[Optional: Insert any additional role(s) and responsibilities that apply to this SPG] PROCEDURE Protocol Development [Describe the process used to draft a protocol] Protocol Finalization including IRB approval [Describe the process used to review, revise, and approve a protocol including IRB approvals] Protocol Maintenance [Describe the process for initiating and writing an amendment to the protocol] [Describe the process used to review, revise and approve a protocol amendment including IRB approvals] [Describe the process for version control of the protocol] [Describe the process for storing and accessing current, and retired versions of an approved protocol] Additional Procedures N/A [Optional: Insert any additional relevant procedures. Provide enough detail to ensure the procedure is consistently carried out, without providing so much detail that violations occur due to normal or expected variations in the work.] REFERENCES Food and Drug Administration (FDA): http://www.fda.gov/Drugs/default.htm FDA Title 21 CFR 312 Subchapter D - Investigational New Drug Application FDA Title 21 CFR 312.23 - IND content and format
[Optional: Insert any additional role(s) and responsibilities that apply to this SPG] PROCEDURE Protocol Development [Describe the process used to draft a protocol] Protocol Finalization including IRB approval [Describe the process used to review, revise, and approve a protocol including IRB approvals] Protocol Maintenance [Describe the process for initiating and writing an amendment to the protocol] [Describe the process used to review, revise and approve a protocol amendment including IRB approvals] [Describe the process for version control of the protocol] [Describe the process for storing and accessing current, and retired versions of an approved protocol] Additional Procedures N/A [Optional: Insert any additional relevant procedures. Provide enough detail to ensure the procedure is consistently carried out, without providing so much detail that violations occur due to normal or expected variations in the work.] REFERENCES Food and Drug Administration (FDA): http://www.fda.gov/Drugs/default.htm FDA Title 21 CFR 312 Subchapter D - Investigational New Drug Application FDA Title 21 CFR 312.23 - IND content and format
Protocol_Development.docx