EDC System Training Mutual Recognition Program

The TransCelerate Site Qualification and Training (SQT) Initiative has developed a mutual recognition program for Electronic Data Capture (EDC) system training, targeted to investigator site personnel.

*Please note TransCelerate does not provide EDC system training.

Is the documentation training acceptable for mutual recognition?

Training on EDC systems previously completed by investigator site personnel may be recognized by TransCelerate Member Companies participating in the program.  This means participating Member Companies can elect not to require redundant, repetitive training, thus reducing the training burden on site staff.

 

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What is meant by the term “Training Provider”?

This is the party who has developed and is administering the training course, e.g. EDC vendor, Member Company, or other.

Where will I find the minimum criteria to check training content acceptability?

TransCelerate has not defined a minimum criteria for EDC system training.  The presumption is that Training Providers create and deliver training that is adequate for the respective system versions they support.

Is there any approval required by TransCelerate in order to participate in the EDC System Training Mutual Recognition Program?

There is no approval required by TransCelerate in order to participate in the program.

Do Member Companies have to agree to mutual recognition?

Mutual recognition of EDC system training is voluntary – it is up to each Member Company to decide on the mutual recognition of EDC system training.

What evidence is sufficient to show completed training?

Documentation (eg. Certificate of completion, EDC report, etc.) should include the following minimum details: Training Provider, EDC system, EDC system version, course title, role trained and completion date. This evidence should be available to site users and sponsors (if requested).

I provide EDC system training; how do I add my courses to the list for mutual recognition by others?

Training Providers and Member Companies can submit details of any EDC system training that they provide here.

Does the EDC System Training Mutual Recognition Program include protocol-specific training?

No. Detailed training around protocol-specific EDC system training and guidelines are not being proposed for mutual recognition as each Sponsor applies differing guidance for how to complete EDC deliverables to be consistent across their programs.

How will I know that a previously completed EDC system training course is acceptable for mutual recognition?

Training Provider and Member Company courses together with title, version and content outline will be posted to the EDC System Training list for reference. The content outline should refer to the general system functionality and role training, and should exclude any protocol-specifics. It is the Member Company’s responsibility to determine acceptability.

What if EDC system training has been completed prior to implementation of mutual recognition process?

Mutual recognition of previously completed training should follow the same process.

What if the EDC system I am using undergoes a version change? How do I know if new or additional training is required?

Sponsors should be aware, based on their own use of the system and requirements for internal sponsor users, of whether additional gap/“delta” training for roles or functions is required to support a new version. In the absence of any information, it is assumed that Member Companies should be able to confirm with their EDC vendor as to the appropriate training needed.

Whom should I contact if I have further questions about this mutual recognition process?

Site personnel should contact their Sponsor representative, for example, to verify completed training is eligible for mutual recognition by other Sponsors. Sponsors or EDC vendors should contact sqt@transceleratebiopharmainc.com.

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