Clinical Data Management Using the DataFax System

Established in June 2009, the IDI Clinical DataFax data management unit has achieved success in data management of single and multi-site clinical trials. A good number of clinical trials have been completed and several are ongoing using either the Fax Data Collection or the Electronic Data Capture methods of Clinical DataFax. The DataFax software conforms to the FDA regulatory requirements and ICH Guidelines for Data Management for Clinical Research including audit trails, rules for password complexity, aging and notification.

With DataFax, we capture documents as well as data. We attach study Case Report Forms (CRFs), worksheets and any patient documents to the data record making it easy to check the source of documents as well as the completeness and accuracy of the data entry at any time throughout the study.

At IDI, our team of Clinical Data Management staff are committed to upholding a standardized, process-driven approach in exceeding the investigators’ expectations. We strive to ensure the highest quality output on every project. We achieve this by putting in place quality checks at every level of data management from database development to database lock and transfer. Our staff adheres to the well-documented processes in order to achieve good quality data.

Services provided include different activities designed to ensure the highest quality outcome:

  • Developing a Data Management Plan, Statistical Analysis Plan and Clinical Trial specific SOPs
  • Case Report Form (CRF) design using Adobe FrameMaker 9.0
  • Timely designing of the Database and Setup using Clinical DataFax 4.2.0
  • Data validation and edit checks programming and testing
  • Data reviewing and generation of queries for error resolution
  • Site user training and setup of faxing equipment
  • Perform Quality Audits for data quality assurance
  • Patient scheduling and CRF Tracking
  • Trail Monitoring Reports and DSMB data preparation
  • Medical Coding of Concomitant Medications and Adverse Events using dictionaries such as MedDRA
  • Training in solutions that adhere to consistent data standards such as Good Clinical Practices (GCP) guidelines and Good Clinical Data Management Practices (GCDMP)

Why us?

  • A well trained and certified clinical data management team driven by innovation, integrity, care, excellence, teamwork and accountability motives. Our data management team is comprised of experienced professionals with Biostatistics, Applied Statistics, Computer Science and clinical medicine degrees. They have wide experience managing both small and large trials in the area of HIV/AIDS and other related diseases.
  • We are equipped with latest data management and statistical analysis software tools like Clinical DataFax 4.2.0, SAS, STATA 11, Adobe FrameMaker 9.0 etc. deployed in a validated environment.
  • We use the latest version of Adverse Events coding dictionary of MedDRA.
  • We provide you with a set of CRF templates from which you can plan your clinical Trial data needs.

Contact us:

Dr. Andrew Kambugu
Head of Research Department
Infectious Diseases Institute
Mulago Hospital Complex
P. O. Box: 22418 Kampala, Uganda
Tel: +256-41-4307000; or +256-31-2307000
Fax: +256-41-4307290; +256-31-2307290
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Mr. Mark Ssennono
Data Operations Manager
DataFax Unit, Research Department
Infectious Diseases Institute
P. O. Box: 22418 Kampala, Uganda
Tel: +256-41-4307000; or +256-31-2307000
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.