Accreditations for Sites
Quality Assurance for your Site and for your Clinical Trial Site Staff
The joint mission of GCSA and IAOCR is to reduce risk to patients and the development of valuable new treatments, through a commitment to doing things “right first time” with “quality built in”.
The distinctive IAOCR and GCSA certification marks (see below), provide reassurance to patients and sponsors that the sites, and the people working within them have undergone rigorous quality assurance assessment and are working to trusted, world-class standards.
GCSA (Global Clinical Site Assessment) provides a system of assessment, gap analysis, improvement support and independent quality assurance certification for clinical trial sites and was developed in close association with a Global Advisory Board whose members include industry leaders from Pharma/Biotech, CROs, Regulatory Authorities and Government. The GCSA standard responds to industry demand for clearly identifiable sites that are “easy to partner with” and “put patients at the heart of clinical research”.
GCSA provides the consistent, robust, gold standard for clinical trial sites globally and is helping sites to enable:
- Increased opportunities for patients to receive innovative new treatments through participation in clinical research
- Opportunities for clinical trial sites to increase income through attracting more clinical trials
IAOCR awards Internationally Qualified Clinical Research Professional status to individuals working in clinical trials, based on robust and independent verification of competence. IAOCR accreditations are developed by international taskforces of industry experts and are mapped to the International Standard Classification of Education Framework developed by UNESCO. Experienced clinical trial site professionals as well as entry level candidates (who have undergone foundation level training) are invited to register for IAOCR professional accreditations launching in Q1 2023.
Benefits for Commercial Sites
- Reduces risk – brings new treatments to market more quickly and safely
- Reduces costs through increased workforce effectiveness, performance and efficiency
- Ensures E8 (R1) compliance –Evidences a ‘right first time’ and ‘quality built in’ approach through robust independent accreditation
- Provides transparency for and reassures sponsors and CROs through clearly recognizable quality marks
- Creates a point of differentiation by positioning your site as a ‘Centre of Excellence’ for clinical research trials
- Improves employee attraction, engagement and retention. Enhances health and well-being of your team
- Competence based career pathways for clinical trial site-staff. Allows employer to tailor performance development to address competence gaps.
Quality Assuring Clinical Trial Sites Through GCSA Accreditation
The GCSA best practice standard was developed with a Global Advisory Board of clinical research industry stakeholders from a broad range of commercial, not-for-profit, regulatory and membership organisations around the world. Their shared ambition is to ensure process excellence that facilitates synergistic partnerships between sites and sponsors, to ensure true patient centricity.
The modular assessment covers:
- R&D Commercial Strategy
- Workforce Quality Accreditation
- Patient Engagement
- Study Start-up and Initiation
- Study Management, Operations and Closedown
Commitment to the GCSA journey demonstrates commitment to quality, the desire for ensuring high quality patient experience and the aspiration to be a clinical trial site of choice.
Find out more about GCSA site accreditation.
Professional Recognition for Clinical Trial Site Staff through IAOCR Accreditation
Working collaboratively under the guidance of IAOCR, the Taskforce for Core Competencies for Clinical Trial Site Staff commenced work in 2021. The Taskforce worked in four groups to identify competencies for the roles of clinical Trial Site Nurse, Investigator, Site Manager, and Coordinator. They successfully delivered the most comprehensive competency framework ever developed for clinical research sites by an international group of broad ranging clinical research organizations.
Experienced clinical trial site professionals and those looking to step into the industry are now invited to register for the following programs which will be launched throughout Q1 2023:
- Foundation Level – Internationally Qualified Clinical Research Professional (F-IAOCR)
Foundations in Clinical Research Accreditaion and ICH-GCP Accreditation
- Qualified Clinical Trial Site Nurse – Internationally Qualified Clinical Research Professional (Q-IAOCR)
- Qualified Clinical Trial Site Coordinator – Internationally Qualified Clinical Research Professional (Q-IAOCR).
- Qualified Clinical Trial Site Manager – Internationally Qualified Clinical Research Professional (QM-IAOCR)
- Qualified Clinical Trial Site Investigator – Internationally Qualified Clinical Research Professional (QM-IAOCR)
How to register for IAOCR Accreditation:
If you are an individual wanting to achieve IAOCR Accreditation in your clinical research role, start your journey to professional recognition here.
If you are a site wanting to accredit a number of your site staff, please contact us directly.