Since the National Archives in Washington were founded they have solved historical mysteries, provided key information, and unlocked a great deal of forgotten knowledge. The power of records and record keeping is influential at all levels of human existence, but also may be harmful to the least empowered individuals in society (such as refugees or the elderly). At PRIM&R's AER Conference, presenters offered insights into essential documentation and stressed the importance of good record keeping and data management for IRBs. Read more
TAG ARCHIVES FOR documentation
by Krystal Bradford, CIP, research compliance specialist at Cincinnati Children’s Hospital Medical Center
Since my last blog post, I have tried to pay closer attention to things discussed at the 2014 AER Conference that I have incorporated into my everyday work. Several items that stand out to me might be considered minor, but there is payoff in the end. One example is documentation.
If you have read any post-site visit letters from OHRP or FDA, there is almost always a reference to documentation that should have occurred but didn’t. Accurate research study [...] Read more