In Viedoc the investigators always have access to their data

The ICH GCP R2 requirement states that "The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data."

Whether or not the investigator has control of and continuous access to their data is not a function of whether or not the servers are remote, but of other aspects as well:

1. Are these servers under the control of the sponsor? For example are they servers owned and operated by the sponsor?
2. Does the sponsor regularly disable investigator access to their data, for example after database lock?

Viedoc servers are under the sole control of PCG Solutions who are a trusted third party, the data is not under the exclusive control of the sponsor. After database lock the investigator can still logon and view all of their data in Viedoc, they are no longer allowed to change their data but the ability to change the data is not demanded by ICH GCP, only that the investigator should have continuous access to it.

At PCG Solutions we are active not only in following all relevant international regulations and guidelines, we work actively with the authorities to ensure that we have a full and correct grasp of their expectations and we develop and test Viedoc to ensure compliance. Viedoc Performance Qualification (PQ) contains a special regulatory test suite that is executed on every release of Viedoc to ensure that the regulatory compliance has not been compromised.

You do not need to export PDFs to store at the site, Viedoc guarantees that your investigators have continual access to their data at all times.

If you have any questions regarding the interpretation of this requirement, do not hesitate to contact us.