DATE: 12-11-2024 STATUS: under development

 

Open

Phases main storyline research

1. Initiation of research and planning

2. Research preparation

3. Research implementation

4. Research publication

5. Research conclusion

Phase 1: initiation of research and planning

Objective: to obtain permission to conduct a study

HORA processes

• setting up research collaboration

• draw up research proposal

• recruit research resources

DLC stage

Trigger: a researcher has a research question and wants to conduct a study.

1. The researcher makes a research proposal containing the components (possibly with research partners).

   1. a research question

   2. a research plan

   3. a research design

   4. the required resources

   5. an initial draft of a data management plan including:

      1. the data sources to be used

      2. the code tables and metadata templates to be used (prescribed by a data governance committee)

   6. a description of the required research environment, additional tools and storage needs

   7. if applicable, control of data subjects suitable for the research

2. The researcher identifies the sources to be used for the research (via Storyline: Search data in metadata)

   1. the researcher searches the catalog for suitable sources

   2. the researcher filters the results if desired to achieve a more accurate result

   3. if necessary to find the required data, the researcher identifies himself to the catalogue

   4. To verify that the data is suitable, the researcher can ask questions directly to the data provider

   5. the researcher includes the identifiers of suitable sources to be used in the project proposal and data management plan.

3. The researcher submits the research proposal to the local research review committee of the institute for an internal review.

4. The local research review committee assesses the research proposal and gives its approval (possibly after hearing both sides).

5. The researcher makes a funding application for the research proposal and submits it to a funder if applicable.

6. The funder assesses the application and approves it (possibly after hearing both sides).

7. The researcher submits the research proposal to a review committee for review. The review may include:

   1. a legal review

   2. an ethical assessment

   3. an assessment of social aspects

8. The review committee assesses the research proposal and gives its approval (possibly after hearing both sides).

9. The researcher registers the approved research proposal and underlying documents in an internal catalogue.

Milestone products:

• an approved research proposal

• first draft of a data management plan

• financial coverage for the study

• consortium formed

Phase 2: research preparation

Objective: prepare all components for carrying out the research

HORA processes

• (re)use research data

DLC stage

Trigger: the research proposal has been approved.

Variant A: the researcher will collect, process and analyze new data

10. The researcher requests a research environment and additional tools from the toolsupplier to

    1. maintain a data management plan for reusable research results

    2. to establish the citizen's say (informed consent / opt-out).

    3. generate and manage data

11. The supplier makes the research environment and additional tools available to the researcher.

12. The researcher completes the Data Management Plan, using code tables and metadata templates prescribed by the data governance committee

13. The researcher configures the additional tools (e.g. the researcher designs an ECRF (Electronic Case Report Form) to collect data).

14. The Local Data Access Committee of the relevant data holder indicates under what conditions of use data may be recorded at the data source for multiple use.

Variants B and C: the researcher needs existing data for the research. The researcher makes a request to get access to the sources to be used for the research (Storyline: Request data)

10. The researcher logs in to the National Health Data Portal and completes a request form for the intended sources, stating:

    1. Identity of the intended data user(s)

    2. Indication of the desired data sets or the data providers

    3. The research design and rationale (including, for example, the duration of the research) for using the desired data sets

    4. The desired analysis on the desired data sets in combination with other data required for the analysis

    5. Safe processing environment and additional tools to be used using the Tool Supplier

    6. Approval from the local research review committee

11. The data usage request is assessed by one or more data access committees.

12. After assessing the terms of use of the dataset(s) and the data in the data request, a data access permit is granted.

13. A data provider draws up a contract and offers it to the submitter of the data usage request

14. The submitter of the data usage request signs the contract

15. After signing the contract, the data provider makes the requested data available to the data user according to the (contractually) agreed conditions.

16. The secure processing environment supplier installs and configures the desired secure processing environment with the desired tools as the data user has requested in the request.

17. Every data provider makes the requested data available (Storyline: Grant access to data )

    1. in the desired safe processing environment (for the duration of the research as agreed in the data request or as determined by law).

       1. The data provider minimizes the data set.

       2. The data provider consults the control register to suppress data for which no permission has been given or for which an objection has been made (if necessary)

       3. The data provider carries out (if necessary) a pseudonymization (by means of the generic pseudomization service) on the requested dataset.

       4. The data provider makes the data available for the desired secure processing environment.

       5. The data provider reports to the localization service which data has been made available for which research

       6. The data provider notifies the data request service that the desired dataset has been made available so that the status of the request can be updated

       7. The data provider guarantees the reproducibility of the dataset, for example to be able to repeat the data release at a later time.

    2. for the purpose of federated analysis

       1. Every data provider involved in this federated analysis minimizes the data set.

       2. Each data provider involved in this federated analysis consults the control register to suppress data for which there is no appropriate control (if necessary).

       3. Each data provider involved in this federated analysis carries out the desired or required pseudonymization (by means of the generic pseudonymization service) on the requested dataset.

       4. Each data provider involved in this federated analysis makes the data available for delivery to the data processor designated for this federated analysis.

       5. Each data provider involved in this federated analysis reports to the localization service which data has been made available for which research.

       6. Each data provider involved in this federated analysis reports to the data request service that the desired dataset has been made available so that the request status can be updated.

       7. Every data provider involved in this federated analysis guarantees the reproducibility of the dataset, for example to be able to repeat the data release at a later time.

Milestone products:

• a safe processing environment

• installed tools

• access to the requested dataset

• updated localization data

• archived dataset

• an updated data management plan

Phase 3: research implementation

Goal: to arrive at research results

HORA processes

• create new research data

• process and analyze research data

• produce research results

DLC stage

Trigger: there is a notification that the requested data is available in the requested research environment

Variant A: Generating and processing/analyzing new research data (Storyline: Generating research data )

31. The data source starts generating new data points.

32. When the data is generated, the data user receives the generated data

33. The data user uses the tools in the research environment to further process and analyze the generated data.

Variant B: Generate new research data and combine it with requested data (https://health-ri.atlassian.net/wiki/spaces/VD/pages/155751332 )

31. The data source starts generating new data points.

32. When the data is generated, the data user receives the generated data

33. The data user uses the tools in the research environment to further process and analyze the generated data.

34. The data user combines the generated data with requested data: the result is the input data for further analysis.

35. The data user instructs the research environment to perform the analysis determined and approved by the data user on the input data.

36. The secure processing environment performs the analysis determined and approved by the data user on the input data.

37. The data user uses code tables and metadata templates prescribed by the data governance committee and that have already been or are currently being recorded in the data management plan to generate the final research results.

Variant C: Analyze requested data (https://health-ri.atlassian.net/wiki/spaces/VD/pages/155751332 )

31. The data user instructs the research environment to perform the analysis determined and approved by the data user on the input data.

32. The secure processing environment performs the analysis determined and approved by the data user on the input data.

33. The data user uses code tables and metadata templates prescribed by the data governance committee and that have already been or are currently being recorded in the data management plan to generate the final research results.

Milestone products:

• dataset with research results

• metadata of the dataset with research results

• developed/trained algorithms (optional)

• analysis scripts or software code

Phase 4: research publication

Objective: to publish a manuscript and make the research results available.

HORA processes:

• disseminate research results

• preserve research results and research data

• guaranteeing the findability of research data

• guarantee accessibility of research data

• guarantee reusability of research data

DLC stage

Trigger: the research has been completed and there are research results to publish

The researcher here acts in the role of data provider. A number of activities can also be carried out by the research institute.

41. The researcher publishes the conclusions and results in a manuscript

42. The researcher ensures that the research data and research results are archived

43. The researcher asks the Local Data Access Committee whether and under what conditions of use the research data and research results may be recorded for multiple use.

44. The Local Data Access Committee of the data holder in question indicates under which conditions of use the research results may be recorded for multiple use.

45. The researcher uses code tables and metadata templates that are prescribed by the data governance committee and that have already been or will be recorded in the data management plan to make the research results suitable for multiple use (optional)

46. The researcher documents the dataset with research results and makes the dataset available

47. The researcher notifies the localization service about the published data if necessary

48. The researcher creates an up-to-date metadata file about the research results dataset and registers and publishes the metadata at a FAIR data point of his or her choice, using a separate application or integrated into an application with data repository or metadata catalog functionality.

49. The researcher registers the FAIR data point used with a FAIR data point register (see, for example, FAIR Data Point) if this has not been done before. It is the responsibility of the catalog to regularly and/or triggered by a search query retrieve the latest status of the metadata from the FAIR data points.

Milestone products:

• manuscript

• published research results dataset

• metadata published on an FDP

• published workflows and/or algorithms (optional)

Phase 5: research conclusion

Objective: to formally conclude the research and clean up the data and environment used

HORA processes

archiving research results

DLC stage

Trigger: the research has been completed and the research results have been published

51. The researcher ensures that the research data, research results and documentation are archived.

52. The researcher sets up the management of the research results dataset and the metadata of the dataset

53. The researcher ensures that the research environment, research data and research results are cleaned up.

Milestone products:

• archived data and documentation

• established data management process