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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: 12 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: Three (3) 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 12-month period. 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 courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:Certificates verifiable online with digital badges issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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.