Momma Can I Have
Done on very large number of subjects to determine safety efficiency and dosing
What is Phase III
Data that is collected in the EDC
what is eCRF's (Electronic Case Report Form)
Subjet must sign before enter into trial; Mist be signed by PI or who PI delegated task to
What is the ICF (Informed Consent Form)
Normal care provided per the sites guidelines
What is the SOC (standard of Care)
An alter within the protocol guidelines that DO NOT affect the subjects safety; If subject deters from protocol on site; Subject came a day later or taken other drugs when not suppose to
What is a PD (Protocol Deviation)
An alter within the protocol guidelines that affects the subjects saftey
What is PV (protocol violation)
Once green light approval of all essential docs are collected and IRB has approved site, and Visit where I go and train site on study
What is the SIV (Site Initiation Visit)
Laboratory certificate that certifies the lab;Expires yearly
What is CLIA (Clinical Laboratory Improvement Amendments)
Log that has everyone at the site listed with task they perform delegated by PI, and PI will also have start date name and signature
What is the SSDL (Site Signature Delegation Log)
Spike or drop in the temperature of the storage location; Site should be instructed to quarantine drug; Site should file a NTF; Instruct site to notify the sposnor
What is a Temperature Excursion
Certification fo knowledge, skills, and abilities required for personnel involved in the process of authorizing and maintaining information systems
What is CAP (Certified Authorization Professional)
Binder located at each site houses all sites essential documents
What is SFN (Study File Notebook)
They approve the protocol, ICF, recruitment materials, acknowledges the IB, and schedule of assessments
What does the IRB approve
Only reviews data never on site, makes sure data entered correctly
What is the DM (Data Management)
System houses all regulatory documents filed at the site, Info must be the same as the info in regulatory binder; Ensure docs are not expired
what is the TMF (Trial Master File)
Range of numbers which a value is placed to determine if a result is normal
What is RR (Reference Ranges)
Laboratory Documents
What is the CLIA (certificate that certifies the lab), CAP (certification of knowledge, skill and ability required for personnel involved in the process of authorizing and maintaining information systems), and RR
Log that has everyone at the site listed with task they perform delegated by PI; PI will also have start date, name, and signature
What is DOA (Delegation of Authority)
Is the international standard of quality for design, monitoring, analyzing, reporting, and reviewing of clinical trials. Essentially it ensures that the subjects rights, welfare and safety are protected
What is Good Clinical Practice
A meeting in which all PI's, SC's, Medical Team, Study team, and sponsor team are present to provide formal training together with all sites participating on the study
What is IM (Investigator Meeting)
International Standard of quality for design, monitoring, analyzing, reporting, and reviewing of clinical trials; Ensures that the subjects rights, welfare, and safety are protected
What is GCP
Study start up docs
What are FDF, CV, CTA, GCP, IB, ML
First sign in visit log; Introduce myself and thank PI for participating on the study; Ask if anyone has questions; Ask that everyone signs the visit attendance log and the SIV training log, Go to the pharmacy if the drug was delivered and count the # of drug onsite and make sure there was no termperature excursion; Review the Regulatory Binder; Inform site that the first RMV will be within the 1st two weeks of subject enroll; Ask when does the site project will enroll their first subject
What is Walk Through a SIV
Walk through RMV
What is First sign visit log, Review any subjects with SAE's, Review new enrolled subjects, Lastly I review subjects that have recently reviewed, Complete drug accountability, Review the regulatory binder, Meet with the PI, Schedule next monitoring visit
Tool used by site to grade adverse events; Grades are 1-5