Study Delivery

Introduction

The study enters the Closure Phase from the Maintenance Phase when the SM receives the Close-out notification from the Partner.

Database Lock

In the Closure phase, the SM initiates the process of locking the study data. The database lock date must be initially mentioned in the SOW for reference.

Overview of the steps and timing for database lock:

• Data cleaning
• Final Data Transfer Date
• Acceptance of Final Data Transfer Sign-off
• Database Lock Date
• Post-Database Lock Data Transfer
• Case book generation for Sites and Sponsor(s)

A soft lock occurs when access to the database is restricted, but the data still remains viewable and in some cases changeable. By contrast, a hard lock occurs where the data is no longer changeable. Soft locks always occur first with the hard lock preceding the final data transfer.

The Medable team works with the Partner to confirm the data is clean and ready for database lock.

As part of the database lock process, the SM  ensures all required study documentation is included in the study document repository.

Archiving

The Medable team archives the study after the database is locked and while casebooks are being created and sent. During this process the SM defines the responsibilities for study archivals, format, who provides distribution information and the scope of tracking the archivals. The steps below are general guidelines of the tasks that must be taken.

1. Archiving is initiated. If the study is undergoing an early termination, then a letter of notification from the Partner is required.
2. Teams are notified of study close-out.

3. Migration plan is prepared, which includes the following activities:

   1. The SM identifies and documents all risks to study configurations.
   2. The Medable team reviews the validation documentation to ensure completion.
   3. The SM develops the retirement schedule and communicates the schedule to the Partner.
   4. The SM collect key end-of-study dates from the Partner.
4. Confirm detailed procedure for study closure, including confirming method for sending data to sites, and issuing formal notices to terminate licenses, support services, contracts, etc.
5. Confirm all quality events are closed, if applicable
6. Confirm to Partner when all archives have been sent to sites.
7. Removal of user access and removal of the Medable solution from the app stores.
8. Ensure any devices are returned, if applicable.
9. Document closeout processes via a final report and ensure approval is received from the Partner.