Good Clinical Practices: Guide to Compliance

What do you know about GCP or Good Clinical Practices?

Here's a book by Barnett Educational Services titled, "Good Clinical Practices: Guide to Compliance"

Good Clinical Practices: Guide to Compliance, provides clear recommendations for full compliance with global regulatory requirements. The Guide includes templates for SOPs and other forms that can be copied and used directly in the GCP environment, including a full set of GCP inspection sheets.

This report will be available in electronic format and includes chapters and appendices covering the following information:

* Comparison of International GCP Regulations
* Regulatory Submission for GCP Data
* Critical Compliance Issues
* Internal and External Inspections and Audits
* SOP Templates

If you're interested in learning more about Good Clinical Practices, make sure to read some of these other books as well:

Advanced Good Clinical Practice (GCP)

Looking to strengthen your Good Clinical Practice (GCP) skills? Perhaps you'd like to attend this course:

Advanced GCP
July 19-20, 2010 | Philadelphia, PA

Course Description

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

Learning Objectives

* Develop and implement site-specific approaches for corrective action of non-compliance
* Describe the elements of a functional Quality System
* Define key GCP terms
* Examine recent trends in non-compliance
* Identify the universal and local components of GCP
* Explain the differences between the legal and procedural elements of GCP
* Recognize key differences in pharmaceutical, device, and biologics GCP
* Describe the overlap between GCP and GMP

Advanced Good Clinical Practice

What do you know about Good Clinical Practice or GCP? Here's what Wikipedia has to say about GCP:

Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

If you're looking for some education and training regarding GCP, then take a look at this upcoming course where you'll learn more about GCP. Here's a brief description:

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP-Focused Regulatory Affairs Professionals.

A pharmaceutical physician job description

If you're a physician and you're looking for jobs in pharma, here's a job description you may see on the Internet (I've intentionally omitted certain details):

Basic Qualification
Physician with US board certification (or equivalent) in internal medicine or clinical pharmacology.

Details
The main focus of this role will be to provide medical guidance and medical monitoring of clinical pharmacology, studies involving both early and late development oncology assets. This will involve developing close working relationships with colleagues in various early and late-stage, clinical oncology drug development programs, project management and clinical operations.

• Contribute to the development and finalization of protocols, protocol amendments, review of study data, and finalization of clinical pharmacology study reports
• Contribute to clinical pharmacology goals and strategies
• Manage external influences on projects (collaborators, opinion leaders etc.)
• Actively participate in the development of scientific talent in the organization.
  
• Provide guidance and coaching to team members.
• Ability to travel 10% of the time

Requirements: Preferred Qualification:

• Evidence of excellent medical and scientific judgement
• Knowledge of clinical pharmacology and oncology is desired
• Understanding of drug development in the pharmaceutical industry, Good Clinical Practice, and regulatory processes, (U.S. and International)
  
• Ability to operate in a complex, matrixed organizational environment
• Strong oral & written communications skills
• Management and leadership ability in direct line and matrix situations plus excellent interpersonal skills
• Alignment with and commitment to (company x) vision and goals

Does this sound interesting to you? Do you qualify? Do you notice that it does not indicate that you must have x number of years working in pharma? I'm sure that would be desirable, but you may be able to demonstrate that you qualify for this job even if you've never been employed by a pharmaceutical company. If you're thinking about this type of pharmaceutical physician job, you may want to search for "Physician Clinical Pharmacology."

Fundamentals of Clinical Research

The Association of Clinical Research Professionals (ACRP) has a two-day course coming up. It's called: Fundamentals of Clinical Research

Sept. 10-11, 2009, Houston, TX
Oct. 15-16, 2009, Alexandria, VA

Fundamentals of Clinical Research is designed for those who aspire to the following roles: clinical research professionals managing studies at clinical research sites or monitoring studies, product managers, clinical investigators, institutional review board members, clinical pharmacologists, and research pharmacists.

Here are the learning objectives (you can receive continuing education credits):

* Discuss the main historical events which led to the increasing regulation of the development of medicinal products, devices and biologics
* Explain the differences in the development processes for medicinal products, devices and biologics
* Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
* Apply the principles of Good Clinical Practice (GCP) in their daily functions
* Identify the main regulations which govern the practice of clinical research
* Observe the additional rules applicable to research funded by the Federal government and bodies like the NCI and NIH
* Identify ethical issues involved with conducting clinical research
* Identify the protections given to human subjects in research
* Describe the process of obtaining informed consent from human subjects
* Describe the respective roles and responsibilities of clinical research professionals notably Clinical Research Coordinators (CRCs), and Clinical Research Associates (CRAs)
* Identify and evaluate Unanticipated Problems
* Define the criteria for reporting unanticipated problems and adverse events

If you're interested in pursuing a career in clinical research, then you may want to evaluate your skills and competencies based on the learning objectives listed above. How well can you explain/identify/describe/discuss/etc. each of the points listed above?

For more information about this course, click here.