IRB Submissions Reviews and Approvals

Description:

Clinical trials are research studies in which people volunteer to help find answers to specific health questions. To initiate they require IRB review and approval. Then, when carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

Clinical trials are conducted according to a plan, called a protocol, reviewed / approved by the IRB, which describes:

• The types of patients who may enter the study;
• The schedules of tests and procedures;
• The drug involved;
• The dosages, or amount of the drug used by patient;
• The length of the study; and
• What the researchers (sponsor) hope to learn from the study.

All such trials are to be conducted under strict rules, such as FDA and ICH requirements, and the specific IRB's requirements.

Why Should You Attend:

This webinar will focus on the US FDA and ICH regulatory requirements for IRB approval for clinical trials on humans. The requirements further ensure that there are rules and terms outlined and mutually agreed to in the IRB submission with the protocol outline, to result in valid data to be used to evaluate the subjects in the trial. Participants and the researchers, doctors and health practitioners all must agree to the terms of the study as outlined in the protocol. All must understand the risks involved. Safety to the human subjects is stressed. The professionals who manage and administer the trials must follow the strict regulatory rules for clinical trials set by the government agencies and outlined in the IRB submission. These rules make sure that those who agree to participate are treated as safely as possible, and that the outcomes are scientifically arrived at.

Areas Covered in the Webinar:

• Clinical trial basics

• Participant safety issues

• FDA's Guidance for IRBs and ICH E6, et al

• IRB Submissions. Reviews and Approvals

• Documentation requirements: Before, during, and after
• Trial administration
• Key steps in the IRB submission and review process
• Deliverable Formats
• Subject safety

Who Will Benefit:

• Marketing
• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel involved in EU Clinical Trials, especially those involved in new product (mainly drug) development, and changes, as to the need for clinical trials held in the EU.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on Validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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