Current Date
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Today M-D-Y
First and Last Name of Investigator
First and Last name of person completing this form.
Phone contact of person completing this form.
Email address of person submitting form.
Is this IND or IDE being managed by Massey Cancer Center?
Yes
No
Is this study being conducted at sites external to VCU?
Yes
No
Is this submission for an IND or IDE?
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IND
IDE
IND/IDE Number (If this is a new IND/IDE, please enter "new")
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Please list serial number of submission. If this is an initial submission, the serial number is 0000. Each submission after the initial submission is the ascending numerical value.
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What are you doing with this submission?
If you are submitting an IND that was in effect prior to August 1, 2014, please choose the "Submitting an Active IND" once you have submitted the information as an active IND any further submissions should be submitted as "Submitting Information on a Current IND"
Please upload your submission for verification of Exempt Status.
Please upload FDA concurrence of Exempt Status.
What are you doing with this submission?
If you are submitting an IDE (SR and NSR) that was in effect prioubmitting an active IDE." After the first submission or to August 1, 2014, please choose the "Sf an IDE to the CRCO, please choose "Submitting information on a current IDE"
How can we help you? Please briefly state your question. The FDA IND/IDE Program will either respond to the email provided to follow up. Please note whether the response should be sent to the person completing this form, the Sponsor, or both.
Please describe how you are monitoring your study(ies) associated with this IND.
Thank you for submitting your existing (in effect prior to August 1, 2014) IND. The following documents should be uploaded.
• FDA 1571
• FDA 1572
• FDA 3674
• CV of PI
• Current Protocol with the FDA
• Last Annual Report
Would you like to upload the above documents individually or as one PDF?
Following this initial submission you will need to submit all new amendments, submissions, correspondence/reports with the FDA to the CRCO.
Please upload FDA 1571/3926
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Please upload FDA 1572
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Please upload CV of PI
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Please upload protocol
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Please upload any additional documents
Please upload the requested documents. (1571, 1572, 3674, CV of PI, Current protocol with the FDA, Last annual report).
Upload 1572(s) (1572 for VCU)
Upload 1572(s) (any 1572(s) for external sites outside VCU)
Current Protocol with the FDA
Does the protocol with the FDA match the current protocol approved by the IRB?
Yes
No
How are the protocols going to be amended so that the IRB protocol and the FDA protocol are the same?
If there is another protocol with this IND please upload here. If there are more protocols please upload them at the end of this survey in the additional upload field.
IRB Number for Additional Protocol
Today M-D-Y NOTE: Annual Report is due to FDA within 60 days of this date
Is this a Multicenter Study?
Yes
No
Multicenter Study= External to VCU Domestic Facilities
Please describe your monitoring plan for both VCU and external sites. If it is multisite, please describe how you are assuring communication with the other site(s).
Have you transfered any sponsor responsibilities to another organization or individual?
Yes
No
Please upload your transfer of obligation agreement.
Is there any other information you would like to provide about your current IND?
For your current IND, what would you like to submit?
Email Address of New Sponsor
Has the VPR approved the transfer of the IND to an external Sponsor?
Yes
No
Upload your additional FDA 1572 (if needed)
Upload Correspondence Regarding the IND
Upload IRB Information regarding the Protocol associated with the IND
Upload Safety Report (or Follow-up Safety Report)
What type of amendment is this?
Please upload the full amendment.
Does your protocol with the FDA match your protocol with the IRB?
Yes
No
How are the protocols going to be amended so that the IRB protocol and the FDA protocol are the same?
Other Information about your current IND
Is/Are the new investigator(s) at a site external to VCU?
Yes
No
If with the addition of the new investigator is at a new external to VCU site, please upload the Multisite Certification Form.
This form can be found at go.vcu.edu/indide
Please upload the 1572 and CV for all new investigators.
Does the protocol being submitted to the FDA and the IRB match?
Yes
No
What will you be doing so that they match?
Is the VCU Sponsor also the Investigator?
Yes
No
Is the study(ies) under this IND going to be done at any sites external to VCU domestic facilities?
Yes
No
Do you have all Certifications/Disclosures of Financial Interest on file for all investigators and FDA form 3454 and 3455 as applicable?
Although these are not submitted with the IND, the FDA recommends preparing these at the start of the study. They can be reviewed by the FDA and must be submitted with an NDA.
Yes
No
Are you transfering any sponsor obligations?
Yes
No
Please upload the agreement for the transfer of obligations.
Are you referring to another IND for portions of your application?
Yes
No
Upload the Reference Agreement.
Upload Introductory Statement and General Investigational Plan
Upload Chemistry, Manufacturing, and Control Information
Upload Pharmacology Toxicology Information
Upload Investigator's Brochure
Upload Additional Clinical Protocols (if applicable)
Upload Additional Clinical Protocols (if applicable)
Upload Additional Clinical Protocols (if applicable)
Upload Summary of Previous Human Experience iwth the Investigational New Drug
Upload Additional Information, if applicable (ex drug dependence and abuse potential, pediatric studies, etc.)
Upload Any Other Relevant Information (if applicable or requested by FDA)
What type of device is this?
Class 1
Class 2
Class 3
Is there a predicate device?
Yes
No
What is the predicate device?
Which risk level is this device or this device in this study?
Significant Risk
Non Significant Risk
Has risk level been confirmed by FDA or IRB?
Yes
No
Yes
No
Name and intended use of the NSR device and the objectives of the investigation.
Brief explanation of why the device is not a Significant Risk Device.
Name and address of each investigator
A statement of the extent to which the good manufacturing practice regulation in part 820 will be followed in manufacturing the device.
IRB correspondence regarding this study.
Upload the SR IDE application to FDA
Upload the Investigator Agreement(s)
Are Financial Certifications and Disclosures and form 3454 and 3455 on file as appropriate?
Yes
No
Upload the Annual Progress Report
Thank you submitting your active SR IDE (in effect prior to August 1, 2014)
Please upload the following documents.
FDA IDE application
Invstigator Agreements
Monitoring Plan
Safety Reports
Annual Report
Would you like to upload these as one document or separately?
Upload as one document
Upload Individually
Upload Annual Reports SR IDE
Upload the Investigator Agreement(s)
Please upload all SR IDE documents.
Upload the Monitoring Plan
Upload the FDA IDE Application
What would you like to submit for your current IDE?
A Question
New Investigator
New Protocol
Protocol Amendment
Safety Report
Annual Report
Final Report
FDA Correspondence
General Information
Change in Sponsor
Is the new spoonsor a VCU employee?
Yes
No
Has the VPR approved the transfer of this IDE outside of VCU?
Yes
No
Please upload FDA Correspondence
Please provide general information.
For your new investigator(s) Please upload investigator agreements.
Please upload new IDE protocol
Does this protocol match the protocol with the IRB?
Yes
No
What will you do so that the protocols match?
Please upload Protocol Amendment.
Has this protocol amendment been submitted to the IRB?
Yes
No
Thank you for submitting your new IDE SR Application to the FDA.
Please upload
FDA application
Upload Investigator Agreements
Please upload your monitoring plan
Is this study to be conducted at sites external to VCU?
Yes
No
Please upload your MultiSite Certification Form
Upload any other information regarding your new IDE submission.
Does the protocol submitted to the FDA and the IRB match?
Yes
No
How do you plan to make them match?
Please note any suggestions you have for improving this form.