ALCOA
•To regard as belonging (to), produced (by), or resulting (from)
What is Attributable?
•To continue in existence; last.”
What is to endure?
Training emphasizes ethical considerations and adherence to regulations, protecting ...
What is Patient Safety?
Site is trained on protocol, procedures, and regulatory requirements during this visit
SIV
•Originating, existing, or happening during the same period
What is Contemporaneous?
•Present and ready for use; at hand; accessible.”
What is available and accessible?
Properly trained staff ensures accurate and timely data collection, reducing errors and enhancing....
What is Data Integrity?
CRAs continue to provide training and coaching during this visit
What is the IMV?
Correct in all details, exact
What is Accurate?
•Having all necessary or normal parts, components, or steps; entire
What is complete?
Comprehensive training helps to address potential...
What are protocol deviations and other risks?
CRAs train the Principal Investigator (PI) about their responsibilities at the end of a trial during
What is the COV?
•Possible to read or decipher; Plainly discernible.
What is Legible
•In agreement; compatible; coherent; uniform
What is Consistent?
Site staff awareness of this part of the protocol can reduce recruitment timelines and delays in bringing the IP to the market
What is the Inclusion and Exclusion Criteria?
CRAs may train the site about a protocol amendment during
What is the IMV?
•The first and genuine form of something, from which others are derived
What is Original?
•Capable of being believed; plausible; worthy of confidence; reliable
What is Credible?
CRCs keep up-to-date with clinical trial best practices by
What is training?
CRAs may train site staff to improve patient recruitment and retention during
What is a booster visit?