Your Easy Guide to Clinical Studies

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 study data is documented, collected, derived, and validated
• How study 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 (e.g. which data is shared, on which platform, with which licence).

 

Health-related data is sensitive data. Consequently, data protection laws, including ethical and confidentiality issues must be considered when sharing this type of data.

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 calculations)?
• 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 (database system)?
• 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 (e.g. licence type)?

 

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)

External Links

SNF – search text

• Data Management Plan (DMP) – Guidelines for researchers