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.
Other Considerations
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.
Cultural Issues
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.
Conclusion
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.
One thing to keep in mind is the eCTD Viewers ability to distinguish varying levels of ‘read only’ permissions. If your company requires you to make your submissions widely available, but keep the proprietary information in non-copyable, non-printable format, it is important you ask the guys providing the Viewer what specific functions ‘read only’ entails. There are products out there that will allow you to do this. Some eCTD Viewers will give users a ‘read only’ access but in actuality, they still have the ability to copy/print . This can, in theory, introduce security risks of your users printing out info for reference and accidentally leaving it out on desks/meetings/etc when they are using submissions for reference.
But do not dispair, there are viewers out there that have the capability of literal read only access so users cannot copy/paste or print info displayed. Definitely something to consider about when shopping for your eCTD Viewer.
Love the blog Monte and keep up the awesome work!
/Jon
That’s a great point, Jon. What I outlined above is a list of things I look for in an eCTD viewer. Anyone purchasing a viewer has to evaluate the software in light of their specific requirements. Having a true read-only viewer could be useful for due-diligence activities, as well as addressing internal security concerns.
Monte
We hear this (restricted acess to document) once in a while. The issue who is accessing the documents? If they are not authorised then they should not have access at all. Once access is provided aren’t they bound by confidentiality to protect the information?
There are many ways to make the documents not printable/copy but in the long run it will only make it impossible for users to work with these documents.
Technically it is possible but does this make a good business sense?
Shy, I share your perspective that employees are bound by confidentiality and should generally have access to submissions, but it’s been an uphill battle everywhere I’ve worked. Many companies are concerned that submissions contain such confidential information that they go to great lengths to prevent inadvertent disclosure. They are willing to inconvenience their employees to avoid a low-probability, high-cost event. I understand that perspective, but have a different view of the costs and benefits.
At one company I put together an information confidentiality policy as part of a system rollout. The policy basically reminded employees that they were being trusted with confidential information and were expected to treat it appropriately. That approach helped us get the buy in we needed to open up access.
Great article! Totally agree with your points. We’ve quoted and posted a link to this article on our web site
-Jimmy
Jimmy,
Thanks for your comment and link. I’ve used a variety of viewers, and like aspects of many of them. I think it’s important for every company to find the viewer that best meets their specific needs. I encourage readers to investigate their options, so I’m not endorsing specific products here.
Monte