COG Regulatory
How do I Find the Up to date Protocol
What is login to the COG website and enter the study number to be taken to the study page
Can a fellow sign a Hospital Consent Form?
Yes if it is a WRNNMC consent form .
How do I know what to get for a COG study?
First you will look at the protocol to see the required items. Once you have looked it up in the protocol under required testing . You will contact Patty or Jo to confirm the requirements and assist with the obtaining samples.
What resource do you use to see if an event is a reportable AE.
CTCAE v5 always review protocol
Oops, I signed the consent in green pen.
You must reprint the consent one sided and resign the consent only in blue or black ink.
Who is our IRB of Record?
What is the Central Institutional Review Board
When do I let the research team know of a new patient and how.
As soon as your hear of a possible or confirmed patients. You will text Dr. Clark Patty Jo and Brittany. -age of the patient
arrival and testing dates
possible cancer
What document is used for APEC14B1 procedures .
What is the APEC14B1 MOP
Is an asymptomatic COVID-19 positive reportable.
Yes report it to the research team as soon as possible
Oops, I only printed one HIPPA
Each consent must have its own HIPPA form
Can a Fellow sign COG Consent forms and why.
No they can not due to them being in a fellow status . In COGs view that is a training status.
How often do you have to complete WRNNMC CITI Training.
Every 3 years unless you take over a different role in research.
What to documents are essential for registering patients with COG.
The Future Contact Form and the COG Registry Form
When and where do I document an adverse events for patients on study.
Document in Essentris or ALTHA terminology and grade from CTCAE .
Opps, I did not sign APEC14B1 consent for a possible ALL patient. Can I still enroll team after the bone marrow has been done.
No . If you think that a patent has ALL but you do not want to sign a full APEC14B1 you must do a additional bone marrow consent prior to the Bone Marrow.
What happens if I write on a consent or cross out items out or sign in the wrong spot on a Consent?
You will have to redo the consents and reobtain signatures from the patient or family.
Who also CO-Signs any COG Consent Notes.
The Current PI
What performance scale do I use?
Karnofsky Scale: age> 16 years old
Lansky Scale: age < 16 years old
ECOG-ACRIN
What grade AE do you report to the research team immeditly?
Any grade 3 or higher
Oops, I put the bone marrow in the freezer can we still use it.
No
What forms are used to consent Non-English speaking patient.
What is a CIRB Short Form
What items dose pathology need a copy of to release samples
They need a copy of the consent with the required testing page from the protocol.
How do I write a APEC14B1 Consent Note?
You will use the template provided in the research folder to write your consent.
How many days dose Dr. Clark and Brittany have to report an SAE to the WRNNMC IRB.
3 days. This is very different than a AE please refer the protocol
Oops, I left samples on the research teams desk with no labels. Can we use them
No