Research data managment Flashcards
What is Research Data Management?
It describes the organization, storage, preservation, and sharing of data collected and used in a research project. It involves the everyday management of research data during the lifetime of a research project.
So RDM can be applied during the entire lifetime of a research project. And is thus involved in all stages of a research project. Describe how RDM is seen during the different stages of a research project:
- before the start of the study
- during the study
- at the end of the study
- before the start of the study → writing a research proposal (where everything is described in regard to data management)
- during the study → the collection of data (how/what/where data is collected) and the analysis of data (storage/cleaning/protection of data)
- at the end of the study → data archiving (data publication, preservation, etc.)
Why is RDM important?
- Nowadays (current paradigm) new data will replace old data.
- When you ensure RDM, data can be reused by other scientists.
True or False
RDM is not important for research with human subjects.
False → RDM always needs to be applied for research with human subjects.
The standard operating procedure on RDM is obligated for:
a. All researchers of every type of research at Amsterdam UMC.
b. All researchers who perform research involving human subjects at Amsterdam UMC
c. Only for researchers involved in WMO-research at Amsterdam UMC
d. Only for the RDM-support employees, to make sure they can help researchers
a. All researchers of every type of research at Amsterdam UMC.
b. All researchers who perform research involving human subjects at Amsterdam UMC
c. Only for researchers involved in WMO-research at Amsterdam UMC
d. Only for the RDM-support employees, to make sure they can help researchers
Complete the sentence
An RDM-policy at Amsterdam UMC is the FAIR guiding principles for research data. It says that data should be….
- Findable
- Accesible
- Interoperable
- Reusable
What results from controlling RDM processes along the research lifecycle?
- Enabling reproductibility of research
- Demonstrate scientific integrity
- Comply with legal requirements and regulations
- Safeguard safe and sustainable access to your data
- Guarantee high quality data
- Sharing and reuse
What is a data management plan (DMP)?
A plan how you are going to manage your data before your research project starts
What kind of roles do DMPs play in general?
- Privacy & security
- Data description
- Data storage during research
- Sharin data with colleagues
- Data archiving after research
- Data licenses/citation
What kind of roles do DMPs play that are specific to clinical research?
- Design of (e)CRFs
- Use of validated data management tools
- Roles and authorization
- Data validation (audit trail, quality/change control)
- Data processing/cleaning
RDM/DMP is divided into 5 phases:
- Phase I → Study Preparation
- Phase II → Data Collection
- Phase III → Processing and Analysis
- Phase IV → Writing and Publishing
- Phase V → Archiving and Open Data
What are the main rules during Phase I: Study preparation?
- Lawfulness, fairness, and transparency
- Specific and explicit purposes for processing
- Data minimization → collect only what is necessary for purposes
- Accuracy
- Integrity and confidentiality security through technical and organizational means
During Phase I: Study Preparation, it is important to think about how long your data is stored (no longer than necessary). Describe for the following types of research, how long data can be stored.
- non-WMO
- WMO (no IMP)
- WMO (IMP)
- MDR
IMP = Investigational medicinal product
MDR = Medical Device Regulation
- non-WMO → 5-15 years
- WMO (no IMP) → 15 years
- WMO (with IMP) → 25-30 years
- MDR → contact experts
No idea how to form a question for these two slides, so just read.
No idea how to form a question for these two slides, so just read.
Skipped slide 24-28
