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Home » GCP: Clinical Trial Monitoring - Documentation and Closure

GCP: Clinical Trial Monitoring - Documentation and Closure (GCP005)

Certification Training
Rated 4.33/5
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Credits: 2 CPD Credits
Length of Course: Approximate time to complete this course is 2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining Program: GCP: Clinical Trial Monitoring - Documentation and Closure
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will familiarize students with areas like the maintenance and review of essential documents, source document verification, and the monitoring of CRFs (case report forms). The procedures and responsibilities most often associated with closeout visits and monitoring processes are also discussed.

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.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 75% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.

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By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. Many of our courses bring to light important changes which have recently taken effect and been applied in various areas of the healthcare, pharmaceutical, and clinical research industries. Through learning tools such as books, recorded seminars, live seminars, online courses, and more, the BioPharma Institute offers proven methods that can help you, your company, and your colleagues to further your education or simply refresh your existing knowledge.

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Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The GCP: Clinical Trial Monitoring - Documentation and Closure course is found in the following professional certification program(s):

Clinical Trials Monitoring Professional Certification Program: GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the wel ... Learn more

Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates and coordinators with the desire to grow ... Learn more


Overview: This session briefly describes the legislative guidelines used to conduct clinical trials.

Monitoring visit: This session outlines the preparation, conduct and follow-up of a routine monitoring visit.

CRF review: Case Report Forms are crucial in conducting a successful clinical trial. This session discusses the monitoring and review of CRFs.

Source document verification: Inadequate understanding of the process involved in source document verification results in the procedure being ineffective. This session explains the importance of source document verification in clinical trials.

Essential documents: Collection and review The ICH GCP guideline identifies a minimum list of essential documents that are required throughout a trial, including specific details of where each document should be filed during the study, and their purpose. This session summarizes these documents. The contents of the Trial Master File and Investigator Site File are also described.

Close-out visit: This session outlines the preparation, conduct and follow-up of a close-out visit. Sponsor site audits This session will focus on sponsor site audits. The purpose of sponsor audits will be described, as well as the role of the CRA and common audit findings.

Fraud and scientific misconduct: CRAs are sometimes faced with serious situations, namely errors, misconduct and fraud. This session will focus primarily on the CRA's role in these unfortunate events.

Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.


Students completing this course should be able to:

--Outline the monitoring activities conducted on a site visit.

--Identify the requirements for accurate and consistent CRF completion by site staff.

--Define the CRA's responsibilities for the monitoring and review of CRFs.

--Define source documents and the procedures for source document verification.

--Identify the essential documents which must be available prior to the commencement of a clinical trial at each investigational site, during the conduct of a clinical trial, and after completion or termination of a clinical trial to comply with ICH Good Clinical Practice (GCP) guidelines.

--Describe the procedures to be conducted to close a trial at each investigational site, when the requirements of the protocol have been fulfilled, or if continuation of the trial is considered inappropriate.

--Explain the importance of sponsor site audits.

--Summarize the role of the monitor in preparation for a site audit.

--Identify the responsibilities of the CRA in identifying and reporting scientific misconduct.

All Courses in the Clinical Trials Management and Monitoring Catalog:

GCP: ICH Good Clinical Practice (ICH-GCP): Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of bre ... Learn more

GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is ... Learn more

GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more

GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more

GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This ... Learn more

GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more

Online Training: The Benefits of eLearning

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  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
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  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
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  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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