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Clinical Trial Monitoring: Documentation and Closure

Clinical Trial Monitoring: Documentation and Closure Certification Training
Rated 4.3 / 5
15 reviews
Program/Course ID: GCP005
Enrollment Period: 12 months.
Average Learning Time: ~180 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2 CPD Credits.
Method of Training: Online, asynchronous, self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: 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: $195.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Clinical Trial Monitoring: Documentation and Closure
Training Provided By: Biopharma Institute

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

Biopharma Institute Reviews

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

After a brief overview, the course consists of topics such as the following: closeout visit, essential documents, source document verification, CRF review, monitoring visit, fraud and scientific misconduct, and a key point summary at the end.

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.


Module overview
Sets out the module's scope, objectives and notes on terminology.

Site monitoring visits
Regular visiting of investigational sites by a CRA is the front line of clinical trial monitoring. The visits allow face-to-face interaction with study site personnel and direct access to source records and site resources, providing the best opportunity for the CRA both to assess and to influence the progress and quality of a trial. In this session, we discuss monitoring tasks, the frequency and duration of visits, preparation for a visit, the kinds of deficiencies that may be found at the site, interaction with study staff, assessment of protocol compliance in a variety of areas, investigational product and subject recruitment issues, review of findings, and report and follow-up.

Data checking
Review and verification of data in CRFs and source documents is considered by many to be the CRA's principal task. It takes up most of his or her time on a monitoring visit and constitutes the primary measure taken on behalf of the sponsor to assure the quality of the data provided by the investigator. In this session, we describe how to carry out CRF review and source document verification (SDV). We discuss the extent of SDV required, outline differences between paper and electronic CRFs, identify aspects of trial conduct for which CRFs and source records should be checked, discuss on-site corrections and resolution of discrepancies, and outline data retrieval and data query procedures.

Close-out visit
Almost all clinical trials require an on-site visit to close the study at a site, irrespective of whether routine monitoring visits have been made. In addition to completing tasks typically carried out at a routine visit, the CRA will be required to perform some actions specific to the end of the trial, such as retrieving or authorizing the destruction of unused supplies, retrieving some essential documents, and reminding the investigator of continuing responsibilities. In this session we describe the close-out of a trial at an investigational site.

Risk-based monitoring
Monitoring of clinical research by traditional methods, particularly as regards data checking, is time consuming and laborious. In recent years, regulatory authorities have focused attention on ways of making quality management in general, and monitoring in particular, more efficient through a risk-based approach. Implications of this approach include: increased emphasis on centralized monitoring rather than site visits; and a move away from 100% source document verification toward risk-based and statistically directed sampling of data. In this session we provide a brief introduction to principles of risk-based monitoring.

Fraud and scientific misconduct
The great majority of healthcare professionals undertaking clinical research act with honesty and integrity. However, cases of scientific misconduct and downright fraud do occur. Besides damaging the reputations of those who commit them, such actions have potentially serious consequences for the research and might even affect public health. In this session we distinguish error, misconduct and fraud, discuss the CRA's role in detecting them, and describe their consequences.

Multiple-choice mastery assessment.


Who will benefit from this module?
The module is intended for those involved in clinical research and development, in particular the monitoring of clinical trials, and those who require an understanding of what this entails. It and its companion module CT06 provide a comprehensive introduction to monitoring for new CRAs, or additional training and professional development for those already working in the field. It will also be of value to a clinical research coordinator (CRC), clinical investigator and other healthcare professionals involved in clinical studies.

Learning objectives
  • Describe how to prepare for and carry out regular monitoring visits to investigational sites.
  • Describe how to review case report forms (CRFs) and verify consistency of data with source documents.
  • Describe how to close out a trial at a site.
  • Discuss the concept and implications of risk-based monitoring.
  • Identify warning signs that raise suspicion of scientific misconduct or fraud.

Clinical Trial Monitoring: Documentation and Closure is included in the following professional certification programs:

Professional Certification Program:

Clinical Research Associate (CRA) Professional Certification Program

Course ID: GCP00A
Price: $845.00.00 (USD) | Learn more

Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Price: $1295.00.00 (USD) | Learn more

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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).
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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.

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