Development↦Data Handling↦Data Quality↦Data Mgmt. Plan
What is it? Why is it important?
The Data Management Plan (DMP) is a formal document that describes how data is handled during study conduct and after the study has been completed.
The aim is to offer long-term perspectives on:
- How data is documented, collected, derived, and validated
- How data is preserved with long-term access to data and metadata
- Data relevance and understanding, including data sharing for future use
DMPs will increasingly standardise data handling practices and allow for the reproducibility of research results.
The ability to openly share research data is the main principle of good scientific practice. This should be defined in the DMP.
Health-related data is sensitive data. Consequently, data protection laws, including ethical and confidentiality issues must be considered when sharing this type of data.
What do I need to do?
Questions to address when writing the DMP:
- What type of data (variables) is collected?
- How will data be collected or created?
- What documentation and type of metadata is included?
- How is data access and security managed?
- How are ethical issues and the use of sensitive data handled?
- How is data stored?
- What are data back-up procedures?
- How and where is data shared?
- How is data archived upon study termination?
- How are copyright intellectual property issues handled?
The DMP should be written:
- In collaboration with the data manager of your study
- Prior to study conduct, as it might be required during grant applications (e.g. SNSF, regulatory institutions)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
SNSF – see in particular
- Data Management Plan – DMP guidelines for researchers
NSF – see in particular
- Data management preparations – DMP general guidelines