Research data managment Flashcards

1
Q

What is Research Data Management?

A

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.

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2
Q

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

A
  • 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.)
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3
Q

Why is RDM important?

A
  • Nowadays (current paradigm) new data will replace old data.
  • When you ensure RDM, data can be reused by other scientists.
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4
Q

True or False

RDM is not important for research with human subjects.

A

False → RDM always needs to be applied for research with human subjects.

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5
Q

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

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

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6
Q

Complete the sentence

An RDM-policy at Amsterdam UMC is the FAIR guiding principles for research data. It says that data should be….

A
  • Findable
  • Accesible
  • Interoperable
  • Reusable
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7
Q

What results from controlling RDM processes along the research lifecycle?

A
  • 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
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8
Q

What is a data management plan (DMP)?

A

A plan how you are going to manage your data before your research project starts

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9
Q

What kind of roles do DMPs play in general?

A
  • Privacy & security
  • Data description
  • Data storage during research
  • Sharin data with colleagues
  • Data archiving after research
  • Data licenses/citation
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10
Q

What kind of roles do DMPs play that are specific to clinical research?

A
  • Design of (e)CRFs
  • Use of validated data management tools
  • Roles and authorization
  • Data validation (audit trail, quality/change control)
  • Data processing/cleaning
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11
Q

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?

A
  • 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
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12
Q

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

A
  • non-WMO → 5-15 years
  • WMO (no IMP) → 15 years
  • WMO (with IMP) → 25-30 years
  • MDR → contact experts
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13
Q

No idea how to form a question for these two slides, so just read.

A
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13
Q

No idea how to form a question for these two slides, so just read.

A
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14
Q

Skipped slide 24-28

A
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15
Q

To ensure people can find your research results, what type of actions could you take?

A

Amsterdam UMC recommends making your research available for reuse by other researchers

16
Q

Take home message

  • Document everything. If it’s not documented, it did not happen
  • If sharing the data is not possible, at the very least share relevant
    supporting documents (metadata)
  • Plan ahead as certain components that apply at the end of the study (archiving, sharing, publication) need to be arranged at the start of the study.
A