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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
University of Cape
Town
Clinical Research
Centre
Title
Number
Version
SAE reconciliation
08e
1
Name
Title
Signature
Date
Reviewer
Authoriser
Effective date
Review date
1. Purpose
To provide instruction to those data management team members delegated responsibility
for Serious Adverse Event (SAE) reconciliation during a clinical study, where SAE data are
stored in the Clinical Data Management System (CDMS) as well as a safety database, and
the two databases are maintained separately.
2. Scope
The Clinical Research Centre (CRC) will advise whether this document is mandatory for
research where UCTs Faculty of Health Sciences (FHS) is the named sponsor or where CRC
facilities are used (CRC SOP 02). This SOP may, however, also be adapted for use for
studies conducted by UCT clinical researchers where UCT is not the sponsor.
3. Templates/forms
CRC 08e.1
CRC 08e.2
CRC 08e.3
4. Glossary/definitions
Master File
Files for each project containing key documents (such as Essential Documents for clinical
trials). The Master File is in two parts a Sponsor File and Investigator Site File (ISF).
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction
Any untoward medical occurrence that at any dose, results in death, is life-threatening,
requires inpatient hospitalization or prolongation of existing hospitalization, results in
persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting).
5. Responsibilities and procedure
5.1.
Clinical Database
5.1.1. A member of the study team responsible for the creation of the CDMS will
ensure that information regarding SAEs is included in the clinical database. The
stored SAE data will need to be standardised to ensure data elements are
compatible with those in the safety database.
5.2.
SAE reconciliation
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
the safety database manager) that all reported SAEs have been reconciled. If no
SAEs were reported, this is confirmed.
5.2.7. Document any final inconsistencies that cannot be reconciled in the Data
Management Protocol.
6. Document history:
Version
Date
Reviewer
Details of changes
No.
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)