Storyline: Request data

DATE: 23-08-2024 STATUS: ADOPTED

Precondition

• The data user has a mandate from their organization to conduct a study and as part of that, the Local review committee launch research has already reviewed and approved the research.

• The data user knows

  • what data is needed

  • what type of safe processing environment is going to be used or whether a federated analysis is desired

  • who will deliver the secure processing environment at which location (when applicable)

Process model

1. The data user selects (a subset of) one or more datasets from the aggregated set of metadata of the data guide.

2. The data user records a data request including

   1. Identification and authentication of the data user(s)

   2. Indication of the desired datasets or the data providers

   3. The research design and the rationale (including, for example, the duration of the study) for the use of the desired datasets

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

   5. Safe processing environment to be applied with the help of the Tool Supplier

   6. Approval of the Local review committee launch research.

3. The research data request service facilitates and administers the process for the data user to request selected dataset(s) from the Central data provider review committee.

4. The Central data provider review committee verifies whether the desired analysis to be carried out meets the conditions of use of the requested dataset(s).

5. The data request service registers the response of the central data access committee and facilitates and administers the process for the data user to request selected dataset(s) from the data provider(s).

6. The approached data provider verifies

   1. that the request complies with the applicable autorization conditions of use of the requested data

   2. that there is no veto from the local review committee data providing on the application

7. The data request service provides feedback on the results of the assessments to the data user

8. The data request service sends the contracts to the parties involved.

9. The parties involved sign the contracts

10. After signing the contracts, the data request service sends a notification to the data provider(s) that the data can be made available on the requested secure processing environment or the data can be made available for federated analysis.

This storyline is followed by Storyline: Central analysis or Storyline: Federated Analysis.

Postcondition

• The complete application has been registered and assessed by all the review committees involved

• The data user has received feedback about his request

• If the outcome is positive, a permit has been granted to use the data in the requested environment

• The contracts have been signed

• A notification has been sent to the related parties (data user, data provider(s), and the supplier of the secure processing environment) to initiate the follow-up process.

Open

Process diagram “Request data”