Introduction to Viedoc PMS

Viedoc PMS is the product on the Viedoc platform that can be used for Japanese Post Marketing Surveillance (PMS) studies. It fulfills all requirements of a PMS study, supports collection of data in booklets, and supports the process of sharing data between site (clinic) and sponsor via the submit-receive-return Kaifu function.

Clinic side versus sponsor side

In Viedoc PMS, the database is shared by two different sides, a clinic side and a sponsor side. The database contains two versions of each data set, one version that is displayed to the clinic side users and one version that is displayed to the sponsor side users. On the clinic side, typically the Investigator enters subject data, while on the sponsor side the Data Manager typically reviews the data and archives (freezes) the data.

Synchronization of data between the clinic side and the sponsor side is not performed automatically and continuously, but is controlled by the clinic side users and sponsor side users via the send-receive-return process. This means that data are only transferred from the clinic side to the sponsor side when the clinic user actively performs a submit action and the sponsor side user actively performs a receive action. Similarly, queries raised by the sponsor side user are only displayed to the clinic side user after a return action is performed by the sponsor side user. The send-receive-return process is described in more detail below.

Booklets

By mirroring the data collection and review process via booklets, Viedoc matches the workflow of a Japanese PMS study. A booklet can be seen as a compilation of data being collected during a specific period of time rather than during a specific event date, which is more typical in clinical trials.

1. Subject details
2. Overview of booklets
3. Content of selected booklet
4. Details of selected booklet

The send/receive/return process for handling booklets (Kaifu)

Sending and receiving data on request is a fundamental requirement for a Japanese PMS study. Viedoc PMS offers support for sending and receiving booklets back and forth between site and sponsor, a process referred to as Kaifu. In the Kaifu process, the clinic user chooses when to share data with the sponsor and the sponsor side user chooses when to receive the data. One of the important characteristics of this process is that the sponsor side user does not have access to any data entered in a booklet, until the booklet has been shared by the clinic through the submit function, and a receive action has been actively performed by the user at the sponsor side.

For more information, see Overview of the submit-receive-return process.

Working with Viedoc PMS

Viedoc PMS is the interface for the end user, and is primarily used by site and study staff (Investigators, Study Coordinators, Monitors, Data Managers, and so on).

The access to Viedoc PMS is by invitation only and provided by either the Study Manager or Site Manager. If invited, you will find the invitation in your email inbox (from no-reply@viedoc.net). In some cases the email can be caught by your email spam filter and in that case you will find it in the email spam folder. For detailed instructions on account activation, see Managing your Viedoc account.

The following actions can be performed in Viedoc PMS:

• Data entry - described in the following lessons:
  • Selection page
  • Entering and editing data in a PMS study
  • Resetting and deleting data in a PMS study
  • Reference data
• Review data, and raise and resolve queries - described in the following lessons:
  • Data review in a PMS study
  • Raising and promoting pre-queries
  • Raising/Approving/Rejecting queries
  • Resolving queries.
• Handle booklets - described in the following lessons:
  • From the clinic side: Sending and recalling booklets
  • From the sponsor side: Receiving and returning booklets, and Freezing booklets
• Data export - described in the lesson Exporting data
• Medical coding - described in the lesson Medical coding in Viedoc Clinic
• View study metrics - described in the lesson Metrics

Languages

Viedoc PMS is available in the following languages:

• English
• Japanese

• Next