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DATA ARCHIVINGIntroduction:

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 RECONCILIATIONSerious 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 SAE recorded for the same clinical trial

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:

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.

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 takenSAEs that are in the clinical data base but not in safety data baseThose 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 baseThe 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.

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.