Drug Evaluation Committee Positioning of the 2010-58 EDC Training Certificate
Related classification: Other
First published: April 2011
Revised: April 2013
Question
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Regarding the handling of the "EDC Training Certificate," is it a document that corresponds to a document or record related to the clinical trial (mandatory document)? If it is not an essential document, can it be lost or reissued as it belongs to the individual?
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If it is a required document, is it a document that should be kept in the clinical trial file as a document that should be kept at the site?
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If it is a document that belongs to the individual, please let us know if it does not need to be preserved.
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Some sponsors say that since the original documents are kept at the sponsor, there is no need to keep them at the site, but what about GCP (including ICH-GCP)?
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Is the certificate of completion given to the CRC by the sponsor an original or a copy? Is it treated as a copy?
SMO CRC will go to another site once the clinical trial they are in charge of is completed. In such cases, the certificate of completion may be shared with other clinical trials.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Training records on the use of EDC are not specified in ICH-GCP "8. Essential documents for the conduct of a clinical trial". However, ICH-GCP 2.8 states that "Personnel involved in the conduct of a clinical trial shall meet the requirements for satisfactory performance of their duties by virtue of their education, training and experience. The ICH-GCP 2.8 stipulates that The site is accountable for ensuring that investigators, subinvestigators, and collaborators have received sufficient education and training to perform their duties, and records showing that they have received EDC training are one way to support this.
On the other hand, as the system owner of the EDC system in the trial, the sponsor must ensure that all system users have been trained in advance and that records of this training are kept. Even EDC systems from the same vendor may have different specifications for each sponsor, so a training record for the same EDC system may not be valid for another sponsor's EDC system.
We believe that the "EDC Training Completion Certificate" in your question was distributed to those who completed the training as a record of user education for the EDC system to be used in the relevant clinical trial. However, some sponsors may treat the training records recorded in the EDC system itself or the list of participants in the training workshop as the official record to be kept.
Therefore, please inquire with the sponsor as to what kind of records are to be stored as EDC training records and where (including whether the originals are to be stored in the clinical trial file or in the clinical trial file, etc.). If the sponsor decides to treat the "EDC Training Completion Certificate" as an official record to be kept, it should be kept as a document or record related to the relevant clinical trial. Also, please inquire with the sponsor about the possibility of reissuing the record in the event that it is lost.
Reason for revision of opinion
For better understanding of the answer to your question, we have added the opinion on the reissuance of such records in the event of loss.