What is it? Why is it important?
Laboratories or other analytical systems generate study data. The ability to import data from these systems into the study database can:
- Simplify the data collection and documentation process
- Avoid human transcription errors
Still, as different software systems utilise different means to document and store data, the transfer between different software systems may entail significant reformatting efforts.
Thus, the translation of information from one system source to another must be defined prior to any data transfer.
Different software systems commonly have different standards regarding data structure. While the information may be intuitively obvious to a human reader, the same does not always hold true for a computer system.
Required adaptations may include:
- Data formatting (e.g. where male gender is coded differently and must be harmonised)
- Structural and technical information (e.g. variable names, column names, dataset location)
Any adaptations should be done by the DMan in collaboration with the study team before data transfer, as only correctly formatted data guarantees successful data import into the database (eCRF) of the study.
What do I need to do?
- Clarify whether data can be exported from a primary system source of interest
- Collect information on the set-up and structure of the data to be exported (e.g. formatting-, metadata information)
- Define with the DMan of yours study how
- Data must be reformatted in order to be compatible with the study database
- To validate any reformatted data based on the requirements of your study database
- Perform any data import only once the data has been appropriately adapted in the primary source
Data manipulation processes:
- Are time-consuming and have a high error risk if done incorrectly (e.g. incorrect reformatting, the skipping of format validation prior to merging, faulty implemented data merging procedures)
- Must be documented and reproducible
As these processes can be quiet challenging, it might be advisable to outsource some of these services.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.5. Trial Management, data handling, and record-keeping