Lab data reconciliation in clinical data management

March 02, 2023

Lab data reconciliation in clinical data management

WHY DATA MANAGEMENT

The main objective of Data Management (DM) is to deliver a qualitative database to SAS Programming, and Statistical Analysis teams in a timely manner in turn helps to generate bug-free reports. The ultimate challenge is managing the third-party vendor data, which loads into the database, and our aim is to reconcile this Vendor data (Lab data, SAE Data) with the related data present in our database.

WHAT IS RECONCILIATION?

“Reconciliation is the comparison of specific data points associated with third-party data reported to the vendor database and the clinical database.”

DATA RECONCILIATION IN CLINICAL DATA MANAGEMENT

CDM data reconciliation is a data review process that compares unique identifiers in the EDC (Electronic data capture) data such as subject number, visit nominal time point, collection dates, and collection times with the same data points in the electronic external data source datasets. The data points to be reconciled are defined at the project level through discussions between the Sponsor, CRO, and electronic external data vendor and documented in a data cleaning plan. Discrepancies between the EDC data and the external data source are identified by CDM, and those discrepancies are addressed by the external data vendor, Clinical Research Associate (CRA), or site. After data reconciliation discrepancies are communicated to the appropriate party (e.g., through site data queries, vendor communication, Sponsor teleconferences, etc.), the data are corrected to ensure both the EDC and electronic external data are reconciled and matching.

Clinical Database – Used for a clinical trial and this database uses an electronic CRF or a paper CRF. In both cases, the relational database allows entry of all data captured on the CRF. Examples of clinical bases are Oracle Clinical, Inform, Rave, etc.

Vendor Database – An external database, known as a vendor database or Third-party database, is where the collected clinical data is entered and collected samples are tested, analyzed and their results are loaded into Clinical Database.

THE FLOW OF LAB DATA IN THE CLINICAL DATABASE

1. Subject arrives at the investigator site, either on the scheduled visit or on an unscheduled visit, to give lab samples like blood, urine, and so on.

2. The Lab kit with a unique Accession Number or Sample ID is assigned to each subject at the investigator site. Lab Kit is consisting of all required materials for sample collection like syringes, ampules etc. as well as a Lab Requisition form.

3. The required samples are drawn.

4. Lab Requisition Form with the Collected Samples is sent to the Vendor. Lab requisition form which comprises of information like site, subject and visit identifiers, gender, date of birth, Lab test (optional), date of sample collection, time of sample collection (optional) and Sample ID or Accession Number is filled.

5. Details of the Collected Sample Data is Entered in the Clinical Database like site, subject and visit identifiers, Lab test (optional), date of sample collection, time of sample collection (optional) and Sample ID or Accession Number using SAS Reports for Data Cleaning.

FLOW OF LAB DATA IN THE VENDOR DATABASE

Lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial.

Vendor laboratory data is very significant for the clinical trial data management process. The reviewer has a significant role to play in the effective management of vendor data.

Ex: Biological samples like blood urine etc., ECG core lab, imaging core lab, cardiovascular core lab, biomarkers, genetic testing, isolation of cancer genes etc.

1. Lab samples received from investigator site are analysed and results collected.

2. Data from Lab requisition form and the collected results are entered in Vendor database.

3. Data is sent to appropriate team per the Data Transfer Agreement (DTA) specification. DTA defines the format of files, frequency of data transfer, file naming conventions, encryption levels, method of transfer, type of transfer (complete versus partial), recipient, test names, formats, high and low value flags or alerts, and any additional information concerning the lab data.

LIST OF DATA POINTS RECONCILED IN LABORATORY DATA RECONCILIATION

The data points that can be reconciled are namely demographic data and procedural data. These data points are retrieved from vendor databases and clinical databases.

Demographic Data

∙ Site Identifier ∙ Subject Identifier ∙ Gender ∙ Date of birth

Procedural Data

∙ Visits for lab sample collected ∙ Lab test name (Optional) ∙ Date of lab sample ∙ Time of lab sample (Optional)

Types of Discrepancies

∙ Incorrect data loaded for subjects ∙ Mismatch in dates entered in Vendor and Clinical Databases ∙ Mismatch in time entered in Vendor and Clinical Databases ∙ Visits incorrectly loaded ∙ Visit dates collection mismatches when data is collected in 24-hour format ∙ Data collected for screen failures

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