Drug Development Process
Around 20-80 healthy volunteers are used in this study phase.
What is a Phase 1 study?
This subject specific log is used to document specific information about an untoward medical occurrence.
What is an adverse event log?
On page 2 of this regulatory document, there is a list commitments a principal investigator must follow to lead a clinical investigation.
What is a Form FDA 1572?
This live document is constantly updated with new study drug information.
What is an investigator’s brochure?
The benefits should always outweigh this.
What are risks?
A new drug or treatment that is given to larger group (100-300) to determine its effectiveness and safety.
What is a Phase II clinical trial?
Two lists of requirements that should and should not be met by a potential study subject.
What is inclusion and exclusion criteria?
This form used to document the study team members roles and responsibilities at the clinical research site.
What is a Delegation of Authority (DOA) Log?
What is a protocol?
A pivotal event in American history which drew attention for the need to have guidelines protecting humans in research.
What is the Tuskegee Experiment?
A new drug or treatment given to large group of people (1000-3000) to confirm effectiveness, monitor side effects, and compares with similar treatments
What is a phase III trial?
Once a principal investigator learns of a serious adverse event (SAE), this much time is given to report the SAE to the sponsor.
What is 24 hours?
The third party organization selected by the sponsor that ensure the study is safe and ethical.
What is an Institutional Review Board?
A two part process involving the research staff presenting and explaining key information about the research study to a potential subject.
What is the Informed Consent Process?
This is the physician that pioneered the conduct of clinical trials.
Who is James Lind?
In this study design, both the subjects and the experimenters are kept in the dark to prevent bias.
What is a double-blind study?
This form is used to report serious adverse events to the FDA.
What is a Form FDA 3500A?
This position involves consenting, creating source documents, performing data entry, maintaining the regulatory binder and lab processing.
What is a study coordinator?
The subject is ____ when asking to be removed from the study.
What is withdrawing consent?
This provides public assurance that the rights, safety and well-being of human subjects involved in research are protected.
What are good clinical practices?
The drug sponsor formally asks FDA to approve a drug for marketing in the United States by submitting a _________.
What is a New Drug Application (NDA)?
This report has a 5 letter acronymn and is used inform the FDA adverse reactions that are unexpected, serious and not listed in the investigators brochure.
What is a Suspected Unexpected Serious Adverse Reaction report?
This person is ultimately responsible for the conduct of the trial at their site.
What is a principal investigator?
When sponsors conduct clinical trials, they are always testing for safety and ______.
What is efficacy?
This group periodically reviews clinical study data throughout the trial for safety purposes.
What is the data safety monitoring board (DSMB)?