Miscellaneous
A system that allows staff to report actual events and near misses that have the potential to cause harm but are caught and corrected before they reach the patient.
What is a RISQ (Reporting to Improve Safety and Quality)?
Grid located in most protocols detailing time points and corresponding assessments.
What is a Schedule of Events?
Unrelated, unlikely, possible, probable, and definite are the choices for the relatedness of an AE or SAE.
What is an Attribution?
A tool or form where data is collected for a research protocol.
What is the Case Report Form (CRF)?
A revision to an existing IRB approved protocol, i.e., change in Inclusion/Exclusion Criteria, change in dosage, change in PI/Investigators, change in design, etc.
What is a Protocol Amendment?
Location of educational materials that can be provided to a study participant.
What is Patient and Caregiver Education Page?
A collection from a study participant used for protocol analysis.
What is a research sample?
An adverse event that meets the seriousness criteria as defined by the protocol; for example, hospitalization or prolongation of existing hospitalization.
What is a Serious Adverse Event (SAE)?
Information that are missing details or have discrepancies with other data may trigger one of these from the sponsor.
What is a Query?
A patient needs to be informed of changes made to the protocol, not encompassing risk changes.
What is a verbal notification?
Documentation authored by CTN during patient clinic visit.
What is a Nursing Encounter Note/ ONE Note?
A paper source documentation of oral study drug administration.
What is a Pill Diary/Investigational Medical Diary?
The position that completes the SAE narrative.
What is a CTN (Clinical Trials Nurse)?
True or False: Toxicity attribution may change during a treatment intervention.
What is True?
This document contains the names of the Consenting Professionals and Sub-Investigators that have delegated authority for a clinical study.
What is the Face Sheet?
Role responsible for bed confirmation and protocol supply availability
What is a primary CTN?
Form needed to reconcile supply of oral investigational drugs accompanied by a pill diary.
What is a Drug Accountability Reconciliation Form/DARF?
An AE that the protocol requires additional reporting, but does not necessarily meet seriousness criteria.
What is an Adverse Event of Special Interest (AESI)?
This is the system developed by the NCI for grading the severity of adverse events in cancer patients.
What is CTCAE?
Study tools that may need to be updated due to an amendment.
What are Lab Reqs/PK Sheets, Checkouts, CTMS Calendar, Protocol Order Set, Eligibility Checklist, Pharmacy Order Set (eATO) or CARS Order Set?
An admission to the hospital ahead of a treatment as required per protocol.
What is a planned admission?
True/False: Study Drugs can be stored/saved in cabinets or locked desks when awaiting reconciliation.
FALSE
Within 24-hours of knowledge of the event.
What is the most common sponsor SAE reporting time frame?
True or False: All SAEs should be reported as an Unanticipated Problem.
What is False?
Before any new research interventions/interactions/next protocol visit. Unless IRB approves a different reconsent timeline.
What is the Re-Consent Timeframe?