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Paper prepared by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology at King Fahad Medical City Riyadh
Quality Management:
• The sponsor should implement a system to manage quality throughout all stages of the trial process.
• The quality management system should use a risk-based approach
• The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs
• The sponsor is responsible for ensuring access for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.
• Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
Contract Research Organization (CRO):
• A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
Medical Expertise:
• The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems.
• If necessary, outside consultant(s) may be appointed for this purpose.
Trial Design
• The sponsor should utilize qualified individuals throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.
Trial Management, Data Handling, and Record-Keeping:
• The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
• The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial
• When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e., validation).
Investigator Selection and allocation of responsibilities:
• The sponsor is responsible for selecting the investigator(s
• Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.
• The sponsor should obtain the investigator's agreement to comply with GCP and other requirements
• Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions.
Compensation to Subjects and Investigators:
• The sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator against claims arising from the trial, except for claims that arise from malpractice and/or negligence.
• The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).
• When trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s).
Financing:
• The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.
Notification/Submission to Regulatory Authority(ies):
• Before initiating the clinical trial(s), the sponsor should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission
• Any notification/submission should be dated and contain sufficient information to identify the protocol.
Confirmation of Review by IRB/IEC:
• The sponsor should obtain from the investigator/institution:
(a) The name and address of the investigator's/institution’s IRB/IEC.
(b) A statement obtained from the IRB/IEC that it is organized and operates according to
GCP and the applicable laws and regulations.
(c) Documented IRB/IEC approval/favorable opinion
• If the IRB/IEC conditions its approval/favorable opinion upon change(s) in any aspect of the trial, such as modification(s) of the protocol, written informed consent form and any other written information to be provided to subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the modification(s) made and the date approval/favorable opinion was given by the IRB/IEC.
• The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC reapprovals/re-evaluations with a favorable opinion, and of any withdrawals or suspensions of approval/favorable opinion.
Information on Investigational Product(s):
• When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial, population to be studied.
• The sponsor should update the Investigator's Brochure as significant new information becomes available
Manufacturing, Packaging, Labelling, and Coding Investigational Product(s):
• The sponsor should ensure that the investigational product(s) is manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding.
• The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions (e.g., protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any.
• The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.
• In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency but does not permit undetectable breaks of the blinding.
Supplying and Handling Investigational Product(s):
• The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s).
• The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation (e.g., approval/favorable opinion from IRB/IEC and regulatory authority(ies)).
• The sponsor should ensure that written procedures include instructions that the investigator/institution should follow for the handling and storage of investigational product(s) for the trial and documentation thereof.
Record Access:
• The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
• The sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
Safety Information:
• The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
• The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's an approval/favorable opinion to continue the trial.
Adverse Drug Reaction Reporting:
• The sponsor should expedite the reporting to all concerned investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected.
• Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
• The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s).
Purpose of monitoring:
• The rights and well-being of human subjects are protected.
• The reported trial data are accurate, complete, and verifiable from source documents
• The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Audit:
• The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
• The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct audits. The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented.
• The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports.
Noncompliance:
• Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by a member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance.
• If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.
• If the monitoring and/or auditing identifies serious and/or persistent non-compliance on the part of an investigator/institution, the sponsor should terminate the investigator's/institution’s participation in the trial. When an investigator's/institution’s participation is terminated because of noncompliance, the sponsor should notify promptly the regulatory authority(ies).
Premature Termination or Suspension of a Trial:
• If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
• The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).
Clinical Trial/Study Reports:
• Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s).
• The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports.
Multicentre Trials:
• For multicentre trials, the sponsor should ensure that:
• All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and given approval/favorable opinion by the IRB/IEC.
• The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data.
• The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial.
• All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
• Communication between investigators is facilitated.