By Barbara Correll, MedNet Solutions
For a majority of clinical trials (an estimated 65%, according to Jody Mehl, project manager at MedNet), mid-study protocol amendments are inevitable. In fact, the longer your study runs and the more complex your study is, the more likely you are to have a mid-study protocol amendment. But don't worry, the more prepared you are for these amendments, the more efficient you'll be at implementing them. And your electronic data capture (EDC) platform should make the process more manageable.
Why are Protocol Amendments Important?
Amendments allow the sponsor to adjust the trial for the safety of subjects, or to further investigate initial interim results. Being able to make changes to your EDC to reflect a protocol amendment is critical to meeting study endpoints and advancement of science and patient care.
Read on to understand what you need to know when implementing a protocol amendment.