The email listed three items. First, the IRB approval letter referenced the wrong protocol version. Second, the IRB-stamped informed consent form in the package was dated two weeks before the IRB approval letter, which should have been impossible. Third, there was no documentation of the IRB's composition on file.

Elena called Marcus Thompson, her lead clinical research coordinator, into her office. "Marcus, we submitted this package last week. How did we miss these?"

Marcus pulled up the regulatory binder. The protocol version discrepancy was immediately apparent: they had submitted the IRB approval letter for Amendment 1, but the package included the original protocol. The stamped consent form dated before the approval letter turned out to be a scanning error that had captured the wrong document. But the third item puzzled him.

"IRB composition documentation?" Marcus asked. "I have never submitted that before. Is that even a requirement?"

It was. And that gap nearly cost Valley Community Health Center its place in a pivotal cardiovascular outcomes trial.

The email listed three items. First, the IRB approval letter referenced the wrong protocol version. Second, the IRB-stamped informed consent form in the package was dated two weeks before the IRB approval letter, which should have been impossible. Third, there was no documentation of the IRB's composition on file.

Elena called Marcus Thompson, her lead clinical research coordinator, into her office. "Marcus, we submitted this package last week. How did we miss these?"

Marcus pulled up the regulatory binder. The protocol version discrepancy was immediately apparent: they had submitted the IRB approval letter for Amendment 1, but the package included the original protocol. The stamped consent form dated before the approval letter turned out to be a scanning error that had captured the wrong document. But the third item puzzled him.

"IRB composition documentation?" Marcus asked. "I have never submitted that before. Is that even a requirement?"

It was. And that gap nearly cost Valley Community Health Center its place in a pivotal cardiovascular outcomes trial.