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This SOP establishes the standard procedure for submitting a clinical gene transfer protocol to the IBC-SCGT for review.
1. The principal investigator (PI) submits an email to Environmental Health & Safety (EHS) stating his/her intent to open the protocol at Dartmouth. firstname.lastname@example.org
2. The PI submits a copy of the following to EHS via email:
a. Clinical Protocol with fully signed signature page
b. Letter of approval from the National Institutes of Health Recombinant DNA Advisory Committee (RAC)
c. Completed Local Standard Operating Procedure (SOP) for conducting a clinical gene transfer research protocol using the Local SOP Template available on the EHS webpage (Local SOP Template)
d. Documentation of Investigational New Drug status (IND) of the test agent, referencing the holder of the IND and the protocol for review.
e. Investigator’s Brochure (IB) for the agent to be studied
f. Documentation of scientific review/merit if available
g. Documentation by the investigational/site pharmacy of ability to receive, house, and dispense study agent.
h. Pharmacy and Laboratory manual for study agent
i. Documentation of completion of appropriate training requirements for all study personnel and pharmacy personnel who will come into contact with study agent
3. EHS will send a copy of the protocol and associated documents to each of the subcommittee members for review.
4. A meeting will be scheduled within a reasonable amount of time. The PI may attend to answer questions posed by the committee.
5. The committee will then privately discuss and vote on the protocol. The protocol may be "approved", "conditionally approved" or "not approved". The Chair will send a letter to the PI stating the committee's decision. If further information is necessary for the committee to reach a decision this will be requested. A copy of this letter is sent to EHS for the files.
6. A copy of each protocol and all information pertaining to that protocol is filed in the EHS office IBC-SCGT files. The IBC-SCGT correspondence with the PI and the approved Local SOP are uploaded into Velos eResearch.
For further information regarding the protocol submission process to the IBC-SCGT, please contact the Biological Safety Officer.
Last Updated: 7/19/13