Thomas Jefferson University

Main menu:

RA 202: Reporting Requirements for the FDA under an IND or IDE

SOP No.: 202     REPORTING REQUIREMENTS FOR THE FDA UNDER AN IND OR IDE
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 Investigators who conduct 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 describes the process and requirements for preparing, distributing and maintaining FDA-required reports on the conduct of FDA-regulated human subject research.

2. GENERAL INSTRUCTIONS AND RESPONSIBILITIES

  1. The Investigator or designee will develop, review and approve FDA-required Progress Reports and Annual Reports.
  2. The designee will label all written reports prominently and clearly with IND or IDE number, protocol number, protocol title, date of report and any other pertinent information for clear report identification Drug/Biologic Study Reporting.

3. SPECIFIC PROCEDURES

3.1 Preparation of Reports

3.1.1 Preparing the Investigational New Drug (IND) Annual Report

In preparing the IND Annual Report, the Investigator will do the following:

  1. Compile all information identified in 21 CFR 312.33 for the IND Annual Report.
  2. Utilize the IND Annual Report Guidelines to write the report (See SOP 202 Attachment A).
  3. Submit the IND Annual Report to the FDA within 60 days of the anniversary of the date the IND was put into effect or approved.
  4. Cease submitting IND Annual Reports when the IND is withdrawn, closed or placed on inactive status.

3.1.2 Preparing the IND Safety Report

In preparing an IND Safety Report, the Investigator will do the following:

  1. Compile and review all available information upon receipt from any sources (e.g., interim study reports, published literature, reports from other investigations) regarding safety and effectiveness of the investigational drug/biologic to ensure timely reporting.
  2. Report all unexpected fatal or life-threatening adverse events associated with the use of the drug/biologic to the FDA by telephone or facsimile within 7 days of the Investigator's becoming aware of the event.  Notify the TJU IRB as specified =OHR POLICY GA120
  3. Notify the FDA, the IRB and all participating Investigators of any relevant information regarding serious or unexpected adverse events associated with the use of the drug/biologic in a written IND Safety Report within 15 days of receiving the information.
  4. Label all such reports prominently as "IND Safety Report."
  5. The Investigator may submit IND Safety Reports using the FDA MedWatch Form 3500A rather than a narrative report (See SOP 202 Attachment D, FDA MedWatch Form 3500A or for an example see http://www.fda.gov/medwatch/SAFETY/3500.pdf).
  6. Notify the FDA, the IRB and all participating Investigators of any animal studies resulting in mutagenicity, teratogenicity, carcinogenicity, serious injury or death within 15 days of receiving the information.
  7. Submit a narrative of any epidemiological or animal study results as part of an IND Safety Report.
  8. For any newly submitted IND Safety Report include a summary of previously filed IND Safety Reports having the same or similar adverse events and include an analysis of the reports to date.
  9. Report the participant's use of any marketed drug(s) when an adverse event occurs that is associated with concomitant use of an investigational drug/biologic.
  10. Promptly investigate all safety information and submit relevant follow-up information to the FDA when available.
  11. For an IND that is placed on clinical hold and/or withdrawn for safety reasons, report the withdrawal and its reason(s) to the FDA, the IRB(s) and all other participating Investigators immediately (within one business day).

3.1.3 Preparing Other Required Reports

  1. To initiate withdrawal of an IND (not withdrawn for safety reasons) submit request to the FDA and notify the IRB and all other participating Investigators.
  2. For any IND placed on inactive status report to the IRB and all other participating Investigators.

3.1.4 Receiving Reports from Other Investigators

The Investigator must receive reports from participating Investigators. The Investigator will require all participating investigators to do the following:

  1. Submit periodic progress reports for preparation of IND Annual Reports.
  2. Report (within 24 hours of discovering the event) all serious or alarming adverse events caused by or probably caused by the drug/biologic to the Investigator and the IRB.
  3. Notify the Investigator and the IRB before deviating from the protocol for any reason or within 24 hours after a deviation has occurred.
  4. Submit a final report of their sites' investigations to the Investigator within 60 days of the site closeout visit.
  5. Inform the Investigator of any relevant financial information via updates to Form FDA 3454 or 3455 (See SOP 105 Attachment A, Form FDA 3454 and SOP 105 Attachment B, Form FDA 3555), or other written reports.

3.2 Device Study Reporting

3.2.1 Preparing Investigational Device Exemption Reports

In preparing the Investigational Device Exemption (IDE) Progress or Annual Reports, the Investigator will do the following:

  1. Review and compile all information from any sources (e.g., interim study reports, published literature, reports from other investigations) regarding safety and effectiveness of the investigational device for use in the preparation of progress or annual reports.
  2. Compile all information necessary from participating Investigators needed for preparing the Progress or Annual Report.
  3. Write the IDE Progress Report (See SOP 202 Attachment B, IDE Progress Report Guidelines).
  4. For significant risk (SR) devices, submit Progress Reports to the FDA at time intervals specified but at least annually. Also submit to the reviewing IRB at time intervals specified.

3.2.2 Preparing IDE Final Report

In preparing IDE Final Reports, the Investigator will do the following:

  1. Notify the FDA within 30 days of the completion or termination of a SR device study.
  2. Submit a Final Report to the IRB, the FDA and all other participating Investigators within 6 months of termination or completion of the significant risk (SR) device study.
  3. Write IDE Final Report (See SOP 202 Attachment C, IDE Final Report Guidelines).

3.2.3 Preparing Required Progress and Final Reports for Non-significant Risk Device (NSR)

Required progress and final reports for non-significant risk (NSR) devices will be prepared by the Investigator as follows:

  1. Submit Progress Reports to the IRB only (not FDA), at time intervals specified by the IRB, but at least annually.
  2. Submit a Final Report to the IRB (but not FDA) within six months of termination or completion of the NSR device study.

3.2.4 Preparing Other Required Reports

For other required reports, the Investigator will do the following:

  1. Submit unanticipated adverse device effect reports (and investigations of reports) to the FDA and the IRB within 10 working days for the first report, or as specified by the FDA.
  2. Report any IRB withdrawal of approval within five (5) working days of the withdrawal to the FDA and all other participating Investigators and the IRB.
  3. Report FDA's withdrawal of IDE approval to the IRB and all participating Investigators within five (5) working days of receiving the FDA notification.
  4. Provide the FDA a current list of participating Investigators every six (6) months after the initiation of a clinical study of a significant risk (SR) device, beginning 6 months after receiving approval of the IDE for the investigation.
  5. Notify the FDA and the IRB of any recall, repair or removal of a device from an investigation within 30 days of request.
  6. Provide the FDA a copy of any Investigator report of an investigational device's use where a participant's informed consent was not obtained, within five (5) working days of learning of the event
  7. Notify FDA of any IRB decision to change a preliminary non-significant risk (NSR) determination made by the Investigator to a significant risk (SR) determination, within five (5) working days of receiving the IRB's decision.

3.2.5 Receiving Reports from Other Investigators

The Investigator must receive reports from participating Investigators. The Investigator will require all participating investigator to do the following:

  1. Notify the IRB on the conclusion of his/her site's investigation, as specified by the IRB's procedures.
  2. Submit a Final Report of his/her site's investigation to the Investigator and the IRB within 3 months of the completion or termination of the study.
  3. Report to the IRB and the Investigator any unanticipated adverse device effect within 10 working days of the effect's occurrence.
  4. Report to the Investigator an IRB's withdrawal of approval within five (5) working days of the withdrawal.
  5. Submit (at least annually) Progress Reports to the Investigator and the site's IRB.
  6. Notify the Investigator and the IRB within five (5) working days of the event, of any deviations from the Investigational Plan (protocol) to protect the life or physical well being of a subject in an emergency.
  7. Notify the Investigator and the IRB as soon as possible of any other deviations from the Investigational Plan (protocol) for any other reason.
  8. Report to the Investigator and the IRB within five (5) working days any investigational device's use where a participant's informed consent was not obtained.
  9. Keep the Investigator informed of any relevant financial information via updates to Form FDA 3454 or 3455, or other written reports.

4. ATTACHMENTS