Investigational Product Management-Study Close Out
The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. If the investigator is also serving as the sponsor, additional regulations apply as they are ultimately responsible for the product. Site: content pending
Regulatory Sponsor
The sponsor should monitor the investigational product accountability and ensure reconciliation of any products. This should occur as soon as possible after the last participant has completed treatment. Once completed, the sponsors should work with IDS on the arrangement of final drug disposition.
Destruction of IP
The sponsor must arrange for the proper destruction/ final disposition for the investigational product. If the study is using IDS for management of the investigational product, the IDS does have the ability to arrange for proper destruction of used, damaged or expired clinical trial medications for other trials as well. IDS CAN accept medications and associated packaging, but CANNOT accept narcotics, dangerous substances, or medical devices. Contact IDS or refer to the IDS website to determine the level of service you are requesting. If you study is not being managed by IDS, you can request assistance for study drug destruction. Please refer to the IDS website for the proper forms to be used for their services.
The IDS does not have the capacity to destroy investigational devices. The site should discuss with the sponsor an appropriate means for destruction.