In research, we are always dealing with acronyms. Using the story below, do you know all of the acronyms represented?
A CRA was hired for a CRO. During training, the CRA learned the CFR, which included information about the ICF, FDF, IRB, IDE and IND. The CRA was monitoring for IDEs and INDs, so they could be submitted as PMAs and NDAs.
During the course of his monitoring visits, he reviewed CRFs in EDCs and posted queries about AEs and SAEs. He worked with PIs and CRCs to review findings. When he had questions, he reached out to his CPM, or his FCE, depending on the nature of the discrepancy. After writing his IMV reports, they went to the CPM for QC, before being finalized and filed in the TMF.
One of his sites was called by the FDA, and he walked them through the BIMO checklist. He hoped they wouldn’t get a WL or even a 483. He knew he’d taught them GCP from Day 1 and as long as they followed the standards, they would fare well.
The site had no findings and thanked the CRA for all the help with GCP and the CFR. The CRA and the sponsor knew that following RBM set them up for success, and they continued with the same MP for the rest of the study. The end.
CRA = Clinical Research Associate
CRO = Contract Research Organization
CFR = Code of Federal Regulations
ICF = Informed Consent Form
FDF = Financial Disclosure Form
IRB = Institutional Review Board
IDE = Investigational Device Exemption
IND = Investigational New Drug
PMA = Pre Market Approval
NDA = New Drug Application
CRF = Case Report Form
EDC = Electronic Data Capture
AE = Adverse Event
SAE = Serious Adverse Event
PI = Principal Investigator
CRC = Clinical Research Coordinator
CPM = Clinical Project Manager
FCE = Field Clinical Engineer
IMV = Interim Monitoring Visits
QC = Quality Check
TMF = Trial Master File
FDA = Food and Drug Administration
BIMO = Bioresearch Monitoring program
WL = Warning Letter
483 = Inspectional Findings
RBM = Risk Based Monitoring
MP = Monitoring Plan
Let us know if you have any additional acronyms you can ASAP! Also, check out the whitepaper below on RBM.
Photo Credit:IMARC Research
