协议提交指南

要启动一个新的IBC协议:

1. 去 维拉.jufacraft.com.
2. 下 研究助理, select “Create a New Study” then click “Study Application – IBC”
3. 完成 IBC研究申请 (protocol form) by addressing all required components and submit before the 每月提交截止日期. 看到 维拉指南- IBC协议手册 获取更多指导.
4. 一次提交, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

Please Note: Other 人员, besides the PI, may author the IBC forms. 然而, the PI must review the forms and signoff on the submission before it is sent to the IBC for review and approval. The PI is responsible for ensuring the accuracy of the submission, 并遵守所有的法规和政策.

问题 谁能当私家侦探? 检查 PI资格要求的APM政策.

IBC生物安全手册 includes the Biosafety Manual and Biohazard Inventory Form. This will be submitted through 维拉 prior to the 每月提交截止日期 and will be reviewed and approved by the Biosafety Officer.

1. 去 维拉.jufacraft.com.
2. 下 研究助理，选择“研究提交表格”，然后按 生物安全手册
3. 完成 生物安全手册(BSM) by addressing all required components and submit before the 每月提交截止日期. 看到 维拉指南- IBC额外的提交形式 获取更多指导.
4. 一次提交, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

请注意，PI和所有实验室人员 must read the approved biosafety manual annually. The PI is responsible for providing hands-on, lab-specific training to all staff.

If submitting several weeks in advance of the monthly committee meeting, a pre-review of the protocol’s submission components may occur, and recommendations for clarifications may be requested. The Committee may request additional clarifications and information during the review process.

所有澄清请求, 额外的信息, and recommendations will be returned to the PI through the 维拉 system in the form of 规定 在一个 提交及回应表格. The PI must respond to and address each stipulation to the satisfaction of the Committee, update/revise the Study Applicati在一个ccording to the stipulations, and resend the submission for review before approval is granted. 看到 维拉指南-处理IBC规定 获取更多指导.

1. 去 维拉.jufacraft.com.
2. 选择 提交响应 任务在维拉主屏幕上.
3. Review and respond to the stipulations returned to you for the submission in the IBC评审回应表.
4. Revise the Study Application/protocol addressing all the stipulations.
5. 附上任何额外要求(e.g. 许可,SOP的…).
6. 提交修订供IBC审查.
7. 一次提交, the PI and Study Contact will receive an auto-generated confirmation of submission email.

Final approval is granted once the following have been completed:

• 所有委员会的要求都得到解决
• The biosafety manual is approved by the Biosafety Officer
• The lab space is inspected and approved by the Biosafety Officer
• 如适用，已取得所需的许可证
• Occupational health requirements requested by EHS have been met, as applicable

注意: 在过渡到维拉期间, if you need to submit an amendment and your protocol has not been converted into the VERAs interactive IBC -学习申请 不过，请联系 biosafety@jufacraft.com 在你提交修正案之前.

Any change to the protocol must be approved by the IBC prior to implementation. 修订可包括但不限于, 程序/方法的变化, 人员, 使用代理, 实验室的位置, 等. 看到 维拉指南- IBC修订手册 获取更多指导.

1. 去 维拉.jufacraft.com
2. Select 形式 under the “Action” column for the protocol you want to amend.
3. Select IBC -修改表格; or if you are making any 人员 changes (additions or removals), you must submit an IBC -仅限人事变动 form.
4. 完成 amendment form by addressing all required components
5. Revise the Study Application/protocol so the newest version incorporates the details of your amendment request.
6. 附上任何额外的文件.
7. 将修正案提交IBC审核.
8. 一次提交, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

Please note, not all amendments require full committee review. Some may be approved administratively in accordance with the IBC policy.

To renew a protocol that is reaching its 3-year expiration date, the PI must submit a new IBC -学习申请 提交IBC审核批准.

维拉 will send auto-generated email reminders to the PI and Study Contact 90, 在到期日前60天和30天.

Please expect a minimum of a month for review and approval of your new protocol. You must receive approval for the new protocol before the old protocol expires, or all work will need to halt until you have the approval to continue the work.