IRB
Do pilot projects require review from the IRB?
Yes
A process in which the subject was able to give voluntary informed consent and agreed to comply with the study protocol. Ample time was given to review the ICF document and all questions were answered. Consent was obtained prior to any study related procedures being conducted and a signed/dated copy was given to the subject.
What is the Informed Consent Process?
What type of studies does WISC handle?
Industry
What certificate must a lab specialist hold?
IATA
True or False: "Emory Midtown Hospital" and "Winship at Midtown" have the same address on the 1572?
True
A study’s annual review is due. However, all aspects of the project are complete except for data analysis. What should the PI do?
Submit a continuing review form to reapprove the study for data analysis
Process where subjects and/or LAR should be re-consented per IRB requirements
What is Protocol and/or ICF Amendments?
You have collaborative study with funding coming from main institution , which OCR group would this flow through ?
Non industry OCR
A person delegated reviewing lab results must hold, what eveidence of training?
advanced medical degree, ie MD, PharmD, PA, or NP
Who gets listed in box 4?
labs and labs processing facilities
Under which type of IRB review should the following project be processed? "A multicenter, randomized, double-blind, parallel group, active controlled study to compare the efficacy and safety of a non-FDA drug in patients with asthma"
Full IRB meeting
True/False: Emory IRB has a reliance agreement with Advarra IRB and WCG IRB
True
When do we submit to OCR?
After we have a calendar?
At Emory who may obtain initial informed consent?
PI, Co-Investigators, CRNs, CRC Team Supervisor(s
What do Bryan Burton, Mashunte Holmes, Blair Dykeman; have in common?
CRC TS
A subject in a clinical research trial experiences a life-threatening, serious, unanticipated adverse drug event. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner within 48 hours of knowing about the event, using the forms provided by the IRB.
An individual or judicial body authorized by law to consent on behalf of a prospective subject to the subject's participation in clinical research (45 CFR 46.102(c)
What is a Legally Authorized Representative (LAR)?
How many RAS submission types are there?
initial, amendment with no budget amendment with budget
True/False It is acceptable to change the Co-I to PI on the embedded DOA log instead of end dating a creating a new log line?
False
Who are the phase 1 APPs?
Elise Hitron, Julie Caperton, Hannah Collins, and Catherine Braga
Miss. Daisy is working as a Research Assistant with Dr. Bright. Dr. Bright’s Colleague, Dr. Night, is leaving the institution and transferring his approved prospective research protocol to Dr. Bright. What should Miss Daisy do?
Miss Daisy should first make sure that Dr. Night informed the IRB of leaving the institution and transferring his research protocols to Dr. Bright. Miss Daisy should advise Dr. Bright to notify the IRB that he accepts the transferred protocols and send amended study documents (especially consents) and add all new research personnel to the amended protocol including herself. Miss Daisy should make sure not to initiate the study before receiving IRB approval.
True/False: After institutional sign off has been granted then an amendment is received the local site language found in the IC checklist must also be updated.
False
Who is Toiya Jones?
Post Award specialist
What are three tasks that existed on our DOA template but are not commonly used by all studies?
Data analysis, Neurocognitive testing, and obtain screening informed consent
Which code of federal regulations is the PI agreeing to follow when they sign the 1572?
21 CFR part 50
21 CFR part 56
21 CFR part 312