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Adherents are included into the List of Code Adherents and can display a Level 1 or Level 2 Compliance Mark for 3 years.
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Level of Compliance Mark depends on the evaluation model selected by the candidate CRO.
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CROs may be audited for the validity of a Compliance Mark within 3 years.
What are the options for adherence?
Adherence Scheme 1: Self-declaration
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- Complete an organizational profile and a Code’s compliance questionnaire (“Compliance Dossier”).
- Submit your compliance dossier to the Code’s Supervisory Body (COSUP).
- COSUP will review the Compliance Dossier and issue its resolution.
Adherence Scheme 2: Audit
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- Complete the Compliance Dossier and submit it through the EUCROF website to the COSUP.
- COSUP Auditor will review each Compliance Dossier for eligibility and completeness, and report to COSUP on the eligibility of the Candidate Adherent.
- Eligible Candidate Adherent will receive the audit plan and be requested to confirm agreement to the proposed process.
- Two COSUP auditors responsible for legal and technical compliance respectively will audit the Candidate Adherents on-site in accordance with the audit plan.
- Upon audit completion, the auditors will report the audit results to the ISO Auditor who will prepare the final report for the COSUP.
- COSUP will communicate the final decision on the Candidate Adherent.
