with the protocol, the applicable regulations, and GCP at their site. Admittedly, they work through the sponsor on critical items such as reporting serious unexpected adverse reactions; however, the regulators usually have some administrative or legal mechanism available to bring to bear against noncompliant investigators. Administrative provisions granting regulators the ability to put clinical holds in place, disqualify clinical investigators, terminate sites, or limit enrollment are tools that regulators have available if serious noncompliance is documented during inspections.
11.7 Summary
In this topic area, we have outlined the roles and responsibilities of the regulatory authority within the context of the GCP Guidelines. It is meaningful to keep in perspective that while the regulatory authority is a player in the clinical trial process, as defined in GCP and has roles and responsibilities, it (the regulator) is not in large measure the focus of the GCP requirements.
The responsibilities of the regulatory authority are founded in law, regulations, and directives and are carried out by governmental agencies or their designees. It is the role of the regulatory authority to act as a gatekeeper, overseer, and evaluator using the legally mandated requirements including GCP.
The regulatory authority has a responsibility to be accountable for its actions through documentation, transparency, and clear communications with sponsors, investigators when appropriate, and IRBs/IECs.
Knowledge Check Questions
1 A primary role/responsibility of the regulatory authority is to review clinical trial applications and then advise the independent ethics Committee whether the trial can begin. True _____ or False____?
2 Regulatory Authorities are called upon to inspect the ICH as well as sponsors and clinical trial sites. True_____ or False______?
3 Unlike the quality assurance audits conducted by clinical trial sponsors, the inspections conducted by regulators can result in enforcement action if: 1) the inspection uncovers significant noncompliance:_____; 2) The sponsor or site refuses to allow inspection______; or 3) The sponsor or site has made significant changes to the study plan without notifying the regulator____; 4) all three situations apply.
4 Communication between the sponsor and the regulator is essential. The regulator will therefore provide the sponsor with several – up to five – points of contact (POCs) within their organization who can be contacted about important changes to the clinical trial plan. Correct? If not how many are considered acceptable?
5 You have recently been hired by a large pharmaceutical drug manufacturer to oversee several of their clinical trial projects. Upon reviewing your assigned projects, you determine that the annual reports to regulators are overdue for every one of the trials. What steps should you be taking on an immediate basis? Prepare a brief plan to serve as an agenda for your meeting with your supervisor and/or the regulatory authority.
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