Cross-Sponsor GCP Certification Transfer

In Study Training, site Learners using VeevaID can submit proof of Good Clinical Practice (GCP) certification in one sponsor Vault and automatically re-use the same proof to complete GCP training in another sponsor’s Vault. With Learner consent to share, Vault automatically copies this proof to each of the Learner’s subsequent External Training Assignments for GCP collection, allowing for individual sponsor review in their Vault without requiring the Learner to retake a course or submit redundant evidence.

Note: This feature is only available for Study Training site Learners using VeevaID and must be configured by a Vault Admin.

Feature Dependencies

Cross-Sponsor GCP Certification Transfer is a specialized use case of the Learner Exemption Requests feature. As a best practice, we recommend configuring Learner Exemption Requests before Cross-Sponsor GCP Certification Transfer.

When an External Training Requirement record’s Training Requirement Transfer Type field is “Site GCP Collection”, site Learners receive a corresponding External Training Assignment for GCP training.

A given GCP assignment invites the Learner to participate in one of two recurring “phases” of GCP training across sponsors’ Study Training Vaults:

The collection phase, during which the Learner submits and consents to sharing proof of their GCP certification in one sponsor Vault. This phase is like most other External Training Assignments, where the Learner uploads their proof of completion, then selects the Complete Training button and enters their electronic signature. Then, Vault sends the CRA or other reviewer a workflow task to approve or reject the assignment.
The subsequent exemption phase, during which the Learner is assigned similar External Training Assignments in other sponsor Vaults. This phase is unique to GCP assignments, and Learners must consent to sharing their proof during initial collection in order to participate. When proof of completion is detected for a given assignment, Vault automatically:
- Creates a Learner Request record and adds the proof as an Attachment.
- Sends that sponsor’s CRA or other reviewer a workflow task to approve or reject the proof of completion.

In certain sponsor Vaults, Learners may always be required to re-submit a different item of proof during the exemption phase. This occurs when a sponsor uses External Training Assignments to assign a specific GCP training for which any other proof of completion is insufficient. In this case, Learners can simply complete the sponsor-specific GCP training, cancel the exemption request, and upload the new proof of completion.

See Limitations for other considerations.

About Recurrence

By default, when an External Training Requirement for GCP recurs, Vault calculates the Next Training Date (Recurrence) for the resulting External Training Assignment using the Evidence Completion Date that Learners populate while completing the assignment during the collection phase.

Note: This behavior applies only to GCP-specific External Training Assignments generated using this feature. Otherwise, Vault uses an assignment’s Completion Date to calculate recurrence, as Vault does not automatically prompt Learners to populate the Evidence Completion Date when completing a non-GCP External Training Assignment task.

About the Update Training Assignment Job

When the Update Training Assignment job processes an External Training Assignment for GCP during the exemption phase, it initiates a secondary Registry Transfer Exemption Job to:

Confirm whether the Learner is a VeevaID user.
Generate the Learner Request record.
Locate and attach the Learner’s previously-uploaded proof to the Learner Request record.

Configuration Overview

To configure your Vault for Cross-Sponsor GCP Certification Transfer:

Within the External Training Requirement object page layout:
- Add the Training Requirement Transfer Type field.
- Add the Transfer Type Warning admin alert below the Training Requirement Transfer Type field. This alert notifies Training Admins of this feature’s behavior when saving a requirement with “Site GCP Collection” as the transfer type.
- Add the standard Is Verification Required? (is_verification_required__v) field and remove the similarly-labeled custom (__c) field. See additional details about the custom field.
Review the External Training Requirement object page layout’s Layout Rules. For any rule that hides the Recurrence Based On field (for example,hide_recurrence_based_on__c), ensure the Layout Rule Expression is recurrence_type__v !='relative__v' || is_recurring__v!=true. This corrects any previous expressions, which may have been indicated as recurrence_type__v !='related__v'.
Review the VT: Learner Exemption Request workflow’s default configuration and adjust according to your organization’s requirements.
This feature includes two standard workflows, VT: GCP Certification Complete and VT: GCP Certification Resubmit. To configure them for full use in your Vault, update each workflow’s Task steps (for example, Complete External Training Assignment) to use the VT: Task: External Training Assignment notification template.
Review your Vault’s Training Assignment object lifecycle configuration for the Assigned state (assigned_state__v). Confirm the conditional Entry Action rules for starting both the VT: External TA: Complete and VT: GCP Certification Complete workflows are configured such that:
- If Training Assignment Type equals External Training Assignment and
- Person is not a Vault user equals No and
- Due Date Timing is blank and
- Training Requirement Transfer Type is not equal to Site GCP Collection
Review your Vault’s Training Assignment object lifecycle configuration for the In Learner Review state. Confirm the conditional Entry Action rules for starting both the VT: GCP Certification Resubmit and VT: External TA: Resubmit workflows are configured such that:
- If Training Assignment Type equals External Training Assignment and
- Training Requirement Transfer Type equals Site GCP Collection

Note: Vault always creates a Learner Request for assignments during the exemption phase, and a reviewer must always accept or reject an item in order for the assignment to be marked as Completed. It is not possible to configure Vault to automatically close or otherwise skip the exemption phase based on the Evidence Completion Date or any other criteria.

About the Is Verification Required? Field

As of 25R1, Training Vaults include the Is Verification Required? field (is_verification_required__v). This standard field is required to use this feature: Vault sets it automatically when a Training Admin creates or updates an External Training Requirement for GCP.

Most Vaults also include a similarly-labeled custom (__c) version of this field. While your Vault’s configuration can continue to use the custom field outside of this feature, we strongly recommend updating any existing configuration to use the standard field, then inactivating the custom field.

About the Learner Exemption Request Workflow

The standard VT: Learner Exemption Request workflow requires configuration according to your organization’s requirements. By default, this workflow’s Start step is configured to use the Vault Owners group as participants. You will need to update this to fit your Vault’s security configuration, where a CRA or other reviewer group reviews a Learner’s submitted proof of GCP training. Otherwise, all review tasks during the exemption phase will be sent to all members of the Vault Owners group.

Creating Training Requirements for GCP Certification

When a Training Admin creates or updates an External Training Requirement and indicates it is for GCP (the Training Requirement Transfer Type field is “Site GCP Collection”), Vault automatically sets the below fields. These fields cannot be blank, and they cannot be updated with different values.

Allow Learner Exemption: No (false)
Is A Substitute Training Requirement: No (false)
Is Verification Required?: Yes. See additional details about this standard (__v) field.
Proof Required: Yes

Additionally, when a GCP requirement recurs (its Does this Training Requirement recur? field is “Yes”), Vault automatically sets the below recurrence-specific fields. A Training Admin can adjust values as required.

Recurrence: 3
Recurrence Unit: Years
Recurrence Based On: Evidence Completion Date

Note: Where possible, we recommend using only one GCP-specific External Training Requirement in your Study Training matrix. Otherwise, a variety of External Training Requirements used to collect or confirm Learner proof can lead to inconsistent or unexpected results across sponsor Vaults.

Limitations

This feature is only available to site Learners using VeevaID. It is not intended for internal Learners. Additionally, Learners must be assigned to the Training User Security Profile.
Only External Training Requirement records can be indicated for GCP training, where Training Requirement Transfer Type set to “Site GCP Collection”. Similarly, GCP requirements cannot be used as Substitute, Prerequisite, or Facilitated Training Requirements.
While Self-Enrollment and Direct Assignment can be used for collecting proof of GCP training, future assignments in other sponsor Vaults must be created as part of the Learner’s training matrix in order to be automatically exempted.
- For example, a site Learner is assigned and completes GCP training via Direct Assignment in VeePharm’s Vault. Then, this same Learner is assigned GCP training in VernBio’s Vault via Direct Assignment. In this case, VernBio’s Vault does not automatically create a Learner Request, and the Learner must complete the External Training Assignment as they would during the collection phase.
- Using the above example, the same logic applies for Self-Enrollment: The Learner may enroll themselves in GCP training in VeePharm’s Vault, however they must be assigned GCP training via their training matrix in VernBio’s Vault in order to be automatically exempted.

Vault automatically assigns VeevaID users to the Training User Security Profile. Site Learners must remain assigned to this profile order to participate in the exemption phase.

To approve exemptions, CRAs or other selected reviewers must be assigned a permission set with Read and Edit permission for the Learner Request object.