The new article describes in detail the regulatory matters related to audits or inspections for GCP compliance, as well as the reports and final application review.
Table of Contents
The Drug Regulatory Authority of Pakistan (DRAP), a county’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the clinical trials applications. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by study sponsors and other parties involved to ensure compliance thereto. The guidance highlights the key points related to the application process, the assessment of the application, and its approval. At the same time, it is important to mention that provisions of the guidance are non-binding, and could be subject to changes, should it be necessary to reflect the respective changes to the underlying legislation.
GCP Compliance Audits
According to the guidance, an audit or inspection should be conducted concerning an entity applying for approval for a clinical trial it is going to undertake. As further explained by the authority, the said audit will be intended to evaluate the acceptability of clinical data submitted to DRAP, and to ensure that legislation, Good Clinical Practice (GCP) principles and practices as elaborated in the latest version of ICH-GCP Guidelines, the Bio-Study Rules 2017 and this guidance adhere.
The document outlines the following key points to be considered:
- An inspection should be carried out by a designated expert team;
- The said inspection could take place before the trial in question is commenced, periodically, or once requested by the Clinical Studies Committee (CSC);
- An additional inspection could be carried out in response to adverse events or complaints.
As explained by the authority, the scope of an inspection covers:
- The facilities and staff used for the trial: as approved by the CSC under the Bio-Study Rules 2017;
- Compliance with the approved Protocol;
- All amendments to the Protocol, which may have been approved;
- Accurate, complete, and current records according to the Protocol;
- Verifying that Serious Adverse Events are reported as required by the Protocol;
- Verifying those inspections intended to monitor and audit the trials are conducted as required by the Protocol and the reports are available for inspection.
Reports and Final Review
The guidance also addresses the matters related to the adverse event reports and the final review of the application for clinical trials.
Under the general rule, in case of an adverse event, the appropriate report should be duly submitted to the respective regulatory body within 7 calendar days calculated from the date the entity responsible for a medical device in question became aware of the issue. As further explained by the authority, the study sponsor is responsible for ensuring that all adverse events will be reported by the investigator without undue delay, unless the immediate report is not required due to the nature of the event. According to the guidance, the immediate report submitted once the event took place should be followed by a written report describing the issue in detail. The authority also states that adverse events and laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the period specified in the protocol. At the same time, the study sponsor is obliged to maintain the records of all adverse events it was informed about.
In general, the following rules are to be followed:
- The information about life-critical adverse events should be communicated to the authority within 7 calendar days, while the sponsor will have 8 more days to provide a detailed report;
- The information about the adverse events that are not life-critical should be provided to the authority without undue delay, but no later than 15 calendar days from the date such information became known to the sponsor;
- The information about non-serious adverse events that don’t meet the reporting threshold should be included in the periodic report.
The aforementioned periodic reports should be submitted on an annual basis. Once the reporting is no longer required, it should be reflected properly in the last report submitted. In such a case, the sponsor should also indicate whether or not clinical trials are continued elsewhere. The authority also mentions that it expects to receive additional information requested from the sponsor within 15 calendar days from the date of such request.
Progress and Final Trial Reports
According to the applicable regulations, progress reports and final results of the clinical trial after the investigation must be communicated to the [authority]. If the study takes longer than 6 months, a study sponsor shall submit an interim report every 6 months. As further explained by the authority, such a report should contain information about:
- The number of patients treated;
- Number and type of Serious Adverse Events (SAEs) reported,
- Number of discontinued patients; and the reasons for discontinuation.
The study sponsor should also duly keep all the records related to the trial to be able to provide them to the authority upon request. In the case of several facilities involved, the final report describing the study results should be submitted no later than 3 months from the date when the study has been completed in all the facilities.
The document also describes the procedures to be followed concerning unused medical devices initially intended for investigational use. According to the requirements, the study sponsor shall keep the appropriate records concerning medical products provided for and used during the study. The authority explicitly states that in the case of medical devices containing radioactive materials special rules should be applied.
In summary, the present guidance highlights certain specific requirements regarding the clinical trials and the way they should be undertaken. The document pays special attention to the reporting rules and requirements and describes in detail the key points to be considered to comply with them.
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