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.
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 results 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
- Timeline designing of the Database using Clinical DataFax 4.0.2
- Data validation and edit checks programming and testing
- Data reviewing and generation of Queries for error resolution
- Perform Quality Audits for data quality assurance
- Patient scheduling and CRF Tracking
- 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)
- 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 4.0.2, SAS 9.2, 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.
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