Draft Home Page

The Draft home page shows a summary of all Draft objects (Edit Checks, Forms etc) as well as recent Activities and a summary of the results of the last draft-lint run.

Editing a Draft

Properties of the Draft such as Draft Name and its associated Standards Global Library can be edited by clicking the Edit button on the Draft Home Page.

While the Draft is locked the button reads View, and the page opens read-only so that you can still see the Draft's Properties. Unlock the Draft if you need to change them.

Download a Draft

You can download an Architect Loader Spreadsheet from TrialGrid by clicking the 'Download' button.

Export a Draft

You can export a Draft from TrialGrid directly to Medidata Rave by clicking the 'Export' button.

Locking a Draft

A Draft can be locked to prevent further changes to the Draft and to any of the objects within it. Only users with a role including the 'Lock Draft' permission can lock a Draft.

While a Draft is locked, its Properties cannot be edited and its objects cannot be added, changed or deleted. This covers Labels, user Assignments and Comments on those objects, and also Diagnostic fixes and saving the work of an Agent into the Draft. Unlock the Draft to make any of these changes.

Unlocking a Draft

A Draft which has been locked may be unlocked by a user whose role includes the 'Unlock Draft' permission.

Approving a Draft

Users can add their Approval to a Draft, if their User Role includes the 'Approve Draft' permission. Approvals are displayed on the Draft Home page and are recorded in the Activity Records for the Draft. Unlike Locking, Approvals do not change whether Draft objects can be edited. Drafts are approved by Role, i.e. if a user with 'Manager' Role has approved a Draft then if another user with the same role approves it there is only one approval recorded.

A Draft may be locked before or after it is approved. A locked Draft can still be approved, approval can still be requested for it, and an Approval already given is kept when the Draft is locked. Locking a Draft before requesting Approval means its contents cannot change while the Approvals are being collected.

Removing Approvals

Approval may be revoked by role, i.e. if a user with 'Manager' role revokes approval then it is revoked for all 'Managers'. Approval may be revoked whether or not the Draft is locked.

Approval is also removed from a Draft automatically if any change is made to the Draft or any of its objects. A locked Draft cannot be changed, so Approvals are not removed this way while the Draft stays locked.

Requesting Approval

Approval may be requested from users who have a role in the project which has not yet approved the Draft. The Request Approval option of the Draft Action menu opens a dialog which lists roles and users in those roles where the role has not yet approved the Draft. Users are notified by email and by alert with a request to approve the Draft.

Importing Applicable Library Objects

When a Draft is linked to a Standards Global Library, the 'Import Applicable Library Objects' option of the Draft Action menu copies Matrices, Edit Checks and Derivations from that Library into the Draft.

An object is applicable when the Draft already has everything it refers to. An Edit Check whose Folders, Forms and Fields are all present in the Draft can be used as it stands, so it is offered; one which refers to a Form the Draft does not have is not. This is the same choice TrialGrid makes for you at the end of creating a Draft from a Library, and it saves you writing a MUST EXIST rule for every Edit Check and Derivation you want.

The dialog names the Library it will copy from - a Draft can only import from its own Standards Global Library - and lets you choose which of Matrices, Edit Checks and Derivations to look for. Each object found is listed with the objects it matches in your Draft, so you can see why it is being offered. Choose the ones you want and click Copy.

Objects are left out of the list when:

  • the Draft already has an object of that name,

  • a MUST NOT EXIST rule in the Library forbids the object,

  • the object refers to Folders, Forms or Fields which the Draft does not have.

A Matrix is copied with only those Folder/Form combinations which exist in the Draft and which the Library's rules allow, so importing a Matrix does not bring in Forms you have not taken. An Edit Check which adds or merges a Matrix can only be imported if that Matrix is in the Draft already or is being imported at the same time; the 'Also needs' column shows when that is the case. Any Custom Function an imported Edit Check or Derivation uses is copied with it.

The option is shown to users whose role includes the 'Edit Objects' permission, on Drafts which are not locked.

Allowing/Disallowing Imports from Draft

By default anyone who can view a Draft can import objects from that Draft into their own Drafts. A user with Create/Edit Draft permission is able to set the Draft so that its contents (Forms, Edit Checks etc) cannot be imported into other Drafts. This is particularly useful when you want to retire a Library so that objects from it can no longer be imported.