Your Easy Guide to Clinical Studies

In studies, the safety of study participants and the quality of study data must be guaranteed through:

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

 

QA activities are defined prior to study start, and can include:

• The establishment of a risk-based Quality Management System (risk-based QMS).
• The establishment of a risk-based monitoring strategy / development of a risk-based monitoring plan
• The development of a study database including quality aspects for data collection procedures (e.g. quality requirements)
• The requirement of qualified study staff including applicable infrastructure

 

QC activities are implemented during study conduct, and can inlcude:

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

 

The SP-INV defines the required QA and QC activities of a study. The Site-INV of a participating study site(s) is required to comply with its defined activities.

As a SP-INV, define the QA activities of your study, such as to:

• Establish a risk-based QMS: Based on the study protocol, assess potential risks to data quality and participant safety and define:
  • QA procedures in SOPs/WIs
  • Risk-control measures
• Establish a risk-based monitoring strategy: Based on study complexity and potential risks to study participants. Define a study monitoring plan
• Develop a QA based database: Validate data collection procedures and tools (e.g. calculated fields, 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). Develop a data management plan.
• Ensure staff qualification and infrastructure: Define qualification and training requirements for your study staff. Only delegate responsibilities to qualified staff able to comply with QA specifications

 

Define QC activities evaluating 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