The Qatar Ministry of Public Health (Q-MOPH) recognizes the standards of the International Council for Harmonization for “Good Clinical Practice” (ICH-GCP). The ICH- GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
The principles of ICH GCP as presented in ICH (2016) E6 are:
- Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approval/favorable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. This principle applies to all records (paper or electronic) referenced in this guideline.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products should be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented.
For more information about IRB functioning and protection of vulnerable population please refer to the following policy “
policy , regulation and guideline for Research involving human "
Submission of Clinical Trials to MOPH
Before proceeding with the on-line application, the approval by both local registered Ethics committees, Data and Safety Monitoring Boards of the affiliated study sites (when applicable), is required. The Sponsor or the Principal investigator are requested to register all the clinical trial on the registration portal of the MOPH.
The review time is different according to the following:
Category A application: include multi-center clinical studies that have been approved by the FDA-USA, the EMA-European Commission or other regulatory agencies (in the UK, Switzerland, Australia, Canada, Germany, South Africa, Japan). Category A application's permission is usually faster than Category B. The review is usually done within four to six weeks.
Category B applications: include Clinical trials with no approval from the above regulatory bodies. These trials are reviewed on a case-by-case basis. Category B application's review is usually done within six to eight weeks.
In all applications, a support letter initiated by MOPH is required in order for the clinical trials to start.
The decision chart shall guide you whether you need to apply for MOPH support letter or not before starting the clinical trial.
