Activities covered by this module are typically split into two parts – one that accompanies development of a grant application and another that is triggered upon the grant award and is coupled timewise to the training (see Module 2 below). 

As the first step, PAASP experts help the applicant team(s) to complete the EQIPD funder tool survey that provides a snapshot of the current research practices. The tool output may be included in the grant application to illustrate already existing solid foundation to conduct the proposed work. 

As the second step, PAASP team conducts in-depth remote and/or on-site assessments 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 (if applicable, with the development of blinding protocols, randomization schedules, etc.)
• authentication of biological resources
• competence and training qualification of scientists involved in the study design, conduct and analysis

This step is concluded by the development and implementation of a study plan and a data management plan (before the application and up to 3 months into the project). 

For each research partner a workshop on Good Research Practice and the EQIPD quality system (link) will be hosted by the research partner and organized by PAASP.  Curriculum of the training will follow the program developed by the ECNP Preclinical Data Forum (link) and EQIPD (link). An agenda can look like this (link). 

The primary objective of this workshop (open to everyone from students to principal investigator(s) (PIs) is to make sure that the research teams (from PIs to students and laboratory associates) fully endorse the values of good research practice. 

Workshops are to be held during months 1-2. 

For each research partner, PAASP will coordinate a time period during the conduct of the study when spot checks can be conducted.  The goal of these spot checks is to prevent: 

• suboptimal handling of raw data 
• issues with utilization of the study plan and data management plan 
• 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, PAASP team will provide support in managing and documenting the critical incidents, 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).  

This module will be performed during the project. 

For each research partner, PAASP will conduct a QC check on generated results and reports, and will produce a final report on compliance with research quality standards. 

This will be at the end of the project. 

PAASP provides support for the implementation of the EQIPD quality system (link) and preparation for the EQIPD certification. This includes:

• Specific introduction (depending on whether Module 1 is included)
• Consultation on specific questions
• Document review
• Spot checks

This module is usually spread over the course of the project but can also be adapted.