Clinical Data Guidance

Owned by Sander de Ridder
Last updated: Jan 25, 2024
2 min read

Generalised Guidance for Creating FAIR Clinical Data Sets from Scratch

 

This is based on the comment attached to “Actor perspective” written over here and should be further discussed/elaborated. Really drafty.

 

General Approach

  1. Define FAIR Objectives & deliverables (Guidance: Metroline Step: Define FAIRification objectives)

  • Here we assume the goal is to

    • Create a new FAIR Clinical dataset

    • Publish this dataset to make it available for others

    • ?

  1. Build study for data collection (Guidance: see Metroline XYZ)

  • Communities already over here?

    • Assuming you want to already collect the data in a standardised way, build the study using knowledge from the communities? Reusing existing eCRFs and Codebooks?

    • (Find out whether work has already been done, which you can reuse. Perhaps a link to a page which talks about the communities? Or perhaps a page which talks about reusing what’s already out there?)

  • Build the eCRFs with the fields of interest in the EDC

  1. Collect the (meta)data (Guidance: see XYZ)

  • Collect the necessary / desired metadata requirements;

    • Required: Core metadata mode

    • Desired: Health metadata model (is this extended core?)

    • Desired: Domain specific model(s) (Petals)

  • Collect the data

    • Collect the data in the EDC

  1. Map (Guidance: see Metroline XYZ)

  •  

  1. Publish the dataset (Guidance: XYZ)

  •  

 

Applied Example

Use case: Researcher will collect Diagnosis data in Castor EDC and wants to make this dataset FAIR.

Step 1: Define FAIR Objectives & deliverables

Objectives

  • make data available for future research

  • ensure others can understand the data

  • ensure data can be with other datasets

Deliverables

  • Queryable FAIR diagnosis data

  • Publish dataset in Castor FDP, which is harvested by HRI catalogue (is it?)

Step 2: Build study for data collection

  • Researcher searches HRI codebook library for a preferred codebook with Diagnosis items

  • Researchers builds a Diagnosis eCRF in Castor using suitable tools

  • (In case items are missing, does she join something like the clinical community? Maybe she should, but I’m not sure whether most researchers would)