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Home » GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA (GCP007)

Certification Training
Rated 3.86/5
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Method of Training: Online / Self-paced eLearning.
Credits: 3 CPD Credits.
Duration: ~3 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational drug. This online course will give students who are, or are becoming, regulatory professionals the necessary detail and background required in order to complete and submit, for FDA approval, an IND application. An IND must contain various pieces of information covering areas such as clinical protocol, manufacturing, toxicology, drug distribution, and animal pharmacology. The application is a stepping stone that is crucial, from nonclinical all the way to clinical testing.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


Module overview
An outline of the module's scope and objectives, and notes on terminology.

Introduction to Investigational New Drug Applications (INDs)
This session explains the role and legal status of an IND, sets out the contexts in which one must be filed, summarizes the responsibilities of sponsors and investigators, and outlines the pre-submission process.

IND content and format requirements
This session sets out IND contents required by regulations and describes how these are incorporated in a CTD-formatted submission. The significance of the FDA forms 1571 and 1572 are discussed. The major components of an application are outlined: general investigational plan, investigator's brochure, clinical protocol, Quality/CMC information, nonclinical data, and clinical information.

Filing and FDA review
Options and requirements for submission of an IND are set out, and the review procedure and its outcomes are described. The roles of FDA reviewers are outlined. The significance of a clinical hold and the sponsor's response to a hold are discussed.

Maintenance of an IND
This session identifies the various types of IND amendments and reports: protocol amendments, IND safety reports, annual reports, and information amendments. It explains when they need to be made and outlines the regulations that govern them. The responsibilities of sponsors and investigators to report safety findings are described, as are requirements for financial disclosure and record retention.

Expanded-access use
This session describes the various types of expanded-access use of investigational drugs to treat patients outside of clinical trials and sketches a scenario of emergency use.

Multiple-choice mastery assessment.


Who will benefit from this module?
  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • Healthcare professionals conducting clinical research as sponsor-investigators or who wish to treat patients under an expanded-access scheme.
Learning objectives
  • Specify the role of an IND and the contexts in which it is required
  • Access key regulatory documents relating to INDs
  • Describe the contents and format of an IND submission
  • Describe the process of FDA review of an IND, the possible outcomes and sponsor's responses
  • Identify actions necessary to maintain an active IND
  • Specify options for expanded-access use of investigational drugs

The GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA Course is Included in the Following Professional Certification Programs:

Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those interested ... Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: This professional certification program is designed for regulatory affairs managers and directors, project managers, or clinical research associates and coordinators with desire to grow their career into these ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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