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Wednesday, February 01, 2023
Home » The General Data Protection Regulation (GDPR) and Clinical Trials

The General Data Protection Regulation (GDPR) and Clinical Trials

Certification Training
Rated 4.3 / 5
3 reviews
Program/Course ID: CP009a
Enrollment Period: 6 months.
Average Learning Time: ~45 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: The General Data Protection Regulation (GDPR) and Clinical Trials
Training Provided By: Biopharma Institute

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

Biopharma Institute Reviews

The General Data Protection Regulation (GDPR) and Clinical Trials course covers how to exchange personal data during and after study conduct while following the GDPR requirements for data protection.

With the increasingly global nature of clinical trials, it is becoming more common to exchange personal data from the European Union to the United States during study conduct and after. This involves following the requirements of the EU's General Data Protection Regulation.

This course covers the exchange of personal data from the European Union (EU) to the United States (US) while following the requirements of the EU's General Data Protection Regulation. Content includes:
- What is applicable to stakeholders in clinical trials,
- How to protect data subject personal information collected and analyzed in clinical trials, and
- The impacts GDPR has to clinical trials and your organization.

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.


Background and History of Personal Data Protection
  • What Data are Personal?
  • Why Personal Data Protection?
  • Background and History
  • Data Privacy in the UK
  • Important GDPR Definitions
  • Who Processes and Who Controls Data?
  • Scenario

GDPR and Clinical Trials
  • GDPR Overview
  • GDPR and Clinical Trials
  • Risk-based Data Protection
  • Eight Rights Under GDPR
  • Data Privacy Policy / Notice
  • When is Re-consent Necessary?
  • Data Privacy and Clinical Trials
  • GDPR and HIPAA Differences
  • HIPAA vs. GDPR High Level Differences
  • Consent to Process Data
  • Where are Studies Conducted?
  • Scenario

Collecting and Safeguarding Personal Data
  • Definitions -Data Protection Organizations and Individuals
  • GDPR Applicability Questionnaire
  • Privacy Impact Assessment
  • Transparency Requirements
  • Requirements of GDPR for Processing Data
  • Accountability
  • Data Protection Officer
  • EU GDPR Data Representative
  • Elements in a GDPR Consent
  • Other Legal Basis for Processing Data & Challenges
  • Data Security Measures
  • Data Breach
  • How to Safely Transfer Data- Binding Corporate Rules
  • Enforcement
  • Helpful Tips
  • Scenario

10 Question Post Assessment


  • Determine the importance of subject data protection related to General Data Protection Regulation (GDPR).
  • Describe the process to collect and analyze private data and ensure its security under GDPR.
  • Recognize potential impacts of the GDPR and how it affects your organization.

Anyone involved in clinical trials, with a focus on the US/EU.

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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