Study Delivery

Introduction

When design freeze is achieved, the study build phase begins, and multiple different activities are kicked off in parallel:

• Study configuration begins
• Planning for the localization process begins
• Data management planning begins

Localization

During the Build Phase, the SMT works with the SM, the external translation provider(s), the Partner, and/or the copyright holder(s) to ensure all required translations are released prior to the anticipated first patient for each country.

Localization for eCOA is the process by which language and country-specific content is developed, obtained, and/or implemented electronically. The SMT works with the parties above to localize the content agreed to in the scope for the target locales defined in the SOW. The Medable product (e.g: User Interface/standard templates) is already translated by Medable and does not require translation by the translation vendor team. The translation vendor is responsible for study related content only and for maintaining consistency with existing product translations as necessary. The SMT will also manage implementation of any eCOA library assessments, if applicable for the study.

Before the Localization process starts, the study team needs to:

• Collect eCOAs, Questionnaires, eDiaries, Validated instruments - Licensee (Either the Partner or Medable) is responsible for obtaining copies of instruments and build requirements All non-licensed (homegrown) materials are provided to Medable by the Partner (unless Medable is scoped to localize with translation vendor)
• PDS v1.0 is signed and design freeze status achieved*
• Study Build configuration completed in US English
• Copyright holder approval on US English screens, when required

No on-screen text must change without consultation with the SMT to plan and assess risk once localization has started.

Note: *In some exceptions the Localization process is able to start prior to PDS v1.0 sign-off for questionnaires that are considered Validated Instruments (VI) with the copyright holder since they are not allowed to be edited by the Sponsor/CRO.

After the steps above are completed, the localization process starts and this process is divided into two phases: IRB/EC Submission and Screenshot Localization and Review.

IRB Submissions

The Partner is required to submit all the patient-facing and supporting material of the study to the Ethic Committees and Health Authorities (EC/HA) of the countries where the study is planned to take place. The process of obtaing regulatory approval for patient facing content is called Institutional Review Board (IRB) Submission. The Partner is responsible to manage the regulatory submissions to IRB/ECs and communicate requirements and deadlines to Medable as early as possible.

Every IRB/EC has different requirements and those requirements change per the scope of the study. The Partner must share these requirements with the Medable in advance (in the KOM if possible), for Medable to be able to provide all the supporting documentation needed during this process in time.

For IRB/EC Submissions, the SM shares a Clinical Trial Approval (CTA) package containing all the relevant information related to the study with the Partner. Medable provides an eConsent Client facing submission package template for some studies depending on the study scope.

Medable provides generic screenshots of our products as our standard approach. In some situations some clients require sample screenshots based on the study design and these screenshots must be agreed between Medable and the Partner and mock-ups are provided if needed.

The Partner submits these documents together with any other document required to the EC/HA of the countries. The US English version of the CTA is the Master version signed by Medable and Partner.

Translated versions of the Master US English content are created in one of two ways based on content type:

• Validated Instruments - Medable or Partner (whichever holds the license agreement with the copyright holder) requests the US English and translated versions from the copyright holder during the licensing process since those are not allowed to be edited by the Partner, therefore not dependent on PDS agreement.
• Non-validated Instruments - Medable or Partner (whichever holds the agreement with the translation vendor) requests the translated versions from the Translation Vendor after PDS v1.0 is signed since the content must be agreed between Medable and Partner before translation.

The timelines vary depending on the number of languages, total word count, and translation methodology and this must be agreed between the parties. The SM or SMT follows up with this process and provides updates to the Partner.

The Partner then submits these documents to the relevant EC/HA of the countries once they are translated.

Note: The US English screenshots and the translated documents are affected if there are any changes in US English content/terminologies requested by the Partner later in the study. This risk will be discussed with the Partner in advance since it requires a new IRB submission round and it adds costs and affects timelines.

Screenshot Localization and Review

The screenshot localization and review process starts after the translation of the IRB submission package is completed and after UAT sign-off. If screenshots are submitted instead of paper content, UAT sign-off is the only trigger to begin screenshot localization and review. Please find more information about the UAT in the next sections.

In instances when screenshots are needed for submissions prior to the date of UAT sign-off, the SMT should be consulted about considerations, risks, and added costs of doing so to communicate and agree on an approach with the Partner. The screenshot localization and review process is used for creating patient-facing content within Study Builder for patients to have their local language on screen. During this process Medable and the Translation Vendor work together to ensure on-screen content is appropriately adapted for electronic use, complete, and adheres to copyrighted instruments when necessary.