View AE completion timeliness report
The AE completion timeliness refers to the time it takes to document, report, and resolve an adverse event (AE). The KRI for AE completion timeliness tracks the time taken from the identification of an AE to its documentation and reporting to the relevant authorities, such as the study sponsor, regulatory agencies, or ethics committees. The KRI also includes the time taken to investigate the AE and determine its causality, severity, and expectedness.
The statistics presented in the AE Completion Timeliness report are pulled from the CTMS application based on the number of KRIs created with the Data Entry Timeliness category and have the risk indicator related to the AE completion. These statistics include the data on the total elapsed days of AE completion, the maximum elapsed days of AE completion, and so on.
-
In the EDC application header, select the REPORTS tab.
-
In the left pane of the page that opens, expand the KRI-Central Monitoring tab to see the list of available reports.
Figure 1. Accessing KRI report group
-
From the list that appears, select AE Completion Timeliness.
-
In the Summary tab that opens, view the summary statistics on AE completion timeliness as explained in the following table.
Figure 2. Viewing summary of AE completion timeliness
Important
There may be no data available in the report or if the data is not the latest, then from the workspace toolbar, select Refresh
to to pull the most recent data from CTMS.Column
Details
Site Code
Represents the unique identifier of the site for which you are analyzing the information related to the completed adverse event data.
Total Number of AE
Represents the total number of AEs that are captured at the site.
Total Elapse Days of AE Completion
Represents the total number of days it took to complete the AE at a particular site. It counts the days since the AE records at a particular were initiated and until they were resolved.
Average Elapse Days of AE Completion
Represents the mean of the number of days it took to complete and submit all the AE cases.
The average is calculated using the following formula:
Total number of elapsed days of all the AE completion of a particular site / Total number of AEs of a particular site
Maximum Elapse Days of AE Completion
Represents the highest number of days an AE took for completion.
Total Elapse Days of AE End Date Entered
Represents the number of days passed between the start and end date of all the AE cases at a particular site.
-
Then switch to the Details tab to view the more detailed statistics on AE completion timeliness as explained in the following table.
Figure 3. Viewing details of AE completion timeliness
Column
Details
Site Code
Represents the unique identifier of the site where the AE is recorded.
[Unique ID Label]
Represents the unique identifier of the subject to whom the AE happened.
The column name depends on the unique ID label configuration of your study in IWRS.If there are additional IDs configured for your study, you see as many such columns as there are IDs.Subject Phase
Represents the subject phase at which the AE is recorded for a patient, for example, Enrolled, Randomized, Completed, and so on.
AESPID
Represents the unique identifier of the reported AE record in the EDC system.
AETERM
Represents the term entered by the reporter to describe the AE, such as "Back pain," Pyrexia," or else.
Serious AE
Represents whether the AE is classified as a serious adverse event (SAE) or not at the time of its completion.
AE Start Date
Represents the date when the AE was first reported.
AE Entered Date
Represents the date when the AE form is first submitted in EDC.
Elapse Days of AE Completion
Represents the number of days it took for the AE to be resolved.
The days are calculated using the following formula:
The date when the AE form is first submitted - The date when the AE started
If AE Entered Date is less than AE Start Date, then the elapsed days are zero, and if the AE form is not submitted, then this field is empty.AE End Date
Represents the date when the AE is completed.
Date of AE End Date Entered
Represents the date when the initial end date of AE is entered in the system.
Elapse Days of AE End Date Entered
Represents the number of days it took to resolve the AE.
The days are calculated using the following formula:
The end date of AE entered in the system - The date when the AE is completed
If Date of AE End Date Entered is less than AE End Date, then the elapsed days are zero, and if the AE form is not submitted, then this field is empty.
You have reviewed the report on AE completion timeliness. You can also export the report as an XLSX file and work with it offline on your computer.
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.
In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.
An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.
Get to know all the possibilities of the app with the comprehensive CTMS User Guide.
An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.
Get to know all the possibilities of the app with the comprehensive IWRS User Guide.
A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.
 |
In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.
An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.