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Feedback on this module
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94% of people completing this module said they would recommend it to their colleagues
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Over 80% gave an overall assessment of this module of 7/10 or better
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Over 80% said that this module met their expectations to a level of 7/10 or better
Overview
This module defines documentation and essential documentation requirements under the European regulations. It looks at each document and its purpose in the trial process, identifying which documents are unique to the TMF and ISF. The location of the files will be explored along with filing conventions. The concept of eTMF and electronic records management will also be discussed.
The why, what, who and when of archiving of paper documents and electronic archiving will be covered.
The specific modalities to the Directive 2005/28/EC on the requirements for non-commercial studies will also be detailed. The requirements of the FDA are not discussed but it must be noted that if a study is conducted under an IND you must satisfy the documentation requirements of the FDA.
The programme is clear and simple in design and gives full instructions for use.
Learning objectives
By the end of this course, you will be able to…
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Define the documentation and essential documentation requirements necessary to meet regulatory standards
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Describe each document and outline its purpose in the clinical trial process – identifying which documents are unique to the TMF and ISF
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Critically appraise methodologies of indexing and filing conventions
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Discuss the concept of eTMF and electronic records management
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Develop coherent strategies to manage and satisfy the requirements of archiving essential documentation
Certification & CPD
At the end of the course you can complete a 20 question,
multiple choice exam, which will test you on the subject matter of the
module. The pass mark for the exam is 75%, but you can take the exam as
many times as you like.
On passing the exam you will have the option of printing
out a certificate which will certify your successful completion of the
course.
