Page 440 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-107 SOP Title: Reportable Events
1. PURPOSE
the purpose of this standard operating procedure (SOP) is to outline the conditions under which a reportable event should be submitted and the procedures to be followed when submitting reportable events.
2. INTRODUCTION
A central focus of clinical research is the safety and well-being of every subject during and following their participation in a clinical trial. This requires strict adherence to the guidelines set forward in Good Clinical Practice (GCP) and FDA regulations wherein it clearly defines the expectations to monitor and report the subject’s medical status during and following the clinical trial. Beyond the subject’s immediate medical treatment, all information regarding response to research intervention and the subject’s involvement on a clinical trial is relevant in the investigation of the clinical trial hypothesis(es) and investigational product.
3. SCOPE
This SOP applies to all clinical trials conducted at Children’s Medical Center and/or under the purview of Children’s Medical Center Research Administration.
4. RESPONSIBILITIES
According to GCP section 4.3.2, the investigator or institution should ensure that adequate medical care is provided to all subjects for any adverse events (AE), including clinically significant laboratory values, related to the trial. Therefore, it is crucial that the principal investigator and study team define the expectations for monitoring, addressing, reporting and documenting all adverse events and serious adverse events (SAE). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP. Additionally, all other reportable events including data safety reports, important study updates, and otherwise must be addressed according to a clearly defined method of monitoring, addressing, reporting and documenting.
For studies using a central IRB, please ensure to familiarize with the reviewing institution’s reporting policies.
5. SPECIFIC PROCEDURE
For an event to be reportable to the Institutional Review Board (IRB), the event must meet all the following criteria:
1. Unexpected (in terms of nature, severity, or frequency), and
2. Definitely or Probably related, and
3. In the opinion of the PI, suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
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