Your Easy Guide to Clinical Studies

In studies, the safety of study participants and the quality of study data must be guaranteed. To ensure that safety and quality are maintained throughout study conduct, requires the implementation of quality aspects:

• Quality Assurance (QA)
• Quality Control (QC)

 

QA activities are procedures defined prior to study start, such as:

• The establishment of a risk-based Quality Management System (risk-based QMS).
• Planning of a risk-based monitoring
• The development of a study database including quality aspects for data collection procedures
• The requirement of qualified study staff and applicable infrastructure

 

QC activities are tasks executed during study conduct, such as:

• The periodic review of implemented QA activities
• The ongoing compliance with the study protocol, ICH GCP, study SOPs/WIs, applicable laws (e.g. Swiss law)

 

The SP-INV of the study defines the required QA and QC activities, which must be complied with by the Site-INV at any participating study site(s).

As a SP-INV, define the Quality Assurance activities of your study, such as:

• The establishment of a risk-based QMS: Based on the study protocol, assess potential risks to data quality and participant safety and define:
  • Quality procedures in study SOPs / WIs
  • Risk-control measures
• Planning of a risk-based monitoring: based on the complexity of the study and potential risks to study participants define a study monitoring plan
• Study database development: define and validate data collection procedures and tools (e.g. questionnaires, lab reports). Throughout the data lifecycle (from collection until analysis), define risks where study data might become distorted due to people’s influence or other external factors (e.g. data import and export)
• Study qualification and infrastructure: Define the qualification and training requirements of your study staff. Ensure study tasks and responsibilities are only delegated to qualified staff able to ensure ongoing compliance with QA specifications

 

Define QC activities that evaluate QA compliance during study conduct

References

ICH GCP E6(R2) – see in particular guidelines

• 5.0 Quality management
• 5.1 Quality assurance and quality control

 

ISO 9001:2015 - Quality Management Systems (access liable to costs) – Requirements

ISO 14155:2020 Medical devices (access liable to costs) - see in particular section

• 9.1 Clinical quality management

Documents

Risk Assessment Form for Clinical Research Projects