Research
When do you put your newly consented patient into oncore
same day as consent
what is a phase I study
first to involve humans
where to find drug return form
pharmacy
A patient has a appointment at 8:00 for the lab and an 845 appointment with the provider. What time should the CRC be at the CTO?
typical guidance is at least 30 minutes early incase the patient arrives before scheduled appointment or incase there is any issue in the lab
prior auths need to be done for what type of drugs
IV Drugs
Protected health information includes what
numbers that identify patients, mail address, vehicle identifiers biometrics
where to find EPIC help
Clinical team -> epic folder
A research patients labs return as grade 3, per protocol the patient cannot be treated today. The provider states that these labs are common for a patient with this level of disease and they treat patients with similar labs all the time and wants the patient to still receive treatment. What should you do as the coordinator?
Patient can not be treated per protocol, patient can go upstairs and get hydration and labs can be redrawn to see if they meet criteria. Reach out to sponsor to inform them and open that dialog with them.
True or false – any APP can see a research patient
False
what does it mean to aliquot
separate a portion of the serum or plasma from blood
where to find “cheat sheet” and reference/ how to tools
Clinical team --> Education – training – reference Documents
a patients partner becomes pregnant on a clinical trial, what do you do?
inform PI and sponsor check for PP ICF and protocol for reporting requirements
SAE needs to be reported within how many hours of CRC/CRN becoming aware
24 hours
What is a target lesion
lesions or lymph nodes that meet RECIST 1.1 measurability criteria and are used to track a patients response while on trial
Where to find standardized documents or templates
Clinical team -- > standardized documents and processes
A patient is in screening, his labs have been drawn twice and do not meet inclusion criteria. The provide states the labs will never meet criteria due to his previous medical history but really wants the patient on trial/does not think this should exclude them. What should you do next?
Inform sponsor to inform them of the situation and connect the medical monitor and the provider. They can further discuss, if the medical monitor approves patient to be on study, print this communication for the patients binder and save the email chain as a PDF into the patients specific folder within the study folder