Quality assurance
Support with quality assurance
Good clinical practices in the context of documentation produced in a clinical study areessential to ensure the integrity, completeness, reliability, and truthfulness of clinical research.
The quality assurance support service ensures that documents prepared throughout the clinical study meet the highest quality standards and streamlines the contractual process by providing downloadable document templates related to all clinical study activities, including participant recruitment, informed consent, data collection, and data management. Each template can be independently adapted, or additional support can be requested from the PCS team for personalised completion. This service also includes the adaptation of existing documentation to align with good clinical practices.
By providing this service, the goal is to increase the efficiency of clinical study preparation and ensure compliance with good clinical practices.
If you need support with quality assurance, simply click on "request service".
What will you have access to when requesting this service?
Templates: Selection of standardised templates for downloading essential documents at all stages of the clinical study, facilitating organisation and compliance.
Documentation quality: Assurance that contractual or standard documentation meets current quality criteria, ensuring integrity and reliability.
Personalised support: Personalised support in completing documents, promoting accuracy and alignment with the specific requirements of the clinical study.
Required documentation
- Protocol or synopsis of the clinical study
- Confidentiality agreements, if applicable
- Templates of contractual documentation from the Sponsor/CRO or CRS, if applicable
