Current Date* must provide value
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 OnCore up to date with all documents related to this IND or IDE? Yes
No
OnCore Study ID Is this study being conducted at sites external to VCU? Yes
No
Is this submission for an IND or IDE? IND
IDE
IND Number IND Title (Study title if only one protocol). Please be consistent with this for future submissiont to the CRCO.
What are you doing with this submission? Submitting a New IND
Submitting Information on a Current IND
Submitting Concurrence of Exemption or Determination by FDA
Submitting an Expanded Access Application
Submitting an Active IND (PRIOR to August 2014)
Asking a Question
Other
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. ( MB)
Please uplaod FDA concurrence of Exempt Status. ( MB)
What other?
What are you doing with this submission? Submitting a New IDE
Submitting Information on a Current IDE
Asking a Question
Other
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"
What other?
How can we help you? Please briefly state your question. The CRCO will either respond to the email provided or call you 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(s) associated with this IND.
Thank you for submitting your existing (in effect prior to August 1, 2014) IND to the CRCO. These documents should be uploaded. Upload files individually
Upload as one
Files have been uploaded into OnCore
Following this initial submission you will need to submit all new amendments, submissions, correspondence/reports with the FDA to the CRCO.
Please upload the requested documents. (1571, 1572, 3674, CV of PI, Current protocol with the FDA, Last annual report). ( MB)
Upload FDA 1571 ( MB)
Upload 1572(s) ( MB)
Upload 1572(s) ( MB)
Upload FDA 3674 ( MB)
CV of PI ( MB)
Current Protocol with the FDA ( MB)
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. ( MB)
IRB Number for Additional Protocol Effective Date of IND Today M-D-Y This is the date approved by FDA or 30 days from their receipt and acknowledgement.
Expiration Date of IND Today M-D-Y NOTE: Annual Report is due to FDA within 60 days of this date
IRB Number NCT # NCT Number of Second Protocol (If Applicable) 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. ( MB)
Is there any other information you would like to provide about your current IND?
For your current IND, what would you like to submit? General Information
FDA 1571
FDA 1572(s)
FDA 3674
CV of PI
Amendment to the Current IND
Correspondence Regarding the IND
IRB Information Related to the IND
Annual Report
Safety Report
Final Report
Change in Sponsor
Other
IND Number* must provide value
NCT # General Information
Email Address of New Sponsor Has the VPR approved the transfer of the IND to an external Sponsor? Yes
No
Upload your FDA 1571 ( MB)
Upload your FDA 1572(s) ( MB)
Upload your additional FDA 1572 (if needed) ( MB)
Upload FDA 3674 ( MB)
Upload CV of PI ( MB)
Upload Correspondence Regarding the IND ( MB)
Upload IRB Information regarding the Protocol associated with the IND ( MB)
Upload Annual Report ( MB)
Upload Safety Report (or Follow-up Safety Report) ( MB)
Upload Final Report ( MB)
What type of amendment is this? New Protocol
Change in Protocol
New Investigator
Informational
Other
Please upload the full amendment. ( MB)
IRB number NCT number(s) 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. ( MB)
Study Title or IND Name (please be consistent with this) IRB protocol number 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
Who is the Investigator? Is the study(ies) under this IND going to be done at any sites external to VCU domestic facilities? Yes
No
Please complete the mult-site certification form and upload. ( MB)
Please upload the Certification for IND/IDE suitability. ( MB)
Do you have all Certifications/Disclosures of Financial Interest on file for all investigators and FDA form 3454 and 3455 as applicable? Yes
No
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. Are you transfering any sponsor obligations? Yes
No
Please upload the agreement for the transfer of obligations. ( MB)
Are you referring to another IND for portions of your application? Yes
No
Upload the Reference Agreement. ( MB)
Upload Cover Letter ( MB)
Upload Form FDA 1571 ( MB)
Upload Form FDA 1572 ( MB)
Upload Investigator CV ( MB)
Upload Form 3674 ( MB)
Upload Table of Contents ( MB)
Upload Introductory Statement and General Investigational Plan ( MB)
Upload Chemistry, Manufacturing, and Control Information ( MB)
Upload Pharmacology Toxicology Information ( MB)
Upload Please upload Investigator's Brochure ( MB)
Upload Clinical Protocol ( MB)
Upload Additional Clinical Protocols (if applicable) ( MB)
Upload Summary of Previous Human Experience iwth the Investigational New Drug ( MB)
Upload Additional Information, if applicable (ex drug dependence and abuse potential, pediatric studies, etc.) ( MB)
Upload Any Other Relevant Information (if applicable or requested by FDA) ( MB)
IDE Number 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
Name of Investigator Is this a VCU Employee? Yes
No
IRB Number NCT # 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. ( MB)
Final Report to the IRB ( MB)
Are financial certifications/disclosures on all investigators on file as appropriate? Yes
No
Upload the SR IDE application to FDA ( MB)
Upload the Investigator Agreement(s) ( MB)
Are Financial Certifications and Disclosures and form 3454 and 3455 on file as appropriate? Yes
No
Upload Safety Report ( MB)
Upload the Annual Progress Report ( MB)
Upload the Final Report ( MB)
Thank you submitting your active SR IDE (in effect prior to August 1, 2014) Upload as one document
Upload Individually
Upload Annual Reports SR IDE ( MB)
Upload the Investigator Agreement(s) ( MB)
Please upload all SR IDE documents. ( MB)
Upload the Monitoring Plan ( MB)
Upload Safety Report(s) ( MB)
Upload the FDA IDE Application ( MB)
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 ( MB)
Please provide general information.
For your new investigator(s) Please upload investigator agreements. ( MB)
Please upload new IDE protocol ( MB)
IRB Number
NCT Number
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
IDE Number
Upload Safety Report ( MB)
Upload Annual Report ( MB)
Upload Final Report ( MB)
Thank you for submitting your new IDE SR Application to the FDA. ( MB)
Upload Investigator Agreements ( MB)
Please upload your monitoring plan ( MB)
Is this study to be conducted at sites external to VCU? Yes
No
Please upload your MultiSite Certification Form ( MB)
Please up load your Certification of IND/IDE Suitability ( MB)
Upload any other information regarding your new IDE submission. ( MB)
IRB number NCT Number 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.
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