What is this acronym?
Who is this person?
Who should you contact?
True/False
What is....
100
SCTR
South Carolina Clinical & Translational Research
100
Manager of Research Operations
Julia Brenner
100
You are dying to bring something to the holiday party!
Linda!
100
The PRG has 43 studies
False we currently have 54 active studies
100
This form is required by federal regulations for Investigators to disclose certain financial interests to ensure that the design, conduct or reporting of federally-funded projects will not be biased.
Financial Disclosure
200
OCR and ORSP
Office of Clinical Research
Office of Research and Sponsored Programs
200
Director of Research Administration
Erica Blender Brown
200
If you have an issue with your computer, a software program, or
The Pediatric Helpdesk (which sends a ticket to Lori and Michael)
200
Originality, Attributability, Legibility, Completeness, Availability, and Accuracy are parts of ALCOA+
True! Please continue to do these things :-)
200
This handbook details a study’s conduct and operations describing a study’s organization, operational data definitions, recruitment, screening, enrollment, randomization, follow-up procedures, data collection methods, data flow, case report forms (CRFs), and quality control procedures.
Manual of Operations (MOO)
300
CTA
Clinical Trial Agreement
300
Vice Chair of Clinical Research, The Charles P. Darby Department of Pediatrics
John M. Costello, MD
300
If you receive an invoice from EPIC research, or if you foresee a charge related to a study?
Jasmen Allen and peds-grants@musc.edu
300
Clinical Trial Phase 2 is done to determine the safety of an IND.
False! Safety of trials are determined during Phase 1. Phase 2 continues with safety but is to determine safe dosing.
300
Signing this document provides assurance that a trial will be conducted according to all stipulations of the protocol and to local legal and regulatory requirements and applicable US federal regulations and ICH E6 Good Clinical Practice (GCP) guidelines.
Protocol Signature Page
400
ROC
Research Operations and Collaborations
400
Chair, The Dr. Charles P. Darby, Jr. Department of Pediatrics
Andrew M. Atz, MD
400
If something is broken (door handle, faucet, toilet)....
Linda
400
A drug is submitted for FDA approval following Phase IV of a clinical trial.
False
A drug is submitted for FDA approval following Phase III (safety and efficacy) and prior to Phase IV (post approval surveillance)
400
An agreement between the investigator and the FDA Code of Federal Regulations, when running a trial to study a new drug or agent, that verifies the investigator has the experience and background required to conduct the trial in a way that is ethical and scientifically sound.
1572
500
IATA
International Air Transport Association
500
Associate Director Research Opportunities and Collaborations
Signe Denmark, MS, CCRP
500
A general question concerning clincard
clincard@musc.edu
500
When a new protocol has been uploaded to the IRB, the PRA team needs to review the documentation to ensure there are not changes to the billables, designations, and time points.
True!
500
This is a letter usually obtained by the by the sponsor from the FDA verifying that the IND was submitted and verified by the FDA to be used for research. (It will usually tell if an IND number is required)
IND Letter