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Tuesday, March 19, 2024
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Clinical Trials Management and Monitoring Training Courses and Certification Programs


Clinical Trials Management and MonitoringDocument your dedication to clinical trials management and monitoring by earning a professional certification from Biopharma Institute.

Choosing Biopharma Institute to provide training on clinical trials management and monitoring demonstrates the importance you place on receiving a reliable, accurate, and high-quality instruction with an emphasis on producing products or services which are safe for the consumers or patients to use. Students earning a certificate of training from Biopharma Institute have an established appreciation for regulatory and compliance and have presented a strong understanding of the subject matter taught. Below is our list of clinical trials management and monitoring training certification courses and programs.

Clinical Research:
Popular Programs & Training Categories



GCP Training – Fundamental Courses


Certification Training GCP: ICH, Harmonization, and Principles (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: ICH, Harmonization, and Principles (Fundamentals)

Course ID: CT03A
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Clinical Research Teamwork (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Clinical Research Teamwork (Fundamentals)

Course ID: CT03B
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Clinical Trial Documentation (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Clinical Trial Documentation (Fundamentals)

Course ID: CT03C
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Clinical Trial Sponsors GCP Responsibilities (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Clinical Trial Sponsors GCP Responsibilities (Fundamentals)

Course ID: CT03D
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Clinical Trial Investigators GCP Responsibilities (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Clinical Trial Investigators GCP Responsibilities (Fundamentals)

Course ID: CT03E
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Informed Consent in Clinical Trials (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Informed Consent in Clinical Trials (Fundamentals)

Course ID: CT03F
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GCP: Clinical Trial Monitors GCP Responsibilities (Fundamentals)
Individual Course w/Certificate of Completion:

GCP: Clinical Trial Monitors GCP Responsibilities (Fundamentals)

Course ID: CT03G
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials in Drug Development (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials in Drug Development (Fundamentals)

Course ID: CT04A
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Protocol Design  (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials: Protocol Design (Fundamentals)

Course ID: CT04B
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Preparation  (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials: Preparation (Fundamentals)

Course ID: CT04C
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Endpoints  (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials: Endpoints (Fundamentals)

Course ID: CT04D
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Statistical Elements  (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials: Statistical Elements (Fundamentals)

Course ID: CT04E
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Study Design  (Fundamentalse)
Individual Course w/Certificate of Completion:

Clinical Trials: Study Design (Fundamentalse)

Course ID: CT04F
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training Clinical Trials: Data Capture  (Fundamentals)
Individual Course w/Certificate of Completion:

Clinical Trials: Data Capture (Fundamentals)

Course ID: CT04G
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Certification Training GxP: Good Practices (GxP) in Drug Development and Manufacturing
Individual Course w/Certificate of Completion:

GxP: Good Practices (GxP) in Drug Development and Manufacturing

Course ID: GXP01
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $95.00


Core Clinical Research Training for Professionals:


Certification Training Clinical Trials Management (US & EU) Professional Certification Program
Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Method of Training: Online, self-paced eLearning.
Price: $1295.00


Certification Training Clinical Research Associate (CRA) Professional Certification Program
Professional Certification Program:

Clinical Research Associate (CRA) Professional Certification Program

Course ID: GCP00A
Method of Training: Online, self-paced eLearning.
Price: $845.00


Certification Training Clinical Research Coordinator (CRC) Professional Certification Program
Professional Certification Program:

Clinical Research Coordinator (CRC) Professional Certification Program

Course ID: CRCPRO
Method of Training: Online, self-paced eLearning.
Price: $995.00


Certification Training GCP: ICH-GCP Good Clinical Practice
Individual Course w/Certificate of Completion:

GCP: ICH-GCP Good Clinical Practice

Course ID: GCP001
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $195.00


Certification Training Clinical Trials: Preparation and Design
Individual Course w/Certificate of Completion:

Clinical Trials: Preparation and Design

Course ID: GCP002
Method of Training: Online, self-paced eLearning.
Length: 240 minutes
Price: $225.00


Certification Training Clinical Trials and Drug Development
Individual Course w/Certificate of Completion:

Clinical Trials and Drug Development

Course ID: GCP003
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $175.00


Certification Training Clinical Trial Monitoring: Site Evaluation and Set-up
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Site Evaluation and Set-up

Course ID: GCP004
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $175.00


Certification Training Clinical Trial Monitoring: Documentation and Closure
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Documentation and Closure

Course ID: GCP005
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $195.00


Certification Training Clinical Trials: Preparing for an Audit or Inspection
Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Course ID: GCP006
Method of Training: Online, self-paced eLearning.
Length: 150 minutes
Price: $225.00


Certification Training Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
Individual Course w/Certificate of Completion:

Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Course ID: GCP007
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Clinical Trials:  How to Obtain Approval to Conduct Clinical Trials in the EU
Individual Course w/Certificate of Completion:

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

Course ID: GCP020
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $175.00


Certification Training DIGR-ACT® Solution: Critical Thinking Skills - Including Root Cause Analysis & CAPA
Individual Course w/Certificate of Completion:

DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPA

Course ID: CP001a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $399.00


Certification Training GCP Refresher Training for the Experienced Professional
Individual Course w/Certificate of Completion:

GCP Refresher Training for the Experienced Professional

Course ID: CP003a
Method of Training: Online, self-paced eLearning.
Length: 35 minutes
Price: $199.00


Certification Training Clinical Trial eSystems Inspection Readiness
Individual Course w/Certificate of Completion:

Clinical Trial eSystems Inspection Readiness

Course ID: CP021a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Safety Reporting in Clinical Trials (Adverse Event Reporting)
Individual Course w/Certificate of Completion:

Safety Reporting in Clinical Trials (Adverse Event Reporting)

Course ID: CT13
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Clinical Trial Safety Reporting Requirements in the EU and USA
Individual Course w/Certificate of Completion:

Clinical Trial Safety Reporting Requirements in the EU and USA

Course ID: CT14
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Good Clinical Practice for Professionals
Individual Course w/Certificate of Completion:

Good Clinical Practice for Professionals

Course ID: GCPFP
Method of Training: Online, self-paced eLearning.
Price: $495.00


Training Specifically for Sponsors and CROs:


Certification Training Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals
Training Program for Professionals:

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

Course ID: GCP00A2
Method of Training: Online, self-paced eLearning.
Price: $895.00


Certification Training Clinical Trials:  How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation

Course ID: CT11
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation

Course ID: CT12
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $175.00


Certification Training Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

Course ID: CP019a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals
Individual Course w/Certificate of Completion:

Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals

Course ID: CP006a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training CRO Oversight
Individual Course w/Certificate of Completion:

CRO Oversight

Course ID: CP007a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
Individual Course w/Certificate of Completion:

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)

Course ID: CP012a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Structure and Content of Clinical Study Reports (ICH E3)
Individual Course w/Certificate of Completion:

Structure and Content of Clinical Study Reports (ICH E3)

Course ID: CP013a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)

Course ID: CP015a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures

Course ID: CP016a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)
Individual Course w/Certificate of Completion:

Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)

Course ID: CP018a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


HIPAA and GDPR For Clinical Research Professionals:


Certification Training HIPAA Training for Clinical Trial Professionals
Individual Course w/Certificate of Completion:

HIPAA Training for Clinical Trial Professionals

Course ID: CP017a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training The General Data Protection Regulation (GDPR) and Clinical Trials
Individual Course w/Certificate of Completion:

The General Data Protection Regulation (GDPR) and Clinical Trials

Course ID: CP009a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Additional Clinical Research Training Programs:


Certification Training GCP Training: ICH E6(R2) - (Refresher Training for Novice)
Individual Course w/Certificate of Completion:

GCP Training: ICH E6(R2) – (Refresher Training for Novice)

Course ID: CP002a
Method of Training: Online, self-paced eLearning.
Length: 75 minutes
Price: $199.00


Certification Training ICH E6(R2) GCP Training for Investigator Site Personnel
Individual Course w/Certificate of Completion:

ICH E6(R2) GCP Training for Investigator Site Personnel

Course ID: CP004a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

Course ID: CP019a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Good Documentation Practices and ALCOA-C
Individual Course w/Certificate of Completion:

Good Documentation Practices and ALCOA-C

Course ID: CP005a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training ISO 14155:2020 Medical Device Standard
Individual Course w/Certificate of Completion:

ISO 14155:2020 Medical Device Standard

Course ID: CP008a
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Medical Device vs. Drug: Comparing and Contrasting
Individual Course w/Certificate of Completion:

Medical Device vs. Drug: Comparing and Contrasting

Course ID: CP010a
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Investigator Initiated Clinical Trials
Individual Course w/Certificate of Completion:

Investigator Initiated Clinical Trials

Course ID: CP011a
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



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Online Training – The Benefits of eLearning:

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: Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training: Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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.