false X
- Must Disclose everyone, not just those who are full time or part time.
✔✔What is an informed consent? - ✔✔What is informed consent? consent given by a
patient to a procedure after understanding the facts and the risks
✔✔What is 21 CFR 56.109 subpart C? - ✔✔IRB review of research
✔✔21 CFR 56 Subpart B is IRB documentation - ✔✔a. true
b. False X
- 21 CFR 56 subpart B is organization and personnel
✔✔The form ___ is used for investigational new drugs (or IND) - ✔✔1571
