Clinical Research

Oracle Clinical Training

Oracle Clinical is a comprehensive Data Management system developed by Oracle Corporation that provides the clinical research industry with an integrated approach for clinical trial conduct and clinical data management in compliance with 21 CFR part 11. Oracle Clinical maintains and manages the clinical trial conduct starting from planning a research study to preparation of clinical study report (CSR). Oracle Clinical can be considered to be the perfect clinical trial management system for successful conduct of a clinical project.

Oracle Clinical is typically bundled together with other products like Thesaurus Management System (TMS), Remote Data Capture (RDC), Adverse Event Report System (AERS). Thesaurus Management System manages the medical dictionaries that provide coding for adverse events and drugs. Adverse Event Reporting System supports the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. Remote Data Capture is a web based interface that allows clinical investigators, monitors, site coordinators to enter the data, monitor trial progress and track source document verification.

Oracle Clinical has the following functional attributes that help in managing and conducting  a clinical trial.

  •  Administration: Create users, assign access, set-up code lists, configure Data Entry, Global Library, Discrepancy Management attributes for a clinical study.
  • Global Library: Create questions, question groups, discrete value groups, extract macros, extract templates etc.
  • Study Design/CRF Modeling: Create the protocol and assign sites, investigators, patients, events, treatment patterns and regimens, load or create treatment randomization.
  • Edit Checks & Derivations: Create validation procedures to perform edit checks across questions/visits and create derivation procedures to calculate derived response to questions.
  • Data Entry/Batch Loading: Manually via Data Entry or RDC and electronically through the Batch Data Load facility.
  • Discrepancy Management: Review and resolve discrepancies; update data and create Data Clarification Forms (DCFs) for Site review.
  • Data Extract Views & SAS Datasets: Create standard views of data in Oracle and SAS.
  • Labs: Manages the external data like lab reports, radiology reports etc.

A typical view of Oracle Clinical navigator is shown below:

 Oracle Clinical Training

Advantages of Oracle Clinical Training:

The clinical research industry needs professionals who are well trained and experienced in Oracle Clinical programming and functionality. Training in the niche areas of Oracle Clinical programming provides an extra edge to the professionals who wish to enter the clinical data management industry. Data Management companies based in Indian cities such as Delhi, Mumbai, Hyderabad and Chennai are constantly hiring candidates trained in Oracle Clinical. Start up position is normally that of an Oracle Clinical programmer and the hierarchy follows as database administrator, database analyst, database manager, developer, project manager etc.

James Lind Institute (JLI) conducts an Advanced Post Graduate Diploma in Clinical Research and Data Management program which covers all aspects of data management and niche areas of clinical research required by the industry. The course curriculum includes live online sessions of Oracle Clinical – RDC practical training using modern screen sharing technologies. For more information please click here: Online Oracle Clinical Training.

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