3.2.3 Implementation of the EQIPD Quality System

Step 1 - Get familiar with the key terms defined by EQIPD

What means quality?

EQIPD defines research quality as the extent to which research data are fit for intended use. Fitness, in this context, is defined by the stakeholders, who can be scientists themselves, but also patients, funders, sponsors, publishers and collaboration partners (e.g., peers in a multi-site research project).

Research rigor

Research rigor refers to measures against systematic error(s) in the estimated effect of an intervention, caused by inadequacies in the design, conduct, or analysis of an experiment.

Raw data

Raw data (please see 2.3.1 Generation, recording, handling and archiving of raw data) means all original records and documentation, which are the result of the observations and activities in a study, such as:

• photographs, videotapes, blots, chromatograms, computer readable media, dictated observations, recorded data from automated instruments, or any other medium capable of providing secure storage of information for a time period required by law or other applicable regulations;
• data directly entered into a computer through an automatic instrument interface, which are the results of primary observations and activities in a study;
• copies of original laboratory records and documentation that are complete and of good quality.

Knowledge-claiming research

Knowledge-claiming research (please see 2.1.4 Purpose of research): EQIPD requires that the maximal rigor possible is applied (and exceptions explained / documented in the study protocol) to research that is conducted with the prior intention of informing a knowledge claim. Examples of research requiring the maximal rigor possible include:

• Experimental studies to scrutinize preclinical findings through replication of results alongside investigations into boundary conditions and robustness through conduct of additional (control) conditions and multicenter studies (Kimmelman et al. 2014)
• Research aimed to generate evidence that enables decisions such as critical studies that, dependent on the outcome, will trigger a chain of activities and events associated with significant resource and time costs (e.g. a decision to initiate a new drug development project or to initiate GLP safety assessment of a new drug candidate)
• Studies for which any outcome would be considered diagnostic evidence about a claim from prior research (Nosek and Errington 2020)
• Labor-, resource- and/or time-intensive studies that cannot be easily repeated

Must vs. should

When reviewing materials provided by EQIPD, please note the use of "must" vs "should".

• "Must" indicates actions that EQIPD considers as imperative and mandatory or as a requirement.
• The system acknowledged that in some cases, the research environment, a specific research project or a research organization do not allow or make it less relevant to adhere to the requirements formulated below.
• In such cases, instead of using the word “must”, the expectations are communicated as “should” or “strongly recommended”. This means that failure to comply with these expectations will not be automatically regarded as a “red flag” but the research organization may need to present a good rationale for not following this strong recommendation.

For more definitions, please see Glossary.

Step 2 - Take a closer look at EQIPD‘s expectations

Please start with viewing the presentation prepared by the EQIPD team that explains why a Quality System is a good solution for research rigor needs, what it is about and how to move forward.

Next, you may want to check how many Core Requirements do you meet by going through the self-assessment overview].

This analysis will help you reveal already at this early stage whether and where major challenges can be encountered.

Once this review is complete, you will be prepared to answer a question - Are most core requirements met?

If the answer is “yes”, we suggest that you complete the self-assessment using the provided template, send it to the EQIPD team for consultation info@EQIPD.online or simply complete the remaining core requirements using information provided by EQIPD online (4.1.2 Self assessment).

If the answer is "no", we suggest that you use the EQIPD tools and follow the suggested implementation path, guided by information provided by EQIPD team.

Step 3 - Guided implementation

The following Figure provides an overview of the Implementation Strategy.

Step-by-step explanation:

1. This wiki provides the necessary background to implement all aspects of the system. Getting familiar with the terms and the Toolbox provides the starting point for implementing the EQIPD QS.
2. The implementation is supported by the Planning Tool developed by EQIPD. This tool can be downloaded here and additional information found at 4.3.2.1 Using the Planning Tool. After downloading the Planning Tool, please make sure that you unzip the file (Help for unzipping file e.g. here).
3. When starting the Planning Tool, the makros should be enabled to allow full functionality. This will directly start the Wizard which guides through the first steps of setting up the EQIPD quality system. The wizard links to information in the Toolbox and to templates in the local Dossier. Providing the necessary information in these templates will already result in compliance with 6 CR.
4. Additional NEEDs from other sources (e.g. industry partner, funding body) might be relevant for your research unit. These needs should be identified and included in the Planning Tool. A current list of the available NEEDs can be found and downloaded here. The downloaded Excel file can be imported into the Planning Tool. For more information visit NEED.
5. The Planning Tool can be used to perform self-assessments via the respective button. When checking the statements of the assessment and documenting the current state, it allows to identify the areas of greatest need for improvements. The file can be easily archived in the Dossier (folder named: 4.1.2 Self assessment) with the “Archive-button”.
6. The Dashboard of the Planning Tool allows to document the implementation of solutions and links to important information. It can also be used to document spot checks on the different requirements.
7. The Dossier was downloaded together with the Planning Tool and is stored locally. The folder structure contains already several EQIPD templates and can be used to organize all relevant information concerning the research unit.

For more information, please contact the EQIPD team at info@eqipd.online.

Step 4 - Assessment by the EQIPD team

Once all core requirements are considered to be met, please approach the EQIPD team info@EQIPD.online that can do an assessment and, in case of a positive evaluation, will certify the successful implementation of the Quality System.

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Item: 3.2.4 Training on specific methods, tasks and activities​