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 conducted 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?
The scripted name or legal mark of an individual, handwritten by that individual
What is the definition of a handwritten signature (within the context of electronic records)?
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?
This kind of system ensures authenticity, integrity, and confidentiality in electronic records, and prevents signer repudiation
What is a closed system?
The purpose of this group is to assess the progress of a clinical trial, the safety data and the critical efficacy points
What is the DSMB?
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, what separate Investigator Brochure's (for one trial) are used for
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?
This component is essential for electronic signatures
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?
In ICH E9(R1)'s estimand framework, this refers to the group of patients for whom the treatment effect is to be estimated, which may differ from the actual patients enrolled in the trial due to eligibility criteria or other practical considerations
What is the target population?
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?
These 3 things cannot be allowed when managing electronic signatures
What is they cannot be easily excised, copied, or transferred?
The primary focus is avoiding these when describing safety and tolerability in clinical trials
What is the occurrence of adverse events and medical risks?
According to ICH E9(R1), this term describes events occurring after treatment initiation that affect either the interpretation or existence of measurements associated with the clinical question of interest, such as rescue medication use or treatment discontinuation
What are intercurrent events?
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?
The printed name of the signer, the date and time of the signing, and the meaning associated with the signature.
What are the requirements for information stored in electronic records (i.e. the details that must be included)?
These define which data are analyzed to ensure consistency and transparency
What are Analysis Sets?
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?