The aim of conducting experiments that follow a specific experimental or study design is to prove a hypothesis, avoiding bias and errors.
The experimental design should ensure compliance with the research plan or the previous experimental design as well as the safe and timely data collection and application of appropriate SOPs.
In order to create a lab specific action plan, the first step is an assessment, which will be carried out by the PREMIER team. The assessment will determine the status quo of the laboratory in regard to existing quality tools. Here you find the general tasks / actions that are necessary to implement the module.
Bias is a distortion or an unintentional influence on results and, in the worst case, a systematic error, e.g. caused by inadequate experimental design (e.g. non-representative sample sizes). Researcher are able to reduce and counteract the omnipresent bias with different tools and methods, such as the described steps of experimental design, adequate statistics in the evaluation of experiments and also the application of suitable standard protocols in the execution of experiments.
Further information can also be found in the manual for bias assessment of the Cochrane and AWMF: https://www.cochrane.de/sites/cochrane.de/files/public/uploads/manual_biasbewertung.pdf
The key processes of basic research in PREMIER are defined in standardized processes (SOPs) and Workinstructions (WIs). They describe the methods and process flows that are necessary for the research work. They regulate how the requirements placed on research can be translated into results and how new methods and models can be developed from them. The Standard Operating Procedures are intended to ensure and document a uniform quality standard of the work performed in academic biomedical research. The purpose is to define organisational processes and procedures for the implementation of research-related processes which, due to their complexity or importance, require standardisation and written specification.
The SOPs and WIs must be continuously reviewed and updated in order to continuously improve the content of these protocols and to ensure their compliance and realization. SOPs follow a defined life cycle: writing, approval, distribution, updating and reset.
The SOPs are binding implementing rules or standardised protocols. We differentiate between organizational and methodical SOPs. The first are specific instructions for action, which are subdivided into overarching SOPs (cross-group and cross-departmental) and specialized area SOPs (assigned to a specialized area in terms of content). Methodical SOPs are specific instructions that describe the implementation of standardized research methods and techniques and/or procedures on equipment.
All SOPs have a uniform layout, which is maintained by using a format template as the basis for the creation of a new SOP.
The content of the SOPs is divided into the following sub-items:
- Changes from the previous version
- Goal / Background
- Implementation (process description)
- Evaluation / Control (if applicable)
- Other applicable documents
SOPs should always be described concisely and should not be too long. Too much detail should be avoided or should be provided as background information via a link. Regulatory requirements and standards (laws, regulations, guidelines) should be taken into account. If possible, the work process should be presented together with the names of the responsible group of people or functional areas (e.g. employees, department heads, AG heads) (clear responsibility).
Each research organisation / laboratory must establish appropriate SOPs covering the activities of the research organisation and the research studies performed.
- The content of the SOPs should follow a standard format defined by the research organization.
- The organization must implement a system for managing SOPs. This includes writing, reviewing, releasing, amending, withdrawing and archiving SOPs.
The successful implementation of SOPs requires:
- Sustained support from all levels of management with commitment to establishing SOPs as an essential and transparent element in the organization and culture of the laboratory.
- An effective SOP management system to ensure that current SOPs are available in the right place. This could be a MediaWiki System, Sharepoint, Lims or others.
WIs (Work Instructions) are non-standardised protocols that can be modified or further developed as required. WIs include, for example, protocols / instructions / recipes / information (can be anything that does not have the binding force of an SOP or the manual). WIs are coordinated by the author with the respective project leader released by them in terms of content. A dedicated person (researcher or QM personel) initiates the document control.
It is essential to define and document the responsibilities at each personnel level regarding laboratory activities in order to determine the role of each individual within the organization. Binding roles and responsibilities are defined by using an organization chart (Organigram) and/or specific responsibility tables.
Responsibilities, roles and activities in basic biomedical research:
|Responsibility for research activities||Director / head of organization||Policy, provision of resources of all types, budget, supervision of activities; use of resources, advice and support, compliance with institutional policy.|
|Project leader||Conduct of study / projects and advice, scientific interpretation of results, verification of data.|
|Researcher||Conduct of experiments and study / projects as required in study design / protocol, generating and analyzing data|
|Technician||Performance of procedures as required in study plan and SOPs, or other documented instruction.|
|Responsibility for review of research activities||Quality assurance personnel or qualified researcher||Assist in implementation and maintenance of quality practices. Help to assure the authenticity, traceability, and consistency of data, and compliance with quality practices, conduct of audits|
|Legal, ethical und quality requirements||All personnel||Compliance with guidelines, policy, legal, ethical and quality requirements|