Does anyone here know to what extent the OC/RDC application supports the following set of requirements:
1. Global study, ie. sites in countries with different regulatory requirements
2. Different protocol versions (and therefore DE screens) may be active in different countries at the same time
3. Sites in country A under protocol v1 CAN'T see/access DE screens specific to protocol v2 at sites in country B.
In other words, is there a way to completely restrict access to any given active DCI on a site per site basis?
As delays in getting regulatory approval for protocol amendments in one or a set of countries creates this requirement for parralell and overlapping but different DE interface.
Any thoughts/ideas are greatly appreciated. The potentially relevant versions here would be 4.5.1, 4.5.3 and/or 4.6, ie. I am curious to learn about this for any one or all of these OPA versions.
There is a feature of versioning for clinical studies within Oracle Clinical, but not sure whether more than one version is active at a time.
For the DCI level restriction, OC 4.6 has a new feature called DCI Accees, for which you can control of accessing DCIs based on roles.
Hope it will be helpful for you.
I am not familiar with 4.6. I assume however that versioning works basically the same way it does in 4.5.1...
As for the DCI access feature: what do you mean by "roles"? Are these database roles, e.g. the ones that are used to manage menu pathway access? User roles?
The issue here is the requirement to limit access, for example, to a particular DCI book and the DCIs within it to a specific collection of users. Preferrably by site. There would be other collections of users at different sites with the same variety of roles. So, I'm not sure this DCI access feature will solve the problem, but I don't really know anything about it.
Any further thoughts?
You are right about versioning of a study, there is no additional features programmed for 4.6. It works as it is.
About DCI Access, there is a new feature in 4.6 for which we need to give access at DCI level,
Usually we assign a site, with update/verify/approve/etc privilege in order to access a DCI, but when it comes to 4.6 on top of the existing privilege the site role should have access to particular DCI in order to access and do any task on to it.
Hope it is clear, let me know if i make u more confused.
Thanks for the additional information. I did some extra research in the mean time. Though it is not precisely clear to me how 4.6 would support these security requirements, it does appear the the additional controls for both complex study design and DCI access in 4.6 do make it possible to have concurrent, but mutually exclusive protocol version active by site.