Protocol Basics
Neither the subject nor the study team know whether the subject is receiving investigational product, standard drug, or placebo.
What is double blinded?
PHI
What is Protected Health Information?
For trials regulated by this agency, the consent document cannot give the subject the option of having data removed.
What is the FDA?
Established by the International Conference on Harmonization (ICH), it is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies.
What is Good Clinical Practice (GCP)?
Person ultimately responsible for the conduct of a research study.
Who is the Principal Investigator?
The 'recipe' for the clinical research study.
What is the protocol?
IRB
What is an Institutional Review Board?
What is a process?
"A living individual about whom an investigator conducting research obtains data through interaction or intervention with the individual or through identifiable private informaiton.
What is a human subject?
An entity that a sponsor can delegate some or all of their responsibilities for trial conduct in writing to.
What is a Contract Research Organization (CRO)?
This type of group assignment is comparable to a flip of a coin and is generally utilized to avoid bias.
What is randomization?
DoA Log
What is Delegation of Authority Log?
This form is a written consent document stating that the elements of informed consent as required have been presented orally to a subject or the subject's LAR if the consent form is not written in their native language.
What is a short form?
Respect for Persons, Beneficence, and Justice.
What are the three principles of the Belmont Report (1979)?
This is an agreement by the investigator to provide information to the sponsor and that they will comply with FDA regulations during the conduct of a drug study.
What is an FDA Form 1572?
This type of research involves following subjects as they move through the study (as opposed to compiling data that has already been collected).
What is prospective research?
COI
What is Conflict of Interest?
What can a participant do if they no longer wish to participate in the research study.
What is Withdraw Consent?
A set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services (DHHS).
What is the Common Rule?
This step comes after becoming document ready in the process of starting a new study.
What is Study Assessment?
This phase of a drug study is the final confirmation of safety and efficacy. It involves testing with large groups of people (1,000-3,000) to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.
What is phase 3?
CFR
What is Code of Federal Regulations?
What must the study team provide to a non-English speaking participant after they have been consented with a short form in their native language and the English consent form.
What is a translated copy of the consent form?
First international document to advocate voluntary participation and informed consent.
What is the Nuremberg Code (1948)?
Degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions.
What is Health Literacy?