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

Implementation has to focus on the Core Requirements. However, implementation can be guided by an Excel tool developed by EQIPD, the EQIPD Planning Tool. This tool includes a Wizard guiding through the first steps of implementation and links to information which are online in the Toolbox and locally in the Dossier. The Planning Tool and a layout for the Dossier can be downloaded here. (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​