Serious Breaches in Clinical Trials
Serious Breaches in Clinical Trials Quiz
Test your knowledge on Serious Breaches in Clinical Trials with this informative quiz! Designed for clinical trial professionals, this quiz covers essential guidelines and responsibilities associated with reporting serious breaches.
- Understand the reporting requirements
- Identify potential reportable events
- Learn about the roles of various stakeholders
If the Sponsor has retained responsibility for Serious Breach reporting via CTIS, Caidya will promptly notify the Sponsor within ___ of detection of any suspected Serious Breach reportable event.
1 Calendar Day
7 Business Days
1 Business Day
7 Calendar Days
3 Calendar Day
This SOP outlines the process for reporting a Serious Breach to any country with Serious Breach reporting requirements
True
False
A suspected Serious Breach reportable event may include
Protocol deviations that are likely to affect to a significant degree the reliability and robustness of the data generated from the approved protocol
An event that is likely to affect to a significant degree the rights of trial subjects
Protocol deviations that are likely to affect to a significant degree the safety and rights of trial subjects
All of the above
Which individuals or entities are responsible for complying with the Serious Breach reporting procedure ?
Clinical trial investigators, contractors and vendors
Caidya employees, contractors, vendors and investigators
European CTIS portal administrators
Sponsor, Caidya employees, contractors, and investigators
All the above
The Sponsor is responsible for executing the SB reporting without undue delay and at the latest within ____
1 Calendar Day
7 Business Days
1 Business Day
7 Calendar Days
3 Calendar Days
Who is responsible for notifying a suspected Serious Breach to the SBEG or the Sponsor?
Only the clinical trial investigator
Any person contributing to the clinical trial
The regulatory authorities
The Serious Breach Expert Group members
It is important to identify who is responsible to submit a Serious Breach reportable event to the CTIS portal, either the Sponsor or Caidya and as specified in the contract.
True
False
If the sponsor has retained responsibility for serious breach reporting to the CTIS portal, Caidya will promptly notify the Sponsor within one business day of detection of any suspected Serious Breach reportable event.
True
False
The sponsor has no responsibility to review a suspected Serious Breach event nor document their decision as to it’s reportability.
True
False
What is the role of the Serious Breach Expert Group (SBEG)?
To conduct clinical trials in different geographic regions
To participate in root cause identification only
To evaluate suspected Serious Breach reports
To manage protocol deviations
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