The more the merrier? Sure, there are many times when that holds true, but not when it comes to having multiple players contribute to writing clinical trial content. Do you sometimes feel like your documents are constantly stuck in the review process?
You are likely stumbling across common pitfalls. To keep your projects moving forward, take these simple steps:
Get stakeholders involved early.
Nobody enjoys being surprised by content that negatively affects their part of a project. Ask yourself who will use the documents and for what purpose. Then be sure to confirm who needs to approve the documents before they are final. You will want to create a plan that includes a sufficient turnaround time for each approving body. You can then determine if any groups can review content simultaneously, why they need to approve the documents, and what parameters they may have on the types of changes they can make. Giving stakeholders notice also helps give you a chance to address concerns well in advance.
Who can make what changes to the clinical trial content?
The most painful and time-consuming part of navigating clinical trial content approvals is unnecessary additional rounds of revisions. To avoid this, evaluate each approving body’s area of expertise. Then, when you send a document for review, be sure to include acceptable types of changes or specific parameters along with your deadline.
Who is the leader?
When approving bodies disagree, who wins? By identifying areas of expertise, you can avoid a direct conflict over a particular piece of text. It helps to identify early on individuals to escalate to within an organization. This can be tricky when teams do not report to a common person. Another smart technique is to specify a clear document owner that has the authority to make final decisions. If the approval process in your organization does not allow you any of these options, you should consider a process improvement initiative, as it could be costing your organization money in wasted time and labor.
A little project planning around your document approval process can save you time, money, and anxiety. Contact us if you need help.
Some of our other clinical trial writing blogs, https://www.imperialcrs.com/blog/2021/06/24/writing-clinical-trial-materials-3-steps-to-simplify-language-increase-readability/, https://www.imperialcrs.com/blog/2018/08/26/clinical-study-content-meets-clinical-trial-design-bringing-project-life/.
Updated: 14 August 2022
