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CRO Oversight

CRO Oversight Certification Training
Rated 4.7 / 5
3 reviews
Program/Course ID: CP007a
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: 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: CRO Oversight
Training Provided By: Biopharma Institute

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

Biopharma Institute ReviewsCRO and vendor oversight is a topic that is important to all Sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product development. Sponsors outsource for many reasons, including but not limited to, meeting the temporary need for a large expanded workforce, additional and sometimes unique expertise, technology, and quality systems. To make these partnerships work, Sponsors must have systems in place to oversee the quality of the CRO's work for the protection of study participants and the reliability of data.

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.


  • 1. Sponsor's Regulatory Requirements for using a CRO
  • a. Increased Scrutiny on Sponsor's Oversight of CROs
  • b. ICH E6(R2), section 5.2 Contract Research Organization (CRO)
  • c. EMA 2013 Reflection Paper on Risk Based Quality Management (RBQM) in Clinical Trials
  • d. EMA RBQM Requirements Noted that Specifically Apply to Vendor Management
  • e. FDA 2013 Oversight of Clinical Investigations A Risk-Based Approach to Monitoring
  • f. Identification of Critical Processes & Data
  • g. FDA BIMO CPGM 2021, Part III Inspectional
  • h. BIMOs Updated Sponsor CPGM
  • i. Sponsor BIMO CPGM: Organization and Personnel
  • j. Sponsor BIMO CPGM: Focus
  • k. Gathering & Organizing Knowledge for Reminders

  • 2. Key Components of Effective Sponsor CRO Oversight
  • a. Optimal Relationship Between the CRO and Sponsor
  • b. Key Sub-Areas of Sponsor CRO Oversight Components
  • c. Sponsor CRO Oversight Components
  • d. Critical Success Factors for Oversight
  • e. Keys to a Successful Relationship
  • f. What do CROs Want?
  • g. Examples of Critical Success Factors Metric Categories

  • 3. Oversight Procedures, Plans, and Documentation Management
  • a. Establish Clear Expectations to Ensure Acceptable Performance by CROs of Critical Activities
  • b. Clinical QMS Elements Integrating RBQM
  • c. Core QMS Elements: Both Stakeholders
  • d. Sponsor QMS Elements for CRO Oversight
  • e. CRO QMS Elements for Quality Performance
  • f. Sponsor's Oversight Plan & CRO Project Plan Commonality
  • g. Factors that Impact the CRO Project Plan & the Sponsor's Oversight Plan
  • h. Clarifying Boilerplates in Guidance and Regulations
  • i. Identifying the SOPs Being Followed for the Trial
  • j. Multi-vendor Teams & More than One CRO
  • k. Working with CROs: Sponsor Documentation
  • l. Oversight Documentation
  • m. Define Roles and Responsibilities
  • n. Communication Plan

  • 4. Real-life Case Scenarios

  • 5. 10 Question Post Assessment


  • Describe the Sponsor regulatory requirements for oversight of CROs.
  • Recognize key components for effective Sponsor CRO oversight.
  • Identify adequate CRO oversight procedures, oversight plans, and documentation management.

All clinical research personnel

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.