Infection Control and Investigational Pharmacy Review for Protocols

Infection control and investigational pharmacy review for protocols

using biological vectors in humans

[Approved by Duke IBC, October 21, 2009]

All protocols with biological vectors:

• The PI must provide an Investigational Product Handling Plan (IPHP) outlining the safe handling of the material to be administered to humans. As appropriate, the IPHP should include receipt, packaging, storage, aliquot preparation, transport, administration, and disposal.

• The PI must also provide a list of the locations where the material will be handled to include as appropriate receipt, packaging, storage, aliquot preparation, transport, administration, and disposal. The list of handling locations can be incorporated into the IPHP or can be a separate document.

• The Biological Safety Officer (BSO) will review the IPHP and may require revisions or additions.

• The BSO will send the IPHP and the list of handling locations to Infection Control and request the following confirmation by the Director or designee:

"I have reviewed the IPHP describing safe work with [name of material] as part of the proposed clinical trial [title of trial]. Appropriate facilities, equipment, and trained personnel are available to address recognized infection control risks when working with this material under the conditions specified at the locations listed."

• If Investigational Pharmacy is responsible for any component of the handling, the BSO will also send the IPHP and the list of handling locations to Investigational Pharmacy to request the following confirmation by the Director or designee:

"I have reviewed the IPHP describing safe work with [name of material] as part of the proposed clinical trial [title of trial]. Appropriate facilities, equipment, and trained personnel are available to work with this material in Investigational Pharmacy under the conditions specified.

• The IPHP and the list of handling locations will be included in the IBC packet and will be approved by IBC as part of the IBC review.

• When the IBC identifies the need for additional discussion and expertise, Infection Control will be asked to participate with the BSO and the IBC in risk assessment and IPHP development.