6 Useful Webinars on Clinical Trial Protocols, SOPs for Clinical Sites, Trial Master Files, Sunshine Act and GCP

This package training will walk the attendee through 10 critical steps in the development of a clinical protocol, which SOPs should be implemented and what methods should be used to develop and document FDA-acceptable conduct of clinical sites activities, essential elements of a TMF for clinical trials, the Sunshine Act, critical elements of Good Clinical Practice (GCP), and how to manage Protocol Deviations and Violations.
Instructor: Mukesh Kumar, Marie Dorat, Dr Charles H Pierce
Product ID: PACK70039

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Sponsors of INDs
  • Regulatory Affairs Professionals
  • Senior Management Executives (CEO, COO, CFO, etc)
  • Drug Discovery and Development Professionals (R&D and CMC)
  • Clinical Trial Managers, Project Managers , Data Managers
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs), Clinical Research Administrators
  • Principal Investigators, Safety Nurses
  • Legal experts involved in assisting physicians and patients alike with medical malpractice
  • Medical accounting companies
  • Senior management for companies developing new products for US market
  • Financial analysts and investors, venture capitalists, insurance professionals
  • Clinical Quality Assurance Professionals
  • GCP-Focused Regulatory Affairs Professionals

Webinars included in the Package:

Writing US FDA-acceptable Clinical Trial Protocols (Duration: 90 Minutes)

If you are involved in writing a clinical trial protocol, this webinar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.

Objectives of the Presentation:

This webinar covers the seven distinct characteristics well managed and successful banks have in their Credit Administration area:
  • The overall structure of a protocol and regulatory requirements
  • Identify who contributes to the protocol development and amendments
  • The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis
  • Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates
  • Common issues with FDA and IRB approval of clinical protocols

Critical SOPs for Clinical Sites (Duration: 60 minutes)

This webinar will highlight which SOPs should be implemented and what methods should be used to develop and document FDA-acceptable conduct of clinical sites activities. The author would address the competing opinions available from various sources about both topic selection and the depth of coverage or detail that is required. In this interactive session, the presenter would share his experience in site management and procedure development. Participants will leave the session with tools to help them assess what is appropriate for their practice setting and an action plan for addressing their site's specific needs.

Objectives of the Presentation:

  • At the end of this webinar, you would understand:
  • Current FDA expectation from clinical sites
  • List of key SOPs critical to demonstrate GCP compliance
  • Best practices related to SOP development and maintenance by clinical sites
  • Current industry practices for SOPs
  • Common issues with FDA audit for site processes

FDA Rules for Trial Master Files (Duration: 90 minutes)

This webinar will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions. If you involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. Common deficiencies identified by FDA auditors during review of TMFs will be discussed with potential solutions to the same. Also discussed will be issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Objectives of the Presentation:

  • FDA's expectation from site and sponsor's documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common errors in TMF management

The Sunshine Act Reporting for Clinical Trials (Duration: 90 minutes)

The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements, and time-lines for compliance and enforcement will be discussed.

Objectives of the Presentation:

  • Clinical trial financial reporting requirements
  • Kind of payments covered and exempted for reporting to CMS
  • Format of reporting to CMS
  • Dealing with CMS's inquiries regarding reported information
  • Acceptable and Unacceptable practices
  • Comparison of Federal reporting requirements with Industry best practices
  • Legal and practical implications of reporting financial information for investigators
  • Regulatory solutions for most common anticipated issues with reporting

Instructor Profile:

Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

ICH-FDA Good Clinical Practice – Managing Clinical Trials (Duration: 60 minutes)

This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes.

Objectives of the Presentation:

  • The Principles of ICH GCP
  • Informed Consent
  • HIPPA Compliance
  • Ethics & IRB Responsibilities
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • Auditing/ Regulatory Authority Inspections

Instructor Profile:

Marie Dorat CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry. She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution. Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer.

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? (Duration: 90 minutes)

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with "I agree". If and when a deviation or violation of the protocol is found, it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significances of "Deviations" and "Violations" must be clearly understood by all persons involved in the conduct of clinical research studies.

Objectives of the Presentation:

  • How to know when the protocol is not followed (PNF)?
  • What is the difference between a protocol deviation and a violation?
  • Importance of the "Protocol" in the number of deviations occurring
  • What is in the Regs about following the protocol?
  • When may the Investigator make changes in the protocol?
  • What are the causes of Protocol Deviations and Violations?
  • How are Protocol Deviations managed?
  • Examples of Protocol Violations and Deviations

Instructor Profile:

Charles H Pierce is the President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

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