I KNOWA ALCOA
Being correct, exact, and free from errors, closely aligning with the true, objective value, free from significant systematic errors or biases.
What is Accurate?
A detailed document that acts as the study's blueprint outlining the objectives, design, methodology, statistical considerations, and organization of a research study.
What is the protocol?
Comparing data entered into a CRF against original source documents to ensure accuracy, completeness, and regulatory compliance.
What is source data verification?
An initial assessment conducted by a study sponsor or CRO to verify that the investigator is qualified, and the site has the necessary staff, equipment, and patient population to conduct the study.
What is a PSV or PSSV?
All Trip reports, SMCs and Follow-up letters must be finalized within ___ calendar days, documented in CTMS and filed in TMF.
What is 14 calendar days?
Existing, occurring, or originating during the same period of time.
What is Contemporaneous?
A document that provides a comprehensive accounting of an individual's income or assets relevant to the sponsor company.
What is a financial disclosure form?
The precise, documented tracking of a study drug, device, or biologic throughout its entire lifecycle at the clinical trial site.
What is IP accountability?
The final formal monitoring visit conducted at a clinical trial site to ensure all study related activities are reconciled, recorded, and reported before the site is officially deactivated.
What is a COV?
What is EOB?
Something that can be detected, followed, or tracked back to its source, cause, or origin.
What is Traceable?
A document outlining your entire academic and professional history.
What is a CV?
The process of reviewing the site training log as compared to the site responsibility log to ensure staff are delegated appropriately.
What is cross checking?
A mandatory meeting between a clinical trial sponsor and research site conducted after the site has been selected and IRB approved but prior to enrolling the first study participant.
What is a site initiation visit (SIV)?
All AIs/CDA findings, and other site related actions should be closed within ____ days
What is 30 days or 56 days (with escalation)?
Creditable to a particular source, event, or person.
What is Attributable?
A written document detailing the purpose, procedures, risks, benefits, and rights associated with the clinical trial.
What is the Informed Consent Form?
The process of compaing, verifying, and aligning documents between the sponsor's eTMF and the site's ISF?
What is reconciliation?
A scheduled, onsite/remote evaluation perform by a CRA during a clinical trial.
What is an interim monitoring visit (IMV)?
All red/amber sites need an action plan to reduce/resolve within ___ days, with visits/SMCs scheduled in CTMS in coming ___ days to reduce or resolve the risks
What is 30 days?
Something that lasts for a long time, persists, or continues to exist despite challenges.
What is Enduring?
A mandatory document in clinical research serving as a legally binding contract between the clinical investigator and the FDA.
What is the 1572?
The process of examining original records in a clinical trial to ensure high quality data collection, protocol compliance, and patient safety.
A clinical trial site visit focused on study compliance, safety, and regulatory documentation rather than 100% verification of data against source records.
What is a (non-SDV IMV) non- Source Data Verification Interim Monitoring Visit.
Expenses to be submitted within __ days of trip, including Site Monitor adherence to Global Travel Policy expensing expectations
What is 14 days?