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CRC SOP 08e SAE reconciliation V1

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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

Standard Operating Procedures

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

Table of variables for SAE reconciliation

CRC 08e.2

SAE reconciliation report

CRC 08e.3

SAE reconciliation form

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)

CRC SOP 08e SAE reconciliation V1

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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

Delegated member(s) of the study team will:


5.2.1. Establish time points throughout the study when SAE reconciliation will be
performed; this could be after each SAE is reported, prior to a data safety
meeting or at the end of the study prior to database lock. Before reconciliation,
the data in the clinical database should be complete, validated, and any
outstanding data clarification forms (DCFs) resolved.
5.2.2. Establish a time in the study after which SAEs will not be included in the
clinical database.
5.2.3. Identify the data variables to be reconciled, to include at least: participant
identification (e.g. study/randomisation number), verbatim term for SAE, onset
and resolution date, outcome, intensity, action taken, relationship to study drug
and SAE type (CRC 08e.1).
5.2.4. Establish how the variables will be compared; an exact match or consistent
match (e.g. if dates should have an exact match, free text such as verbatim
terms need to be consistent).
5.2.5. Create a full list of SAEs from the clinical and the safety databases, using a
manual compare of the listings, check that all SAEs have been captured in both
databases, cross check all data variables that have been identified as critical for
reconciliation, and summarise the reconciliation process in a SAE reconciliation
report (CRC 08e.2).
5.2.6. Document discrepancies identified during SAE reconciliation on an SAE
reconciliation form (CRC 08e.3) and ensure that any changes to data which
might result from SAE reconciliation are correctly updated in the clinical
database. All SAE reconciliation forms need to be completed prior to database
lock, and confirmation must be obtained by the data manager of the CDMS (from
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)

CRC SOP 08e SAE reconciliation V1

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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)