Regulatory Objectives
True or False:
A regulatory objective can have more than one lead submission.
False
What is the wizard called that is used to create clinical amendment activities?
Impact Assessment Report - Clinical Study
What lifecycle state does an activity need to be in prior to linking the Regulatory Objective and Lead Submission?
Pending Strategy
How many GRIP requests should you receive for a new Clinical Trial Submission Planning?
One GRIP request is expected to create the Event, Activities, Registrations, Applications, Regulatory Objectives, and Submissions.
Can a Regulatory Objective/Submission be created if an Activity is required but does not exist or is not known?
No. Do not create a Regulatory Objective/Submission if the expected activity is not provided or is not found in AMGEN RIM.
Is the country code required to be included in the name of an event and why?
No. Events are global changes only. The activities are country specific.
What lifecycle state does an activity need to be in after being linked to a Regulatory Objective and Lead Submission?
Strategy Execution
On a new clinical trial Submission Planning request, what is the attachment that must be on the request in order to move forward with creating anything?
The email from the GRL, detailing which countries are participating, which product it is applicable to, which study number, and which branches (if applicable).
Can you link more than one Regulatory Objective to an Activity?
No. While you can link more than one Activity to one Regulatory Objective, you can only link one Regulatory Objective/Lead Submission to an Activity.
Can an Event be related to more than one drug product?
No. One product per global event change.
When do you create activities manually vs. using the wizard, and why is it important?
When additional country activities are requested to be added to an event that already has existing activities. This avoids duplication of those existing country activities.
How many Submission Planning GRIP requests should you receive for a clinical protocol amendment?
At least two. One for the event and activity creation for all countries, and one for each country/region for the Regulatory Objective and Submission creation (you can receive multiple countries on one GRIP request).
What Activity assessments do not need to be linked to a Regulatory Objective or Submission?
Not Reportable or Not Applicable. When these assessments are completed by the regulatory rep, the system automatically completes the Activity.
Of the types of Events (CMC, Labeling, Clinical Trials, Original MA, & Other), which ones are RDA's responsibility to create and edit?
Only Clinical Trials (includes initial CTAs and amendments), Original MA, and Other.
What do you do when asked to link a protocol amendment activity that is not yet assessed to a Regulatory Objective and Lead Submission?
Reach out to the requestor to ensure the activity is assessed and the lifecycle is updated to Pending Strategy. Put the request on hold until the assessment and lifecycle are updated. The request can be cancelled if there is no response/action taken within 5 business days. Check the activity prior to cancelling, as the requestor may have updated but not responded to your query.
If a Submission Planning GRIP request is received for a bundle of protocol amendments (i.e. protocol amendment, ICF update, and IB update), are all Activities required to be added to the Regulatory Objective?
Yes. For a protocol amendment submission (not a new clinical trial submission), each part of the bundle in the submission is required to be represented with an Activity.
When is it not required to create and link a clinical amendment Activity to the applicable Regulatory Objective?
For a new clinical trial Regulatory Objective, clinical amendments that are included in the submission do not need to be linked to the Regulatory Objective if they do not already exist. If the amendment Activity does exist (this should be searched for in RIM), link that Activity to the Regulatory Objective.
Is an Event and Activity required for a bucket Regulatory Objective?
Bucket ROs will not require Events and Activities (e.g. reports). We will only receive one Submission Planning GRIP request to create the RO and/or submission. There also is no JC implications.
When new protocol activities are created using the impact assessment report, what is the regulatory assessment populated automatically by the system?
Reportable - Approval Required. The lifecycle state of the Activity will remain In Regional Assessment until the regulatory rep appropriately assesses.
I have received a Submission Planning GRIP request with no planned approval date. Can I assume no approval is expected?
You cannot assume. You must review the Activity assessment. If the assessment is Reportable - Approval Required, query the requestor for the planned approval date. Please note that this is critical for the 'Formal Approval Required?' field on the Regulatory Objective.