How to Adhere

  • Adherents are included into the List of Code Adherents and can display a Level 1 or Level 2 Compliance Mark for 3 years.

  • Level of Compliance Mark depends on the evaluation model selected by the candidate CRO.

  • 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

    • 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

    • 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.