A monitoring plan is an essential part of each SFDA clinical trial. It describes the monitoring methods, responsibilities, and requirements for the CT and should include a brief description of the study, its objectives, and the critical data and procedures.

Clinical trials (CT) are research that studies new substances, tests, and treatments to evaluate their effect on human health outcomes. They could be part of the SFDA registration requirements for some drug products. This article will explain the SFDA requirements and regulations for conducting a clinical trial in Saudi Arabia.

Clinical Trials Phases

Most clinical trials in Saudi Arabia are related to phases III and IV. There are 4 phases of clinical trials:

• Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
• Phase II studies test treatments that were proven safe in Phase I, but they now need a larger group of human subjects to monitor for any adverse effects.
• Phase III studies are conducted on larger populations in different regions and countries and are often the step right before a new treatment is approved.
• Phase IV studies take place after country approval, and there is a need for further testing in a broad population over a longer timeframe.

SFDA Clinical Trials Application CTAp

SFDA requires sponsors without a legal entity in Saudi to apply through an SFDA-licensed Saudi CRO. On the other hand, sponsors with a Saudi legal entity can apply directly or through a CRO.

The SFDA also specified who should apply according to the CT sponsorship. If the Clinical trial is sponsored by:

• The Governmental Sectors: The applicant will be the research centre, hospital, CRO, or principal investigator the sponsor authorises.
• Private Sector: The sponsor institution or the CRO.
• Unsponsored clinical trial: The applicant will be the principal investigator or the CRO.

To Initiate the Clinical Trial Application (CTAp) in Saudi Arabia, sponsor or licensed CROs should create an account on the Saudi Clinical Trials Registry (SCTR) to comply with the SFDA clinical trials regulations.

Clinical Trials Fees

The applicant must pay fees for SFDA clinical trial evaluation, refer to SFDA fees post for the amount details.

Trials excluded from paying the fees are:

• Clinical trials that Governmental Sectors sponsor.
• Unsponsored CT submitted by researchers.
• Phase four IV studies.

CRO Requirements

Organisational Structure

The CRO organisational structure should include departments or individuals that ensure the conduct of high-quality, compliant, credible, and accurate clinical trials. The structure should also reflect the services provided to perform one or more clinical trial-related activities; accordingly, it should be updated every five years or per institutional policy.

Monitoring of the Clinical Trials

Deligation

Sponsors delegate CROs to perform clinical trial monitoring responsibilities. CROs must operate under a written agreement with the sponsors that defines all required responsibilities, including the Saudi pharmacovigilance system.

Monitoring Plan

A monitoring plan is an essential part of each SFDA clinical trial. It describes the monitoring methods, responsibilities, and requirements for the CT and should include a brief description of the study, its objectives, and the critical data and procedures.

On-site monitoring is an in-person assessment by the sponsor or CRO personnel at the clinical trial’s site. Factors affecting the extent of the monitoring plan and may necessitate on-site monitoring are:

• Complex Study Design (e.g. adaptive designs, stratified designs, or complex dose titrations).
• Study Endpoints (interpretative or subjective).
• Study Population (seriously ill or vulnerable).
• Geography
• Experience of the Principal Investigator (PI).
• The Electronic data capture (EDC).
• Stage of the study (initiation and during the early stages of a trial).
• Quantity of data

Trial Master File (TMF)

The sponsor is ultimately responsible for the trial activities and oversight. Therefore, the sponsor should allow access to the TMF for the Saudi-licensed CRO and specify the parts that the licensed CRO can access to fulfil their responsibilities. The sponsor or the CRO should implement risk-based quality checks (QC) or review processes to ensure the TMF is up-to-date and includes all essential documents.

Clinical Research Associate Employees (CRA)

The sponsor and the licensed CRO should select qualified monitors based on education, training, and experience. The SFDA recommended that CRA employees should be:

• A citizen or permanent legal resident in Saudi Arabia; the permanent resident should be authorised to work in Saudi Arabia.
• The sponsor or licensed CRO should submit documents to prove CRA education, training and experience qualifications.

Clinical Trials Agreement

The sponsors or CRO should submit the clinical trial agreement to the SFDA in bilingual (Arabic and English). The legal department or licensed attorney should review them.

Documents & Data retention

The applicant must keep the essential document(s) and data generated from conducting the clinical trial in Saudi Arabia for at least 15 years after completion or discontinuation of the trial or at least two years after registering the investigational medicinal product (IMP) at SFDA.