Acronyms Federal
HHS Department
What is Department of Health & Human Services?
This person is responsible for the conduct of the study
Who is the Principle Investigator?
AE
What is an adverse event?
In this stage of the trial the primary focus is long term safety and effectiveness
What is a phase 4 study?
This determines if the study is right for your site
What is a study feasibility?
OHRP office of
What is the Office of Human Research Protections?
This person is responsible for the informed consent process.
Who is the principal investigator?
CRF
What is a case report form?
In this stage of the trial the primary focus safety & effectiveness, dose ranging, therapeutic exploratory
What is a Phase 2 study?
This visit is to determine if your site has the resources to conduct the study.
What is a pre site visit or site qualification visit?
NIH an agency of HHS
What is the National Institutes of Health?
This person is responsible for accurate and complete case forms.
Who is principle investigator?
EDC
What is electronic data capture?
In this stage of the trial the primary focus safety, human pharmacology
What is a phase 1 study?
This is the plan to meet your sites enrollment goals
What is the subject recruitment plan?
ORI office of
What is the Office of Research Integrity?
This person is responsible for the training of the research staff listed on the DOA Delegation of Authority log.
Who is the Principal Investigator?
GCP
What is Good Clinical Practice?
In this stage of the trial the primary focus is safety & effectiveness, less common side effects, therapeutic confirmatory.
What is a phase 3 study?
This visit will activate your site
What is a site initiation visit?
OIG office of
What is the Office of Inspector General?
This person determines attributability and severity of adverse events
Who is the principle investigator?
ALCOAC
What is Attributable, Legible, Contemporaneous, Original, Accurate, Complete?
This is submitted at the end of Phase 3 to the FDA to request marketing approval.
What is a New Drug Application?
The IRB will not release approval until this is received
What is an executed contract?