The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority.
Documentation is a tangible trail that tells the story of the trial from conception to completion, reflecting adherence to applicable regulations and demonstrating trial integrity through transparency.
IMARC’s CEO and President, Sandra Maddock along with Clinical Research Associate, Rebecca York, recently published an article in ORTHOWORLD’s BoneZone Magazine, “Daily Documentation Essentials: A Tour of the Regulatory Binder.” The article covers topics of:
- A Tour of the Typical Regulatory Binder
- Tables of Essential Documents for Before, During, and After a Study
- Do’s and Don’ts of Documentation
Essential Documents are named such because that is exactly what they are: absolutely necessary to the conduct of a trial. But perhaps the most essential concept in understanding the regulatory obligation of Essential Documents is not a document at all, but a phrase that merits repeating: if it wasn’t documented, it wasn’t done! the most essential concept in understanding the regulatory obligation of Essential Documents is not a document at all, but a phrase that merits repeating: if it wasn’t documented, it wasn’t done!
Do you have any lingering questions about documentation or the regulatory basis for their maintenance? Share your comments with us.