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HIPAA Training for Clinical Trial Professionals

HIPAA Training for Clinical Trial Professionals Certification Training
Rated 4.7 / 5
3 reviews
Program/Course ID: CP017a
Enrollment Period: 12 months.
Average Learning Time: ~60 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: HIPAA Training for Clinical Trial Professionals
Training Provided By: Biopharma Institute

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

Biopharma Institute Reviews

This Health Insurance Portability and Accountability Act (HIPAA) training for Clinical Research Professionals covers best practices for sites and sponsors/CROs working together under HIPAA including use or disclosure of Protected Health Information (PHI) by Covered Entities for research purposes.

HIPAA's requirements for the use and disclosure of PHI (Protected Health Information) during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questions that provide an ability to manage and facilitate the needs of all stakeholders. The regulatory authority of HIPAA and FDA agree that the two sets of regulations work well together. HIPAA does not restrict the GCP requirements of a site.

This course covers Key Terminology & Concepts Specific to HIPAA and Clinical Trials; Protected Health Information, Assurances for Covered Entities, Authorization vs. Waiver; Security Rule, Privacy Rule, & Enforcement Rule; Sites and Sponsors Working Together Under HIPAA; and extensive real-life interactive case scenarios.

A foundation training applicable for all clinical research professionals involved with the conduct of clinical trials in the United States. This course includes extensive real-life case scenarios with review of example best answers.

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.


Key Terminology & Concepts Specific to HIPAA and Clinical Trials
  • HIPAA Background
  • Glossary of Terms
  • Why was HIPAA Created?
  • Who Must Follow HIPAA?
  • Covered Entity
  • Qualifications of a Covered Entity
  • Business Associate
  • Business Associate after HITECH?
  • Is My Site/Investigator a Covered Health Care Provider?

Protected Health Information, Assurances for Covered Entities, Authorization vs. Waiver
  • Health Information
  • Health Information Since HITECH
  • Protected Health Information (PHI)
  • Individual's Rights Under HIPAA
  • Maintenance or Transmission of PHI
  • De-identified PHI (Protected Health Information)
  • PHI (Protected Health Information) Identifiers
  • How Can PHI (Protected Health Information) be Used for Clinical Research?
  • Assurances for Covered Entities
  • Individual Authorization to Use or Disclosure of PHI (Protected Health Information)
  • Required Elements of an Authorization for Use or Disclosure of PHI
  • Waiver of Authorization
  • Some Questions Regarding Authorizations & Sponsors
  • Data Use Agreements
  • Disclosure of PHI for Monitoring
  • Exception to Review Preparatory to Research (RPR)

Security Rule, Privacy Rule, & Enforcement Rule
  • Distinction Between the Security and Privacy Rule
  • 21 CFR Part 11 Compliance, HIPAA, and Covered Entity
  • Security Rule
  • Enforcement Rule
  • Privacy Rule: Enforcement Highlights
  • FDA Q&A from
  • PHI (Protected Health Information) Safeguards and Monitoring

Sites and Sponsors Working Together Under HIPAA
  • Good Clinical Practice & Good Privacy Practice
  • Investigator Oversight & Availability of Records
  • Remote Clinical Trials
  • Centralized Monitoring
  • Some FDA Examples that are Linked to Potential Remote PHI Review
  • OCR Guidance & FAQ
  • Sponsor Remote Site Monitoring
  • Clearly Define Pertinent Source for Remote Review
  • Remote Clinical Trials
  • PHI Safeguards and Monitoring
  • Revision to Processes to Support Remote Review and Access
  • Support Relationships Between Sites & Sponsors/CROs

Extensive Real-life Case Scenarios

10 Question Post Assessment


1. Define key terminology and concepts specific to the HIPAA Privacy Rule in clinical research.

2. Describe when sites are covered entities and the sponsor roles and responsibilities related to the HIPAA Privacy Rule.

3. Discuss the requirements of the Privacy Rule relating to clinical research source documentation use and disclosure.

HIPAA Training for Clinical Trial Professionals is included in the following professional certification programs:

Professional Certification Program:

Clinical Research Coordinator (CRC) Professional Certification Program

Price: $995.00.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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.