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.
What do I need to do?
As a SP-INV, when writing the DMP ask yourself the following questions:
- What type of data do I plan to collect on my study (e.g. study data, variables)?
- How will data be collected or created (e.g. raw data, automated data processing)?
- How must I document my study data (e.g. metadata, variable specification)?
- How is data access and security managed (e.g. Swiss law, server management)?
- How are ethical issues and the use of sensitive data handled (e.g. data confidentiality, data coding and anonymisation)?
- 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. SNF, 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
SNF – search text
- Data Management Plan (DMP) – Guidelines for researchers