It's hard for most people to grasp important eCTD concepts like lifecycle and granularity until they've seen them in action. The best way I've found to teach these concepts is by using an eCTD viewer. There are a number of viewers on the market, ranging from free desktop applications to large scale web-based viewers. While I have my favorites, any of them will serve to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I'm not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD.
What To Look For In A Viewer
There are a few things to look for in buying a viewer, besides cost. (Many viewers are bundled with eCTD validation packages. While these packages are essential to the publishing process, they are not essential for viewing.) Here are the characteristics I look for in a viewer:
- Fast loading: people don't like waiting for windows to load. A good viewer should load a large submission in under a minute.
- Clear presentation of document lifecyles in Current and Cumulative view. Cumulative view shows everything that's been submitted, Current view hides documents that have been replaced or deleted. Both views should clearly display different lifecycle operations.
- The ability to easily navigate an application with hundreds of sequences. Sometimes you just want to look at one sequence, sometimes you want the whole thing. You should be able to switch with a couple clicks.
- Window management. I like to be able to close the navigation pane when I'm viewing a document and open it when I'm looking for something. For people with laptops this makes a huge difference (and most of your executives probably have laptops).
- Clear presentation of study tagging files (STFs). STFs often contain hundreds of files — too many to scroll through. The viewer should present each file tag as a virtual folder, allowing you to look at case report forms by site, or just the analysis datasets.
- Clear presentation of submission metadata, such as indication, dosage form, sequence number, and submission date. Regulatory people love this, since it makes it easy to understand the chronology of events.
There are a couple additional points I would consider when selecting a viewer. The first is whether or not the viewer can present non-eCTD submissions. It can be incredibly useful to have a single viewing archive of all submissions, paper and electronic, so this is a plus. The second is that I prefer web-based viewers over desktop viewers. Web viewers are easier to deploy, since you don't have to install software on everyone's desktop, and they are usually faster to load submissions. Desktop viewers have to parse all the xml files every time they load an application. Web viewers cache the information in a database, so it loads more quickly. Web-based viewers also provide an extra level of security, in that people can't get to the submission archive through the viewer.
The biggest issue you may encounter in deploying an eCTD viewer is cultural, not technical. In many companies, Regulatory Affairs does not provide access to submissions to people outside the department. I encourage you to buck this trend. Limiting access leads people to create shadow copies of submissions, or worse still, treat drafts of documents they sent to Regulatory as official. Giving people direct access to authoritative documents virtually eliminates these problems. Some viewers allow you to limit access on an application by application basis. This can be useful, but managing those permissions can be a big job. At one company I worked at over 150 people had a legitimate reason to have access to a particular submission. Adding people to that list became a tiresome chore.
The most important thing is to get out and show people how to use the viewer. The viewer applications are generally easy to use, but the eCTD concepts are not. Even if you're just starting with eCTD using a free desktop viewer, get out and show people what granularity means in m3, and create demo submissions so they can see how document lifecycles work. The best investment you can make is to educate your teams about eCTD.