IRB
Investigator
Site
GCP
Essential Documents
100
Safeguards the rights, safety and well being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.
What is the responsibilities of the Institutional Review Board?
100
For trial conduct and safety an investigator must have qualified facilities and (blank)
What is qualified staff?
100
Meets the requirements of the clinical trial and is invited to participate
What is site selection?
100
What does GCP stand for?
What is Good Clinical Practices?
100
Investigator(s) will supply this essential document to subject(s) who freely give permission to participate in the clinical trial
What is informed consent
200
True or false: an investigator may participate and act to vote in committee meetings
What is false?
200
Trial-related medical decisions are determined by these groups
What is qualified physician/dentist?
200
I visit the site to review and collect patient information
What is the CRA/Monitor?
200
Why is clinical research regulated?
What is ensure rights, safety and well being of subjects?
200
21CFR Part 54 requires applicants woh submit a marketing application for a drug, biological product or device to submit certain information concerning the compensationto, and financial interests and arragements of any clinical investigator conducting clinical studies covered by the regulation.
What is a Financial Disclosure?
300
This group(s) safeguards the rights, safety and well-being of trial subjects
What is the IRB/IEC?
300
This person should be qulified by education, ,training and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requiremetns and should provide evidence of such qualifications through up to date CV and/or other relevant documentation requested by the sponsor, IRB/IEC and or the regulatory authorities
Who is the investigator?
300
What must the site have before they can be selected. This is our first point of contact when we call the site
What is Clinical Research Coordinator?
300
We are the branch of the United States Department of Health and Human Services?
What is the FDA?
300
This is a contract between the FDA and investigator that outlines logistics, addresses and committments of the investigator?
What is a 1572?
400
Relevant documentation including a current curriculum vitae of the investigator is reviewed to assess
What is qualifications?
400
Needed to conduct study according to the protocol, GCP, and local regulatory regulations investigator
What is adequate resources?
400
Who besides the monitor can audit a site?
What is the FDA or regulatory body?
400
I am Part 50 of CFR Title 21
What is Protection of Human Subjects?
400
Sites must submit this before the trial start? It shows whether specimens are in range?
What are Normal Values/ranges for lab tests?
500
There are 3 areas of composition of the IRB/IEC who collectively have the qualifications and experience to review and evlauate the science, medical aspects, and ethics of the proposed trial. The three areas are:
What are: 1) Consists of at least 5 members 2) One member whose primary area of interest in in a nonscientific area 3) At least one member who is independent of the institution/trial site.
500
If the investigator has an emergency and can't evaluate the patient, who can do this in his presence?
What is a sub-investigator?
500
We are not located where mostly subjects are seen who are participating in the clinical trial?
What are satellite sites?
500
I conduct trials according to GCP Weigh risks vs benefits Protect the subjects Have adequate information to justify a trial Write a sound protocol Receive a IRB/IEC approval Use qualified physicians
What are Principles of ICH GCP?
500
This is an agreement between the sponsor and investigator?
What is a signed protocol?
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