Level Up
The agreed dollar that will be paid to site for each subject and visit performed for the study.
What is the approved budget?
Legal contract between CRO and sponsor
What is a CDA (Confidential Disclosure Agreement)
Application submitted after completion of Phase I, Phase II, Phase III
What is the NDA
Document that provides a detailed description regarding a discrepancy noted during the clinical study
What is the Note to File (NTF)
Person on site that enters the subjects data and answer EDC queries
Who is the DC (Data Coordinator)
The system maintains and manages planning, performing, reporting functions, along with participant, contract information, tracking deadlines and milestones.
What is the CTMS
Committee used in research in US that has been formally designated to approve, monitor and review biomedical and behavioral research involving humans
What is the IRB - Institutional Review Board
Differences between Severity vs Serious
What is Severity - intensity of the event: mild, moderate, severe
Serious - outcome of the event
Binder located at each site houses all sites essential documents
What is the RB (Regulatory Binder)
Person at site responsible for maintaining the regulatory binder
Who is the Regulatory Coordinator (RC)
Events are serious and related to study drug and unexpected.
What is SUSAR (Serious Unexpected Suspected Adverse Reaction)
Guidlines/standard set by FDA for data collection
ALCOA (Attributable, Legible, Comtemporaneous, Original, and Accurate
Provide sponsor with information about investigators qualifications and clinical site that enables he sponsor to establish and the site is an appropriate location at which to conduct the clinical investigation.
inform the investigator of his/her obligations and obtain the investigators commitment to follow pertinent FDA regulations
what is the purpose of the 1572
Visit is within 14 days of first enrollment, contact site, Tell CS to (Schedule RMV, Do drug accountability, Review site RB), Schedule time meet with PI, Email confirmation letter, put schedule visit date in CTMS, Send confirmation letter and follow letter to TMF
What are things done before RMV
Any untoward (unexpected) event that may or may not be related to study which results in death, hospitalization for greater than 24 hours, cause congenital anomaly, incapacitation, life threatening or considered medically significant
What is SAE (Serious Adverse Event)
Date is not expired
Signature of PI or (whoever delegated)
Protocol name
Site name
Every page initialed
No procedure taken before consent date
What do you look for when reviewing ICF?
Done during Phase 1
What is Safety, Done on very small # of health subjects, PK are normally done to figure out how the body absorbs the PI (cross over study), 3+3 design
Project that brings together regulator authorities of Europe, Japan and the US to discuss scientific and technical aspects of pharmaceutical product registration
Done during walk through RMV 1st visit
What is Sign in, Ask SC what time meeting with PI, Ask where RB, Look at RB for SSDL/DOA, Check ICF's;check signatures, Add info in monitoring notes, Match chart to EDC, Make sure all inclusion/exclusion criteria has met, Drug accountability
Temp Log, Packing, Subject Dispersing, Destruction Log
What to collect for drug accountability at RMV
You discover an unreported SAE, so you do
What is Address the SC, Retrain SC, Ensure SC knows they need to report issue to safety team, Collect fax transmission sheet, Request NTF review other charts, Notify CTM, Discuss with PI about unreported SAE, Make sure issue is documented in trip report
These are in the EMR Source Documents
Documents in Regulatory Binder
What are the:
CV's on PI Sub-I, Pharmacist and lab director
IRB Approval documents
ICF's
Current protocal
IB
Monitoring visit log
Enrollment log
Safety reports
any correspondence
During COV TV
What is Sign In, Pull up EDC system (drug accountability, RB), Go to pharmacy (see if they still have drug; Have them sent back or destroyed), Collect temperature log (RR-make sure everything is present), Check delegation log (Have PI sign and date it), Make sure all paperwork is complete, Financial info hasn't changed, Deactivate site access to EDC (database lock DL), Pull original paperwork and upload TMF
Occurs before COV
What is Run TMF before calling site (See what information may be missing), Contact site (send confirmation letter, enter date visit will occur in CTMS, In confirmation letter ask for missing information, Inform IRB site is closing)