Documentation in EQIPD
EQIPD Quality System is lean and does not require excessive documentation.
The following table describes the documentation required to address the EQIPD Core Requirements.
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.
|Categories||No||Core Requirement||Toolbox reference||Implementation of the Core Requirements|
|Stand-alone document||EQIPD expectations|
|Research team||1||Process owner must be identified for the Quality System||126.96.36.199||No||Process Owner should act and be recognized as such by the research unit members.|
|2||Communication process must be in place||1.2||Yes||A concise overview of the organisational structure and the communication lines can be described using the Communication plan template provided by EQIPD or in a similar document.|
|Quality culture||3||The research unit must have defined quality objectives ||1.1||Yes||The Mission statement template of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.|
|4||All activities must comply with relevant legislation and policies||1.4.2||(Yes)||Research unit complies with all applicable national and international legislation and policies and there are no compliance issues. For research units conducting studies using laboratory animals, there must be either a full accreditation by AAALAC (or equivalent) or a standalone description of animal care and use program according to the EQIPD checklist|
|5||The research unit must have a procedure to act upon concerns of potential misconduct||4.2.3||No||It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.|
|Data integrity||6||Generation, handling and changes to data records must be documented||2.3.1||Yes||Can be described using the Documentation plan template provided by EQIPD or in a similar document.|
|7||Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs||3.1.3||Yes||Can be described using the Documentation plan template provided by EQIPD or in a similar document.|
|8||Reported research outcomes must be traceable to experimental data||188.8.131.52||Yes||Can be described using the Documentation plan template provided by EQIPD or in a similar document.|
|9||Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome||2.4||No||it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.|
|Research processes||10||Investigator must declare in advance whether a study is intended to inform a formal knowledge claim||2.1.4||No||This requirement is most optimally met by providing corresponding information in the study protocol, see 2.1.1 Study protocol.|
|11||All personnel involved in research must have adequate training and competence to perform assigned tasks||3.2.1||No||For legally required / mandatory training, training records are typically available. For other training, Process Owner decides on whether and what form of documentation should be maintained. EQIPD expects that all research units members are trained on what is considered to be raw data and how to record and handle data. Further, EQIPD expects a training program for new members of the research unit.|
|12||Protocols for experimental methods must be available||3.5.2||No||Methods can be described in either standalone protocols or be part of study protocol. (template)|
|13||Adequate handling and storage of samples and materials must be ensured||3.3.3||No||Although there is no requirement to have a standalone document describing the overall process of handling and storage, it is nevertheless in many circumstances to be expected that certain aspects of handling and storage are supported by relevant documentation (e.g. electronic or paper-based system for keeping a control over research chemicals and reagents).|
|14||Research equipment and tools must be suitable for intended use and ensure data integrity||3.3.2||No||It is expected that protocols of experimental methods clearly state whether maintenance or calibration is needed and, if yes, describe the procedure.|
|Continuous performance||15||Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data||4.1.1||No||Study protocols are expected to have a dedicated section summarizing measures against risks of bias, see 2.1.1 Study protocol. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the Risk assessment template.|
|16||Critical incidents and errors during study conduct must be analyzed and appropriately managed||4.2.2||No||Critical incidents and errors can be recorded in laboratory notebooks or using Error reporting template or using another electronic or paper-based system.|
|17||An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues||4.1.2||No||Evidence for such approach is provided indirectly by the information described in the Self assessment template that is completed at regular intervals (as a minimum, annually).|
|Sustainability||18||Resources for sustaining the EQIPD Quality System must be available||1.5.5||No||No documentation needed but EQIPD does not accept lack of resources as an argument for not following the best research practices.|
Additional information about expectations can be found in this pdf document.