Process
This chapter will cover:
- Internal processes
- Information governance frameworks
- SOPs
- Best practices for processes
To ensure a successful inspection, internal processes must also be clearly defined in relevant policies, procedures, work instructions, and manuals.
These information governance frameworks will ensure that users create, process, manage, and retain data and documents systematically and consistently in accordance with all applicable regulations (see the graphic below for an illustration of how the information governance framework knits together by the HSRAA).
For data, documents, and systems, organisations will need policies and SOPs to cover (among others) the following:
- System procurement and implementation
- System management and change control
- Data collection, analysis, interpretation, verification
- Data sharing protocols
- Data normalisation/transformation
- Classification and metadata schema
- Data and document filing and formats
- Security and access policies/information-sharing protocols
- Quality control measures
- Retention schedule
- Digital preservation strategy
- Destruction procedures
- Training materials
- User manuals
- Data migration and conversion (see flow charts below, which are free to download from the HSRAA website)
Best practice for processes
- Build quality into clinical study design and conduct from the outset or kick-off meeting to set long-term document expectations
- Define systematic, consistent, and repeatable approaches to ensure accuracy of data and document inputs and outputs
- Agree data [correction] conventions prior to study start-up
- Align processes to quality management systems (use risk-based approaches to manage quality throughout the study duration)
- Establish governance frameworks that instil confidence that data are reliable and of high quality (data and document ownership, accountability, and custodianship: system purchase, evaluation, purchase, implementation, retirement and decommissioning)