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Project support

EQIPD provides support to organizations that are developing new projects / project proposals and are interested in introducing additional research quality training, assessments and monitoring.

EQIPD's support is particularly relevant for research projects that can be described as:

  • 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), or
  • Labor-, resource- and/or time-intensive studies that cannot be easily repeated

Collectively, EQIPD calls these types of studies "research conducted with an intent to inform a formal knowledge claim" or, in short, "knowledge-claiming research".

General principles of the EQIPD contribution are outlined below and can be customized for the needs of a specific project or organization.

Please contact the EQIPD team for more information.

 

Part 1 – General training

EQIPD provides an on-site or virtual two-day training on Good Research Practice hosted by the research organization and organized by EQIPD.  Curriculum of the training workshop generally follows the program developed by the Preclinical Data Forum (here).

The primary objective of these workshops (open to everyone from students to PIs) is to make sure that the research teams fully endorse the values of confirmatory mode of research.

These workshops are typically held at the beginning of the project (e.g. Months 1-2).

 

Part 2 – Initial assessments and research rigor planning

Coupled timewise to the training workshops, for each research partner, the EQIPD team conducts an on-site or virtual assessment of quality practices with, if needed, assistance in identifying, building and implementing required solutions.

Focus of these assessments is on the following: 

  • data management and documentation practices (goals: secure storage of raw data; transparent and traceable handling of raw data);
  • internal validity of studies to be-conducted (goals: mitigate the risks of bias by measures such as blinding, randomization, pre-specification of hypotheses, analysis plans, exclusion / inclusion criteria, etc.)
  • authentication of research tools and reagents (including biological resources)
  • training qualification of scientists involved in the study design, conduct and analysis

This step is concluded by the development of a study plan (with feasibility assessment) that can be pre-registered using one of the public online platforms or using other means.

These activities are typically concluded during Months 3-6, dependent on the complexity of the project and the number of research teams / sites involved.

 

Part 3 – Spot checks, critical accident and error management

For each research partner / site, EQIPD coordinates a time period during the conduct of the study when spot checks can be conducted (i.e. unannounced visits to research sites to test compliance with the pre-defined study protocol and research practices).  The goal of these spot checks is to prevent:

  • suboptimal handling of raw data
  • inadequate control of risks of bias (such as performance bias)
  • unplanned / unintended unblinding before the study analysis is completed

Further, operating mostly in a remote manner, the EQIPD team can provide support in managing and documenting the critical accidents, errors and deviations from the pre-agreed plan (by establishing a decision tree on how to handle errors and providing advice on specific cases to avoid unnecessary bureaucracy while maintaining maximum transparency). 

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