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RA 201: Contacts and Submissions for FDA

SOP No.: 201    CONTACTS AND SUBMISSIONS FOR FDA
Author:    Office of Human Research
Effective Date:  October 1, 2007 Supercedes document dated:              N/A
Last Reviewed on:     N/A                                  Results of Review:               N/A
This SOP pertains to:  All personnel involved in corresponding with FDA and in developing submissions pertaining to FDA-regulated human subject research within the Thomas Jefferson University.
Responsibility for executing this SOP:  Investigator and Designated Research Personnel
Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)

1. PURPOSE

This procedure outlines the process for conducting effective correspondence with the FDA, both oral and written, for conducting meetings with the agency, and for preparing certain formal submissions to the agency.

2. SPECIFIC PROCEDURES

2.1 Oral and Written Correspondence with the FDA

  1. The Investigator should contact the FDA as early as possible to learn the name of the appropriate administrative reviewer (Consumer Safety Officer or CSO) to call with questions and requests concerning correspondence and submissions.
  2. For unique situations (e.g., treatment use of an investigational drug/biologic/medical device, compassionate use of a drug/biologic, humanitarian use of a device), or other situations in which the appropriate FDA review process is uncertain or evolving (combination investigational products, novel or controversial therapeutic products/procedures), the Investigator must contact the OHR and inform of pending submission before proceeding. The OHR can be consulted for advice and support.
  3. The date, time, parties and discussion summary of all oral discussions with the FDA personnel should be recorded on a Telephone Contact Log (See SOP 201 Attachment A).
  4. If the FDA requests a written response in its correspondence, the Investigator must submit replies by the due date or obtain an extension in advance from the agency.
  5. The Investigator must maintain a current and complete Regulatory Master File of FDA correspondence, including copies of all oral contact summaries, electronic mail, and written correspondence. The OHR must have access to all study files as necessary to ensure clinical research compliance.

2.2 Meetings with the FDA

  1. The Investigator should refer to guidelines on setting up and conducting a meeting with the FDA (See SOP 201 Attachment B).
  2. For meetings specified in the FDA regulations and guidance (End-of-Phase 2; pre-NDA, pre-IDE), Investigator should ascertain additional, specific requirements by calling the CSO and asking for further instructions.
  3. All meeting materials and related correspondence must be maintained in the appropriate section of the Regulatory Master File.

2.3 IND Development and Submission

  1. The Investigator should follow the guidance provided for preparing the content of a new IND and for tracking that all required forms and documents are collected (See SOP 201 Attachment C , IND Submission Checklist).
  2. The Investigator should obtain current versions of FDA-required forms by using the instructions in (See SOP 201 Attachment D , Accessing FDA Forms over the Internet).
  3. Before submitting the IND to the FDA, the Investigator must provide the OHR with a full copy of the submission.
  4. The Investigator will maintain a copy of the full IND and all related submission material in the appropriate section of the Regulatory Master File.
  5. The Investigator may proceed with the clinical study with IRB approval and after the receipt of the FDA's IND determination letter that either assigns an IND or grants an exemption from filing the IND.
  6. If the FDA requires additional information prior to granting approval of the IND, the Investigator should provide that additional information within specified timeframes or as soon as possible.
  7. The Investigator should ensure that the IRB reviews and approves changes to the study as required by SOPs (Reference SOP 302, Clinical Protocol Amendments).
  8. The Investigator should file IND amendments as required by the FDA.
  9. The Investigator may not proceed with the change to the IND until it has been submitted to the FDA and approved by the IRB.
  10. If significant safety issues arise during the conduct of a clinical study, the Investigator must ensure that required reporting and notifications to the FDA, the IRB and other applicable internal regulatory groups and other applicable Principal Investigators are carried out as required.
  11. If any regulatory authority (e.g., the FDA, the IRB and the Dean of School) issues a clinical hold, the Investigator may not proceed with the study until all issues identified by the regulatory authority are resolved.
  12. If a clinical hold is issued after the study has begun, the Investigator must cease enrolling new study participants and ascertain how to treat participants currently enrolled (e.g., continue study medication and follow-up, stop study medication etc.).
  13. If the clinical hold letter from the FDA specifies that the study may proceed after certain corrections are made without its prior approval, then the Investigator may proceed with the study after the corrections are put into place. If the terms of the clinical hold require an FDA notification to proceed with the study, then that notification is required to proceed with the study after the terms of the clinical hold are satisfied.
  14. If FDA orders a termination of all or part of the IND, then the Investigator must stop the study and either recall or otherwise arrange for disposal of unused investigational product (Reference SOP 505, Study Closeout Visit).

2.4 IDE Development and Submission

  1. The Investigator should determine whether the investigational medical device is a Significant (SR) or Non-Significant Risk (NSR) device (See SOP 201 Attachment F, Medical Device Risk Determination Form).
  2. The Investigator should check with the OHR and the FDA website (www.fda.gov/cdrh/ or www.fda.gov/cber/) to ascertain whether any device-specific written guidance on content for required submissions already exists.
  3. For NSR devices, a regulatory submission to the FDA may still be required for marketing (See 510(k) notification). The Investigator should contact the FDA CSO to ascertain the best approach to acquiring FDA advice on such submissions, including protocol and clinical data requirements.
  4. If the Investigator determines the investigational device is an SR device, the Investigator should contact the FDA to arrange for possible pre-IDE meetings or other FDA guidance (pre-IDE protocol review).
  5. Once the investigational plan and clinical protocol are approved, the Author should follow the guidance (See SOP 201 Attachment G, IDE Submission Checklist) for preparing the content of the IDE submission and for tracking that all required information is collected for the submission.
  6. Before submitting the IDE to the FDA, the Investigator will provide the OHR with a copy of the complete submission.
  7. Once completed, the Investigator should mail the original IDE and two copies to the address provided in the checklist, using registered mail or an appropriate courier service.
  8. The Investigator will maintain a copy of the full IDE and all related submission material in the appropriate section of the Regulatory Master File.
  9. The Investigator may proceed with the investigational medical device clinical study after the receipt of the FDA's IDE determination letter that assigns an IDE number or grants an exemption from filing the IDE, and the trial is approved By the IRB.
  10. If FDA requires additional information prior to granting approval of the IDE, the Investigator should provide that additional information within specified timeframes or as soon as possible.
  11. Using additional guidance, the Investigator should ascertain when additional information or changes to the study must be reported to the FDA in an IDE supplement (See SOP 201 Attachment H, IDE Supplement Checklist).
  12. The Investigator will ensure that the IRB reviews and approves changes to the study as required by its SOPs (Reference SOP 302, Clinical Protocol Amendments).
  13. The Investigator should file IDE supplements as required by the FDA.
  14. The Investigator may not proceed with the change to the IDE until it has been submitted to the FDA and approved by the IRB.
  15. The Investigator should submit all required IDE reports (Reference SOP 202, Reporting Requirements for the FDA).
  16. If significant safety issues arise during the conduct of a clinical study, the Investigator must ensure that required reporting and notifications to the FDA, the IRB and other applicable individuals or organizations are carried out as required.
  17. If the FDA disapproves an IDE, the Investigator may not proceed with the study until all issues the FDA identifies are resolved and an approval is granted.
  18. If the FDA withdraws an IDE after the study has begun, the Investigator must cease enrolling new study participants and ascertain how to treat participants currently enrolled (e.g., continue study treatment and follow-up, stop study treatment etc.).
  19. If the disapproval letter from the FDA specifies that the study may proceed after certain corrections are made without its prior approval, then the Investigator may proceed with the study after the corrections are put into place.
  20. If the terms of the disapproval letter require a FDA notification to proceed with the study, then that notification is required to proceed with the study after the terms of the disapproval letter are satisfied.
  21. If the FDA orders a termination of all or part of the IDE, then the Investigator must stop the study and either recall or otherwise arrange for disposal of unused investigational product (Reference SOP 505, Study Closeout Visit).

3. ATTACHMENTS

A. Telephone Contact Log

B. FDA Meeting Guidelines

C. IND Submission Checklist

D. Accessing FDA Forms Over the Internet

  • Form FDA 3454 Certification: Financial Interests and Arrangements of Clinical Investigators
  • Form FDA 3455 Disclosure: Financial Interests and Arrangements of Clinical Investigators
  • Form FDA 1571 Investigational New Drug Application (IND)
  • Form FDA 1572 Statement of Investigator
  • Form FDA 3500A MEDWATCH Mandatory Reporting Form

E. IND Amendment Checklist

F. Medical Device Risk Determination Form

G. IDE Submission Checklist

H. IDE Supplement Checklist