Requirements for the Clinical Research Practitioner Registry and the new GCP certification
In a strategic move aimed at enhancing the quality of medical research in Saudi Arabia, the Saudi Commission for Health Specialties a comprehensive procedural guide to regulate the registration process for the "Clinical Research Practitioner Registry." This decision, which implements the Commission's membership regulations issued by the Board of Trustees in 2024, represents a significant step forward in the governance of research practices and the regulation of their outcomes.
A regulatory framework that aligns with Vision 2030
This new regulation comes at a time when the Kingdom is witnessing significant activity in the research, development, and innovation sector, in line with the objectives of Saudi Vision 2030 , which prioritizes the health sector. These regulations aim to create a safe and reliable research environment that conforms to international standards, thus enhancing the Kingdom's position as a leading destination for clinical studies in the region. Regulating the Clinical Research Practitioner Registry is not merely an administrative procedure; it is a fundamental pillar for ensuring the safety of patients and research participants, and for guaranteeing the reliability of the data generated from these studies.
Registration requirements and Good Clinical Practice (GCP) certification
The authority has established precise criteria for inclusion in the register, stipulating that applicants must already be registered in one of its accredited professional registers to be eligible for registration. This ensures that the practitioner possesses the necessary scientific and professional qualifications. As a fundamental requirement with no exceptions, the new regulations mandate that all applicants submit a valid copy of their Good Clinical Practice (GCP) .
The GCP certification is an international standard for the ethics and scientific quality of designing, conducting, recording, and reporting on trials involving human participants. Adherence to these standards ensures the protection of participants' rights, safety, and well-being, and that clinical data complies with local and international laws.
Application process and timeframes
The authority clarified that the application process is conducted exclusively through its online platform, beginning with payment of the service fees, after which it proceeds to the review and auditing stage by the relevant department. The validity period for registration in the Clinical Research Practitioner Register is three full years , commencing from the date of final approval of the application and successful completion of all verification stages, not from the date of submission.
Strict procedures for verification and combating counterfeiting
In its commitment to the integrity of the registry, the authority has granted applicants a 20-day period to complete any missing documents. Failure to do so will result in automatic cancellation of the application. All documents undergo rigorous verification processes, including direct communication with the certification bodies (Dataflow) or engagement with specialized entities.
The authority categorically warned that any negative verification result would lead to the immediate rejection of the application and referral of the practitioner to the Committee for Reviewing Members' Violations, which could result in severe penalties. The guidelines also emphasized that the failure of the entity to which the document is attributed to respond to verification requests within the specified timeframe constitutes sufficient grounds for rejecting the application due to the inability to substantiate the documents.
