5 Essential Courses on Principles and Practice on Clinical Trials

OnlineCompliancePanel has complied 5 essential courses in clinical trial and clinical research. These webinar trainings cover 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.
Instructor: Mukesh Kumar, Dr Charles H Pierce
Product ID: PACK70014

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, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

Clinical Research Administrators, Data Managers | Clinical Research Associates (CRAs) and Coordinators (CRCs) | Clinical Research Scientists (PKs, Biostatisticians, ...) | Clinical Trial Managers | Drug Discovery and Development Professionals (R&D and CMC) | Financial analysts and investors, venture capitalists, insurance professionals | Legal experts involved in assisting physicians and patients alike with medical malpractice | Medical accounting companies | People investing in FDA-regulated product development projects | Principal and co-Investigators participating in industry-sponsored clinical trials | Principal Investigators and Sub Investigators | Project Managers and Clinical Trial Specialists | QA/QC Auditors and Staff | Recruiting Staff | Regulatory affairs professionals, research analysts | Regulatory Compliance Associates and Managers | Research Managers | Safety Nurses | Senior Management Executives (CEO, COO, CFO, etc) | Sponsors of clinical trials | Sponsors of INDs | Study Monitors


Webinars included in the Package:

Writing USFDA-acceptable Clinical Trial Protocols (Duration 90 minutes)

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.

Per FDA and ICH guidelines, a clinical protocol should be based on sound scientific rationale, conducted in a suitable population, include all appropriate procedures that help meet the endpoints, and be protective of study participants both physically and ethically. On an average about one of every three clinical trials fail to meet their primary goals due to poor design, faulty statistical strategy, lower recruitment, poor management of resources, and regulatory issues. Most of these causes of failure can be mitigated by a well-designed clinical trial protocol.


Objectives of the Presentation:

  • 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.

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.


Critical SOPs for Clinical Sites (Duration 60 minutes)

Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.

Recent FDA guidance documents suggest that clinical investigators develop standard procedures (SOPs) for key activities conducted at their site and assure that staff members (e.g., subinvestigators and clinical research coordinators) appropriately follow the same. Several industry organizations have similarly proposed multiple SOPs that are critical for maintaining quality procedures at clinical sites.


Objectives of the Presentation:

  • 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.

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.


The Sunshine Act Reporting for Clinical Trials (Duration 60 minutes)

Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.

Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS). These disclosures are in addition to the financial disclosure requirements to the FDA under IND regulations. Sponsors are required to collect detailed financial information and report to the CMS, which will verify it with the investigators, after which the information about each individual investigators will be made available on CMS’s website to general public. Non-compliance could subject both the sponsors and investigators participating in clinical trials to hefty fines. This seminar will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. This seminar would also assist sponsors and investigators to develop standard practices to meet federal requirements.


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 investgators
  • 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.


FDA Rules for Trial Master Files (Duration 90 minutes)

The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.

The regulations describe the various kinds of documentations that an investigator needs to maintain to demonstrate compliance. Sponsors are required to assure site compliance with the protocol tasks, training and provide any resources necessary to assist site’s ability to perform their tasks. The TMF not only acts as a warehouse for all the study-specific documents, but also acts a tool for quality control and quality assurance.

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.


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

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.


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”.


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, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator esponsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.Dr. Pierce has served as an advisor to several clinical research organizations.


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