Definitions & Standards for Expedited Reporting (E2A)
For a medicinal product not yet approved for marketing in a country, the document that is used as the source for determining whether an adverse event is expected
What is Investigator's Brochure?
A clinical trial is being conjected to determine safety and tolerability of a new anti-emetic IP. The Sponsor expects to enroll 20 subjects. This is a Phase __ trial
What is Phase I trial?
How a handwritten signature is defined in the context of electronic records
What is the scripted name or legal mark of an individual, handwritten by that individual?
DSMB stands for
What is Drug and Safety Monitoring Board?
The purpose of this is to summarize at a population-level what the outcomes would be in the same patients under different treatment conditions being compared
What is an estimand?
The number of calendar days in which fatal or life-threatening, unexpected adverse drug reactions (ADRs) occurring in clinical investigations must be reported to regulatory agencies
What is 7 days?
Trial type for a clinical trial where only the pharmacist and the sponsor know the identity of the IP. The pharmacist has no direct contact with the trial subject and the clinical team
What is double-blind?
The main objectives when using closed systems for electronic records
What is ensuring the authenticity, integrity, and confidentiality, and preventing signer repudiation?
The purpose of the DSMB
What is to assess the progress of a clinical trial, the safety data and the critical efficacy points?
This is the classification of subjects according to the potential occurrence of an intercurrent event on all treatments
What is principal stratification?
According to the guidelines, uses for separate Investigator's Brochures
What is different product presentations and uses?
How long after the last dose the trough blood level for a once-daily should be drawn
What is 24 hours?
Essential component for electronic signatures, per the regulations
What is clear linkage between signature/record and the signer?
Research design where subjects are randomized to one of two or more arms, each arm being allocated a different treatment
What is parallel design?
This can represent the population of patients targeted by the clinical question
What is the entire trial population, or a subgroup defined by a characteristic measured at baseline?
Max number of calendar days allowed to submit a more complete report, following the initial report of a serious, unexpected ADR that is fatal or life-threatening
What is 8 days?
Uncertainties and potential sources of bias should be addressed in this stage, to the extent possible
What is study design?
How electronic signatures must be managed
What is by ensuring they cannot be easily excised, copied, or transferred?
The primary focus when describing safety and tolerability in clinical trials
What is the occurrence of adverse events and medical risks?
The effect that consistent results from Full Analysis Set (FAS) and Per Protocol Set (PPS) analyses have
What is increasing confidence in the trial results?
Post-event finding that is recommended to be provided when available to facilitate the assessment of an adverse event case
What are autopsy or other post-mortem findings (including a coroner's report)?
Exploratory studies are primarily designed to investigate these aspects of a drug
What is safety and efficacy in a selected population?
A requirement regarding the information stored in electronic records, i.e. the details that must be included
What is the printed name of the signer, the date and time of the signing, and the meaning associated with the signature?
The role of the Analysis Sets outlined in the document
What is defining which data are analyzed to ensure consistency and transparency?
This is a series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying model assumptions and limitations in the data
What is a sensitivity analysis?