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Wednesday, February 01, 2023
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Investigator Initiated Clinical Trials

Certification Training
Rated 4.5 / 5
2 reviews
Program/Course ID: CP011a
Enrollment Period: 6 months.
Average Learning Time: ~30 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, Asynchronous, Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Investigator Initiated Clinical Trials
Training Provided By: Biopharma Institute

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

Biopharma Institute ReviewsWhat are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved product. Such trials can help answer important questions about medical products and devices. When investigators initiate the clinical trial, they also must fill the role of a sponsor. From the regulatory side, there is not a lot of guidance on such trials, but there is a focus on them for inspections. The sponsor-investigator is ultimately responsible for the regulations that are applicable for sponsors AND investigators. Do you know which regulations and guidelines are applicable and that they have different definitions?

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


  • 1. Overview of IITs, Guidance, and Regulations
  • a. Definitions in IIT
  • b. Federal Regulations for IITs
  • c. Guidance for IND in IITs
  • d. FDA IND Submissions for IITs
  • e. Warning Letters in IITs
  • f. Industry Collaboration
  • g. Purpose of IIT
  • h. Sponsor-Investigator WL Example & Discussion

  • 2. Considerations before Starting IIT
  • a. Relationship with Manufacturer
  • b. Pros and Cons to Manufacturer Involvement
  • c. Independent Compounding of Investigational Product (IP)
  • d. Requests for IP
  • e. Shipments of IP
  • f. Conflict of Interest and Bias
  • g. IRB Review
  • h. Regulatory Reporting Requirements
  • i. Sponsor-Investigator Regulatory Deficiencies

  • 3. Minimizing Pitfalls
  • a. FDA Scrutiny
  • b. Risk Mitigation
  • c. Objectivity in IITs
  • d. Reducing Protocol Bias
  • e. Independent Monitoring and Data
  • f. Safety Reporting - Drug and Device
  • g. IP Accountability
  • h. Essential Documentation

  • 4. Scenarios
  • 5. 10 Question Post Assessment


  • Recognize the importance of identifying roles in investigator initiated trials and ensuring clear expectations.
  • Review the steps involved in initiating an investigator initiated trial.
  • Identify actions that can help minimize risks associated with investigator initiated trials by identifying and learning to prevent common pitfalls

All clinical research personnel with a focus on investigator initiated trials.

Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.