Viedoc Study Build Service – General

The purpose of this document is to give a general high-level description of Viedoc’s study build service. If a customer is purchasing the study build from Viedoc, the standards described in this document will apply.

Important! If a customer has tight timelines for a study start-up, they are encouraged to get the Work Order with Viedoc signed as soon as possible so that the study build can be scheduled. No study build will commence or be scheduled without a signed WO in place. For an average sized study of medium complexity, the timelines are generally around 8 weeks from starting the build until going live.

Preparation for the Study Build

Dedicated Project Manager

As soon as the Work Order (WO) is signed, a Project Manager (PM) from the Professional Service department at Viedoc will be assigned to the study. He/she will be the customer’s point of contact throughout the project and will start the study build process via an initial information gathering and introductory email and schedule a kick-off meeting.

Input Documents for CRF Creation

To start the build, Viedoc requires all required input documents, such as the final study protocol as well as validated surveys, questionnaires, or diary forms (as applicable) to be used in the CRF design. Other documents, such as paper CRFs (pCRFs), CRF drafts from previous similar studies, and so on, can also be helpful and should be provided at this stage if available as further instructions to Viedoc.

Kick-Off Meeting

The kick-off meeting (KOM) is usually scheduled to a few days before the study build starts. The meeting is intended to step by step go through the WO scope, study timelines, and clarify responsibilities and commitment for both parties. It is recommended that everyone who is planning to take part in the user acceptance testing (UAT) process attends the KOM. During the KOM, the assumptions in the WO will also be reviewed to ensure that what is included in the WO is in line with the customer’s expectation. If the customer is new to Viedoc, the Viedoc PM can also schedule a demo in association with the KOM.

Timing and Build Timelines

Once the WO has been signed the customer will be provided with timelines for the study build. For an average sized study of medium complexity, the timelines are generally around 8 weeks from starting the build until going live. This includes the CRF design, review rounds for the customer, and edit check configuration. A customer is recommended to sign the WO well in advance so there is some buffer time to use, for example, if the study is complex or the customer prefers longer review rounds.

When drafting the timelines, adaptations can be made to review slots to the customer needs. As example, if there would be a preference to have longer review rounds compared to the default, this could be included in the timeline.

For urgent builds there is a possibility of going live without edit checks. Generally, this would make it possible to go live a couple of weeks earlier. See more information on going live without edit checks.

Viedoc Commitment

The Viedoc Build Team will be highly committed to adhering to the communicated timelines. They will book their resources in advance to guarantee to have the resources available for each slot in the timeline. This also means the same commitment is needed from the customer. If review comments from the customer are delayed, the build team will miss their scheduled slots when they have reserved time and will need to re-schedule resources. In the end, this will lead to delays in the study build.

Customer Commitment

Critical to keeping the study build timelines is that the customer can commit to responding quickly to questions during the study build and to provide clear and concise review comments by the end of each review round. In the timelines, it is planned for the following reviews (exceptions to this can be made when suitable):

Review of CRF design (excluding edit checks): During this review the customer can test the forms, form dynamics, visit workflow, and other features such as ViedocMe and randomization. Normally 4-5 days are planned for this review.
Review of edit check specification: During this review the customer can review edit checks suggested by the Viedoc build team for the study and provide comments to modify, add, or remove edit checks. The draft edit check specification is delivered in Excel format. Normally 2-3 days are planned for this review.
Finally, the customer can review the updated CRF design, including implemented edit checks. Normally 3-4 days are planned for this review. Only minor modifications are expected to be done after this review.

Important! Providing review comments in time and per Viedoc’s instructions is critical to keep the study timelines! The customer is strongly recommended to schedule time for their review rounds just like the Viedoc build team schedule time for their parts of the build. This is the single most important task for meeting the targeted timelines.

The suggested length of review rounds can vary based on size and complexity of the study, but it is generally not recommended to shorten these review rounds since it often leads to additional comments late in the build process and therefore delays.

A customer can upfront add additional review rounds in the WO if that is required. It is normally not recommended to use additional review rounds since it is rarely needed, will prolong the build timelines, and has a tendency of making each user less committed to each review.

It is also strongly recommended that anyone who will review the CRF is involved and asked to review the CRF in the first round as well. The goal is to capture as many of the comments as possible in the first review round.

The Study Build

The Different Phases of the Study Build

CRF Design without Edit Checks

In the first phase of the build, the build team will review all documentation provided and start specifying the CRF contents. At this stage there will be questions sent to the customer to ensure protocols and other documents are interpreted correctly. Quick responses will be important to keep the timelines of the build.

The CRF will always be designed in accordance with recommendations in CDASH unless otherwise requested.

The first CRF will be delivered without edit checks, but complete with form design, the visit workflow and visibility conditions to trigger items, forms and events only when relevant.

In association with the first delivery, a “hand-over demo” is scheduled. This is intended to make sure the customer has the access needed, and understand Viedoc, to be comfortable enough to start their UAT of the CRF.

Edit Check Specification

Once the first version of the CRF has been delivered, the build team will create an edit check specification with suggested edit checks for the study. This will be delivered in Excel format and the customer will be asked to provide any comments for adding, modifying, or removing edit checks.

Updated CRF with Implemented Edit Checks

Once comments to the CRF design and edit checks have been provided, the build team will update the CRF according to the comments and configure the edit checks. The customer will now be able to test the CRF including edit checks for a final UAT. Only minor findings are expected at this stage.

Deliverables

During the study build the following documentation will be delivered:

Annotated CRF (PDF, generated automatically from the system)
Configuration Report (Excel, generated automatically from the system)
Edit Check Specification (Excel)

The customer will also be provided with template documents to complete and return to the Viedoc representative, like a customer review log (for adding review comments during the CRF UAT), a site log (for adding details on production sites), and a study build approval form (for approving the study build).

Other documents, such as the CRF design in ODM-XML format, blank CRF (PDF), workflow (PDF), and validation documentation will be delivered upon request.

Validation

Viedoc’s QC

The build team is performing a QC on each step of the build process and before every delivery. The review performed is documented in the documents listed below. It is important to highlight that Viedoc’s build team is reviewing the study build to ensure it is correctly configured according to their understanding of the protocol, questionnaires, and other input documents. All validation documentation will be shared with the customer upon request.

Validation documents normally generated are Study Build Validation Plan, review report, edit check QC log, edit check test scripts, and Study Build Summary Report.

Customer’s UAT

Like mentioned above, Viedoc will quality check the build so that it is matching the build team’s understanding of the protocol and other documents. However, the build team will still rely on the customer to perform the UAT to ensure it is matching their requirements, understanding, and preferences. The customer is ultimately responsible for the UAT and will confirm that the study build is approved by signing a study build approval form.

The customer will be able to perform their UAT in each step by logging with access to a demo sites and add patients, data, randomize subjects, enter ePRO data, test edit checks and so on.

Going Live

Once the customer has approved the study build by signing the approval form, the approved design version will be assigned to the production sites. The procedure to go live from when the Viedoc representative receives the signed approval form will only take a couple of minutes.

Going Live without Edit Checks

For urgent builds, there is the option to go live without edit checks. The procedure for the setup will be the same, but the go-live activity would happen before the build team start implementing the edit checks. This will give the customer the advantage of going live with the CRF to start the data collection a couple of weeks earlier. The edit checks will then be implemented in a revision which means that all future data will be validated going forward AND data already collected will be validated by these checks when the revision is approved and applied to the production sites.

After Going Live

Continuous Support

After going live, the Project Manager will continue to be the point of contact for the customer. He/she will not have any access to the production data. In case there are questions on system features, possible issues, and requests for CRF updates, the customer can at any time reach out to the Project Manager for support.

Viedoc Training

In the WO there is generally one Viedoc Training included. The customer is free to use this training when they want, but normally this session is used for training the customer including Data Managers and Monitors. These users can then in their turn train site users and other users.

The eLearning system will also be added to the study so that users can easily find information they need on how to use the system. These eLearnings consist of text, images, and video clips.

Read more about our study build service here: