Registry In Box Wizard
De RIB Wizard is bedoeld als leidraad voor bestaande en opstartende registers. Alle hoofdstukken, behalve hoofdstuk 6, zijn in checkliststijl, waardoor het makkelijk te gebruiken is.
The RIB Wizard
Lead design
Amsterdam UMC - VUmc: Sander de Ridder, Jeroen Beliën
Betrokken deskundigen
Nederlands Kanker Instituut: Mariska Bierkens, Annemieke Hiemstra
Lygature: Rita Azevedo, Jan-Willem Boiten
SURFSara: Ruud Ross
Dutch Techcentre for Life Science: Rob Hooft
Trial Data Solutions: Gerben Rienk Visser
De Wizard is getest door experts uit het veld van Trial Data Solutions, Health-RI, NKI en VUmc. Momenteel hosten we de Wizard in Google Forms. We bieden momenteel twee versies van de Wizard:
- Anonieme Wizard - In deze versie geeft u de wizard geen e-mailadres. Dit betekent ook dat Forms je geen kopie van je antwoorden kan sturen.
- Niet-anonieme Wizard - In deze versie geef je de wizard wel een e-mailadres. Forms kan je desgewenst een kopie van je antwoorden sturen.
Onderstaande hoofdtukken zijn beschikbaar in het Engels.
Let op: hoofdstuk 06 is alleen beschikbaar in niet-anonieme vorm vanwege het vrije tekstformaat.
Chapter 01. Registering the Registry
Introduction
For registries registration is not yet mandatory. However, this may soon change. The questions in this chapter are mostly based on the mandatory fields from the Netherlands Trial Register http://www.trialregister.nl/
Aim
In this chapter essential information is gathered.
Links
Non-Anonymous URL: https://forms.gle/3QM6urEDgYGCvqc4A
Anonymous URL: https://forms.gle/rsdScWiqnQXbVCY7A
Chapter 02. Technical Aspects
Introduction
You will need a solution that allows you to collect, store and perhaps analyse your data. Such a solution consists of one or more programs, which are maintained by your own organisation or an external organisation. It can be (part of) an existing infrastructure (e.g. Health-RI or at your local institute), or a single, sometimes (commercial) custom-made, database.
Aim
This chapter provides questions which can help you determine whether your solution is suitable
Links
Non-Anonymous URL: https://forms.gle/86np535TRRAaBg9j7
Anonymous URL: https://forms.gle/fVwmQ1q24hoprhcs5
Chapter 03. Data Management Plan
Introduction
A data management plan (DMP) is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. Funders nowadays often demand that a data management plan is provided.
Aim
This chapter aims to help you create your DMP by providing links to 1) existing DMPs, 2) the DTL Datastewardship Wizard
Links
Non-Anonymous URL: https://forms.gle/9aaZMPUWeVbw2suX9
Anonymous URL: https://forms.gle/rMHVa9dEd8YWrCcQ6
Chapter 04. Informed Consent
Introduction
An essential aspect of data collection, storage and sharing is the informed consent (IC), as without the proper consent data may not be collected, used and/or shared.
Aim
In this chapter some essential aspects of the IC are verified.
Links
Non-Anonymous URL: https://forms.gle/5q9E1NjKsLC7FPgj8
Anonymous URL: https://forms.gle/1JEKyJueykFJjJ7r5
Chapter 05. Existing Data Sources
Introduction
Before you start collecting all data of interest yourself, you should check whether data of interest already exists in existing sources. This saves time, money and prevents overburdening both patients and people responsible for collecting the data. Coupling your data with existing sources requires collecting key variables, which vary per source. Therefore it is essential the appropriate variables are collected.
Aim
This chapter aims to a) point you to a list with secondary sources; b) ensure you are aware of some essential aspects when using a secondary source.
Links
Non-Anonymous URL: https://forms.gle/BogwqvWZkFumv4LM7
Anonymous URL: https://forms.gle/6ghe8NTwnRyYJXyz9
Chapter 06. Plan Data Collection
Introduction
In this chapter, data collection preparation according to the FAIR principles, where applicable, is explored. An important aspect of data collection is standardisation of your data. By being compatible with existing datasets and/or international standards, the value of the data is increased. Furthermore, by adhering to minimal metadata standards, you can ensure that essential metadata is captured, improving reusability.
Aim
In this chapter the aim is to 1) provide guidance on how to design your dataset; 2) ask questions about data collection quality assurances.
Note
The number of questions may seem daunting, but this is due to each datatype (clinical / biosample / imaging / experimental) having its own section.
Links
Non-Anonymous URL: https://forms.gle/DLYDDSB7o8wB5qku8
Anonymous URL: https://forms.gle/qXqdb4ipfXJzwqbY9
Chapter 07. Data Sharing
Introduction
Funders generally expect you to share your data. In such a case they expect you to provide a data sharing plan, which complies to their data sharing policy. As a registry, you may also want to specify a data sharing policy, detailing the conditions of re-use
Aim
This chapter aims at collecting essential data sharing information. In the future the aim is to be able to generate a data sharing plan
Note
The number of questions may seem daunting, but this is due to each datatype (clinical / biosample / imaging / experimental) having its own section.
Links
Non-Anonymous URL: https://forms.gle/Xs3H68pJE6YsAvrD6
Chapter 08. Using the Data
Introduction
Depending on the type of registry, the data may be used in varying ways. For example, the data in a quality registry could be used to compare health-care providers, whereas a disease registry could be used for disease progression research purposes or perhaps to select eligible patients for clinical trials. Furthermore, all registries are likely to need data on progress, e.g. how many patients are included, etc.
Aim
This chapter aims at 1) ensuring a data analysis plan has all the necessities; 2) informing about data analysis solutions; 3) informing about data reporting solutions.
Links
Non-Anonymous URL: https://forms.gle/LRyUvANUJpsmwuKR7
Anonymous URL: https://forms.gle/SsXwkVdw3a9prtk16
Chapter 09. ELSI
Introduction
Ethical, Legal and Social Implications (ELSI) form an important aspect of a registry. The general recommendation is to go to the ELSI website (https://www.elsi.health-ri.nl/) and/or contact the ELSI servicedesk.
Aim
This chapter currently aims at providing information on intellectual property.
Links
Non-Anonymous URL: https://forms.gle/1o5NGRZ5V3uZ6szj7
Anonymous URL: https://forms.gle/kBxfXK4BCzLUKRc19
Chapter 10. Governance
Introduction
Governance refers to guidance and high-level decision making, including purpose, funding, execution, and dissemination of information.
Applying proper governance principles should ensure that robust operational procedures and processes are in place, clearly communicated, and easy to access for everyone involved in the data life cycle. Besides basic managerial and operative functions, the goal of apt governance should also be transparency to stakeholders in operations, decision making, and in reporting of results.
Aim
In this chapter some essential aspects of Registry Governance are handled
Links
Non-Anonymous URL: https://forms.gle/renf36bz58HAk29RA
Anonymous URL: https://forms.gle/Z2zMAFzTCxNQgW2Z6