DATA

ARCHIVING

Introduction:
Clinical data archiving includes the planning, implementing and
maintaining of a repository of documents and records that
contain clinical data together with any interpretive information
from a clinical trial.
The clinical data archive should include a centralized table of
contents for all studies.
Clinical trial documents must be maintained for a period of two
years after completion of Clinical trials

Scope
This section provides an outline to help clinical data managers
develop an archiving strategy.
It includes a discussion of the regulatory requirements
surrounding clinical data archives, a description of the
components of an archive and information about data formats
that can be used to support that archive.
This document focuses on the components of the study archive
that are the responsibility of data management.
There is no discussion about the archiving of study
documents such as the study protocol and other regulatory
documents, as these sections seldom, if ever, are a data
management responsibility.

A summary of the types of information that should be included

in a clinical data archive

Clinical data:
All data collected in the trial. This includes both CRF data and
data that is collected externally (i.e., labs, ECGs or electronic
patient diaries).

External data:
For data that is collected externally and loaded into a CDMS
system, the archive should include all of the load files.

Coding dictionaries:
a copy of the dictionary should be included.

Lab ranges:
Laboratory reference ranges. If more than one version of
reference ranges were used in the course of the trial, each
version should be retained in the archive.

Audit trail:
Entire contents of the study audit trail.

Queries:
Copies of all queries, query correspondence and query
resolutions. Paper queries may be scanned and indexed.

CRF images in PDF format:

for paper-based trials, scanning the forms and converting them
to PDF format typically obtain CRF images. For Electronic
Clinical Trials, the EDC/M Application may create PDF images
of the electronic forms.

Minimum Standards
The clinical data archive should include a
centralized table of contents for all studies.
The accessibility of the clinical data archive
should be tested following every major upgrade
of the active clinical data management system.

SAE
RECONCILIATI
ON

Serious Adverse Event data Reconciliation is the comparison

of key safety data between two data bases (Clinical data base
defined as a closed data base and a safety data base defined
as an open data base).
Clinical data base defined as a closed since it can receive data
only for a very short period of time.
A safety data base defined as an open data base since it
continues receive new SAEs or updates of pre-existing
SAEs.

SAE Reconciliation is done to assure consistency

Between the two bases for the numerosity of

recorded for the same clinical trial

SAE

Among the key safety data defined in DMP/SOP

SAE Reconciliation occurs several times during the whole

study period and it depends on

the frequency of data received

the scheduling of safety updates and the timing of interim

and final reports from Pharmacovigilance to regulatory
authorities on serious adverse event findings.

The capture of SAEs in both the clinical trials database and

the safety database should be standardized with regard to
data captured and coding of terms (e.g., event description,
start and stop date, relation to study drug, verbatim term
coding, etc.).
All information (data and metadata elements) to be reconciled
during this procedure shall be identified and documented in
the study plan before the first patient is enrolled in the clinical
research protocol.

When comparing the key safety data it is

necessary that
key safety data values are same (both in manual and
electronic form)
they are in same format(electronic comparison)
they share the same values code list for the same field
when applicable(both in manual and electronic
comparison)

Procedure
Before starting with SAE Reconciliation the DM department
should ensure that all data to be included in the process have
been entered , coded and validated with no dcf pending , data
must be final for that/ those patient(s) at the time of
Reconciliation.
The procedure organized as it follows:
1. retrieving data from the two data base:
First step is to retrieve the data from the data base and to
create two hard copy listing/two electronic listings and two
sources will be reconciled through direct comparison by
adding each difference this step can be done by DM
department when receiving data from Pharmacovigilance
department or vice versa.

2. Check between information

Checks to be done by DM before starting comparing the key
safety data:
Verify that number of patients that experienced SAEs in
both the data bases is the same at the time of reconciliation.
Verify that all SAEs recorded in the safety data bases are
recorded in the clinical data base as well and vice versa at the
time of reconciliation.
Verify all the key safety data defined as mandatory in the
DMP.

Actions to be taken
SAEs that are in the clinical data base but not in safety
data base
Those can be potentially unreported events, so copies of the
appropriate CRF pages must be forwarded to
Pharmacovigilance.
SAEs that are in safety data base but not in clinical data
base
The DM has no right to add new SAE without any data
clarification form signed by the Investigator. No SAEs can
be added to the clinical data base without been monitored
against the source documents.

Actions taken on key data base discrepancies (acceptable)

If difference in the key data value then depending on the
nature of discrepancy the DM will decide to issue data
clarification form to the site or to accept those discrepancies
since defined as acceptable in the DMP and so there is no need
to query the investigator.
Actions taken on key data base discrepancies (unacceptable)
The review of all unacceptable discrepancies is made by
comparing the information reported in the clinical database
and SAE form that is attached to a CRF
Before issuing the DCF an agreement with the
Pharmacovigilance department is taken since the nature of
DCF can change SAE from non-expedited to expedited.

4. Process tracking
All the necessary actions will be taken by the two
departments to solve the corresponding discrepancies and
the forms will be signed for the approval from the concerned.
Changes to either database, as a result of reconciliation
activities, will be made in a timely manner to expedite
clinical study closure activities and/or safety reporting
requirements.