The delivery driver handed Sarah a shipping manifest and a temperature log. She signed for the delivery and immediately began her receiving procedures. The first box she opened contained not only the investigational product vials but also a packet of documents: a certificate of analysis, shipping temperature verification, and handling instructions. Everything appeared to be in order.

Then she noticed something that made her pause.

The vial labels indicated Protocol Version 4.0. But Sarah's regulatory binder contained only Protocol Version 3.2. She had received notification of Amendment 4 three weeks ago, but the IRB approval for the amended protocol had not yet arrived. According to her records, the site was still operating under Version 3.2.

Sarah set down the vial and reached for her phone. This shipment could not be accepted until she understood what was happening. Was this investigational product manufactured according to the old protocol or the new one? Were the dosing instructions different? Had the sponsor shipped product that the site was not yet authorized to use?

It would take four hours and seven phone calls to sort out the discrepancy. In the end, the product was acceptable, but the documentation gap had exposed a weakness in the site's pre-study document management: they had the protocol, but they did not have the complete chain of documentation linking the protocol to the investigational product.

The delivery driver handed Sarah a shipping manifest and a temperature log. She signed for the delivery and immediately began her receiving procedures. The first box she opened contained not only the investigational product vials but also a packet of documents: a certificate of analysis, shipping temperature verification, and handling instructions. Everything appeared to be in order.

Then she noticed something that made her pause.

The vial labels indicated Protocol Version 4.0. But Sarah's regulatory binder contained only Protocol Version 3.2. She had received notification of Amendment 4 three weeks ago, but the IRB approval for the amended protocol had not yet arrived. According to her records, the site was still operating under Version 3.2.

Sarah set down the vial and reached for her phone. This shipment could not be accepted until she understood what was happening. Was this investigational product manufactured according to the old protocol or the new one? Were the dosing instructions different? Had the sponsor shipped product that the site was not yet authorized to use?

It would take four hours and seven phone calls to sort out the discrepancy. In the end, the product was acceptable, but the documentation gap had exposed a weakness in the site's pre-study document management: they had the protocol, but they did not have the complete chain of documentation linking the protocol to the investigational product.