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Wednesday, February 01, 2023
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CRO Oversight

Certification Training
Rated 4.7 / 5
3 reviews
Program/Course ID: CP007a
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: 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 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. 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 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.