OBIC Handbook
Awards/grants remain in 'ended' for _____ days after the end date.
90
Applicable law requires ___ years of record retention
Two
Use of Name provisions should be mutual. True or False
True
SOW
Scope of Work or Statement of Work
Scope of Work is often a protocol while statement of work is usually a work order that falls under a master.
Buck ID.
There is also a way to print using your name.# and your password.
21 CFR part ____ requires users of electronic medical records to implements controls and system validation and DOES NOT apply to CTAs.
11
A sponsor can use Ohio State's logo as long as it's the Athletic logo. True or False
False
Sponsor can not use any Ohio State logo.
ICF
Informed Consent Form
OGC-005
The OGC-005 must be signed by the PI and their chair in order to spend on a trial that is set up as a prelim or that is pending a formal amendment.
Prelims can be set up at 90 days, NCE's can be extended 60 days.
"Following the Retention Period, as instructed by Sponsor, Institution will either forward such records to Sponsor at Sponsor's expense, _________ such records for an addtional charge to be negotiated or destroy the records and send SPosnor proof of such destruction."
Retain
This language puts the onus on the sponsor to tell us what to do during the time period instead of requiring the university to reach out for their determination.
Under what circumstances can a sponsor use Ohio State's name?
Name Ohio State/Investigator as a participant/award recipient
Listing a study on clinicaltrials.gov or their own website (factual only)
FDA reporting
CTMO
Clinical Trial Management Office
CTMO is the budgeting arm of the CCRM (Center for Clinical Research Management). Deanna & Jordan work for CCRM, while the RBA's work for CTMO. (Kind of like OSP & OBIC).
Mike has a dog named Thor. What is Thor's REAL name?
God of Thunder
Ohio State is a no-fly zone. If research involves the use of a _______ or other unmanned aircraft, refer the PI to the appropriate policy.
Drone.
There is a Use of Unamnned Aircraft Systems policy.
Ohio State does not notify prior to document _________.
Destruction
Ohio State will provide proof of destruction afterwards, but will not notify/ask for permission in advance.
At board meetings, these 3 items are disclosed:
Sponsor's name
Study Title
Funding amount
DHHS
Department of Health and Human Services.
DHHS is Ohio State's cognizant agency.
When deobligating funds, only change the amounts on the _______.
Budget.
Authorized amount, award line amount, sponsor direct and sponsor indirect amounts should not be changed on the award, only the budget should be reduced.
Retention periods greater than 2 years can be agreed upon, provided _____________ and ____________.
It is at Sponsor's expense and it is payable in full at study close.
There is no way for the university to limit its use of a sponsor's name in its internal reporting.
False - if a sponsor INSISTS, there are measures that can be taken. Approval from a manager or Sr. SPO is required.
ALCOA+
Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA-CCEA or ALCOA+ is the FDA's good data integrity practice. While Ohio State follows it in spirit (and we can agree to these lowercase terms), we do not want to be legally bound to prove ALCOA compliance.